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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - vs. Sitagliptin; BRIEF: The purpose of the study is to evaluate the efficacy, tolerability and short-term safety of LIK066 to support dose selection for phase 3. ; DRUG USED: LIK066; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Confirmed diagnosis of T2DM by standard criteria 2. Drug-naïve patients, defined as patients not having received any anti-diabetic medication previously, 3. Currently untreated patients , who, after the diagnosis of T2DM, have received anti-diabetic medication for not more than 12 consecutive weeks, and have not received any anti-diabetic treatment within 12 weeks prior to Visit 1 4. Patients being treated with mono-therapy for at least 8 consecutive weeks prior to Visit 1 with the following OADs: metformin, dipeptidyl peptidase-4 inhibitors (DPP-4i), SU, glinide, alpha-glucosidase inhibitor (AGI) 5. HbA1c ≥ 7 to ≤ 10.5% at Visit 1 for drug-naïve/currently untreated patients 6. HbA1c ≥ 7 to ≤ 9.5% at Visit 1 for patients treated with OAD monotherapy 7. HbA1c ≥ 7 to ≤ 10.5% at Visit 199 for ALL patients 8. Age: ≥18 and ≤ 75 years old at Visit 1 9. BMI ≥22 to ≤45 kg/m2 at Visit 1 Exclusion Criteria: 1. FPG ≥270 mg/dl (15 mmol/L) for drug-naïve/currently untreated patients or ≥240 mg/dl (13.3 mmol/L) for patients on OAD monotherapy at Visit 1 2. Insulin treatment >4 consecutive weeks in the last 6 months, corticosteroid use >7 days in the last 8 weeks, use of growth hormones in the last 6 months, or use of weight control products > 4 weeks in the last 6 months 3. History of acute metabolic complications, CV disease, type 1 diabetes mellitus, hepatic disorders, pancreatitis, chronic diarrhea 4. Significant lab abnormalities such as TSH outside of normal range, UACR>300 mg/g creatinine, eGFR <60 ml/min/1.73m2, hemoglobin <12 g/L in men and <11 g/L in women, hematuria 5. ECG abnormalities including AV block, long QT syndrome or QTc>450 msec for men and >470 msec for women 6. History of malignancy 7. Women of child-bearing potential not using effective methods of contraception Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Change from baseline in glycated hemoglobin (HbA1c) after 12 weeks; SECONDARY OUTCOME 1: Change from baseline in Fasting Plasma Glucose[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - APEKS-cUTI; BRIEF: The purpose of this study was to determine the efficacy and safety of intravenous cefiderocol (S-649266) in hospitalized adults with complicated urinary tract infections caused by Gram-negative pathogens. ; DRUG USED: Fetroja; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Shionogi; CRITERIA: Inclusion Criteria: - Hospitalized male and female patients ≥ 18 years - Clinical diagnosis of either complicated urinary tract infections (cUTI) with or without pyelonephritis or acute uncomplicated pyelonephritis - cUTI diagnosed with a history of ≥ 1 of the following: - Indwelling urinary catheter or recent instrumentation of the urinary tract - Urinary retention (caused by benign prostatic hypertrophy) - Urinary retention of at least 100 mL or more of residual urine after voiding (neurogenic bladder) - Obstructive uropathy - Azotemia caused by intrinsic renal disease (blood urea nitrogen and creatinine values greater than normal laboratory values) OR Pyelonephritis and normal urinary tract anatomy, ie, acute uncomplicated pyelonephritis AND At least 2 of the following signs or symptoms: - Chills or rigors or warmth associated with fever (temperature greater than or equal to 38 degrees Celsius) - Flank pain (pyelonephritis) or suprapubic/pelvic pain (cUTI) - Nausea or vomiting - Dysuria, urinary frequency, or urinary urgency - Costo-vertebral angle tenderness on physical examination AND All subjects had to have urinalysis evidence of pyuria demonstrated by 1 of the following: - Dipstick analysis positive for leukocyte esterase - ≥ 10 white blood cells (WBCs) per μL in unspun urine, or ≥ 10 WBCs per high power field in spun urine - Positive urine culture within 48 hours prior to randomization containing ≥10^5 colony forming unit (CFU)/mL of a Gram-negative uropathogen likely to be susceptible to imipenem (IPM) - Patients who were treated previously with an empiric antibiotic other than the study drugs but failed treatment, both clinically and microbiologically, were eligible for the study if they had an identified Gram-negative uropathogen that was not susceptible to the previously used empiric treatment and likely to be susceptible to IPM - Subjects receiving antibiotic prophylaxis for UTI who present with signs and symptoms consistent with an active new UTI Exclusion Criteria: - Urine culture identifies only a Gram-positive pathogen and/or a Gram-negative uropathogen resistant to IPM - Urine culture at study entry isolates more than 2 uropathogens or patient has a confirmed fungal UTI - Asymptomatic bacteriuria, the presence of >10^5 CFU/mL of a uropathogen and pyuria but without local or systemic symptoms - Patient is receiving hemodialysis or peritoneal dialysis ; PRIMARY OUTCOME: Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Test of Cure; SECONDARY OUTCOME 1: Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Early Assessment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ORION-13; BRIEF: This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C). ; DRUG USED: Leqvio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Homozygous Familial Hypercholesterolemia (HoFH) diagnosed by genetic confirmation - Fasting LDL-C >130 mg/dL (3.4 mmol/L) at screening - On maximally tolerated dose of statin (investigators discretion) with or without other lipid-lowering therapy; stable for ≥ 30 days before screening - Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m2 at screening Exclusion Criteria: - Documented evidence of a null (negative) mutation in both LDLR alleles - Heterozygous familial hypercholesterolemia (HeFH) - Active liver disease - Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome - Major adverse cardiovascular events within 1 month prior to randomization - Previous treatment with monoclonal antibodies directed towards PCSK9 (within 90 days of screening) - Treatment with mipomersen or lomitapide (within 5 months of screening) - Recent and/or planned use of other investigational medicinal products or devices Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Percentage (%) change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 330; SECONDARY OUTCOME 1: Time-adjusted percent change in LDL-C from baseline after Day 90 and up to Day 330[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PA-CL-CHINA-01; BRIEF: This study evaluates the efficacy of PA21 in comparison with sevelamer carbonate (Renvela®) in lowering and maintaining serum phosphorus in adult Chinese subjects with CKD on dialysis after 12 weeks of treatment. ; DRUG USED: Velphoro; DRUG CLASS: Non-NME; INDICATION: Hyperphosphatemia; TARGET: Phosphate; THERAPY: Monotherapy; LEAD SPONSOR: Vifor Fresenius Medical Care Renal Pharma; CRITERIA: Inclusion Criteria: 1. Chinese subjects receiving either maintenance haemodialysis (HD) or peritoneal dialysis (PD) for at least 12 weeks prior to screening. No home HD or nocturnal HD (overnight stay at site) will be allowed 2. Subjects with a history of hyperphosphataemia (HP). 3. Subjects with serum phosphorus levels >5.5 mg/dl (>1.78 mmol/l) at screening or during the washout period. 4. Male and female adult subjects (aged ≥18 years at time of consent). 5. Subjects with the ability to understand the requirements of the study and abide by the study restrictions, and who agree to return for the required assessments (in the Investigators opinion). 6. Subject (or legally acceptable representative) has provided the appropriate written informed consent. Subject must provide written informed consent before any study-specific procedures are performed including screening procedures. Exclusion Criteria: 1. Subjects with intact parathyroid hormone (iPTH) levels >800 ng/l (>800 pg/ml or 88 pmol/l) at screening. Subjects with iPTH >600 ng/l (>600 pg/ml or 66 pmol/l) at screening must be considered stable (in the Investigators opinion). 2. Subjects with planned or expected parathyroidectomy within the next 6 months (in the Investigators opinion). 3. Subjects on peritoneal dialysis (PD) with a history of peritonitis in the last 3 months or ≥3 episodes in the last 12 months. 4. Subjects with serum total calcium >10.5 mg/dl (>2.6 mmol/l) or <7.6 mg/dl (1.9 mmol/l) at screening. 5. Subjects with: - Any history of major gastrointestinal (GI) surgery likely to influence the outcome of treatment with PBs - Clinically significant, active GI disorders (e.g., active peptic ulcer, Crohns disease, colitis ulcerative, irritable bowel syndrome, intestinal motility disorder (symptomatic gastroparesis (during treatment or untreated), intestinal obstruction, moderate/severe constipation (including persistent symptoms with regular use of laxatives or enemas and limitations in activities of daily living), intestinal pseudo-obstruction, megacolon, mechanical obstruction)) or any GI disorders under medical treatment. - Clinically significant, active hepatic disorders or any hepatic disorder under medical treatment 6. Subjects currently with (in the Investigators opinion): - Swallowing difficulties/dysphagia - Estimated life expectancy of less than 12 months - Anticipated renal transplantation during study participation 7. Subjects with known seropositivity to human immunodeficiency virus or positive HIV test at screening. 8. Subjects with active/current fulminant hepatitis B infections and/or hepatitis C virus ribonucleic acid positivity at screening. 9. Subjects with a history of haemochromatosis or other iron accumulation disorders that might lead to iron overload. 10. Subjects with serum ferritin >800 mcg/l (1,797.6 pmol/l) or transferrin saturation (TSAT) >50% at screening. 11. Subjects with raised alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of the normal range at screening. 12. Subject is taking any prohibited medication(s) which cannot be stopped at least one week before study treatment start. Prohibited medications include: oral calcium supplements, any drugs/agents having a phosphate binding action that contain aluminium, magnesium or calcium (apart from hyperkalaemia drugs), phosphate binders in addition to sevelamer carbonate), nicotinamide, oral iron products, oral vitamins containing iron and other oral iron containing supplements (See Section 7.7). 13. Subject has known hypersensitivity and/or intolerance to any of the study products to be administered. 14. Subject has previously been randomised into this study. 15. Subject is currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening, or is receiving other investigational agent(s). 16. Subjects who are pregnant (e.g., positive human chorionic gonadotropin test) or breastfeeding. 17. Subjects of childbearing potential, not using adequate contraceptive precautions must agree to use a highly effective method of birth control during the study and for 1 month after the last dose of study medication. 18. Subject has a history of drug or alcohol abuse within 2 years prior to screening. 19. Subject has a significant medical conditions or anticipated need for major surgery during the study, which (in the Investigators opinion), may be associated with increased risk to the subject, or may interfere with study assessments or outcomes, or the ability to provide informed consent or comply with study procedures. ; PRIMARY OUTCOME: Serum phosphorus (mmol/l ); SECONDARY OUTCOME 1: Serum phosphorus (mmol/l )[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Acute Anterior Uveitis; BRIEF: The purpose of the study is to determine whether topical ocular administration of LME636 60 mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber (AC) associated with acute anterior uveitis (AAU). ; DRUG USED: OCS-02; DRUG CLASS: Non-NME; INDICATION: Uveitis (Ophthalmology); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Alcon Research; CRITERIA: Inclusion Criteria: - Provide written informed consent. - Diagnosis of non-infectious AAU in at least 1 eye. - Anterior chamber cell score of 2+ or 3+ as per Standardization of Uveitis Nomenclature (SUN) in at least one eye. - Able to communicate well with the Investigator, to understand and comply with the requirements of the study. - Other protocol-specified inclusion criteria may apply. Exclusion Criteria: - Women of child-bearing potential unwilling to use effective contraception methods as defined in the protocol. - AC cell score of 4+ (SUN) or hypopyon. - Onset of anterior uveitis more than 2 weeks prior to enrollment in the study. - Presence of intermediate-, posterior-, or panuveitis in either eye. - Administration of stable doses >10 mg daily systemic prednisone or corticosteroids as described in the protocol. - Recurrent corneal abrasion or ulceration in either eye (past or present). - Tuberculosis (past or present). - Other protocol-specified exclusion criteria may apply. ; PRIMARY OUTCOME: Number of Responders at Day 15; SECONDARY OUTCOME 1: Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - Monotherapy (SC); BRIEF: The primary objective of this study is: - To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA). The secondary objectives of this study are: - To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061 and to explore potential dose regimens for ALX-0061 monotherapy, based on safety and efficacy, for further clinical development. - To obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (TCZ) s.c. in the same clinical trial RA population. ; DRUG USED: Vobarilizumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 Receptor (IL-6R); THERAPY: Monotherapy; LEAD SPONSOR: Ablynx, a Sanofi company; CRITERIA: Inclusion Criteria: - Diagnosis of RA (according to the 2010 EULAR/American College of Rheumatology (ACR) classification criteria) for at least 6 months prior to screening, and ACR functional class I-III. - Received previous or current treatment with methotrexate (MTX), and is considered intolerant to MTX, or for whom continued treatment with MTX is inappropriate or has contraindications for MTX use. - Subjects must not have received MTX for at least 4 weeks before first administration of the study drug. - Have active RA with at least 6 swollen and 6 tender joints(66/68 joint count) at the time of screening and baseline - Others as defined in the protocol Exclusion Criteria: - Have been treated with DMARDs (Disease Modifying Antirheumatic Drugs)/systemic immunosuppressive drugs during the 4 weeks, or 12 weeks for hydroxychloroquine, chloroquine, or leflunomide (except when an adequate wash-out procedure for leflunomide was completed), prior to first administration of study drug. - Have received approved or investigational biological or targeted synthetic DMARD therapies for RA (including tumor necrosis factor alpha-inhibitors, abatacept, rituximab, or Janus kinase [JAK]-inhibitors) less than 6 months prior to screening. - Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs (including JAK inhibitors), for RA. - Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time. - Others as defined in the protocol. ; PRIMARY OUTCOME: Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12; SECONDARY OUTCOME 1: Number and Percentage of Subjects With ACR50 and ACR70 Response at Week 12[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Japan; BRIEF: The purpose of this study is to determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with uterine fibroids. ; DRUG USED: Orgovyx; DRUG CLASS: New Molecular Entity (NME); INDICATION: Uterine Fibroids; TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. The participant has been diagnosed with uterine fibroids and has never received surgical treatment for the myoma. 2. The participant is a premenopausal woman. 3. The participant has one or more measurable noncalcified myomas confirmed by transvaginal sonography. 4. The participant has experienced regular menstrual cycles 5. The participant is diagnosed as menorrhagia Exclusion Criteria: 1. Participants with a screening Hb <8 g/dL 2. Participants with a previous or current history of blood disorders 3. Participants with a known history of severe hypersensitivity or severe allergy to sanitary goods 4. Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis 5. Participants with a previous or current history of thyroid dysfunction 6. Participants with a previous or current history of pelvic inflammatory disease 7. Participants with a positive PAP smear test result 8. Participants with a history of panhysterectomy or bilateral oophorectomy 9. Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding 10. Participants with a previous or current history of a malignant tumor 11. Participants who have been treated with any of the following drugs: anticoagulant drug, antiplatelet drug, tranexamic acid, selective estrogen receptor modulator (SERM), activated vitamin D, other vitamin D, calcitonin, ipriflavone, steroid hormone, vitamin K, teriparatide, or denosumab 12. Participants who have been treated with any of the following drugs: oral contraceptive and sex hormone preparation, gonadotropin-releasing hormone (GnRH) analogue, dienogest, danazol, or aromatase inhibitor 13. Participants who have been treated with a bisphosphonate preparation 14. Participants with a previous or current history of severe hypersensitivity or severe allergy to drugs 15. Participants with non-diagnosable abnormal genital bleeding 16. Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases 17. Participants with clinically significant cardiovascular disease or uncontrollable hypertension 18. Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings 19. Participants with active liver disease or jaundice, or with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin > 1.5 times the upper limit of normal (ULN) ; PRIMARY OUTCOME: Decrease in menstrual blood loss; SECONDARY OUTCOME 1: Decrease in menstrual blood loss[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - LATITUDE w/Prednisone & ADT; BRIEF: The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration). ; DRUG USED: Zytiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Cytochrome P450c17; THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Newly diagnosed metastatic prostate cancer within 3 months prior to randomization with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology - Distant metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan - At least 2 of the following high-risk prognostic factors: Gleason score of greater than or equal to (>=8); presence of 3 or more lesions on bone scan; presence of measurable visceral (excluding lymph node disease) metastasis on CT or MRI Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 scan - Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2 - Adequate hematologic, hepatic, and renal function - Agrees to protocol-defined use of effective contraception Exclusion Criteria: - Active infection or other medical condition that would make prednisone use contraindicated - Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 mg prednisone per day - Pathological finding consistent with small cell carcinoma of the prostate - Known brain metastasis - Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer (the following exception are permitted): up to 3 months of androgen deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or antagonists or orchiectomy with or without concurrent anti-androgens prior Cycle 1 Day 1; participants may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 28 days prior to Cycle 1 Day 1) ; PRIMARY OUTCOME: Radiographic Progression-Free Survival (PFS); SECONDARY OUTCOME 1: Time to Initiation of Chemotherapy[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ZONDA (Oral CS Reducing); BRIEF: The purpose of this trial is to confirm if benralizumab can reduce the use of maintenance OCS in systemic corticosteroid dependent patients with severe refractory asthma with elevated eosinophils. ; DRUG USED: Fasenra; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Female and male aged from 18 to 75 years, inclusively. 3. History of physician-diagnosed asthma requiring treatment with medium dose ICS and LABA. 4. Elevated level of peripheral blood eosinophil 5. Documented treatment with high-dose ICS and LABA for at least 6 months prior to Visit 1 6. Chronic oral corticosteroid therapy for at least 6 continuous months directly preceding Visit 1. Subjects must be on doses equivalent to 7.5 - 40 mg/day of prednisolone/prednisone at Visit 1 and be on a stable dose for at least 2 weeks prior to randomization. Patients must agree to switch to study required prednisone/prednisolone as their oral corticosteroid for the duration of the study. 7. Patients with documented failures of OCS reduction within 6 months prior to Visit 1 will not be required to proceed through the dose optimization phase during run-in. 8. Morning pre-bronchodilator (Pre-BD) FEV1 of <80% predicted 9. Evidence of asthma as documented by either: Airway reversibility (FEV1 ≥12% and 200 mL) demonstrated at Visit 1, Visit 2, or Visit 3 using the Maximum Post-bronchodilator Procedure OR Documented reversibility in the previous 24 months prior to Visit 1 OR Airway hyperresponsiveness (PC20 FEV1 methacholine concentration ≤8mg/mL) documented in the previous 12 months prior to planned date of randomization OR Airflow variability in clinic FEV1 ≥20% between 2 consecutive clinic visits documented in the 12 months prior to the planned date of randomization (FEV1 recorded during an exacerbation should not be considered for this criterion). All patients must have reversibility testing performed before randomization to establish a baseline characteristic. If patients do not demonstrate airway reversibility at either Visit 1 or Visit 2 and this is needed to qualify the patient for randomization, the site should reiterate the need to withhold short- and long-acting bronchodilators prior to Visit 3 in an effort to meet this inclusion criterion. 10. At least 1 documented asthma exacerbation in the previous 12 months prior to the date informed consent is obtained 11. Optimized OCS dose reached at least 2 weeks prior to randomization 12. Additional asthma controller medication must not have been initiated during run in/optimization period (not applicable for management of exacerbations during screening/ run in optimization phase) 13. At least 70% compliance with OCS use 14. At least 70% compliance with usual asthma controller ICS-LABA 15. Minimum 70% (i.e. 10 of 14 days) compliance with asthma daily diary (morning and evening diary) Exclusion criteria: 1. Clinically important pulmonary disease other than asthma or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts. 2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: - Affect the safety of the patient throughout the study - Influence the findings of the studies or their interpretations - Impede the patients ability to complete the entire duration of study 3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period 4. Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during run-in/optimization period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patients ability to complete entire duration of the study 5. History of life-threatening asthma 6. Asthma control reached at an OCS dose of ≤5mg during run-in/OCS optimization phase 7. Qualifies for 3 consecutive dose reductions at Visits 2-4 and continues to meet OCS dose reduction criteria at Visit 5 8. Receipt of oral corticosteroids, other than prednisone or prednisolone, as the maintenance oral steroid controller for asthma symptoms from Visit 1 and throughout the study. 9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.5 times the upper limit of normal (ULN) confirmed during screening period ; PRIMARY OUTCOME: Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control; SECONDARY OUTCOME 1: Number and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma Control[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - TEAM - vs. Dacarbazine; BRIEF: The purpose of this study is to determine whether nilotinib is efficacious in the treatment of metastatic and/or inoperable melanoma harboring a c-Kit mutation. ; DRUG USED: Tasigna; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: BCR-ABL Fusion Protein, KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Histologically confirmed mucosal or acral 2. Presence of a c-Kit mutation of exon 9, 11 or 13, or mutations Y822D and mutations D820Y, Y823D of exon 17, as confirmed by the central laboratory 3. Stage III unresectable or stage IV disease 4. The presence of one or more measurable lesions as detected by radiological or photographic methods and assessed according to RECIST 1.0. Lesions must have a size of at least 10mm at longest diameter (using a slice thickness of 5 mm)or double the slice thickness to be considered a target lesion. Target lesions should not be selected in previously irradiated fields unless there is clear evidence of progression 5. WHO performance status 0 - 2 Exclusion Criteria: 1. C-Kit mutation of exons 17(except mutations D820Y, Y822D or Y823D) or any other exon not allowed by the inclusion criteria 2. Patients with c-Kit amplifications only and no mutation 3. Patients with any history of brain metastases 4. Patients who have had any prior treatment with TKIs 5. Patients receiving medications or herbal extracts which interfere with nilotinib metabolism which are not discontinued by the time of the baseline visit 6. Acute or chronic liver or renal disease considered unrelated to melanoma Other protocol-defined inclusion/exclusion criteria may have applied. ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: Durable Overall Response Rate (DORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - MRI Endpoints; BRIEF: Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imaging, x-rays and by standard clinical assessment. ; DRUG USED: Xeljanz/Xeljanz XR; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Adult patients with moderate to severe early rheumatoid arthritis (< 2 years) who are methotrexate and biologic disease modifying antirheumatic drug naive. Exclusion Criteria: - Pregnant or lactating patients; - Patients with renal or hepatic impairment or other severe or progressing disease; - Patients with contraindication to magnetic resonance imaging with gadolinium contrast. ; PRIMARY OUTCOME: Change From Baseline to Month 3 in Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Wrist and Metacarpophalangeal (MCP) Synovitis; SECONDARY OUTCOME 1: Change From Baseline to Months 1, 6, and 12 in OMERACT RAMRIS Wrist and MCP Synovitis[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - LIMBER-313 (w/Ruxolitinib); BRIEF: The purpose of the study is to compare the efficacy of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis. ; DRUG USED: Parsaclisib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelofibrosis (MF); TARGET: p110 delta/PIK3CD; THERAPY: Combination; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Diagnosis of PMF, PPV-MF, or PET-MF. - DIPSS risk category of intermediate-1, intermediate-2, or high. - Palpable spleen of ≥ 5 cm below the left costal margin on physical examination at the screening visit. - Active symptoms of MF at the screening visit, as demonstrated by the presence of a TSS of ≥ 10 using the Screening Symptom Form. - Participants with an ECOG performance status score of 0, 1, or 2. - Screening bone marrow biopsy specimen and pathology report(s) available that was obtained within the prior 2 months or willingness to undergo a bone marrow biopsy at screening/baseline; willingness to undergo bone marrow biopsy at Week 24 and every 24 weeks there after. Screening/baseline biopsy specimen must show diagnosis of MF. - Life expectancy of at least 24 weeks. - Willingness to avoid pregnancy or fathering children. Exclusion Criteria: - Prior use of any JAK inhibitor. - Prior therapy with any drug that inhibits PI3K (examples of drugs targeting this pathway include but are not limited to INCB040093, idelalisib, duvelisib, buparlisib, copanlisib, and umbralisib). - Use of experimental drug therapy for MF or any other standard drug (eg, danazol, hydroxyurea) used for MF within 3 months of starting study drug and/or lack of recovery from all toxicities from previous therapy to ≤ Grade 1. - Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications. - Recent history of inadequate bone marrow reserve. - Inadequate liver and renal function at screening. - Active bacterial, fungal, parasitic, or viral infection that requires therapy. - Active HBV or HCV infection that requires treatment or at risk for HBV reactivation. - Known HIV infection. - Uncontrolled, severe, or unstable cardiac disease that in the investigators opinion may jeopardize the safety of the participant or compliance with the Protocol. - Active invasive malignancy over the previous 2 years. - Splenic irradiation within 6 months before receiving the first dose of study drug. - Concurrent use of any prohibited medications. - Active alcohol or drug addiction that would interfere with the ability to comply with the study requirements. - Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half lives(whichever is longer) before the first dose of study drug or anticipated during the study. - Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy. - Currently breastfeeding or pregnant. - Any condition that would, in the investigators judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. - History of Grade 3 or 4 irAEs from prior immunotherapy. - Receipt of any live vaccine within 30 days of the first dose of study drug ; PRIMARY OUTCOME: Proportion of participants achieving targeted reduction in spleen volume; SECONDARY OUTCOME 1: Proportion of participants who have a targeted reduction in Total Symptom Score (TSS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Non-Metastatic; BRIEF: This is a study of how one or more injections of HSP-130 under the skin effect the white blood cell counts and drug levels in women with breast cancer that has not spread to distant sites in the body (non-metastatic). This will be studied in women before breast surgery or while receiving chemotherapy. Safety will also be studied. Additionally, the purpose of this study is to evaluate the effects and safety of single and multiple doses of HSP-130 in subjects with non-metastatic breast cancer. This study will determine the dose to move forward for future clinical trials. ; DRUG USED: Nyvepria; DRUG CLASS: Biosimilar; INDICATION: Breast Cancer; TARGET: Granulocyte-colony Stimulating Factor (G-CSFR)/CD114; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - A subject will be eligible for study participation if all of the following criteria are met at Screening: 1. Is informed, has been given ample time and opportunity to read about participation in the study and has signed and dated the written informed consent form approved by an Independent Ethics committee (IEC) prior to any study related activities 2. Females ≥ 18 years 3. Histologically confirmed and documented invasive breast cancer 4. Breast cancer without evidence of distant metastases (Stage 4) based on staging work-up 5. Chemotherapy naive, who have not received chemotherapy in the neoadjuvant setting and who are candidates for chemotherapy in the adjuvant setting of taxane/cyclophosphamide-based regimen, e.g., TAC, as background chemotherapy 6. Zubrod/WHO/ECOG performance status ≤ 2 7. Adequate bone marrow, hepatic, and renal function reserve as evidenced by: 1. Hemoglobin ≥ 10 mg/dl 2. ANC ≥ 1.5 x 10^9/L 3. Platelet count of ≥ 100 x 10^9/L 4. Total bilirubin ≤ 2 mg/dl 5. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 x the upper limit of normal (ULN) of the reference lab 6. Serum creatinine of ≤ 1.5 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of ≥ 60 mg/min 8. Body mass index (BMI) of 19 to 40 kg/m^2 , inclusive 9. Subjects of childbearing potential, and their partners, agree to pregnancy prevention throughout the duration of the study (through the Follow-up Visit). Specific type of pregnancy prevention should be discussed with, and acceptable to, the treating oncologist in the context of the tumoral hormone receptor status. Subjects and their partners must agree to use of an effective method of contraception, to avoid impregnation of females throughout the course of the study Medically acceptable forms of birth control can include, with approval of the treating physician: 1. Barrier methods (condom or diaphragm with spermicide) 2. Intrauterine device (IUD) 3. Hormone contraceptives (such as oral [pill], injection, skin patch, implant, cervical ring) 4. Subjects using oral contraceptives must be on a stable regimen for at least 3 months prior to Screening. Sexually active subjects must use contraception while on HSP-130 from admission to the final Follow-up Visit 10. Able to understand verbal or written instructions and comply with all study requirements, to communicate effectively with study personnel and is available for the planned duration of the study Exclusion Criteria: - A subject will NOT be eligible for study participation if any of the following criteria are met at Screening: 1. Previous G-CSF exposure, including filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim, granulocyte/macrophage colony stimulating growth factor (GM-CSF), or any other branded or biosimilar G-CSF 2. Prior autologous stem cell harvest of any type 3. Drug sensitivity, allergic reaction, or known hypersensitivity or idiosyncratic reaction to E. coli - derived proteins, filgrastim, other G-CSFs, or pegylated agents 4. Known hypersensitivity to docetaxel, polysorbate 80, or doxorubicin 5. For subjects receiving doxorubicin, no concurrent use of inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp or with trastuzumab due to increased risk of cardiac dysfunction 6. Chemotherapy other than that included in this study (taxane/cyclophosphamide-based regimen, e.g., TAC or TC) or neoadjuvant chemotherapy; or known immunosuppressive agents including chronic oral corticosteroid use, or radiation therapy within 4 weeks of first dose of HSP-130, prior bone marrow or stem cell transplantation, or malignancy within 5 years 7. Known HER2 + ( overexpressing breast cancer) 8. Known triple negative (estrogen receptor-negative, progesterone receptor-negative and HER2-negative) breast cancer 9. ≥ Grade 2 underlying neuropathy 10. Current diagnosis of active tuberculosis or other severe infection, such as sepsis, abscesses or opportunistic infections 11. Treatment with systemically active antibiotics within 72 hours before chemotherapy 12. Known infection with HIV 13. Known sickle cell disease 14. Known severe persistent drug-induced myelosuppression 15. New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina, clinically significant ECG abnormalities) or MI within the previous 6 months before the first administration of HSP-130 16. Any malignancy other than breast cancer, with exception of adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ, within 5 years before the first administration of the HSP-130 17. Current or recent treatment (within 30 days before the first administration of the HSP-130) with any other investigational medicinal product 18. Pregnancy or lactation; Subjects planning to be pregnant or to breastfeed before, during, or within 12 months after administration of the HSP-130 are not permitted to enroll in the study 19. Received a live, live-attenuated, or non-live vaccine within 4 weeks before the first administration of the HSP-130 20. Patient has evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, physical examination finding or clinical lab finding giving reasonable suspicion of a disease or condition that contraindicated the use of an HSP-130, or patient is high risk for treatment complication ; PRIMARY OUTCOME: Area Under the Effect Curve for Absolute Neutrophil Count (AUECANC): Cycle 0; SECONDARY OUTCOME 1: Maximum Effect for Absolute Neutrophil Count (ANC_Emax): Cycle 0[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Mild to Moderate AD; BRIEF: This is a Phase I clinical study to assess the safety, tolerability and biologic activity of in vivo AAV-mediated delivery of CERE-110. Up to 12 subjects will receive open label CERE-110 in dose-escalating fashion. All subjects will receive bilateral, stereotactic injections of CERE-110 for a total of four (Dose A and B) and six (Dose C) injections to target the basal forebrain region of the brain containing the nucleus basalis of Meynert (NBM). All study participants will be observed for a 24-month period and then followed annually. ; DRUG USED: CERE-110; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Nerve growth factor (NGF)/receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sangamo Therapeutics; CRITERIA: Inclusion Criteria: - Alzheimers disease as determined by NINCDS/ADRDA criteria. - Score of ≤ 4 on a modified Hachinski Ischemia Scale - Mini-Mental State Exam (MMSE) score in the range of 16 to 28, inclusive - No significant neurological or medical abnormalities contraindicating surgery, MRI/PET imaging or study participation - Subjects stable on standard-of-care medications (i.e., acetylcholinesterase inhibitors) for Alzheimers disease for 3 months prior to entry - A Hamilton Depression Scale score of ≤ 12 on a 17-item scale and no history of major depressive episode within the last 2 years - A score of < 15 on the Beck Depression Inventory - Adequate visual and auditory acuity to allow neuropsychological testing - Good health with no clinically significant medical or psychological conditions - An MRI of the head at screen that is negative for evidence of infection, tumor, infarction or other focal (e.g., subdural hematoma) or generalized lesions(e.g., v hydrocephalus) and without clinical symptoms suggestive of intervening neurological disease - Normal serum B12, thyroid function tests, and negative syphilis antibody test - The informed consent document must be signed by both: a competent and willing subject, and a surrogate identified by the participant, or a legally authorized power of attorney for Health Care, or a family member Exclusion Criteria: - History of cancer within the last five years, except superficial basal or squamous cell skin cancer or cervical carcinoma in situ - History of alcohol abuse or dependence within the last two years - Liver serum transaminases (AST and/or ALT) > 5 times the upper limit of normal; total and/or direct bilirubin > 1.5 mg/dL, hemoglobin < 9mg/dL; PT and PTT > 2 times the upper limit of normal; creatinine clearance < 30 mL/min; positive serology for HBV or HCV; absolute neutrophil count < 1,500 cells/mm3 and a platelet count < 100,000/mm3 - Any significant systemic illness, unstable or severe medical condition(s) that could put the subject at risk during the study, interfere with outcome measures or affect compliance with the protocol procedures - Centrally active beta-blockers, anti-Parkinsonian medications, psychostimulants, antipsychotics, neuroleptics, or narcotic analgesics, long-acting benzodiazepines or barbiturates, hypertensive agents with a CNS effect, short-acting anxiolytics or sedative hypnotics more frequently than two times per week within 14 days of screening, herbal products for Alzheimers disease, antidepressants with significant cholinergic side effects (e.g., tricyclics), initiation or change in dose of standard treatment for Alzheimers disease - Other medication with significant cholinergic or anticholinergic side effects - Warfarin (coumadin), nonsteroidal anti-inflammatory drugs, aspirin, Prozac, or Ginkgo biloba within 14 days of surgery - Subjects who have received investigational agents or been exposed to investigational devices for 30 days prior to enrollment - Subjects with a history of receiving gene transfer products of any kind - Subjects who cannot undergo MRI or PET screening ; PRIMARY OUTCOME: Safety and tolerability of three different doses of CERE-110 in subjects with mild to moderate Alzheimers disease; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - IRIS-2 (EU); BRIEF: Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of the neurokinin type 2 receptor antagonist Ibodutant in improving IBS-D symptoms. ; DRUG USED: MEN-15596; DRUG CLASS: New Molecular Entity (NME); INDICATION: Irritable Bowel Syndrome (IBS); TARGET: Neurokinin Receptor, Tachykinins; THERAPY: Monotherapy; LEAD SPONSOR: Menarini Group; CRITERIA: Inclusion Criteria: At start of the run-in period: - Male or female patients aged 18 - 70 years with a clinical diagnosis of IBS-D according to the Rome III criteria: - Recurrent abdominal pain/discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: 1. improvement with defecation; 2. onset associated with a change in the frequency of stool; 3. onset associated with a change in form (appearance) of stool. - Symptom-onset at least 6 months prior to diagnosis. - Loose/watery stools at least 25% of the time in the last 3 months AND hard/lumpy stools less than 25% of the time in the last 3 months. - More than 3 bowel movements per day at least 25% of the time in the last 3 months. - For patients older than 50 years OR patients with positive family history of colorectal cancer: Normal results from colonoscopy or flexible sigmoidoscopy. - Mentally competent, able to give written informed consent. - For women of childbearing potential: Use of a highly effective contraceptive method throughout the entire study period and up to 30 days post-treatment. - Normal physical examination or without clinically relevant abnormalities. At randomisation: -Confirmation of IBS-D severity in terms of bowel movement frequency and abdominal pain intensity along the 2-week run-in period. Exclusion criteria: - Organic abnormalities of the gastrointestinal tract, including history of colonic or major abdominal surgery. - History of gluten enteropathy. - Lactose intolerance as assessed by response to diet. - History of positive tests for ova or parasites, or occult blood in the stool. - Previous diagnosis of diabetes mellitus (either type 1 or 2). - Unstable medical condition. - Major psychiatric, neurological, or cardiovascular disorders, or uncontrolled metabolic disease. - Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months. - Use of concurrent medication with drugs known to interfere with gastro-intestinal motility or sensitivity. - Pregnancy or breastfeeding. ; PRIMARY OUTCOME: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT).; SECONDARY OUTCOME 1: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - PT019; BRIEF: This is a 73-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe plaque psoriasis. Ten (10) subjects will receive 200 mg of RA-18C3 via subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of 3 injections. Study drug will be administered under close observation in a facility equipped to handle medical emergencies. Subjects will not be discharged from the facility until at least 1 hour following the end of the injection or 1 hour after their vital signs have stabilized. Safety will be assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and the recording of adverse clinical events. ; DRUG USED: Bermekimab; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-1 (Interleukin-1); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: 1. Subjects 18 years of age or older 2. Diagnosis of plaque psoriasis for ≥ 6 months; INCLUDING subjects with chronic guttate lesions. 3. Psoriasis area-and-severity index (PASI) score of ≥ 12 4. Involvement of ≥ 5% of body-surface area 5. For female subjects of childbearing age, a negative urine pregnancy test at screening and at specified time points throughout the trial. For subjects with reproductive potential, a willingness to utilize adequate, double barrier contraception during the study and including 3 months after study completion. Sexually active men must use an accepted method of contraception during the study and including 3 months after study completion. 6. Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed Exclusion Criteria: 1. Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer). 2. Treatment with conventional systemic psoriasis therapy within last 4 weeks 3. Treatment with phototherapy within the last 4 weeks 4. Topical psoriasis treatment with the last 2 weeks 5. History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months), ongoing congestive heart failure, and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol. 6. Hemoglobin <10.0 g/dL, WBC <3.0 x 103/mm3, platelet count <125 x 103/mm3, creatinine > 1.5mg/dL, AST/ALT >2 x ULN, alkaline phosphatase >2 x ULN 7. Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody. 8. History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin. 9. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. 10. History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA) 11. Infectious disease: CRP >30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening 12. Immunodeficiency 13. History of treatment with Tysabri or Raptiva 14. Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding 15. Receipt of a live (attenuated) vaccine within 3 months prior to Screening 16. Major surgery within 28 days prior to Day 0 17. Participation in an investigational drug or device trial within 30 days prior to Screening ; PRIMARY OUTCOME: Safety and Tolerability; SECONDARY OUTCOME 1: RA-18C3 Pharmacokinetics[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IMAgINE 2 Ext. Study; BRIEF: This was a multicenter, open-label study to evaluate the human monoclonal anti-TNF-α antibody adalimumab as an effective therapy for maintaining clinical response in pediatric participants with Crohns disease (CD) and to gather long-term safety and tolerability data in this population. Participants were allowed to enroll in the study if they participated in and successfully completed Study M06-806 (NCT00409682) through Week 52. ; DRUG USED: Humira; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: - Participant must have successfully enrolled in and completed Study M06-806 through Week 52. - Participant must have been a responder at any time point during the M06-806 study (defined as having achieved at least a 15-point reduction in the Pediatric Crohns Disease Activity Index (PCDAI) from Baseline). - If female, participants who were sexually active and of child-bearing potential were to be practicing an approved method of birth control throughout the study and for 150 days after study drug administration. Examples of approved methods of birth control included the following: 1. Condoms, sponge, foam, jellies, diaphragm or intrauterine device (IUD) 2. Oral, parenteral or intravaginal contraceptives 3. A vasectomized partner - Participant of legal age, parent or legal guardian, as required, voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form, after the nature of the study was explained and the participant of legal age, participants parent, or legal guardian, as required, had the opportunity to ask questions. Participants were to be included in all discussions, and if required, their signature on an assent form was to be obtained. - Parent or legal guardian of participant who was not of legal age, as required, must have been willing to actively supervise storage and administration of study drug and to ensure that the time of each dose was accurately recorded in the participants diary. - Participants of legal age, must have been willing to actively store, administer, and accurately record study drug administration in the participant diary. - Participant was judged to be in acceptable medical condition, as determined by the Principal Investigator based upon results of clinical and laboratory evaluations done throughout the preceding Crohns disease study M06-806. Exclusion Criteria: - For any reason, the participant was considered by the Investigator to be an unsuitable candidate for continuing therapy in the M06-807 study. - Participant had abnormal laboratory or other test results that in the opinion of the Investigator would make the participant unsuitable to participate in this study. - History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma in-situ of the cervix. - History of listeriosis, histoplasmosis, chronic or active hepatitis B infection, human immunodeficiency virus (HIV) infection, any immunodeficiency syndrome, central nervous system (CNS) demyelinating disease or active TB (receiving treatment or not receiving treatment). Ongoing severe infections such as sepsis and opportunistic infections were exclusionary. - Participant with known, symptomatic obstructive strictures. - Participant who was planning surgical bowel resection at any time point while enrolled in the study. - Participant who had short bowel syndrome as determined by the Investigator. - Participant who was receiving total parenteral nutrition (TPN). - Participant who was unwilling to discontinue growth hormone prior to the first dose of open-label study drug at the Baseline visit of M06-807. - Female participant who was pregnant or currently breastfeeding. - Participant with a history of clinically significant drug or alcohol abuse in the last year. - Participant with a poorly controlled medical condition such as: uncontrolled diabetes, recurrent infections, unstable ischemic heart disease, moderate to severe heart failure, recent cerebrovascular accidents or any other condition which, in the opinion of the Investigator or the Sponsor, would put the participant at risk by participation in the protocol. - Participant with any prior exposure to Tysabri (natalizumab). - Participant with a known hypersensitivity to the excipients of adalimumab as stated in the label. - Participant with a previous history of dysplasia of the gastrointestinal tract. ; PRIMARY OUTCOME: Number of Participants Who Achieved Pediatric Crohns Disease Activity Index (PCDAI) Clinical Remission Over Time; SECONDARY OUTCOME 1: Number of Participants Who Were in Crohns Disease Activity Index (CDAI) Clinical Remission Over Time[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Chemotherapy (Platinum-Resistant, TP-53-Mutated); BRIEF: Adavosertib in combination with carboplatin, paclitaxel, gemcitabine, or PLD. ; DRUG USED: AZD1775; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Tyrosine Kinases, Wee1 Inhibitor ; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion - Has read and understands the informed consent form (ICF) and has given written IC prior to any study specific procedures. - Histologic or cytologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer. - Progressed within 6 months of completing at least 4 cycles of a first-line platinum-containing regimen for Stage III/IV disease. Patients with refractory disease (progression during platinum-containing therapy) are ineligible. - No more than 2-4 prior treatment regimens for Stage III/IV disease, defined as investigational, chemotherapy, hormonal, biologic, or targeted therapy. - Prior doxorubicin (or other anthracycline) at a cumulative dose of ≤ 360 mg/m² or cumulative epirubicin dose of ≤ 720 mg/m² (calculated using doxorubicin equivalent doses: 1 mg of doxorubicin = 1 mg PLD = 0.3 mg mitoxantrone = 0.25 mg idarubicin). Subjects without any prior anthracycline exposure can also be included. Applies to Arm D only. - At least 1 measurable lesion according to RECIST v1.1. - Any prior palliative radiation therapy must be completed at least 7 days prior to start of study treatment and patients must have recovered from any acute adverse effects prior to start of study treatment. - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 - 1. - Baseline Laboratory Values: 1. ANC ≥1500/μL 2. HgB ≥ 9 g/dL with no blood transfusions in the past 28 days 3. Platelets ≥ 100,000/μL 4. ALT & AST ≤3 x ULN or ≤5 x ULN if known hepatic metastases 5. Serum bilirubin within normal limits (WNL) or ≤1.5 x the ULN in patients with liver metastases; or total bilirubin ≤3.0 x ULN with direct bilirubin WNL in patients with well documented Gilberts Syndrome. 6. Serum creatinine ≤1.5 x the ULN and a calculated creatinine clearance (CrCl) ≥45 mL/min by the Cockcroft-Gault method. - Left ventricular ejection fraction (LVEF) WNL of the institution as determined by multiple uptake gated acquisition (MUGA) or echocardiography (ECHO) (applies to Arm D only). - Female patients, ≥18, (not of childbearing potential and fertile female patients of childbearing potential) who agree to use adequate contraceptive measures from 2 weeks prior to the study and until 1 month after study treatment discontinuation, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start. - Predicted life expectancy ≥ 12 weeks Exclusion - Use of a study drug (approved or investigational drug therapy) ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of study treatment. For study drugs for which 5 half-lives is ≤21 days, a minimum of 10 days between termination of the study drug and administration of study treatment is required. - Major surgical procedures ≤ 28 days of beginning study, or minor surgical procedures ≤ 7 days. No waiting period following port-a-cath placement, or any other central venous access placement. - Grade >1 toxicity from prior therapy (except alopecia or anorexia). - Known malignant CNS disease other than neurologically stable, treated brain metastases, defined as metastasis having no evidence of progression or haemorrhage after treatment for at least 2 weeks (including brain radiotherapy). Must be off any systemic corticosteroids for the treatment of brain metastases for at least 14 days prior to enrolment. - Patient has had prescription or non-prescription drugs or other products (i.e. grapefruit juice) known to be sensitive CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors or inducers of CYP3A4 which cannot be discontinued 2 weeks prior to Day 1 of dosing and withheld throughout the study until 2 weeks after last dose of study drug. - Caution should be exercised when inhibitors or substrates of P-gP, substrates of CYP1A2 with a narrow therapeutic range, sensitive substrates of CYP2C19 or CYP2C19 substrates with a narrow therapeutic range are administered with adavosertib. - Herbal medications should be discontinued 7 days prior to the first dose of study treatment. - Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) ≥ Class 2: 1. Unstable angina pectoris 2. Congestive heart failure 3. Acute myocardial infarction 4. Conduction abnormality not controlled with pacemaker or medication 5. Significant ventricular or supraventricular arrhythmias (patients with chronic rate controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible). - Adavosertib should not be given to patients who have a history of Torsades de pointes unless all risk factors that contributed to Torsades have been corrected. Adavosertib has not been studied in patients with ventricular arrhythmias or recent myocardial infarction. - Corrected QT interval (QTc) >470 msec at study entry or congenital long QT syndrome. - Pregnant or lactating. - Serious active infection at the time of enrolment, or another serious underlying medical condition that would impair the patients ability to receive study treatment. - Presence of other active cancers, or history of treatment for invasive cancer within 3 years. Patients with Stage I cancer who have received definitive local treatment within 3 years, and whom are considered unlikely to recur, are eligible. Patients with previously treated in-situ carcinoma (i.e., non-invasive) are eligible, as are patients with prior non-melanoma skin cancers. ; PRIMARY OUTCOME: Objective Response Rate (ORR); SECONDARY OUTCOME 1: Disease Control Rate (DCR)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - PHROG; BRIEF: The purpose of this study is to test if a specific research medication could increase the response to low blood glucose in people with type 1 diabetes. The response of the body to low blood sugar will be measured in healthy people as a reference point. ; DRUG USED: MBX-2982; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: GPR119/Glucose-Dependent Insulinotropic Receptor (GDIR); THERAPY: Monotherapy; LEAD SPONSOR: AdventHealth Translational Research Institute; CRITERIA: Inclusion Criteria: Type 1 diabetes cohort 1. Age >20 years 2. Diagnosis of T1DM according to American Diabetes Association (ADA) criteria continuously requiring insulin for survival 3. Diabetes diagnosis performed more than 5 years before enrollment 4. Fasting C-peptide levels < 0.7 ng/mL with a concurrent plasma glucose concentration > 90 mg/dL 5. For female participants: agrees not to become pregnant during the study and for at least 2 weeks after the last dose of the study medication. For male participants: agrees not to donate sperm or not to get a woman pregnant during the study and for at least 2 weeks after the last dose of the study medication. Healthy subject cohort 1. Age >20 years 2. General good health 3. Creatinine clearance >80 mL/min based on MDRD equation 4. Fasting blood glucose (FBG) >70 mg/dL and <100 mg/dL 5. No history of diabetes Exclusion Criteria: 1. BMI >30 kg/m2 and <18.5 kg/m2 2. No evidence by history, EKG or exams of symptomatic cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, clinically significant abnormalities on EKG, presence of cardiac pacemaker, implanted cardiac defibrillator) 3. Evidence of autonomic neuropathy 4. Liver disease (AST or ALT >2.5 times the upper limit of normal) 5. Kidney disease (creatinine >1.6 mg/dl or estimated GFR <60 ml/min). 6. Dyslipidemia, including triglycerides >500 mg/dl, LDL >200 mg/dl or unstable hyperlipidemia. Treatment with a single lipid lowering agents is allowed if stable within the previous 3 months. 7. Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women) 8. Thyroid dysfunction (suppressed thyroid stimulating hormone (TSH), elevated TSH <10 µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic) 9. Uncontrolled hypertension (BP >160 mmHg systolic or >100 mmHg diastolic) or treatment with more than 2 antihypertensive medications 10. History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable). 11. History of organ transplant 12. History of HIV, active Hepatitis B or C, or Tuberculosis 13. Pregnancy, lactation or 6 months postpartum from the scheduled date of collection 14. Females of childbearing potential (any female except those with tubal ligation, hysterectomy, or absence of menses >2 years) unwilling to use an approved method of contraception (one medically accepted method of contraception with ≥99% effectiveness when used consistently and correctly: implantable uterine device (IUD), hormonal contraception). Male participants: unwilling to use appropriate contraception (e.g. condoms) and/or their partner uses a medically accepted form of contraception during the study. 15. History of Major Depression in the last 5 years 16. History of an eating disorder 17. History of bariatric surgery 18. History of drug or alcohol abuse (> 3 drinks per day) within the last 5 years 19. Psychiatric disease prohibiting adherence to study protocol 20. Use of oral or injectable anti-hyperglycemic agents: metformin, sulfonylureas, DPP IV inhibitors, SGLT-2 inhibitors, thiazolidinediones, acarbose, GLP-1 analogs 21. Current use of beta-adrenergic blocking agents or their use was stopped less than one month before recruitment 22. Initiation or change in hormone replacement therapy within the past 3 months (including, but not limited to thyroid hormone or estrogen replacement therapy) 23. Use of any medications known to influence glucose, fat and/or energy metabolism within the last 3 months (e.g., growth hormone therapy, glucocorticoids [steroids], prescribed medications for weight loss, etc.) 24. Current night shift worker 25. Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participants ability to complete study visits Additional exclusion Criteria for type 1 diabetes cohort 26. History of T2DM or any form of diabetes other than T1DM 27. Hypoglycemia unawareness as assessed using the GOLD score 28. Using a predictive low blood glucose suspend mode on an insulin pump or a hybrid closed loop algorithm for insulin delivery. For those applying these strategies for everyday management of blood glucose and willing to participate, the algorithm will be stopped at enrollment where possible. 29. Two or more episode of severe hypoglycemia per month in the past six months. 30. QTcF >450 ms for males and >470 ms for females 31. Using non-insulin agents to control blood glucose levels. 32. No evidence of moderate or severe end-organ diabetic complications of retinopathy, nephropathy or neuropathy. Non-proliferative retinopathy and microalbuminura will be allowed. Additional exclusion Criteria for the healthy cohort 33. Insulin treatment ; PRIMARY OUTCOME: Maximal glucagon concentration during hypoglycemia; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 701 (Healthy Subjects, Australia); BRIEF: This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate the safety and tolerability of verdinexor. Verdinexor or placebo will be given on Days 1 and 3 to healthy adult participants. ; DRUG USED: Verdinexor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Antiviral - Other Treatments; TARGET: Exportin-1/CRM1/XPO1; THERAPY: Monotherapy; LEAD SPONSOR: Karyopharm Therapeutics Inc; CRITERIA: Inclusion Criteria: - Participants must be in good health as determined by the investigator, based on the medical history, ECG, physical examination, and safety laboratory tests at screening. - Participants must be identified as a non-smoker at the screening visit (a non-smoker is defined as an individual who has abstained from smoking for at least 1 year prior to the screening visit and who has a ≤ 15 pack year history of lifetime cigarette use). A urine cotinine test will be performed at screening and at the time of clinic check-in prior to study drug treatment. Exclusion Criteria: - The participant has any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug such as gastrectomy, Crohns disease, or liver disease. - The participant has a history of clinically significant allergies. Hay fever is allowed unless it is active or has required treatment within the previous 2 months. - Presence of a chronic condition(s) with clinical or historical evidence of recent exacerbation, or other information to suggest non-control of such condition(s). - History of alcohol abuse or drug addiction within 12 months of the screening visit. - Any participant with active cataracts or medical history of cataracts. ; PRIMARY OUTCOME: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs); SECONDARY OUTCOME 1: Area Under the Concentration-time Curve From Time Zero to the Last Non-zero Concentration (AUC0-t) of Verdinexor[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib - Mild to Moderate Parkinsons Disease +/- LRRK2 Mutation; BRIEF: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL201 in subjects with Parkinsons disease. ; DRUG USED: DNL201; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: LRRK2 (leucine-rich repeat kinase 2); THERAPY: Monotherapy; LEAD SPONSOR: Denali Therapeutics Inc.; CRITERIA: Key Inclusion Criteria: - Body mass index (BMI) between 18 and 35.0 kg/m2, inclusive - Clinical diagnosis of Parkinsons disease meeting UK Brain Bank criteria and H&Y Stage I, II, or III. - sPD subgroup without a LRRK2 mutation; PD LRRK2 subgroup with LRRK2 mutation - Screening dopamine transporter (DAT) SPECT scan with a DAT deficit consistent with Parkinsons disease - Able to hold Parkinsons disease medications 8 hours (overnight) prior to specific study assessments Key Exclusion Criteria: - Any history of clinically significant asthma, chronic obstructive pulmonary disease, or emphysema within 5 years of screening, or other clinically significant pulmonary disease within 6 months of screening - Abnormal Vitals including Respiratory Rate, Body Temperature, and Blood Pressure - Pulmonary Function Tests (PFTs) (FVC <60% predicted, FEV1 <50% predicted, FEV1:FVC ratio <0.6, DLCO <70% predicted) - Clinically significant neurologic disorder other than Parkinsons disease, including history of stroke, cognitive impairment, seizure within 5 years of screening, or head trauma with loss of consciousness within 6 months of screening - Montreal Cognitive Assessment (MoCA) score of <24 at screening ; PRIMARY OUTCOME: Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL201[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/Ritonavir; BRIEF: The primary purpose of this study is to assess the effect of ritonavir, on the single-dose pharmacokinetics (PK) of JNJ-61393215 in healthy participants. ; DRUG USED: JNJ-61393215; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Hypocretin/orexin receptor ; THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Healthy male participants or female participants of non-childbearing potential between 18 and 55 years of age, inclusive - Before enrollment, female participants must be of non-childbearing potential; postmenopausal state is defined as no menses for 12 months without an alternative medical cause, as documented by medical records or physicians notes and Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy - Participants must have a body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive (BMI = weight/height^2) and body weight not less than 50 kg - Participant must be healthy based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and admission to the clinical unit. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable - Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic Exclusion Criteria: - Participant has any clinically significant abnormal findings in physical examination, vital signs or 12-lead ECG [including QT corrected according to Fridericias formula (QTcF) greater than (>) 450 milliseconds (msec) and less than or equal to (=<) 470 (milliseconds) msec for females, Left Bundle Branch Block, atrioventricular (AV) Block second degree or higher, permanent pacemaker or implantable cardioverter defibrillator (ICD)] at screening or admission (up to Day 1 predose), which in the opinion of the investigator are not appropriate and reasonable for the population under study - Participant has a history of or current liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable - Participant has any liver function test (including alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), alkaline phosphatase (ALP) and bilirubin at screening >1.5 * ULN (upper limit of normal) - Participant has estimated glomerular filtration rate (eGFR) less than (<) 60 milliliter per minute per 1.73 square meter (mL/min/1.73m^2) at screening (provided by the local laboratory) - Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening ; PRIMARY OUTCOME: Maximum Plasma Concentration (Cmax) of JNJ-61393215; SECONDARY OUTCOME 1: Number of Participants with Adverse Event as a Measure of Safety and Tolerability[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ia/Ib - +/-Nivolumab; BRIEF: The purpose of this study is to evaluate the safety and tolerability of OMP-31M32 as a single agent or in combination with nivolumab. OMP-313M32 is an experimental anti-TIGIT antibody that was developed to block TIGIT from binding PVR allowing the bodys T-cells to destroy cancer cells. ; DRUG USED: Etigilimab; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Immune System, TIGIT; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: OncoMed Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Histologic documentation of locally advanced, recurrent or metastatic solid malignancy that has progressed and standard therapy has been ineffective or intolerable. Phase 1b subjects must also have experienced disease progression after treatment with an anti PD-1 or PDL-1 agent. 2. Ability to understand the willingness and to sign a written informed consent document 3. Age >/= 18 years 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Life expectancy >/=12 weeks 6. Measurable disease per response evaluation criteria in solid tumors. 7. Adequate hematologic and organ function 8. For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit. Exclusion Criteria: 1. Anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks or 5 half lives, whichever is shorter, prior to initiation of study treatment 2. Active autoimmune disease or a history of severe autoimmune disease or syndrome 3. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. 4. Inability to comply with study and follow-up procedures. 5. Pregnancy, lactation, or breastfeeding women. 6. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina. 7. Known clinically significant liver disease, 8. Major surgical procedure within 28 days prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study. 9. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications. ; PRIMARY OUTCOME: Incidence of dose limiting toxicities (DLTs); SECONDARY OUTCOME 1: Pharmacokinetic Outcome Measures (AUC) - Phase 1a[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Study 211; BRIEF: Open-label, extension study to evaluate the safety and efficacy of combination therapy and its effect on sustained viral response biomarkers. ; DRUG USED: Vebicorvir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: Hepatitis B/HBV; THERAPY: Combination; LEAD SPONSOR: Assembly Biosciences; CRITERIA: Inclusion Criteria: 1. Willing and able to provide informed consent. 2. Previously enrolled on Study ABI-H0731-201 (NCT03576066) or ABI-H0731-202 (NCT03577171) and completed the treatment period, with demonstrated compliance in the opinion of the investigator. 3. Female subjects must agree to use an effective birth control method for the duration of the study and follow-up, or be surgically sterile for at least 6 months, or at least 2 years postmenopausal with serum follicle-stimulating hormone (FSH) levels consistent with a postmenopausal status. Effective birth control methods include male or female condom (may not be used together due to increased risk of breakage), vasectomy, intrauterine device (IUD), diaphragm, or cervical cap. Female subjects of childbearing potential must have a negative serum pregnancy test. 4. All heterosexually active male subjects must agree to use an effective birth control method for the duration of the study and follow-up. Effective birth control methods include male or female condom (may not be used together due to increased risk of breakage), vasectomy, hormone-based contraception (only female partner of a male subject), IUD, diaphragm, or cervical cap. 5. Agreement to adhere to Lifestyle Considerations (including abstaining from alcohol abuse [defined as alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol)] and the use of illicit substances, herbal or other substances, or unnecessary over-the-counter medications throughout study duration. 6. In good general health except for chronic HBV infection. 7. Have the ability to take oral medication and be willing to adhere to the ABI-H0731-211 regimen in the opinion of the Investigator. Exclusion Criteria: 1. Must not have had evidence of HBV resistance-associated variants (RAVs) or lack of compliance on a previous study of ABI H0731. 2. Must not have had a treatment-emergent adverse event or laboratory abnormalities deemed clinically significant and possibly or probably related to drug while on a previous study of ABI-H0731, that in the opinion of the Investigator or the Sponsor makes the subject unsuitable for this study. 3. Current clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment, or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that in the opinion of the Investigator or the Sponsor makes the subject unsuitable for the study. 4. Females who are lactating or pregnant or wish to become pregnant within the duration of the ABI-H0731-211 study. ; PRIMARY OUTCOME: Sustained Viral Response (SVR) at 24 Weeks Off Treatment; SECONDARY OUTCOME 1: Number of Subjects With Adverse Events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - PoC; BRIEF: This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM). ; DRUG USED: Zynquista; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Lexicon Pharmaceuticals; CRITERIA: Inclusion Criteria: - Adults >=18 to <=55 years of age - Confirmed diagnosis of T1DM, diagnosed prior to age 40 years, and for at least 6 months prior to Screening - Willing to refrain from using carbohydrate counting to adjust insulin during the study - Willing and able to wear and operate a continuous glucose monitor - Willing and able to self-assess blood glucose - Willing and able to provide written informed consent. Exclusion Criteria: - History of type 2 diabetes mellitus or diabetes resulting from acromegaly, Cushings disease, chronic pancreatitis, or pancreatectomy - Two or more severe episodes of hypoglycemia that required emergency treatment within 3 months prior to Screening - Use of premixed insulin - History of diabetic ketoacidosis within 1 year of screening - Presence of active hepatic disease or clinically significant abnormal liver function tests - History of chronic pancreatitis - Participants with a history of heart attack, severe/unstable angina, or coronary revascularization procedure - History of clinically significant cardiac arrhythmias within 1 year prior to screening - Participants with congestive heart failure - Participants with uncontrolled Stage III hypertension - History of human immunodeficiency virus (HIV) or hepatitis C - History of illicit drug or alcohol abuse within 12 months prior to Screening - Use of any investigational agent or device within 30 days prior to Screening or any therapeutic protein or antibody within 90 days prior to Screening - Use of medication or herbal supplements taken for weight loss within 2 weeks of screening - Chronic use of any antidiabetic therapy other than insulin within 2 months prior to Screening - Use of systemic or inhaled corticosteroids within 2 weeks prior to Screening - Participants who underwent major surgery within 6 months prior to Screening - Inability or difficulty swallowing whole tablets or capsules - Women who were pregnant or breastfeeding. ; PRIMARY OUTCOME: Percent Change From Baseline in Total Daily Bolus Amount of Exogenous Insulin Required Calculated Over Days 3 to 27 (Treatment Outpatient Period); SECONDARY OUTCOME 1: Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - SOAR (AIHA); BRIEF: The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA). ; DRUG USED: Tavalisse; DRUG CLASS: New Molecular Entity (NME); INDICATION: Autoimmune Hemolytic Anemia (AIHA); TARGET: Spleen Tyrosine Kinase (syk); THERAPY: Monotherapy; LEAD SPONSOR: Rigel Pharmaceuticals; CRITERIA: Inclusion Criteria: Subject must have had a diagnosis of primary or secondary warm antibody AIHA. - Must have failed at least 1 prior treatment regimen for AIHA. Exclusion Criteria: - Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria. - Subject with a platelet count of < 30,000/μL. - Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy. - Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg. ; PRIMARY OUTCOME: Hemoglobin response; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ALEX (vs. Crizotinib; Naïve Anaplastic); BRIEF: This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study is expected to last approximately 144 months. ; DRUG USED: Alecensa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Anaplastic lymphoma kinase (ALK); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test - Life expectancy of at least 12 weeks - Eastern cooperative oncology group performance status (ECOG PS) of 0-2 - Participants with no prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC - Adequate renal, and hematologic function - Participants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment - Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1) prior to the administration of study treatment - Prior brain or leptomeningeal metastases allowed if asymptomatic (e.g., diagnosed incidentally at study baseline) - Negative pregnancy test for all females of child bearing potential - Use of highly effective contraception as defined by the study protocol Exclusion Criteria: - Participants with a previous malignancy within the past 3 years - Any gastrointestinal (GI) disorder or liver disease - National cancer institute common terminology criteria for adverse events (NCI CTCAE) (version 4.0) Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia) - History of organ transplant - Co-administration of anti-cancer therapies other than those administered in this study - Participants with baseline QTc greater than (>) 470 milliseconds or symptomatic bradycardia - Recipient of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose until the end of study treatment - Recipient of any drug with potential QT interval prolonging effects within 14 days prior to the first dose for all participants and while on treatment through the end of the study for crizotinib-treated participants only - History of hypersensitivity to any of the additives in the alectinib and crizotinib drug formulation - Pregnancy or lactation - Any clinically significant disease or condition (or history of) that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the principal investigator, pose an unacceptable risk to the participant in this study - Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the participant before trial entry ; PRIMARY OUTCOME: Progression-Free Survival (PFS) by Investigator Assessment; SECONDARY OUTCOME 1: PFS Independent Review Committee (IRC)-Assessed[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SYNERGY; BRIEF: The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems. ; DRUG USED: Solifenacin/Mirabegron; DRUG CLASS: Non-NME; INDICATION: Overactive Bladder (OAB); TARGET: Beta-3 adrenergic receptor (ß3 adrenoceptor), Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Europe B.V.; CRITERIA: Inclusion Criteria: - Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings; - Subject had symptoms of wet OAB (urinary frequency and urgency with incontinence) for at least 3 months; Exclusion Criteria: - Subject had significant PVR volume (> 150 mL); - Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinsons disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion. - Subject had an indwelling catheter or practices intermittent self catheterization. - Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis. - Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin. - Subject had moderate to severe hepatic impairment - Subject had severe renal impairment - Subject had a clinically significant abnormal ECG - Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening. - Subject had an average QTcF interval > 450 ms for males or > 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia). - Subject had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg. ; PRIMARY OUTCOME: Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours; SECONDARY OUTCOME 1: Change From Baseline to EoT in Mean Volume Voided Per Micturition[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Multiple Rising Doses (IPF Patients); BRIEF: The primary objective is to investigate safety and tolerability of BI 1015550 in patients with IPF. The secondary objectives are to evaluate the pharmacokinetics (PK) of BI 1015550 in patients with IPF. ; DRUG USED: BI 1015550; DRUG CLASS: New Molecular Entity (NME); INDICATION: Idiopathic Pulmonary Fibrosis (IPF); TARGET: ; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion Criteria: - Signed and dated written informed consent prior to admission to the study in accordance with ICH Harmonised Tripartite Guideline for Good Clinical Practice (ICH-GCP) and local legislation - Male or female patients aged ≥40 years at visit 1. - A clinical diagnosis of IPF based on ATS/ERS/JRS/ALAT 2011 guideline within the previous 5 years as confirmed by the investigator based on chest high-resolution computed tomography (HRCT) scan taken within 12 months of visit 1 and confirmed by central review prior to visit 2. - Forced Vital Capacity (FVC) ≥50% of predicted normal at visit 1 - Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin [Hb] [Visit 1]): > 30% of predicted normal at visit 1 Exclusion Criteria: - Patients with a significant disease or condition other than IPF which in the opinion of the investigator, may put the patient at risk because of participation, interfere with study procedures, or cause concern regarding the patients ability to participate in the study. - Any laboratory value outside the reference range that the investigator considers to be of clinical relevance - Surgery of the GI tract that could interfere with PK of the trial medication (except appendectomy) - Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders including but not limited to mood disorders. - Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings. - History of allergy or hypersensitivity to the trial medication or its excipients - Use of drugs within 30 days prior to administration of trial medication that are known to influence the results of the trial including time between start of the Q-wave and the end of the T-wave in an electrocardiogram (QT) / QT interval corrected for heart rate using the method of Fridericia (QTcF) or Bazett (QTcB) (QTc) - A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening - A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome) - Participation in another trial where an investigational drug has been administered within 30 days or less than 5 half-lives (whichever is greater) of the respective drug prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug. - Inability to refrain from smoking on trial days - Alcohol abuse (consumption of more than 20 g per day) - Active drug abuse - Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial - Inability to comply with dietary regimen required for the trial - Patient is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study - Male patients who do not agree to minimize the risk of female partners becoming pregnant from first dosing day until two months after the study completion. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive used for at least two months prior), true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient), or surgically sterilized, including vasectomy. - Females who are not surgically sterilised or who are not postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of Follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory). - Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC <0.7) at visit 1 - Patients who have previously been treated with nintedanib or pirfenidone within 30 days of visit 1. - Positive fecal occult blood (no retest allowed), - Positive testing for hematuria if confirmed by microscopic urine analysis (retest allowed) - Any lifetime history of suicidal behavior (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) - Any suicidal ideation of type 2 to 5 on the C-SSRS in the past 12 months (i.e. active suicidal thought without method, intent or plan; active suicidal thought with method, but without intent or plan; active suicidal thought with method and intent but without specific plan; or active suicidal thought with method, intent and plan). ; PRIMARY OUTCOME: Safety and tolerability of BI 1015550 by the percentage of patients with drug-related AEs on-treatment; SECONDARY OUTCOME 1: AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Geographic Atrophy; BRIEF: The purpose of this study was to to demonstrate superiority of AL-78898A intravitreal (IVT) injections compared to sham injections by assessing mean geographic atrophy (GA) lesion size change from baseline at Month 12. ; DRUG USED: APL-1; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dry Age-Related Macular Degeneration (Dry AMD)/Geographic Atrophy (Ophthalmology); TARGET: Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Alcon Research; CRITERIA: Inclusion Criteria: - Ability to provide informed consent and comply with the protocol. - Diagnosis of bilateral geographic atrophy (GA) of the macula secondary to age-related macular degeneration, confirmed within 14 days prior to randomization. - Study eye: Maximum best-corrected visual acuity (BCVA) of 55 letters (20/80 Snellen equivalent) and a minimum BCVA of 20 letters (20/400 Snellen equivalent) at screening - BCVA of 20 letters (20/400 Snellen equivalent) or better in the non treated eye at screening without conditions other than AMD that, in the opinion of the investigator, could cause a rapid loss of vision. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Any history or current evidence of exudative (wet) AMD in study eye. - Retinal disease other than AMD in the study eye. - Any ophthalmologic condition in study eye that reduces the clarity of the media and that, in the opinion of the Investigator interferes with ophthalmologic examination, such as advanced cataract or corneal abnormalities. - Any ophthalmologic condition in study eye that prevents adequate imaging of the retina judged by the site or reading center. - A history or current medical diagnosis of glaucoma or ocular hypertension in study eye. - Any ophthalmic condition in study eye that may require surgery during the study period. - Current ocular or periocular infection in the study eye. - History of any disease or current use of medication expected to cause systemic or ocular immunosuppression, such as RESTASIS®. - History of uveitis or endophthalmitis in the study eye. - History of intraocular surgery (including cataract surgery) in the study eye within 90 days prior to dosing. - History of intravitreal or periocular injection in the study eye at anytime. - Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 6 weeks or during active period of drug (whichever is longer) prior to the start of study treatment. - History of any medical or psychiatric condition, or substance abuse, that in the Investigators opinion is likely to interfere with the patients participation in the study, or likely to cause serious adverse events during the study. - Women of child bearing potential UNLESS they are using a highly effective method of birth control. - Known or suspected allergy or hypersensitivity to fluorescein or other injectables. - Other protocol-defined exclusion criteria may apply. ; PRIMARY OUTCOME: Mean Change From Baseline in GA Lesion Size at Month 12 as Assessed With FAF Imaging; SECONDARY OUTCOME 1: Yearly GA Lesion Size Growth Rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - A2207 (CIAS); BRIEF: This is a study in chronic stable Schizophrenia with the purpose to answer the question of whether agonism of the nicotinic alpha7 receptor is capable of enhancing cognition in a well defined chronic stable patient population treated with antipsychotics as standard of care, and thus to support the future development of AQW051 for the treatment of cognitive impairment associated with Schizophrenia (CIAS). ; DRUG USED: AQW-051; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Nicotinic Acetylcholine Receptor - a7 subtype &lt;br&gt;(a7 nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Diagnosis of schizophrenia - Symptomatically stable and currently treated with a stable regimen for at least 3 (three) months prior to dosing with one of the following second generation of antipsychotics: risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole. - Specific cognitive impairment - Smokers and non-smokers Exclusion Criteria: - Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system, and/ or treatment with cholinesterase inhibitor within the last three (3) months prior to dosing. - Current treatment with conventional antipsychotics (e.g fluphenazine, haloperidol) or clozapine. - History of neuroleptic malignant syndrome. - Diagnosis of substance abuse (other than nicotine) within the last month and alcohol or substance dependence (other than nicotine) within the last 6 months. - Score 4 or 5 on the Suicidal Ideation item or any yes on the Suicidal Behavior item of the CSSR-S that is related to suicidal behavior occurring during the last 2 years Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Visual learning and memory at 4 weeks; SECONDARY OUTCOME 1: Effect on cognitive function after 12 weeks of treatment - CogState test battery.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Chronic Bronchitis; BRIEF: To test the hypothesis that treatment with the inverse agonist nadolol will improve smoking cessation in patients with chronic cough associated with long-term smoking, with or without airflow obstruction, including those with established chronic obstructive pulmonary disease (COPD) (chronic bronchitis dominant) or non-obstructive chronic bronchitis (NCB), compared to placebo and standard of care, while undergoing a validated smoking cessation program. ; DRUG USED: INV102; DRUG CLASS: Non-NME; INDICATION: Smoking Cessation; TARGET: Beta Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Invion, Inc.; CRITERIA: Inclusion Criteria: Potential study participants will be referred from approved smoking cessation programs or be willing to enter a smoking cessation program administered by the participating sites. Individuals who meet all of the following criteria at Visit 1 are eligible for enrollment as study participants: 1. Active cigarette-smoking males and females between the ages of 18-70 with chronic cough associated with long-term smoking, with or without airflow obstruction, including Non-obstructive chronic bronchitis (NCB) or physician-diagnosed COPD (chronic bronchitis dominant), as defined by the American Thoracic Society. 2. Committed desire to quit smoking in conjunction with participation in an approved smoking cessation program administered by the participating sites. Enrollment in the smoking cessation program must take place prior to Visit 3 (third dose escalation visit). 3. Diagnosis of COPD (chronic bronchitis dominant) or NCB, or presenting with chronic cough associated with long-term smoking. 4. Pre-bronchodilator FEV1 greater than 55% of predicted 5. Baseline blood pressure ≥ 110/65mm Hg 6. Baseline heart rate ≥ 60 beats/min. 7. Smoking at least 10 cigarettes per day prior to participation in the approved smoking cessation program. 8. Self-reported prior failure(s) to quit smoking during participation in a smoking cessation program. 9. Able to complete diary cards and comply with study procedures. 10. Females of childbearing age may participate only if they have a negative pregnancy test, are non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study. Exclusion Criteria: Subjects who meet ANY of the following criteria are not eligible for enrollment: 1. Diagnosis of asthma, cystic fibrosis, or PiZZ emphysema 2. Inability or unwillingness to give written informed consent 3. History of upper/lower respiratory tract infection, COPD exacerbation requiring systemic steroids, antibiotics, and or ER visit or urgent care within 6 weeks of Visit 1 4. History of adverse reaction or allergy to nadolol 5. History of neurological, hepatic, renal, or other medical conditions that may interfere with the interpretation of data or the patients participation in the study or may increase safety concerns 6. History of cardiovascular diseases including uncontrolled hypertension (BP >160/100), ischemic heart disease, congestive heart failure (NYHA III or IV), valvular heart disease or cardiomyopathy 7. Known allergy or sensitivity to atropine or ipratropium bromide 8. Documented or self-reported current history of alcoholism or drug abuse 9. Participation in another research trial within 30 days of starting this trial 10. Unwillingness or inability to comply with study procedures 11. Inability to swallow the study medication 12. Pregnant or nursing 13. Current use of any OTC remedies containing pseudoephedrine, ephedrine-based or containing dietary or herbal supplements. 14. Scheduled for surgery requiring general anaesthesia 15. Referred for smoking cessation without serious commitment to quit ; PRIMARY OUTCOME: Change From Baseline in the Average Number of Cigarettes Smoked Per Day; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb (BP Depression); BRIEF: The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms of bipolar I depression and to make sure it is safe in humans. ; DRUG USED: RG2417; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bipolar Disorder; TARGET: Mitochondria, Nucleoside/Nucleotide; THERAPY: Monotherapy; LEAD SPONSOR: Repligen Corporation; CRITERIA: Inclusion Criteria: - Bipolar I Disorder, most recent episode depressed - History of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms Exclusion Criteria: - Current manic, hypomanic or mixed episode - Rapid cycling bipolar disorder (4 or more mood episodes in the last year) - Dementia or any other Axis I diagnosis (besides bipolar I) that requires treatment - Alcohol or drug dependence within 6 months; alcohol or drug abuse within 3 months - Positive urine drug test for amphetamines, cocaine metabolites, opiates and/or phencyclidine(PCP) - Axis II diagnosis likely to interfere with study compliance - Serious suicidal or homicidal risk - Sensitivity to any of the drug ingredients, including lactose - Women who are pregnant, breast feeding or refuse to use adequate birth control - Current seizure disorder - Current episode of depression is longer than 1 year ; PRIMARY OUTCOME: MADRS Score; SECONDARY OUTCOME 1: CGI-BP-S[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/IIa - PURPLE; BRIEF: The purpose of this study is to investigate whether Lorexys is effective and safe to treat premenopausal women who have lost their sexual desire to a distressing degree. ; DRUG USED: Lorexys; DRUG CLASS: Non-NME; INDICATION: Female Sexual Arousal Disorder; TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: S1 Biopharma, Inc.; CRITERIA: Inclusion Criteria: 1. Age 25 to 50 and still having regular menstrual periods. Women with intact ovaries are classified as premenopausal for this study, even if they have had a hysterectomy. Women who have had both ovaries removed, even if under age 50 and with an intact uterus, are not acceptable for this study. 2. In a stable, monogamous, communicative, reasonably amicable relationship for at least one year 3. Meets DSM-IV-TR criteria for Generalized Acquired Hypoactive Sexual Desire Disorder and HSDD is her main sexual disorder 4. Over the prior month, didnt respond to sexual initiations by partner 5. At screen and baseline, low or no and infrequent or rare desire for sex 6. At screen, has clinically relevant sexual distress as per FSDS-R score 7. Otherwise healthy physically and mentally. Minor chronic conditions not affecting sexual function are allowed. Side effects from any continuing concomitant medications must be mild and stable or nil. 8. Not pregnant or lactating for six months; using medically reliable contraception, i.e., diaphragm or (male or female) condom and spermicide, IUD, tubal sterilization, hormonal contraception (oral, vaginal, or implant), or (if the investigator finds the patient credibly monogamous) vasectomy of male partner. 9. Gives informed consent for and is willing to undergo all of the scheduled evaluations 10. Prompt for screening and baseline visits, is cooperative, and takes reasonable directions without excessive explanations 11. Her sexual partner is in a monogamous relationship with her, is sexually unimpaired (erectile dysfunction allowed only if adequately treated), and is available to her at least half of the time (in days per week). Exclusion Criteria: 1. Masturbates more than once a month. 2. Sexual aversion or sexual pain disorder 3. Chronic conditions that may reasonably be expected to be unstable or to affect sexual function (e.g., gastrointestinal bleeding, diabetes, frequent asthma, Major Depressive or anxiety disorder, history within the prior 6 months of suicidality or drug abuse; history of breast, cervical, uterine, ovarian or other systemic cancer). 4. BMI (a standard ratio of weight to height) over 35.0 (obese) 5. Requires CYP3A4, CYP 2B6, or CYP 2D6 strong inhibitor or inducer drugs 6. Takes any sex hormone other than an approved hormonal contraceptive 7. Takes an antiepileptic/mood stabilizer, antipsychotic, antidepressant, anti-anxiety, or hypnotic drug or has a history of allergic reaction to such drugs 9. Drinks more than 7 alcoholic drinks per week (12-oz beer, 4-oz wine, 1 ½ oz liquor etc) 10. Drinks more than 6 cups of coffee or tea per day 11. History of seizures 12. Long QT syndrome (QTc <=480 msec), other significant cardiovascular disease 13. moderate or severe dysfunction of the liver (any LFT >=3x ULN) or renal dysfunction (BUN > 30 or Cr >2.0) 14. Uses sedating antihistamines or prescription sedatives 15. History of blood clots or abnormal bleeding tendencies, including daily use of medications adversely affecting coagulation, e.g., NSAIDs, systemic corticosteroids, or >81 mg aspirin daily. ; PRIMARY OUTCOME: Change in Desire domain of the Female Sexual Function Index; SECONDARY OUTCOME 1: Change in Female Sexual Distress Scale-Revised[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - P07057 (India); BRIEF: This study will investigate the efficacy and safety of the monophasic combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in healthy fertile Indian women. ; DRUG USED: Zoely; DRUG CLASS: New Molecular Entity (NME); INDICATION: Contraception; TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta), Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Organon and Co; CRITERIA: Inclusion Criteria: - Sexually active and at risk for pregnancy - Of Indian descent, born in India, never emigrated out of India, with Indian home address - Body mass index (BMI) ≥17 and ≤35 kg/m^2 Exclusion Criteria: - Presence or history of venous or arterial thrombotic/thromboembolic events or cerebrovascular accident - Presence or history of prodromi of a thrombosis - History of migraine with focal neurological symptoms - Diabetes mellitus with vascular involvement - Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis - Severe hypertension - Severe dyslipoproteinemia - Presence or history of pancreatitis associated with severe hypertriglyceridemia - Presence or history of severe hepatic disease - Undiagnosed vaginal bleeding - Known or suspected pregnancy - Currently breastfeeding or breastfeeding within 2 months of starting trial medication - Investigational drug use or participation in another clinical trial within 2 months of signing Informed Consent Form for current trial ; PRIMARY OUTCOME: Number of In-treatment Pregnancies; SECONDARY OUTCOME 1: Number of Participants Experiencing an Adverse Event (AE) or Serious AE[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ia - 18R5-001 (Solid Tumors); BRIEF: This is an open-label Phase 1 dose escalation study of OMP-18R5 in subjects with a solid tumor for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed. Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon enrollment, subjects will receive intravenous (IV) infusions of OMP-18R5 at a assigned dosing schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there is no evidence of disease progression or if the tumor is smaller, then subjects may continue to receive IV infusions of OMP-18R5 every week until disease progression. Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled in a cohort will not be treated on the same day. The dose may be administered at any time during the day. Three subjects will be treated at each dose level if no dose-limiting toxicities (DLTs) are observed. If 1 of 3 subjects experiences a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be dosed at that level and 3 additional subjects will be added to the preceding dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be assessed for DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled subjects, if appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to continue to receive weekly doses of OMP-18R5 until disease progression. An additional 14 subjects will be enrolled at the highest dose level that result in < 2 of the 6 subjects experiencing a Grade 3 (not including a Grade 3 infusion reaction that resolves in 24 hours) or 4 adverse event (DLT). ; DRUG USED: Vantictumab; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: WNT Signaling Pathway; THERAPY: Monotherapy; LEAD SPONSOR: OncoMed Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Subjects must have a histologically confirmed malignancy that is metastatic or unresectable for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. In addition, subjects must have a tumor that is at least 1 cm in a single dimension and is radiographically apparent on CT or MRI. 2. Subjects must have received their last chemotherapy, biologic, or investigational therapy at least 4 weeks prior to enrollment, 6 weeks if the last regimen included BCNU or mitomycin C. 3. Age >18 years 4. ECOG performance status <2 (see Appendix B) 5. Life expectancy of more than 3 months 6. Subjects must have adequate organ and marrow function as defined below: Absolute neutrophil count >1000/µL Hemoglobin >9.0 g/dL Platelets >100,000/µL Total bilirubin <1.5 X institutional upper limit of normal (ULN) AST (SGOT) and ALT (SGPT) < 3 X institutional ULN (for subjects with hepatic metastases < 5 X institutional ULN) PT and PTT within 1.5 X institutional ULN Creatinine <1.5 X institutional ULN OR Creatinine clearance >60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal 7. Women of childbearing potential must have had a prior hysterectomy or have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug. Men must also agree to use adequate contraception (barrier method of birth control, abstinence) prior to study entry and from study entry through at least 6 months after discontinuation of study drug. Should a woman enrolled in the study or a female partner of a man enrolled in the study become pregnant or suspect she is pregnant while participating in this study or within 6 months after discontinuation of study, she should inform the Investigator immediately. 8. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: 1. Subjects receiving any other investigational agents 2. Subjects with brain metastases (subjects must have a CT scan or MRI of the head within 28 days prior to enrollment to rule out brain metastases), uncontrolled seizure disorder, or active neurologic disease 3. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy 4. Significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 5. Pregnant women or nursing women 6. Subjects with known HIV infection 7. Known bleeding disorder or coagulopathy 8. Subjects receiving heparin, warfarin, or other similar anticoagulants, except for subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents. 9. New York Heart Association Classification III, or IV (see Appendix D) 10. Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease. 11. Subjects with known osteopenia or osteoporosis. ; PRIMARY OUTCOME: To determine the safety of OMP-18R5 in subjects with previously treated solid tumors; SECONDARY OUTCOME 1: To determine the pharmacokinetics of OMP-18R5 in subjects with previously treated solid tumors[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - TDU14518; BRIEF: Primary Objective: To assess the tolerability and safety of SAR438544 after single ascending subcutaneous (SC) doses in healthy subjects and in type 1 diabetes mellitus (T1DM) patients. Secondary Objective: To assess the preliminary pharmacodynamics (PD) and pharmacokinetic (PK) parameters of SAR438544 after single ascending SC doses in healthy subjects and in T1DM patients. ; DRUG USED: SAR438544; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperinsulinemia/Hypoglycemia; TARGET: Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : Healthy subjects: - Male or female subjects, between 18 and 45 years of age, inclusive. - Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive. - Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). - Female subject must use a double contraception method, including a highly effective method of birth control, except if she has undergone sterilization defined as tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and bilateral tubal ligation at least 3 months earlier or is postmenopausal. - The accepted double contraception methods include the use of intrauterine device or hormonal contraception started at least 30 days prior to the screening start and continued for at least 3 months after IMP dosing in addition to one of the following contraceptive options: (1) condom plus spermicide; (2) diaphragm plus spermicide or cervical/vault cap plus spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma FSH level >30 UI/L in women older than 40 years of age - Having given written informed consent prior to undertaking any study-related procedure. - Not under any administrative or legal supervision. - Male subject, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom, diaphragm or cervical cap, plus spermicide) plus (intra-uterine device or hormonal contraceptive) from the inclusion up to 3 months after the last dosing (except if sterilized). - Male subject, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 3 months after the last dosing. - Male subject has agreed not to donate sperm from the inclusion up to 3 months after the last dosing. T1DM patients: - Male or female patients, between 18 and 60 years of age, inclusive, with T1DM for at least one year, as defined by the American Diabetes Association. - Total (basal+short acting) daily insulin dose of <1.2 U/kg/day. - Body weight between 50.0 and 110 kg, inclusive, the BMI between 18.5 and 30.0 kg/m^2, inclusive. - Fasting serum C-peptide <0.3 nmol/L. - Glycohemoglobin (HbA1c) ≤75 mmol/mol (≤9%). - Stable insulin regimen for at least 2 months prior to study and self-monitoring of blood glucose before screening visit. - Certified as otherwise healthy for T1DM by assessment of medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculoskeletal system), unless the Investigator considers any abnormality to be clinically irrelevant and not interfering with the conduct of the study. - Female subject must use a double contraception method, including a highly effective method of birth control, except if she has undergone sterilization defined as tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and bilateral tubal ligation at least 3 months earlier or is postmenopausal. - The accepted double contraception methods include the use of intrauterine device or hormonal contraception started at least 30 days prior to the screening start and continued for at least 3 months after IMP dosing in addition to one of the following contraceptive options: (1) condom plus spermicide; (2) diaphragm plus spermicide or cervical/vault cap plus spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma FSH level >30 UI/L in women older than 40 years of age. - Having given written informed consent prior to undertaking any study-related procedure. - Not under any administrative or legal supervision. - Male subject, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom, diaphragm or cervical cap, plus spermicide) plus (intra-uterine device or hormonal contraceptive) from the inclusion up to 3 months after the last dosing (except if sterilized). - Male subject, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 3 months after the last dosing. - Male subject has agreed not to donate sperm from the inclusion up to 3 months after the last dosing. Exclusion criteria: Healthy subjects: - Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness. - Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month). - Blood donation, any volume, within 2 months before inclusion. - Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position. - Presence or history of any drug allergy or allergic disease that in the opinion of the Investigator may interfere with subject safety or data integrity during the study. - History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis). - Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study. - If female, pregnancy (defined as positive beta-human chorionic gonadotropin [β-HCG] blood test), breast-feeding. - Any medication (including St Johns Wort) within 14 days before inclusion or within 5 times the elimination half-life or PD half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. - Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. - Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab) and human immunodeficiency virus 1 antigen (HIV1 Ag). - Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates). - Positive alcohol breath test. T1DM patients: - Any history or presence of clinically relevant cardiovascular (includes ischemia, atrioventricular [AV] block; arrhythmias), pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness. - Severe hypoglycemia resulting in coma/seizures or requiring assistance of another person, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit. - Frequent severe headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month). - Blood loss (>300 mL) within 3 months before inclusion. - Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position. - Presence or history of any drug allergy or allergic disease that in the opinion of the Investigator may interfere with patient safety or data integrity during the study. - Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol. - If female, pregnancy (defined as positive β-HCG blood test), breast-feeding at screening and before any treatment periods (defined as positive β-HCG urine test). - Any patient who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. - Positive result on any of the following tests: HBs Ag, anti-HCV Abs, anti-HIV1 and anti-HIV2 Abs and HIV1 Ag. - Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates). - Positive alcohol breath test. - Known hypersensitivity to glucagon, lactose or any other constituent in GlucaGen^® HypoKit and SAR438544 and their excipients. - Any contraindication from the use of glucagon: - Pheochromocytoma - Insulinoma and glucagonoma The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Number of patients with adverse events; SECONDARY OUTCOME 1: Assessment of PD parameter: continuous monitoring of blood glucose levels over a period of 6 hours post-dose[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Motion Sifnos; BRIEF: Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness. ; DRUG USED: Tradipitant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Emesis; TARGET: Neurokinin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Vanda Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male or non-pregnant, non-lactating female patients aged 18 - 75 years (inclusive); - Body Mass Index (BMI) of ≥18 and ≤30 kg/m2; - History or symptoms consistent with motion sickness Exclusion Criteria: - Chronic nausea due to condition other than motion sickness; - A positive test for drugs of abuse at the screening or evaluation visits; - Clinically significant deviation from normal clinical laboratory results ; PRIMARY OUTCOME: Reduction in the incidence of vomiting; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Escalating Doses (16-1); BRIEF: The purpose of this study is to evaluate the safety and tolerability of ASP1235 (AGS62P1) given at three dosing schedules (Schedule A, every three weeks [Q3W] or Schedule B, every other week of a 4 week cycle [Q2W] or Schedule C once a week for 3 weeks of a 4 week cycle) in subjects with acute myeloid leukemia (AML) and determine the maximum tolerated dose (MTD). In addition, this study will assess the pharmacokinetics (PK), the immunogenicity and the anti-leukemic activity of ASP1235 (AGS62P1). ; DRUG USED: AGS62P1; DRUG CLASS: Biologic; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Antibody-drug Conjugate (ADC), FMS-like tyrosine kinase 3 (FLT-3) ; THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Global Development, Inc.; CRITERIA: Inclusion Criteria: - Subject has morphologically documented primary or secondary AML by the World Health Organization (WHO) criteria (2008) which is relapsed or refractory after failing at least 1 regimen and is not a candidate for established salvage treatment regimens. For expansion cohorts, patients are eligible if they have had ≤ 3 prior lines of therapy. Lines of therapy include initial induction (up to 2 cycles) with consolidation/maintenance, if applicable, and subsequent salvage regimens. Consolidation alone and stem cell transplantation are not counted as lines of therapy. - Subject has an Eastern Cooperative Oncology Group performance score (ECOG) ≤ 2 - Subject has adequate renal function with an estimated creatinine clearance of ≥ 30 mL/min by the Cockcroft-Gault equation adjusted for body weight - Subject has a total bilirubin ≤ 1.5 x upper limit of normal (ULN), albumin ≥ 2.5 g/d, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) - Subjects must be competent to comprehend, provide written informed consent, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form - A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies: - Not a woman of childbearing potential (WOCBP) OR - WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final study drug administration. - Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration. - Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration. - A male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration. - A male subject must not donate sperm during the treatment period and for at least 6 months after the final study drug administration. - Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration. Exclusion Criteria: - Subject has a diagnosis of acute promyelocytic leukemia (APL) - Subject has preexisting sensory or motor neuropathy Grade ≥ 2 at baseline - Subject has received small molecule therapy, radiotherapy, immunotherapy, monoclonal antibodies, investigational drug, or chemotherapy within 14 days before first dose of study drug, with the exception of hydroxyurea - Subject has any Grade ≥ 2 persistent non-hematological toxicity related to allotransplant - Subject with Graft vs. Host Disease (GVHD) who is receiving treatment with systemic glucocorticoids > 10 mg/day equivalent of prednisone; however, treatment with low dose glucocorticoids (≤ 10 mg/day equivalent of prednisone) is permitted - The use of systemic glucocorticoids in excess of 10 mg/day equivalent of prednisone is permitted provided it is not for the treatment of GVHD (e.g. chronic obstructive pulmonary disease, anti-emetic, infusion reactions). The chronic use of topical, inhaled, and locally injected steroids is permitted - Subject has known current central nervous system (CNS) disease - Active angina or Class III or IV Congestive Heart Failure (CHF) (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of the first dose of study drug, including myocardial infarction, unstable angina, Grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrhythmias not controlled by medication - Subject has clinical evidence of Disseminated Intravascular Coagulation - Subject has known positivity for human immunodeficiency virus - Subject has known active hepatitis B (positive hepatitis B surface antigen [HBs Ag]) or C infection. For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded. Subjects with positive serology but negative hepatitis C virus (HCV) ribonucleic acid (RNA) test results are eligible. - Subject has an uncontrolled active infection requiring treatment and grade 3 or higher fever 48 hours before the first dose of study drug. Controlled infections (i.e. 3 negative cultures completing antibiotics and/or stable fungal infection in therapy) are allowed provided the subject has a temperature of < 38.3°C within 48 hours of the first dose of study drug. - Subject has a known sensitivity to any of the components of the investigational product ASP1235 (AGS62P1): - ASP1235 (AGS62P1) - L-Histidine base - L-Histidine HCl - α, α -Trehalose Dihydrate - Polysorbate 20 - Major surgery within 28 days of the first dose of study drug - Subject is pregnant or lactating - Subject has a condition or situation which may put the subject at significant risk, may confound the study results, or may interfere significantly with subjects participation in the study - Subject has any medical, psychiatric, addictive or other disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures - Subject has ocular condition such as: - Active infection or corneal ulcer - Monocularity - History of corneal transplantation - Contact lens dependent (if using contact lens, must be able to switch to glasses during the entire study duration) - Uncontrolled glaucoma (topical medications allowed) - Uncontrolled or active ocular problems (e.g., retinopathy, macular edema, active uveitis, macular degeneration) requiring surgery, laser treatment, or intravitreal injections - Papilledema or other active optic nerve disorder ; PRIMARY OUTCOME: Incidence and nature of adverse events; SECONDARY OUTCOME 1: Incidence of antidrug antibody (ADA) formation to the fully human monoclonal antibody (AGS62P) and antibody-conjugate (ASP1235 [AGS62P1])[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Persistent (Adults/Adolescents); BRIEF: A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids. ; DRUG USED: Arnuity Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Signed informed consent - Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks prior to first visit - Both genders; females of child bearing potential must be willing to use appropriate contraception - Pre-bronchodilator FEV1 of 40-90% predicted - Reversibility FEV1 of at least 12% and 200mLs - Current asthma therapy that includes inhaled corticosteroid for at least 4 weeks prior to first visit Exclusion Criteria: - History of life threatening asthma - Respiratory infection or candidiasis - Asthma exacerbation requiring OCS within last 4 weeks or overnight hospital stay within the last 3 months - Concurrent respiratory disease or other disease that would confound study participation of affect subject safety - Allergies to study drugs, study drug excipients, medications related to study drugs - Taking another investigational medication or medication prohibited for use during the study - Previous treatment with FF or FF/VI in a phase II or III study - Night shift workers - Children in care ; PRIMARY OUTCOME: Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period; SECONDARY OUTCOME 1: Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Extension SAR245408/SAR245409; BRIEF: Primary Objective: The purpose of this study was to determine the long term safety and tolerability of SAR245408 and SAR245409 as a monotherapy or as part of a combination regimen in participants who were benefiting from treatment. ; DRUG USED: SAR245408; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: PI3K/AKT pathway; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : I 01. Males or females enrolled in Phase 1 or Phase 2 studies of SAR245408 or SAR245409 as monotherapy or in combination with other regimens who had completed data collection for the primary endpoint(s) of the parental study or who were being treated beyond the parental study cut-off and meet all the criteria to continue to be treated per the parental protocol. I 02. All sexually active participants (male and female) must agreed to continue to use accepted methods of barrier contraception (i.e., condoms) during the course of the study and for 3 months after discontinuation of study treatment. For women of childbearing potential and for men who could father a child, a second method of contraception in addition to a barrier method is recommended. Hormonal contraception should be avoided in participants taking SAR245408 due to possible drug-drug interaction. I 03. Female participants of childbearing potential must had a negative pregnancy test at baseline. Females of childbearing potential were defined as sexually mature women without prior hysterectomy or who had any evidence of menses in the past 12 months. However, women who had been amenorrheic for 12 or more months were still considered to be of childbearing potential if the amenorrhea was possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression. Exclusion criteria: E 01. The participant discontinued the parental study due to toxicity. E 02. Ongoing Grade 3 or higher Adverse Event (AE). E 03. Ongoing Serious Adverse Event (SAE). E 04. Participants with ongoing dose interruption for any reason unless the participant fulfilled the criteria in the parental protocol for restarting IMP. In such case participant started the treatment-extension study on Day 1 of the initiation period. E 05. The participant had any of the following laboratory values ≥ Common Terminology of Adverse Events (CTCAE) Grade 3 - Absolute neutrophil count (ANC), - Platelet count, - Hemoglobin, - Bilirubin, - Serum creatinine or calculated creatinine clearance, - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST), - Fasting plasma glucose (FPG), - Prothrombin time/international normalized ratio (PT/INR) and activated partial thromboplastin time (aPTT). E 06. The participant had a baseline corrected QT interval (QTc) >481 millisecond (msec) or if a participant has had a QTc interval increase of ≥ 60 msec from parental protocol baseline to an absolute value of > 470 msec. E 07. The participant had a known allergy or hypersensitivity to components of the study treatment formulation(s). E 08. The participant was pregnant or breastfeeding. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - persevERA (w/Palbociclib, ER+, HER2-); BRIEF: This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer. ; DRUG USED: Giredestrant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Estrogen, Selective Estrogen Receptor Degrader (SERD); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment - Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent - Documented ER-positive tumor and HER2-negative tumor, assessed locally - Patients who have bilateral breast cancers which are both ER-positive and HER2-negative can be included in the study because the metastases are suitably targeted by the study treatments. If patients have bilateral tumors which are of different biomarker status, then proof of the ER and HER2 status of the metastases is required for study entry - No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease - Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months - Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed - Eastern Cooperative Oncology Group Performance Status 0-1 - Adequate organ function Exclusion Criteria: - Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor - Prior treatment with a selective estrogen receptor degrader (SERD) - Treatment with any investigational therapy within 28 days prior to study treatment - Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization - Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term - Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease - Active cardiac disease or history of cardiac dysfunction, as defined in the protocol - Pregnant or breastfeeding ; PRIMARY OUTCOME: Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1; SECONDARY OUTCOME 1: Overall Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - At-Risk Adults Aged 18 to 65 (Germany); BRIEF: The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers). ; DRUG USED: Bexsero; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Group B; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Vaccines; CRITERIA: Inclusion Criteria: 1. 18 - 65 years of age inclusive who have given written informed consent at the time of enrollment; 2. Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period); 3. In good health as determined by medical history, physical examination and clinical judgment of the investigator; 4. Who are or might be routinely exposed to cultures of N. meningitidis serogroup B. Sponsors employees are considered eligible to participate in the trial as per inclusion criteria. Exclusion Criteria: 1. Pregnancy or nursing (breastfeeding) mothers; 2. Females of reproductive age who have not used or do not plan to use acceptable birth control measures, for the 3 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods for at least 60 days prior to study entry; 3. Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease); 4. Individuals with history of any progressive or severe neurologic disorder, or seizure disorder. A single episode of febrile convulsion is not an exclusion criteria; 5. History of any serogroup B meningococcal vaccine administration; 6. Previous known or suspected disease caused by N. meningitidis; 7. History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine; 8. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example): - Receipt of any chronic immunosuppressive therapy - Receipt of any chronic immunostimulants - Immune deficiency disorder, or known HIV infection 9. Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study; 10. History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study; 11. Any significant chronic infection; 12. Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time; 13. Family members and household members of research staff; 14. Participation in another clinical trial within the last 30 days or planned for during study. ; PRIMARY OUTCOME: Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib - PROMPT (Pediatric, blood cancers); BRIEF: This is an open-label, safety study of a single ProHema-CB product administered following myeloablative conditioning regimen in pediatric subjects with hematologic malignancies. ; DRUG USED: ProHema; DRUG CLASS: Biologic; INDICATION: Bone Marrow Transplant and Stem Cell Transplant; TARGET: Prostaglandin E Receptor 2 (PTGER2), Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Fate Therapeutics; CRITERIA: Inclusion Criteria: 1. Male and female subjects aged 1 to 18 years, inclusive. 2. Subjects with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate. 1. Acute Myelogenous Leukemia (AML) in high risk 1st or subsequent CR 2. Acute Lymphoblastic Leukemia (ALL) in CR 3. NK cell lymphoblastic leukemia in any CR 4. Biphenotypic or undifferentiated leukemia in 1st or subsequent CR 5. Myelodysplastic Syndrome (MDS) at any stage. 6. Chronic Myelogenous Leukemia (CML) All subjects with evidence of CNS leukemia must be treated and be in CNS CR to be eligible for trial. 3. Lack of 5-6/6 HLA matched related or 8/8 HLA A, B, C, DRß1 matched unrelated donor; or unrelated donor not available within appropriate timeframe, as determined by the transplant physician. 4. Availability of suitable primary and secondary umbilical cord blood (UCB) units. 5. Adequate performance status, defined as: 1. Subjects ≥ 16 years: Karnofsky score ≥ 70%. 2. Subjects < 16 years: Lansky score ≥ 70%. 6. Cardiac: Left ventricular ejection fraction at rest must be > 40%, or shortening fraction > 26%. 7. Pulmonary: 1. Subjects > 10 years: DLCO (diffusion capacity) > 50% of predicted (corrected for hemoglobin) 2. FEV1, FVC > 50% of predicted; Note: If unable to perform pulmonary tests, then O2 saturation > 92% on room air. 8. Renal: Serum creatinine within normal range for age, or if serum creatinine outside normal range for age, then renal function (creatinine clearance or GFR) > 70mL/min/1.73m2. 9. Hepatic: Bilirubin ≤ 2.5 mg/dL (except in the case of Gilberts syndrome or ongoing hemolytic anemia); and ALT, AST and Alkaline Phosphatase ≤ 5 × ULN. 10. Signed IRB approved Informed Consent Form (ICF). Exclusion Criteria: 1. Female subjects that are pregnant or breastfeeding. 2. Evidence of HIV infection or HIV positive serology. 3. Current uncontrolled bacterial, viral or fungal infection. 4. Prior allogeneic hematopoietic stem cell transplant. 5. Autologous transplant < 12 months prior to enrollment. 6. Prior autologous transplant for the disease for which the UCB transplant is being performed. 7. Active malignancy other than the one for which the UCB transplant is being performed within 12 months of enrollment. 8. Inability to receive TBI. 9. Requirement of supplemental oxygen. 10. HLA-matched related donor able to donate. 11. Use of an investigational drug within 30 days prior to screening. 12. Subject is unlikely to comply with the protocol requirements, instructions and study-related restrictions ; PRIMARY OUTCOME: Safety Profile, Primarily Assessed by Neutrophil Engraftment; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - PROTON (w/PegIFN + RBV, 24-48 weeks); BRIEF: Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA < lower limit of detection [15 IU/mL] from Weeks 4 through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV. Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus PEG+RBV for 12 weeks. ; DRUG USED: Sovaldi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Males or females aged 18 to 70 years, inclusive, at screening - Documented chronic genotype 1, 2, or 3 HCV infection - No previous treatment with HCV antiviral mediations - Body mass index (BMI) of greater than 18 kg/m2, but not exceeding 36 kg/m2. - Liver biopsy obtained within 3 years prior to the Day 1 visit, with a fibrosis classification of non-cirrhotic as judged by a local pathologist - Willing to refrain from beginning any new exercise regimens during the first 3 months of the study - Fasting blood glucose ≤ 300 mg/dl and/or glycosylated hemoglobin (HbA1c) ≤ 8 - History of hypertension only if managed effectively on a stable regimen of two or fewer antihypertensives for at least three (3) months prior to screening Exclusion Criteria: - Females who were breastfeeding - Males and females of reproductive potential who are unwilling to use an effective, protocol-specified method(s) of contraception during the study - Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab. - History of any other clinically significant chronic liver disease - Treatment with herbal/natural remedies with antiviral activity within 30 days prior to baseline. - Significant history of immunologically mediated disease, cardiac or pulmonary disease, seizure disorder or anticonvulsant use - History of ascites, variceal hemorrhage, hepatic encephalopathy, or conditions consistent with decompensated liver disease - Use of medications associated with QT prolongation within 30 days prior to dosing - Screening electrocardiogram (ECG) QTc value greater than 450 ms and/or clinically significant ECG findings - Personal or family history of Torsade de pointes. - Positive results for drugs of abuse test at screening - Abnormal hematological and biochemical parameters, including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 5 times the upper limit of the normal range (ULN) - History of major organ transplantation with an existing functional graft - History of uncontrolled thyroid disease or abnormal thyroid-stimulating hormone (TSH) levels at screening - Clinically significant drug allergy to nucleoside/nucleotide analogs - History or current evidence of psychiatric illness, immunologic disorder, pulmonary, cardiac disease, seizure disorder, cancer or history of malignancy that in the opinion of the investigator makes the patient unsuitable for the study - History of systemic antineoplastic or immunomodulatory treatment within 6 months prior to dosing, or the expectation of such treatment during the study ; PRIMARY OUTCOME: Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period; SECONDARY OUTCOME 1: Change in HCV RNA From Baseline to Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Onset 8; BRIEF: This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in combination with insulin degludec in adults with Type 1 Diabetes Mellitus. ; DRUG USED: FIAsp; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female, age greater than or equal to 18 years ( for Japan and Taiwan: age greater than or equal to 20 years) at the time of signing informed consent - Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) 12 months or more prior to screening - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index less than or equal to 35.0 kg/m^2 Exclusion Criteria: - Within the past 180 days any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack - Subjects presently classified as being in New York Heart Association (NYHA) Class IV Currently planned coronary, carotid or peripheral artery revascularisation - Diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening (Visit 1) - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of three months before screening (Visit 1) ; PRIMARY OUTCOME: Change From Baseline in HbA1c 26 Weeks After Randomisation; SECONDARY OUTCOME 1: Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Same-Day Dosing; BRIEF: The purpose of this study is to compare the effect of Eflapegrastim on duration of neutropenia in patients with early-stage breast cancer when administered at varying intervals following Docetaxel and Cyclophosphamide administration. ; DRUG USED: Rolontis; DRUG CLASS: Biologic; INDICATION: Neutropenia / Leukopenia; TARGET: Granulocyte-colony Stimulating Factor (G-CSFR)/CD114; THERAPY: Monotherapy; LEAD SPONSOR: Spectrum Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: - Willing and capable of giving written Informed Consent and able to adhere to study drug dosing time and blood draw schedules - New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer - Candidate to receive adjuvant or neoadjuvant TC chemotherapy - Age must be at least 18 years for the Early Phase, and between 18 to ≤55 years for the Expansion Phase - ANC ≥1.5×10^9/liter (L). - Platelet count ≥100×10^9/liter (L). - Hemoglobin >10 grams per deciliter (g/dL). - Calculated creatinine clearance >50 milliliter per minute (mL/min). - Total bilirubin ≤1.5 milligrams per deciliter (mg/dL). - Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤2.5×upper limit of normal (ULN). - Alkaline phosphatase ≤2.0×ULN. - Eastern Cooperative Oncology Group (ECOG) ≤2 - Willing to practice 2 forms of contraceptives (1 must be a barrier method), from study entry through 30 days after last dose of study drug/ early discontinuation - Negative urine pregnancy test within 30 days before randomization Exclusion Criteria: - Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease - Known sensitivity to Escherichia coli (E. coli) derived products - Concurrent adjuvant cancer therapy other than the trial-specified therapies - Locally recurrent/metastatic breast cancer - Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 3 months prior to the administration of study drug - Receiving anti-infectives, has an underlying medical condition or other serious illness that would impair the ability to receive protocol-specified treatment - Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study - Prior bone marrow or stem cell transplant - Prior radiation therapy within 30 days prior to enrollment - Major surgery within 30 days prior to enrollment - Pregnant or breastfeeding ; PRIMARY OUTCOME: Time to Recovery of Absolute Neutrophil Count (ANC) From Nadir to ≥1.5×10^9/L in Cycle 1; SECONDARY OUTCOME 1: Duration of Grade 4 Neutropenia (DSN) in Cycle 1[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 16568 (higher doses); BRIEF: The purpose of this study is to evaluate the efficacy and safety of investigational doses of dulaglutide in participants with type 2 diabetes on metformin monotherapy. ; DRUG USED: Trulicity; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification - Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory - Have been treated with stable doses of metformin for at least 3 months - Have a body mass index (BMI) ≥25 kilograms per square meter Exclusion Criteria: - Have type 1 diabetes (T1D) - Have used any glucose-lowering medication other than metformin 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past - Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke) - Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial - Have had chronic or acute pancreatitis any time prior to study entry - Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation - Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c (HbA1c); SECONDARY OUTCOME 1: Percentage of Participants With HbA1c of <7.0%[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - T-Force Green; BRIEF: Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of NBI-98854 administered once daily (qd) for a total of 6 weeks of treatment. This study will enroll approximately 90 male and female pediatric subjects clinically diagnosed with Tourette Syndrome. ; DRUG USED: Ingrezza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Tourettes Syndrome; TARGET: Vesicular monamine transporters (VMATs); THERAPY: Monotherapy; LEAD SPONSOR: Neurocrine Biosciences; CRITERIA: Inclusion Criteria: 1. Have a clinical diagnosis of Tourette Syndrome (TS) 2. Have at least moderate tic severity 3. Have TS symptoms that impair school, occupational, and/or social function 4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]), be on stable doses 5. Be in good general health 6. Adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen 7. Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study Exclusion Criteria: 1. Have an active, clinically significant unstable medical condition within 1 month prior to screening 2. Have a known history of long QT syndrome or cardiac arrhythmia 3. Have a known history of neuroleptic malignant syndrome 4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed) 5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors 6. Have a blood loss ≥250 mL or donated blood within 30 days prior to screening 7. Have a known history of substance dependence, substance (drug) or alcohol abuse 8. Have a significant risk of suicidal or violent behavior 9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study 10. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study ; PRIMARY OUTCOME: Change From Baseline to Week 6 in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS); SECONDARY OUTCOME 1: Clinical Global Impression of Tourette Syndrome (CGI-TS) - Improvement Score at Week 6[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 006 - Myeloid Blast Phase; BRIEF: The purpose of this study is to see what effect an investigational drug (BMS-354825) has on subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (CML) and who are either resistant to or intolerant of imatinib mesylate. Another purpose of the study is to see what side effects this drug may have on subjects. ; DRUG USED: Sprycel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Myelogenous Leukemia (CML); TARGET: BCR-ABL Fusion Protein, Src Kinase Family, Tyrosine Kinases; THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Subjects with myeloid blast phase chronic myeloid leukemia - Subjects who are either resistant or intolerant of imatinib mesylate Exclusion Criteria: - Subjects who are eligible and willing to undergo transplantation - Serious uncontrolled medical disorder or active infection - Uncontrolled or significant heart problems, such as congestive heart failure, recent heart attack, etc - Subjects receiving medications that may affect heart rhythm - Other malignancy/cancer other than CML - History of significant bleeding disorder unrelated to CML - Pregnant or breastfeeding women (subjects must avoid becoming pregnant) - Subjects received imatinib within 7 days, interferon or cytarabine within 14 days, a targeted anticancer medication within 14 days, an antineoplastic agent (other than hydroxyurea or anagrelide) within 28 days, or any other investigation medication in 28 days - Subject is receiving medications that affect platelet function or an anticoagulant ; PRIMARY OUTCOME: Major and Overall Hematologic Response (MaHR and OHR); SECONDARY OUTCOME 1: Median Duration of Major Hematologic Response (MaHR)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - PAGANINI; BRIEF: Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC). Study drug BAY1817080 is a new drug under development for the treatment of long-standing cough. It blocks proteins that are expressed by the airway sensory nerves which are oversensitive in patients with long-standing cough. This prevents the urge to cough. Researchers also want to learn the safety of the study drug and how well it works in reducing the cough frequency, severity and urge-to-cough. Participants in this study will receive either the study drug or placebo (a placebo looks like the test drug but does not have any medicine in it) tablets twice daily for 12 weeks. Observation for each participant will last about 18 weeks in total. Participants will be asked to wear a digital device to record the cough and to complete questionnaires every day to document the symptoms. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug. ; DRUG USED: BAY-1817080; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Cough; TARGET: P2 (Purine) Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Adults ≥ 18 years of age at the time of signing the informed consent. - A cough that has lasted for at least 12 months (unresponsive to treatment options) with a diagnosis of refractory chronic cough and/or idiopathic (unexplained) chronic cough. - Persistent cough for at least the last 8 weeks before screening. - Women of childbearing potential must agree to use acceptable effective or highly effective birth control methods during the study and for at least 30 days after the last dose. - Capable of giving signed informed consent. Exclusion Criteria: - Smoking history within the last 12 months before screening (all forms of smoking, including e-cigarettes, cannabis and others), and any former smoker with more than 20 pack-years. - Ongoing or previous exposure to inhalational toxic fumes (e.g., ammonia, chlorine, nitrogen dioxide, phosgene and sulfur dioxide) within the last 12 months before screening. - Respiratory tract infection within 4 weeks before screening. - History of chronic bronchitis. - Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening visit. - Positive SARS-CoV-2 virus RNA and/or serology IgG tests at screening visit. ; PRIMARY OUTCOME: Change From Baseline in 24-hour Cough Count After 12 Weeks of Intervention; SECONDARY OUTCOME 1: Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Cough Count After 12 Weeks of Intervention[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - AVN007; BRIEF: This is a multiple dose clinical study to be conducted with SRX246 capsules to determine the safety, tolerability and pharmacokinetics of the drug over a 14 day dosing period. ; DRUG USED: SRX246; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psychiatric Disorder or Disease; TARGET: Vasopressin receptors; THERAPY: Monotherapy; LEAD SPONSOR: Azevan Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Males and non-pregnant, non-lactating females of non-childbearing potential. Female patients should be either post-menopausal or surgically sterile. 2. Age ≥18 and ≤55 years. 3. Body mass index (BMI) of 18.5 to 34.0 kg/m2, inclusive, and a total body weight of >50kg (110 pounds). 4. In good health as determined by medical history, a baseline physical examination, vital signs, clinical laboratory tests and electrocardiogram (ECG) measurement. 5. Subject is willing and able to sign written informed consent prior to receipt of any study medication or beginning study procedures. 6. Subject is willing and able to follow instructions, comply with the protocol requirements and make all required study visits. Exclusion Criteria: 1. Pregnant or lactating females, or females of childbearing potential. 2. Subject is positive for HIV, hepatitis B surface antigen or hepatitis C antibody tests at screening. 3. Subject with a positive urine test for drugs of abuse or alcohol at screening or at admission to the clinic on study Day -1. 4. Evidence of any out-of range laboratory value at screening that has not been reviewed, approved and documented as not clinically significant by the Principal Investigator. 5. Subject who has resting supine blood pressure outside of a systolic blood pressure range of 90-140 mmHg or a diastolic blood pressure outside a range of 50-90 mmHg on two consecutive measurements taken up to 10 minutes apart. 6. Subject who has resting supine pulse rate greater than 100 bpm or less than 50 bpm on two consecutive measurements taken up to 10 minutes apart. 7. Subject has taken any alcohol within 48 hours of ANY study-related activities AND cannot abstain from drinking alcohol during the entire duration of the subjects study participation. 8. Subject has used any tobacco products in the past 12 months. 9. A history of significant drug allergy or systemic allergic disease (e.g., urticaria, atopic dermatitis). 10. A general medical or psychological condition or behavior, including current substance dependence or abuse that, in the opinion of the investigator, might not permit the subject to complete the study or sign the informed consent. 11. Any clinically significant abnormality on screening resting 12-lead ECG (e.g., heart block, conduction disorders, ventricular and/or atrial arrhythmias). 12. Any other condition or clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening that, in the opinion of the Principal Investigator or the Physician Sub-Investigator, would make the subject unsuitable for the study or put them at additional risk. 13. Routine or PRN consumption of medications or herbal supplements that the subject is unable or unwilling to discontinue during the study. 14. Inability to understand or follow study instructions. 15. Treatment with an investigational drug within 30 days preceding the first dose of study medication. 16. Known allergy or hypersensitivity to the investigational study drug/placebo components. ; PRIMARY OUTCOME: Safety will be determined by performing vital sign measurements, ECGs, complete physical examinations, hematology and clinical chemistry tests, and recording of any reported adverse experiences.; SECONDARY OUTCOME 1: Pharmacokinetics of SRX246 will be determined by taking periodic blood samples for measurement of SRX246 levels.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - vs. Vancomycin; BRIEF: The purpose of this study is to compare the clinical cure rates of two dosing regimens of iclaprim with vancomycin (every 12 hours [q12h]) in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), or health-care-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens. ; DRUG USED: Iclaprim (IV); DRUG CLASS: New Molecular Entity (NME); INDICATION: Hospital Acquired (Nosocomial) Pneumonia (HAP) (Antibacterial); TARGET: Dihydrofolate reductase (DHFR); THERAPY: Monotherapy; LEAD SPONSOR: Arpida AG; CRITERIA: Inclusion Criteria: - Suspected or confirmed acute bacterial pneumonia due to Gram-positive pathogens in one of the following subgroups: - hospital-acquired pneumonia (HAP), i.e., pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission; or - ventilator-associated pneumonia (VAP), i.e., pneumonia that arises more than 48 hours after endotracheal intubation; or - health-care-associated pneumonia (HCAP), i.e., pneumonia diagnosed within 48 hours of hospital admission, in a patient who fulfills at least one of the following criteria: 1. hospitalization for at least two days within 90 days of the current infection, 2. residence in a nursing home or long-term care facility, 3. recipient of intravenous antibiotic therapy, chemotherapy, or wound care within 30 days of the current infection Exclusion Criteria: - Acute Physiology and Chronic Health Enquiry (APACHE) II score < 8 or ≥ 25. - Pneumonia not requiring empiric or targeted treatment effective against Gram-positive pathogens. - Pulmonary infection due to Gram-positive organisms known to be resistant to either study medication prior to study entry. ; PRIMARY OUTCOME: Efficacy: Clinical cure rate - comparison of the two iclaprim dosing regimens versus vancomycin; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Study 0110; BRIEF: A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild, moderate, or severe renal impairment disease and healthy subjects with normal renal function. ; DRUG USED: Oxbryta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Disease / Renal Failure; TARGET: Hemoglobin; THERAPY: Monotherapy; LEAD SPONSOR: Global Blood Therapeutics; CRITERIA: Inclusion Criteria: All subjects: - Males or females, 18 to 80 years old - Willing and able to give written informed consent Subjects with renal impairment: - Severe renal impairment (eGFR < 30 mL/min/1.73m2, not on dialysis) - Moderate renal impairment (30 mL/min/1.73m2 = or < eGFR < 60 mL/min/1.73m2) - Mild renal impairment (60 mL/min/1.73m2 = or < eGFR < 90 mL/min/1.73m2) Healthy subjects: - Match in age, gender and body mass index with renal impaired subjects - Healthy and without clinically significant abnormalities in vital signs, ECGs, physical exam, clinical laboratory evaluations, medical and surgical history Exclusion Criteria: All subjects: - Participation in another clinical trial of an investigational drug (or medical device) within 30 days of the last dose of investigational drug or 5 half lives whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device) - Any signs or symptoms of acute illness at screening or Day -1 - History or presence of clinically significant allergic, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease Subjects with renal impairment: - History of clinically significant hepatic disease e.g. hepatitis, cirrhosis and or liver enzymes (ALT, AST, GGT and total bilirubin) > 5 times the upper limit of normal within the past year ; PRIMARY OUTCOME: Cmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function; SECONDARY OUTCOME 1: Number of subjects with treatment-related Adverse events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - ST-001; BRIEF: Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion, First-In-Human (FIH) clinical study of CC-90011 in subjects with advanced unresectable solid tumors (enriched for grade 2 NENs, grade 2 NETs and NECs) and R/R NHL (MZL, including extranodal MZL [EMZL], splenic MZL [SMZL], nodal MZL [NMZL], and histologic transformation of MZL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90011 to estimate the maximum tolerated dose (MTD) of CC-90011. The expansion part (Part B) will further evaluate the safety and efficacy of CC-90011 administered at or below the MTD in 3 selected expansion cohorts of approximately 10-20 evaluable subjects each, in order to further define the RP2D. ; DRUG USED: CC-90011; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Lysine-specific demethylase-1 (LSD1)/KDM1A; THERAPY: Monotherapy; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: - Advanced or unresectable solid tumors including those who have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy or for whom no other approved conventional therapy exists - Eastern Cooperative Oncology Group Performance Status of 0 to 1 Exclusion Criteria: - Prior autologous stem cell transplant ≤ 3 months before first dose or those who have not recovered - Symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and gastrointestinal tract hemorrhages - Impaired cardiac function or clinically significant cardiac diseases - Poor bone marrow reserve as assessed by Investigator Refer to protocol defined exclusion criteria for parts C and D. Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Dose-Limiting Toxicity (DLT); SECONDARY OUTCOME 1: Clinical Benefit Rate (CBR) determined by response and stable disease rates by disease appropriate response criteria[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - OPH 1000 ; BRIEF: The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of E10030 intravitreous injection when administered as monotherapy or in combination with Lucentis® 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD). ; DRUG USED: Fovista; DRUG CLASS: New Molecular Entity (NME); INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: Platelet-derived growth factor (PDGF); THERAPY: Monotherapy; LEAD SPONSOR: Ophthotech Corporation; CRITERIA: Inclusion Criteria: Subfoveal choroidal neovascularization (CNV) due to AMD Exclusion Criteria: - Any of the following underlying diseases including: - Diabetic retinopathy. - History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 19.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months, ventricular tachyarrythmias requiring ongoing treatment. - History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation. - Clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function. - Stroke (within 12 months of trial entry). - Any major surgical procedure within one month of trial entry. Previous therapeutic radiation in the region of the study eye. Any treatment with an investigational agent in the past 60 days for any condition. Known serious allergies to the fluorescein dye used in angiography, to the components of the ranibizumab formulation, or to the components of the E10030 formulation. ; PRIMARY OUTCOME: Ophthalmic DLTs; SECONDARY OUTCOME 1: adverse events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SPIRE-FH; BRIEF: This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C. ; DRUG USED: Bococizumab; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Treated with a statin. - Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL. - High or very high risk of incurring a cardiovascular event. - Heterozygous familial hypercholesterolemia. Exclusion Criteria: - Pregnant or breastfeeding females. - Cardiovascular or cerebrovascular event of procedures during the past 30 days. - Congestive heart failure NYHA class IV. - Poorly controlled hypertension. ; PRIMARY OUTCOME: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12; SECONDARY OUTCOME 1: Percent Change From Baseline in Total Cholesterol (TC) at Week 12[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III (Progenics); BRIEF: To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen. ; DRUG USED: Relistor IV; DRUG CLASS: Non-NME; INDICATION: Postoperative Ileus; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Bausch Health Americas, Inc.; CRITERIA: Inclusion Criteria: - Male and female participants at least 18 years of age. - All participants must meet American Society of Anesthesiologists (ASA) physical status I, II, or III. - Participants must sign an informed consent form (ICF). - Participants must be scheduled for a segmental colectomy via open laparotomy with general anesthesia. - Females of childbearing potential must have a negative serum pregnancy test at the screening visit. - Negative for history of chronic active hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection. Exclusion Criteria: - Participants who received any investigational new drug in the 30 days prior to screening visit. - Females who are pregnant or lactating. ; PRIMARY OUTCOME: Time to First Bowel Movement; SECONDARY OUTCOME 1: Time to Discharge Eligibility[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - +/- Rituximab or Obinutuzumab; BRIEF: This Phase 1/2, multicenter, open-label study to evaluate CC-220 alone, as well as in combination with an anti-CD20 mAb (rituximab or obinutuzumab) in subjects with relapsed or refractory (R/R) lymphoma. Subjects must have received at least 2 prior lines of therapy, and have at least one measurable lesion according to Lugano 2014 classification. Study will consist of two parts: Part 1 (Dose Escalation) which will be followed by Part 2 (Dose Expansion). ; DRUG USED: Iberdomide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hematologic Cancer; TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Has histologically confirmed (per local evaluation) diagnosis of lymphoma according to 2016 World Health Organization (WHO) classification including: 1. Cohort A: all subtypes including B-cell, T-cell and Natural killer (NK)-cell Non-Hodgkin lymphoma (NHL), and Classical Hodgkin lymphoma (cHL). 2. Cohort B: all B-cell NHL. 3. Cohort C: FL Grade 1-3a and MZL including extranodal marginal zone lymphoma (ENMZL) of mucosa-associated lymphoid tissue (MALT lymphoma), nodal marginal zone lymphoma (NMZL) and splenic marginal zone lymphoma (SMZL) 4. Cohort D: aggressive B-cell lymphoma and FL grade 1-3a 5. Cohort E: aggressive B-cell lymphoma including DLBCL NOS, high-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements, Grade 3b FL and PMBCL 6. Cohorts F and G: FL Grade 1 to 3a 3. Relapsed or refractory disease according to the following definitions: 1. Aggressive B-cell lymphoma 2. Follicular lymphoma (FL) and Marginal zone lymphoma (MZL): following at least 2 prior lines of systemic therapy (being previously exposed to at least 1 anti-CD20 mAb and 1 alkylating agent). 3. Mantle cell lymphoma (MCL): following at least 2 prior lines of therapy including at least 1 immunochemotherapy and 1 bruton tyrosine kinase (BTK) inhibitor. 4. Peripheral T-cell lymphoma (PTCL): following at least 2 prior lines of therapy OR after 1 prior line of standard therapy and being not eligible for any other approved regimen. 5. Classical Hodgkin lymphoma (cHL): following at least 2 prior systemic lines of therapy and previously exposed to brentuximab vedotin and anti-PD1. 6. All other subtypes: following at least 2 prior lines of therapy. 7. Subjects previously treated with CAR-T therapy can be enrolled (irrespective of the indication). 4. Subjects must not be eligible for any other approved treatment for their underlying lymphoma as assessed by the Investigator. 5. Must have measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification. Site of measurable disease cannot be previously irradiated. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. 7. Must have the following laboratory values: 1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L or ≥ 1.0 x 109/L 2. Hemoglobin (Hb) ≥ 8 g/dL. 3. Platelets (Plt) ≥ 75 x 109/L or ≥ 50 x 109/L 4. Aspartate aminotransferase / serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase / serum glutamic pyruvic transaminase (ALT/SGPT) ≤ 2.5 x ULN. 5. Serum total bilirubin ≤ 1.5 ULN except in cases of Gilberts syndrome, then ≤ 3.0 ULN. 6. Estimated serum creatinine clearance of ≥ 50 mL/min 8. All subjects must: 1. Have an understanding that the study drug could have a potential teratogenic risk. 2. Agree to follow all requirements defined in the Pregnancy Prevention Program for CC-220 Pregnancy Prevention Plan for Subjects in Clinical Trials. 9. Females of childbearing potential (FCBP1) must: a. Have 2 negative pregnancy tests as verified by the Investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. 10. Male subjects must: 1. Practice true abstinence2 or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment: 1. Any significant medical condition, active infection (including severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2) suspected or confirmed, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 2. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 3. Life expectancy ≤ 3 months. 4. Diagnosis of lymphoblastic lymphoma. 5. Aggressive lymphoma relapse requiring immediate cytoreductive therapy to avoid potential life-threatening consequences (eg, due to tumor location). 6. Prior Grade 3 or 4 infusion related reaction with rituximab (for Cohorts B, E and F) or obinutuzumab (for Cohorts C and G). 7. Prior therapy with the cereblon-modulating drug CC-99282. 8. Chronic systemic immunosuppressive therapy or corticosteroids. 9. Prior ASCT ≤ 3 months prior to starting CC-220 or > 3 months AND with unresolved, Grade > 1, treatment-related toxicity. 10. Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-220 or > 6 months with unresolved, Grade > 1, treatment-related toxicity. 11. Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients of rituximab or obinutuzumab. 12. Known allergy to thalidomide, pomalidomide or lenalidomide. 13. Inability or unwilling to undergo protocol required thromboembolism prophylaxis. 14. Major surgery ≤ 2 weeks prior to starting CC-220; 15. Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v5.0). 16. Documented or suspected central nervous system (CNS) involvement of disease. 17. Subject with clinically significant cardiac disease. 18. Known seropositivity for or active viral infection with human immunodeficiency virus (HIV). 19. Known chronic active hepatitis B 20. History of other malignancy, unless the subject has been free of the disease for ≥ 3 years; exceptions to the ≥ 3-year time limit include history of the following: 1. Incidental histologic finding of prostate cancer (or prostate cancer that has been treated with curative intent Other protocol defined inclusion/exclusion criteria could apply ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD); SECONDARY OUTCOME 1: Adverse Events (AEs)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - TULIP-LN1; BRIEF: The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN). ; DRUG USED: Saphnelo; DRUG CLASS: Biologic; INDICATION: Lupus Nephritis; TARGET: Interferon-alpha (IFNa); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Main Inclusion Criteria: 1. Age 18 through 70 years at the time of screening 2. Fulfils at least 4 of the 11 criteria of the revised 1982 ACR classification criteria for SLE, at least one of which must be: 1. Positive antinuclear antibody (ANA) test (1:40 or higher) or 2. Elevated anti-dsDNA antibodies at screening (reported as equivocal or positive results), as per the centrallaboratory; or 3. Anti-Smith antibody at screening elevated to above normal (ie, positive or equivocal results) as per the central laboratory 3. Class III (±Class V) or Class IV (±Class V) LN according to the World Health Organisation (WHO) or 2003 ISN/RPS classification based on a renal biopsy obtained within 12 weeks prior to signing the ICF or during the screening period: 4. Urine protein to creatinine ratio >1 gm/gm (113.17 mg/mmol), obtained on a 24-hour urine collection at screening 5. Estimated glomerular filtration rate ≥35 mL/min/1.73 m2 6. Must not have active or latent TB on either chest radiograph or by Quantiferon gold test 7. Women of childbearing potential must have a negative serum beta-hCG test at screening and negative urine pregnancy test prior to the first dose of sponsor-provided MMF. Main Exclusion Criteria: 1. Receipt of any investigational product (small molecule or biologic) or commercially available biologic agent within four weeks or 5 half lives prior to signing of the ICF, whichever is greater 2. Pure Class V membranous LN on a renal biopsy obtained within 12 weeks prior to signing ICF or during the screening period 3. Known intolerance to ≤1.0 gm/day of MMF 4. History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6 month period after enrolment 5. Subjects, who at the time of signing the ICF, received any of the following immunosuppressive therapies after their qualifying biopsy 1. Oral corticosteroids >0.5 mg/kg/day for more than 8 weeks or 2. Oral or IV pulse methylprednisolone >3.0 gm (cumulative dose) or 3. IV cyclophosphamide >2 pulses of high-dose (≥0.5 gm/m2) or >4 doses of low dose (500 mg every 2 weeks) or 4. Average MMF >2.5 gm/day (>1800 mg/day of enteric-coated mycophenolate sodium) for more than 8 weeks or 5. Tacrolimus >4 mg/day for more than 8 weeks 6. Major surgery within 8 weeks before signing the ICF or major surgery planned during the study period 7. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF 8. Confirmed positive test for hepatitis B or hepatitis C 9. Any severe herpes infection at any time prior to randomization 10. Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years prior to randomization (vaginal, oral and skin candidiasis is not an exclusionreason). 11. History of cancer, apart from: 1. Squamous or basal cell carcinoma of the skin that has been successfully treated 2. Cervical cancer in situ that has been successfully treated 12. Concurrent enrolment in another clinical study with an IP within 4 weeks prior to ICF signing or within 5 half-lives of the IP used in that clinical study, whichever is longer. 13. During screening (within 30 days before Day 1 [Week 0 visit]), any of the following: 1. Aspartate transaminase (AST) >2.5×upper limit of normal (ULN) 2. Alanine transaminase (ALT) >2.5×ULN 3. Total bilirubin >ULN (unless due to Gilberts syndrome [based on Investigators judgement]) 4. Glycosylated haemoglobin (HbA1c) >8% (or >0.08) at screening (diabetic subjects only) 5. Neutrophil count <1x103/μL (or <1.0 GI/L) 6. Platelet count <25x103/μL (or <25 GI/L) 7. Haemoglobin <8 g/dL (or <80 g/L). ; PRIMARY OUTCOME: Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR); SECONDARY OUTCOME 1: Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 1293.10; BRIEF: The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development. ; DRUG USED: BI 655064; DRUG CLASS: Biologic; INDICATION: Lupus Nephritis; TARGET: Cluster of Differentiation 40 (CD40); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Males and females 18-70 years. Women of childbearing potential must be ready and able (as assessed by investigator) to use simultaneously two reliable methods of birth control, one of which must be highly effective. Highly effective method, per ICH M3(R2) is a method that result in a low failure rate of less than 1% per year when used consistently and correctly. - Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology (ACR) criteria 1997, at least 4 criteria must be documented, one of which must be a positive anti-dsDNA antibody OR a positive antinuclear antibody (ANA) at screening or around time of start of induction therapy - Lupus Nephritis Class III or IV (International Society of Nephrology (ISN)/Renal Pathology Society (RPS) -2003 classification) with either active or active/chronic disease, co-existing class V permitted, proven by renal biopsy within 3 months prior to screening or during screening if induction therapy has not yet been started - Active renal disease evidenced by proteinuria ≥ 1.0 g/day [(Uprot/Ucrea) ≥ 1] - Signed and dated written informed consent Exclusion criteria: - Clinically significant current other renal disease - Glomerular Filtration Rate <30ml/min/1.73m² - Dialysis within 12m of screening - Antiphospholipid syndrome - Diabetes mellitus poorly controlled or known diabetic retinopathy or nephropathy - Evidence of current or previous clinically significant disease, medical condition or finding in the medical examination that in the investigators opinion would compromise the safety of the patient or the quality of the data - Any induction therapy for Lupus Nephritis within the last 6 months prior to randomisation except induction with Mycophenolate Mofetil and high dose steroids started within 6 weeks prior to randomisation - Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20, anti-CD22,) within 12 months prior to randomisation - Treatment with abatacept within 12 months prior to randomisation - Treatment with tacrolimus or cyclosporin within 4 weeks prior to randomisation - Treatment with cyclophosphamid within 6 months prior to randomisation - Treatment with investigational drug within 6 months or 5 half-lives, whichever is greater before randomisation - Contraindication for MMF or corticosteroids and/or known hypersensitivity to any constituents of the study drug. - Chronic or relevant acute infections, including but not limited to HIV, Hepatitis B and C and tuberculosis (including a history of clinical tuberculosis (TB) and/or a positive QuantiFERON TB-Gold test - Any active or suspected malignancy or history of documented malignancy within the last 5 years before screening, except appropriately treated carcinoma in situ and treated basal cell carcinoma. - Live vaccination within 6 weeks before randomisation - Patients unable to comply with the protocol in the investigators opinion. - Alcohol abuse in the opinion of the investigator or active drug abuse . - Women who are pregnant, nursing, or who plan to become pregnant while in the trial - Impaired hepatic function, defined as serum Aspartate Transferase/Alanine Transferase, bilirubin or alkaline phosphatase levels > 2 x Upper Limit of Normal - Further exclusion criteria apply. ; PRIMARY OUTCOME: Percentage of Patients With Complete Renal Response (CRR) at Week 52; SECONDARY OUTCOME 1: Percentage of Patients With Complete Renal Response (CRR) at Week 26[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CANBERRA; BRIEF: The studys main purpose is to asses the safety, tolerability, and effect of oral administration of RG7774 on the severity of diabetic retinopathy (DR) in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) and good vision. ; DRUG USED: RG7774; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Retinopathy (Ophthalmology); TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria - Able and willing to provide written informed consent and to comply with the study protocol according to International Conference of Harmonization (ICH) and local regulations - Male and female patients of at least 18 years of age - Treatment naïve with moderately severe to severe NPDR defined as ETDRS DRSS 47 or 53 - Patients are eligible with and without DME in either eye - BCVA score at screening of at least 70 letters in study eyes without DME and at least 75 letters in case DME is present - Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images. - Diagnosis of diabetes mellitus (DM) type 1 or type 2 - Hemoglobin A1c (HbA1c) </= 12%. - A female is eligible to participate if she is not pregnant, not breastfeeding Exclusion Criteria Ocular criteria for study eye: - Prior treatment for DR or other retinal diseases with any approved or investigational therapy, including but not limited to intravitreal steroids, intravitreal anti-VEGF, light therapy, periocular pharmacological intervention, and laser (e.g. focal, grid, micropulse, or pan-retinal) - Uncontrolled glaucoma - Any concurrent intraocular condition (e.g. retinal detachment, dense cataract, epiretinal membrane with traction, or vitreomacular traction, etc.) that in the opinion of the Investigator could reduce the potential for improvement, require medical surgical intervention or may confound the visual and functional assessment and interpretation of study results Concurrent ocular conditions in either eye: - Any active ocular infection - Any active intraocular inflammation General Criteria: - Previous systemic use of anti-VEGF drugs within 6 months prior to screening - Complications of diabetes such as end-stage renal disease or liver disease - Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to screening - Uncontrolled blood pressure ([BP] defined as systolic > 180mmHg and/or diastolic >100 mmHg while patient at rest) - History of concurrent cardio-vascular disease not considered well controlled by the Investigator - Any major illness or major surgical procedure within one month before screening - History of or currently active other diseases, metabolic dysfunction, physical examination finding, malignancies not considered cured, or clinical laboratory findings giving reasonable suspicion of a condition that contraindicated the use of the investigational medicinal drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications in the opinion of the investigator - Known hypersensitivity to any of the excipients of the drug used, fluorescein dye or dilating eye drops - Use of systemic medications known to be toxic to the lens, retina or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol) used during the 6-month period prior to screening or likely need to be used ; PRIMARY OUTCOME: Proportion of Participants with >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) from Baseline at Week 36 Measured in the Study Eye; SECONDARY OUTCOME 1: Percentage of Participants with Anterior Segment Neovascularization (ASNV), new Proliferative Diabetic Retinopathy (PDR), new Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - CodeBreaK 100; BRIEF: Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors. ; DRUG USED: Lumakras; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: KRas; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Men or women greater than or equal to 18 years old. - Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing. Exclusion Criteria - Active brain metastases from non-brain tumors. - Myocardial infarction within 6 months of study day 1. - Gastrointestinal (GI) tract disease causing the inability to take oral medication. ; PRIMARY OUTCOME: Primary: Number of subjects with treatment-emergent adverse events; SECONDARY OUTCOME 1: Secondary: Plasma concentration (Cmax) of sotorasib[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TRINOVA-1 (w/Paclitaxel); BRIEF: The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow. ; DRUG USED: Trebananib; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: Angiopoietins; THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Female 18 years of age or older at the time the written informed consent is obtained - Gynecologic Oncology Group (GOG) Performance Status of 0 or 1 - Life expectancy >= 3 months (per investigator opinion) - Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma , mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with clear cell or mucinous histology are excluded) - Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including at least a unilateral oophorectomy - Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with modifications - Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy administered after surgical or non-surgical assessment. - Adequate organ and hematological function - Generally well controlled blood pressure with systolic blood pressure <= 140 mmHg and diastolic blood pressure <= 90 mmHg prior to randomization. The use of anti-hypertensive medications to control hypertension is permitted - Radiographically documented disease progression either on or following the last dose of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer Exclusion Criteria: - Subjects who have received more than 3 previous regimens of anti-cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers - Subjects who have received paclitaxel as consolidation therapy, maintenance, or monotherapy are excluded - Subjects with primary platinum-refractory disease - Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy - Radiotherapy <= 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities - Previous abdominal or pelvic radiotherapy - History of arterial or venous thromboembolism within 12 months prior to randomization - History of clinically significant bleeding within 6 months prior to randomization - History of central nervous system metastasis - Has not yet completed a 21 day washout period prior to randomization for any previous anti cancer systemic therapies (30 days for prior bevacizumab) - Enrolled in or has not yet completed at least 30 days (prior to randomization) since ending other investigational device or drug, or currently receiving other investigational treatments - Unresolved toxicities from prior systemic therapy that are Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 >= Grade 2 in severity except alopecia - Known active or ongoing infection (except uncomplicated urinary tract infection [UTI]) within 14 days prior to randomization - Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor - Treatment within 30 days prior to randomization with strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and lenalidomide - Clinically significant cardiovascular disease within 12 months prior to randomization - Major surgery within 28 days prior to randomization or still recovering from prior surgery - Minor surgical procedures, except placement of tunneled central venous access device within 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minor surgical procedure. ; PRIMARY OUTCOME: Progression-Free Survival; SECONDARY OUTCOME 1: Overall survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/Ibrutinib; BRIEF: TP-0903 is an inhibitor of AXL kinase. TP-0903 has shown potent inhibition of AXL kinase and other TAM family members in a biochemical kinase assay. TP-0903 demonstrates corresponding activity in cancer cell lines and mouse xenograft efficacy models. TP-0903 is shown to block cancer cell epithelial-to-mesenchymal transitions. AXL was identified as a potential therapeutic target in chronic lymphocytic leukemia (CLL). TP 0903 was shown to induce apoptosis in CLL B-cells taken directly from patients.TP-0903 was equally potent against CLL cells regardless of risk-factor. TP-0903 is a novel oral inhibitor that targets AXL kinase and reverses the mesenchymal phenotype associated with advanced cancers. TP-0903 has demonstrated profound single agent activity in CLL B cells taken directly from patients even if the patient has high risk factors (ie, 17p/P53 deletions) or progressed on other agents (ie, ibrutinib). TP-0903 is currently being evaluated in patients with refractory solid tumors (TP-0903-101). This proposed study is designed to identify the maximum tolerated dose (MTD), safety profile and recommended Phase 2 dose (RP2D) of TP-0903 in patients with previously treated CLL. Treatment cycles may be repeated if the patient continues to show benefit and if TP-0903 is reasonably well tolerated. The study will investigate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of TP-0903. ; DRUG USED: Dubermatinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Axl Receptor Tyrosine Kinase; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Sumitomo Pharma America, Inc.; CRITERIA: Inclusion Criteria: 1. Be ≥18 years old 2. Have an established, pathologically confirmed diagnoses of CLL/ Small Lymphocytic Lymphoma (SLL) requiring therapy according to the 2018 IWCLL guidelines 3. Have received at least one prior therapy for CLL/SLL and can be classified in one of two patient groups: - Group 1 (TP-0903 monotherapy): Patients with CLL/SLL who are intolerant to, or have progressed on B-cell receptor antagonists and/or BCL-2 antagonists or other investigational treatments for CLL/SLL - Group 2 (TP-0903 and ibrutinib combination therapy): Patients with CLL/SLL who have progressed on ibrutinib, yet the treating provider considers continuation of ibrutinib therapy to be in the best interest of the patient 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2 5. Have adequate hematologic function: - Absolute neutrophil count (ANC) ≥500/µL - Platelet count ≥30,000/µL - Hemoglobin ≥8 g/dL in the absence of transfusions within the previous 2 weeks 6. Have adequate organ function: - Creatinine clearance ≥30 mL/min - Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) level ≤2.5 × upper limit of normal (ULN) - Have a total bilirubin level ≤1.5 × ULN (unless secondary to Gilbert syndrome, hemolysis, or leukemia) 7. Have acceptable coagulation status: • Activated partial thromboplastin (aPTT) and prothrombin time (PT) ≤1.5 × ULN 8. Have a negative pregnancy test (if female of childbearing potential) 9. Be nonfertile or agree to use an adequate method of contraception. Sexually active patients and their partners must use an effective method of contraception (hormonal or barrier method of birth control, or abstinence) prior to study entry and for the duration of study participation and for at least 30 days after the last study drug dose. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. 10. Have read and signed the Institutional Review Board (IRB) approved informed consent form (ICF) prior to any study related procedure. (In the event that the patient is rescreened for study participation or a protocol amendment alters the care of an ongoing patient, a new ICF must be signed.) 11. Are able to comply with the requirements of the entire study Exclusion Criteria: 1. Have undergone prior autologous or allogeneic stem cell transplant within ≤3 months, have not recovered from transplant associated toxicities, or requires graft versus host immunosuppressive therapy 2. Have known central nervous system (CNS) involvement 3. Have Richters transformation of CLL 4. Have received any monoclonal antibody therapy directed at treatment of the patients malignancy within 2 weeks prior to anticipated first dose 5. Have received any anticancer therapy including chemotherapy, radiotherapy, or an investigational anticancer drug within less than 5 half lives of the last dose of that treatment • This exclusion criterion is not applicable to patients requiring continuation on ibrutinib. (Note: Certain patients with a rapidly rising white blood cell count while on ibrutinib may need to remain on this drug for medical reasons. These patients will need to be approved by the Medical Monitor and treated in accordance with the protocol.) 6. Have received >20 mg/day of prednisone and 0.1 mg/day of mineralocorticoids within 7 days prior to anticipated first dose 7. Have a corrected QT interval of >450 msec (males) and >470 msec (females) using Fridericias correction formula 8. Have a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, or cardiovascular disease or any other medical condition that, in the opinion of the Investigator, would adversely affect his/her participation in the study 9. Are pregnant and/or nursing, or refuse to use appropriate contraceptives during the course of the study and for at least 30 days after the last dose of study drug 10. History of another malignancy in the last 5 years except for the following adequately treated: - Local basal cell or squamous cell carcinoma of the skin - Carcinoma in situ of the cervix or breast - Papillary, noninvasive bladder cancer - Early stage prostate cancer for which observation is clinically indicated - Other Stage 1 or 2 cancers currently in complete remission - Any other cancer that has been in complete remission for 2 years or surgically cured. Medical Monitor may be contacted for additional determination of acceptable prior cancer history 11. Have known gastrointestinal disorders (eg, malabsorption syndrome), complications (eg, dysphagia), or surgery that could make consumption or absorption of oral medications problematic 12. Have an uncontrolled systemic infection (viral, bacterial, or fungal) or fever and neutropenia within 7 days prior to anticipated first dose 13. Have active and uncontrolled autoimmune cytopenias for 2 or more weeks including autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura (ITP) 14. Have received prior therapy with an AXL inhibitor 15. Have exhibited allergic reactions to a similar structural compound, biological agent, or formulation 16. Are unwilling or unable to comply with procedures required in this protocol 17. Have a history of severe adverse reaction (eg. hypersensitivity reaction, anaphylaxis) to sulfonamides ; PRIMARY OUTCOME: PHASE 1: Incidence of Dose-limiting Toxicities (DLTs) and Treatment Emergent Adverse Events.; SECONDARY OUTCOME 1: PHASE 1: Area Under the Plasma Concentration-time Curve From Zero to Infinity of Oral TP-0903 in the Defined Patient Groups[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - STRATOS 1 (Adults/Adolescents); BRIEF: A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist ; DRUG USED: Tralokinumab; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-13 (Interleukin-13); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Age 12 -75 2. Documented physician-diagnosed asthma. 3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA 4. Morning pre-BD FEV1 value of ≥40 and <80% value (<90% for patients 12 to 17 years of age) of their PNV. 5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1 6. ACQ-6 score ≥1.5 Exclusion Criteria: 1. Pulmonary disease other than asthma 2. History of anaphylaxis following any biologic therapy 3. Hepatitis B, C or HIV 4. Pregnant or breastfeeding 5. History of cancer 6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years 7. Previous receipt of tralokinumab ; PRIMARY OUTCOME: Annualised Asthma Exacerbation Rate (AAER) up to Week 52; SECONDARY OUTCOME 1: Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Roll-Over Safety Study; BRIEF: The purpose of this study is the evaluation of long-term safety of osilodrostat in patients who have already received osilodrostat treatment in a previous Global Novartis-sponsored trial and who, based on investigators judgement, will continue benefiting with its administration. ; DRUG USED: Isturisa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cushings Syndrome; TARGET: Aldosterone synthase (CYP11B2); THERAPY: Monotherapy; LEAD SPONSOR: RECORDATI GROUP; CRITERIA: Inclusion Criteria: - Patient is currently participating in a Global Novartis-sponsored study receiving osilodrostat for any type of endogenous CS and has fulfilled all their requirements in the parent study. - Patient is currently benefiting from treatment with osilodrostat, as determined by the Investigator. - Patient has demonstrated compliance, as assessed by the Investigator, with the parent study protocol requirements. - Willingness and ability to comply with scheduled visits and treatment plans. - Written informed consent obtained prior to enrolling into the roll-over study before evaluating the applicability of the subjects participating in the study. -- If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness. Exclusion Criteria: - Patient has been permanently discontinued from osilodrostat study treatment in a parent Novartis-sponsor study. - Patients who are receiving osilodrostat in combination with unapproved or experimental treatments for any type of endogenous CS. - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. Pregnant or nursing (lactating) women - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week of study after stopping medication. Highly effective contraception methods include: - Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception - Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation. at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment - Male sterilization (at least 6 months prior to baseline). The vasectomized male partner should be the sole partner for that subject - Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. ; PRIMARY OUTCOME: Number of participants with adverse/serious adverse events; SECONDARY OUTCOME 1: Percentage of patients with clinical benefit[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Long Term (Study 103); BRIEF: The purpose of this study is to evaluate the long-term safety and efficacy of ACH-0144471 in participants with paroxysmal nocturnal hemoglobinuria (PNH) who have demonstrated clinical benefit from ACH-0144471 in Study ACH471-100. This study is designed to include up to 12 participants. ; DRUG USED: Danicopan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Paroxysmal Nocturnal Hemoglobinuria (PNH); TARGET: Factor D (alternate complement pathway); THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Study designed to include up to 12 participants who completed treatment in Study ACH471-100 and demonstrated clinical benefit from ACH-0144471 with no significant safety or tolerability concerns. - Negative pregnancy test for females prior to dosing and throughout the study. Exclusion Criteria: - Have developed any clinically relevant co-morbidities while participating in Study ACH471-100 that would make the participant inappropriate for the continuation of treatment with ACH-0144471, in the opinion of the Investigator. - Have developed any clinically significant laboratory abnormalities while participating in Study ACH471-100 that, in the opinion of the Investigator, would make the participant inappropriate for the study or put the participant at undue risk. - Females who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration or participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration. ; PRIMARY OUTCOME: Change From Baseline in LDH Level at Week 25; SECONDARY OUTCOME 1: Change From Baseline in LDH Level at Weeks 49 and 169[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Multi-schedule; BRIEF: This is a dose ranging study comparing different vaccine schedules of rPA vaccine for anthrax. Safety and the capability to induce an immune response will be evaluated. ; DRUG USED: SparVax; DRUG CLASS: Vaccine; INDICATION: Anthrax Infection (Antibacterial); TARGET: Anthrax protective antigen , Bacillus anthracis (Anthrax), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: PharmAthene UK Limited; CRITERIA: Inclusion Criteria: 1. Healthy males or females. 2. Aged between 18-55 years (inclusive). 3. A body mass index (BMI) of 18-35. 4. Signed informed consent, which includes information about the potential risks and effects of rPA. 5. A medical history without major organ pathology (e.g. cardiac, immunological, psychiatric, endocrine or neurological disorders, cancer or other wasting diseases - (adequately treated actinic keratosis, or basal cell carcinoma [BCC], or carcinoma in situ [CIS] of the cervix are permitted). 6. A female may be enrolled if one of the following criteria applies: Either If of child-bearing capacity then: A female is not pregnant or breast feeding AND is routinely using adequate injectable or transdermal (administered at the recommended frequency) or oral contraception (at a stable dose for at least three months prior to the first dose of vaccine) and will continue to do so during the study, augmenting this contraceptive measure with a barrier method OR is sexually abstinent OR is monogamous and has a partner who has had a vasectomy (>1 month previously) OR is using a commonly recognised copper and hormone implanted intrauterine device (IUD) such as TCu-380A, TCu-220C, MLCu-375, Nova-T or LNG-20. In addition, the subject must have a negative blood pregnancy test prior to enrolment into the study and negative urine pregnancy test pre-dose. Or A female is post menopausal (defined as a female with no menstrual cycle for at least 24 months and of menopausal age (>45 years). Or A female with no menstrual cycle for between 12 and 24 months and of menopausal age (>45 years) who has a negative blood pregnancy test prior to enrolment into the study and a negative urine pregnancy test pre-dose. Or A female has been surgically sterilised (confirmed by review of medical record). Or A female has had a total hysterectomy at least 3 months prior to the start of the study (confirmed by review of medical record). 7. A male may be enrolled if willing to use barrier methods of contraception and whose partner is using an acceptable form of contraception for 3 months post each dose. 8. Able to understand the informed consent form and other documents required to be read by the subject. Exclusion Criteria: 1. Presence of any clinically significant medical condition as determined by the Investigator. 2. Medically significant hypersensitivity or idiosyncratic reaction related to any medical product including vaccines. 3. History or evidence of drug abuse. 4. Participation in a clinical study of an investigational vaccine within 3 months prior to the start of the study or an investigational drug product within 30 days prior to the start of the study. 5. Use of any prescription or non-prescription medication within 7 days prior to the first dosing with the exception of over-the-counter (OTC) antihistamine, non-steroidal anti-inflammatory drugs (NSAID), acetaminophen, OTC decongestants or oral/injectable/transdermal contraceptives. Any medication taken within 7 days of the first dosing will be recorded. 6. History or suspicion of inability to co-operate adequately. 7. Donation of blood or blood products for a period of 4 weeks prior to participation in the study. 8. Immunodeficiency or clinically active autoimmune disease. 9. Positive urine alcohol and drug screen for drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, and barbiturates). 10. Positive test for human immunodeficiency virus (HIV), and/or hepatitis B and/or hepatitis C. 11. Vaccination(s) with a live vaccine in the previous 4 weeks or killed / inactivated vaccines in the previous 3 weeks. 12. Blood or plasma transfusions, or pooled gamma-globulin in the previous 3 months and need for blood or plasma transfusions during this study. 13. Received anthrax vaccine or anthrax immune globulin or been otherwise exposed to B. anthracis. 14. Clinically relevant abnormal findings on routine physical examination. 15. Clinically significant out-of-range laboratory tests at screening including: urinalysis, serum creatinine, lactate dehydrogenase (LDH), potassium, glucose, liver function tests (LFT); absolute neutrophil count, platelet count, white blood cell count, electrolytes, clotting and blood haemoglobin. 16. Twelve-lead ECG recording with clinically relevant signs of pathology and conduction disturbances as judged by the investigator. 17. Presence of tattoos that cover or partially cover the upper arm. ; PRIMARY OUTCOME: Safety of rPA vaccine; SECONDARY OUTCOME 1: Immunogenicity of rPA vaccine[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PNEU-TRUE; BRIEF: The primary objectives are to evaluate the safety and tolerability of V114 and to compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) across 3 different lots of V114. The primary hypothesis is that all 3 lots of V114 are equivalent as measured by the serotype-specific OPA GMTs for 15 serotypes in V114 at 30 days postvaccination. ; DRUG USED: Vaxneuvance; DRUG CLASS: Vaccine; INDICATION: Pneumococcal (Streptococcus pneumoniae) Vaccines (Antibacterial); TARGET: Immune System, Streptococcus pneumoniae / Pneumococcus; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Participant has good health in the opinion of the investigator. Any underlying chronic condition must be documented to be in stable condition according to the investigators judgment. - Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - Female participant is eligible to participate if she is not pregnant, not breastfeeding, and is not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to use agreed upon contraception during the treatment period and for at least 6 weeks after the last dose of study intervention. Exclusion Criteria: - History of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1). - Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine. - Known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease. - Coagulation disorder contraindicating intramuscular vaccinations. - Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of study vaccine. - History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. - A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1). - Has received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside of the protocol. - Has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry. - Has received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination. (Note: Topical, ophthalmic, intra-articular or soft-tissue [e.g., bursa, tendon steroid injections], and inhaled/nebulized steroids are permitted). - Is receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease. - Has received any non-live vaccine within the 14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine within 30 days following receipt of any study vaccine. (Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of any study vaccine or at least 15 days after receipt of any study vaccine.) - Has received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine. If this exclusion criterion is met, then Day 1 Visit may be rescheduled for a time when criterion is not met. - Has received a blood transfusion or blood products, including immunoglobulin, within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion. - Currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study. - In the opinion of the investigator, has a history of clinically relevant drug or alcohol use that would interfere with participation in protocol-specified activities. - History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participants participation for the full duration of the study. - Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study. ; PRIMARY OUTCOME: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots; SECONDARY OUTCOME 1: Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - AdvanTIG-203 (w/Tislelizumab); BRIEF: A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma. ; DRUG USED: BGB-A1217; DRUG CLASS: Biologic; INDICATION: Esophageal Cancer; TARGET: Immune System, TIGIT; THERAPY: Monotherapy; LEAD SPONSOR: BeiGene; CRITERIA: Key Inclusion Criteria: 1. Histologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC. 2. Have PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC. 3. Have measurable disease as assessed by RECIST v1.1. 4. Have confirmed PD-L1 TAP ≥ 10% in tumor tissues tested by the central lab. 5. Eastern Cooperative Oncology Group Performance Status score of 0 or 1. Key Exclusion Criteria: 1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways. 2. Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta). 3. Evidence of complete esophageal obstruction not amenable to treatment. 4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention). 5. Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug. Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Objective Response Rate (ORR) Assessed By The Investigators Review Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1; SECONDARY OUTCOME 1: Overall Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - VT-001; BRIEF: Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia ; DRUG USED: VTI-001; DRUG CLASS: New Molecular Entity (NME); INDICATION: Refractive Errors (Ophthalmology); TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Visus Therapeutics; CRITERIA: Inclusion Criteria: - Male or female in good general health - Must have presbyopia Exclusion Criteria: - History of allergic reaction to the study drug or any of its components - Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results ; PRIMARY OUTCOME: Change from baseline in near VA; SECONDARY OUTCOME 1: Change from baseline in distance VA[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - SAD; BRIEF: This is a Phase 1 study to investigate the safety, tolerability of the novel plasma kallikrein inhibitor, KVD001 in subjects with diabetic macular edema. The study is the first step to investigate the hypothesis that plasma kallikrein plays an important role in the disease process behind diabetic macular edema in many patients ; DRUG USED: KVD001; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: Kinin-Kallikrein System ; THERAPY: Monotherapy; LEAD SPONSOR: KalVista Pharmaceuticals, Ltd.; CRITERIA: Inclusion Criteria: 1. Male or female adult subjects 18 years of age and older 2. Confirmed diagnosis of Type I or Type II diabetes mellitus 3. Best corrected visual acuity, using Early Treatment Diabetic Retinopathy Study (ETDRS) electronic visual acuity (EVA) testing, of between 20/40 and 20/400 (Snellen equivalent) in the study eye 4. Fellow eye acuity 20/80 or better measured as above with no expectation of requirement for anti-VEGF treatment in fellow eye within 2 months of study drug administration 5. Presence of central involved DME in the study eye defined as Optical Coherence Tomography (OCT) Central Subfold Thickness (CST) ≥305 µm in women and ≥320 µm in men in the study eye 6. Subjects who fulfil one of the following criteria: 1. Subjects who have not previously received an anti-VEGF treatment and who, in the view of the Investigator, can have initiation of anti-VEGF treatment in the study eye deferred for at least 2 months following the date of anticipated study drug administration 2. Subjects who are receiving regular anti-VEGF intravitreal injections who: - Have received at least 3 intravitreal injections of an anti-VEGF treatment within the last 5 months (study drug administration will be at least 6 weeks after the most recent intravitreal administration of anti-VEGF) and - In the view of the Investigator, can have continuation of anti-VEGF treatment in the study eye deferred for at least 2 months following the date of anticipated study drug administration 3. Subjects who have received anti-VEGF in the past (>3 months prior to study inclusion) but are not actively receiving treatment and who in the view of the Investigator, can have resumption of anti-VEGF or alternative treatment in the study eye deferred for at least 2 months following anticipated study drug administration 7. Subjects, who in the view of the Investigator, are not expected to require panretinal laser photocoagulation or intravitreal steroids or intraocular surgery in the study eye for at least 2 months following anticipated study drug administration 8. No prior treatment with panretinal photocoagulation or intravitreal steroid in the study eye within the previous 3 months 9. No prior treatment with systemic corticosteroids or systemic anti-VEGF therapy within the previous 3 months 10. Study participant voluntarily agrees to participate in this study and signs the Institutional Review Board (IRB) approved informed consent prior to performing any procedure Exclusion Criteria: 1. Females who are pregnant or lactating, or expecting to become pregnant during the course of the study 2. Poorly controlled diabetes mellitus 3. Uncontrolled hypertension 4. Significant co-existing disease 5. Participation in an investigational intervention clinical study within 2 months prior to study inclusion 6. History of alcohol and/or drug abuse in the last 2 years 7. Men not willing to use appropriate birth control methods 8. Media clarity or pupillary dilation inadequate to obtain reasonable quality OCT and/or fundus image 9. Subjects employed by the Sponsor or in any relationship of dependence with the Sponsor and/or Investigator ; PRIMARY OUTCOME: Number of participants with Adverse Events as a measure of safety and tolerability; SECONDARY OUTCOME 1: Measurement of KVD001 plasma levels over time following intravitreal injection (with calculation of Tmax, Cmax, AUC and t1/2)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - IDP-118; BRIEF: Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area affected will be enrolled in the study. ; DRUG USED: Duobrii; DRUG CLASS: Non-NME; INDICATION: Psoriasis; TARGET: Glucocorticoid Receptor (GR), Retinoic acid receptor (RARs); THERAPY: Monotherapy; LEAD SPONSOR: Dow Pharmaceutical Sciences; CRITERIA: Inclusion Criteria: - Male or female of any race, 18 to 65 (inclusive) years of age. - Freely given verbal and written informed consent obtained from the subject. - Clinical diagnosis of psoriasis at the Screening and Baseline visits with - At least 10% - 20% of total treatable BSA involvement, and - an Investigators Global Evaluation score of 3 or 4 ( moderate or severe) on a scale of 0 to 5 - Good general health as determined by the Investigator based on the subjects medical history and physical examination, with Screening hematology, serum chemistry, and urinalysis laboratory values within normal range limits. Exclusion Criteria: - Presence of psoriasis that was previously treated with prescription medication prior to the Screening visit and is non-responsive to corticosteroid treatment, as determined by the Investigator. - Presence of any concurrent skin condition that could interfere with the evaluation of the study drug, as determined by the Investigator. - History of adrenal disease - Female who is pregnant, nursing an infant, or planning a pregnancy during the study period. ; PRIMARY OUTCOME: The incidence of HPA axis suppression after treatment with investigational drug product and the comparators; SECONDARY OUTCOME 1: To evaluate the safety and cutaneous tolerability of the two formulations and the comparators[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - COMMANDER-HF (HF/CAD); BRIEF: The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure. ; DRUG USED: Xarelto; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: Coagulation Factor X; THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Must have symptomatic heart failure for at least 3 months prior to Screening - Participants must have an episode of decompensated heart failure (index event) requiring (a) an overnight stay [that is, staying past midnight] in a hospital, emergency department, or medical facility with the capability of treating with intravenous medications and observing heart failure patients before randomization or (b) an unscheduled outpatient visit to a heart failure management center, where parenteral therapy is required for heart failure stabilization. An episode of decompensated heart failure is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization/outpatient visit heart failure medications. Participants are eligible for randomization at discharge from the facility treating the index event and up to 30 days after discharge if they are in stable condition - Must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40 percent (%) within 1 year before randomization - Must have evidence of significant coronary artery disease - Must be medically stable in terms of their heart failure clinical status at the time of randomization - Must have a brain natriuretic peptide (BNP) level greater than or equal to (>=) 200 picogram per milliliter (pg/mL) or N-terminal-proBNP (NT-proBNP) level >=800 pg/mL (preferred assay) during the Screening period and before randomization Exclusion Criteria: - Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 28 days of randomization - Severe concomitant disease such as (a) atrial fibrillation (AFib) or another condition that requires chronic anticoagulation (participants with isolated transient AFib may be allowed at the discretion of the treating physician investigator) and (b) Documented acute myocardial infarction (MI) during index event - Prior stroke within 90 days of randomization - Has been hospitalized for longer than 21 days during the index event - Planned intermittent outpatient treatment with positive inotropic drugs administered intravenously ; PRIMARY OUTCOME: Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke; SECONDARY OUTCOME 1: Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Subjects; BRIEF: This study has three parts. Each participant will enroll in one part. Part A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Part A will measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Part B: The purpose of Part B is to evaluate the safety and tolerability of tirzepatide intravenous (IV) formulation when administered into a vein. Part C: The purpose of Part C is to evaluate the safety and tolerability of tirzepatide following multiple SC weekly doses of a solution. This study will last approximately 70 days for Part A or Part B and 92 days for Part C. This does not include screening. Screening is required within 28 days prior to the start of the study. ; DRUG USED: Tirzepatide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GIP Receptor (GIPR)/Glucose-Dependent Insulinotropic Polypeptide Receptor, GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Overtly healthy males or females, as determined by medical history and physical examination - Male participants: agree to use an effective method of contraception for the duration of the study and for 3 months following the last dose of investigational product - Female participants: not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they are greater than or equal to (≥)45 years old and have not taken hormones or oral contraceptives within the last year and had cessation of menses for at least 1 year. Or, have had at least 6 months of amenorrhea with follicle-stimulating hormone levels consistent with a postmenopausal state - Have a body mass index of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive Exclusion Criteria: - Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study - Received treatment with a drug that has not received regulatory approval for any indication within 30 days of screening - Have a history of heart block, or a pulse rate (PR) interval greater than (>)200 milliseconds (msec), or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study - Have a significant history of or current cardiovascular (myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study medication, or interfering with the interpretation of data ; PRIMARY OUTCOME: Pharmacokinetics (PK) Part A: Area Under the Concentration versus Time Curve (AUC) of Tirzepatide; SECONDARY OUTCOME 1: Pharmacokinetics (PK) Part C: Area Under the Concentration versus Time Curve (AUC) of Tirzepatide[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 204; BRIEF: To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week open-label extension period. All eligible participants will be invited to continue treatment for an additional 48-week Long-term extension period (also open label). ; DRUG USED: INCB54707; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hidradenitis Suppurativa; TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - HS disease duration of at least 3 months before screening. - Willingness to avoid pregnancy or fathering children. - Active HS in at least 2 distinct anatomical areas. - Participants agree NOT to use topical antiseptics on the areas affected by HS lesions during the placebo-controlled 16-week treatment period Exclusion Criteria: - Draining fistula count of > 20 at screening or baseline. - Women who are pregnant (or who are considering pregnancy) or lactating. - Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator. - History of failure to treatment of inflammatory diseases with JAK inhibitors. - Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis. - Participants known to be infected with HIV, Hepatitis B, or Hepatitis C. - Laboratory values outside of the protocol-defined ranges. ; PRIMARY OUTCOME: Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16; SECONDARY OUTCOME 1: Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 01-023; BRIEF: The objectives of the study were: 1. To show that a single dose of YF476 blocks gastrin receptors in healthy subjects 2. To show that YF476 retains its ability to block gastrin receptors after repeated dosing despite losing its ability to suppress gastric acidity. ; DRUG USED: YF-476; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastroesophageal Reflux Disease (GERD); TARGET: Cholecystokinin 2 (CCK2 or CCKB) / Gastrin receptor; THERAPY: Monotherapy; LEAD SPONSOR: Trio Medicines Ltd.; CRITERIA: Inclusion Criteria: - Healthy male or female volunteers. - Aged 18-45 years. - A body mass index (Quetelet index) in the range 18.0-30.9. - Women at risk of pregnancy must use a reliable method of contraception. - No clinically relevant abnormal findings in the clinical history or physical examination at the screening assessment which could interfere with the objectives of the study or make the volunteers participation hazardous. - No clinically relevant abnormal laboratory values at the screening evaluation, including a normal ECG. - Sufficient intelligence to understand the nature of the study and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire study. - Willingness to give written consent to participate after reading the Consent Form, and after having the opportunity to discuss the study with an investigator or his deputy. Exclusion Criteria: - Women who are pregnant or lactating. - Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-study screening assessment that could interfere with the objectives of the study or the safety of the volunteer. - Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteers participation in the study or make it unnecessarily hazardous. - Positive test for Helicobacter pylori. - Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness. - Presence or history of severe adverse reaction to any drug or a history of severe allergic disease. - Use of a prescription medicine (except oral contraceptives in females) during the 30 days before the study or use of an over-the-counter medication, with the exception of paracetamol, during the 7 days before the study. - Participation in other clinical studies of a new chemical entity or a prescription medicine within the previous 3 months. - Smokers. - Presence or history of drug or alcohol abuse, or intake of more than 28 units of alcohol weekly (for men) or 21 units of alcohol weekly (for women). - Blood pressure and heart rate in seated position at the screening examination outside the ranges 90-160 mm Hg systolic, 40-95 mm Hg diastolic; heart rate 40_100 beats/min. - Possibility that the volunteer will not cooperate with the requirements of the protocol. - Evidence of drug abuse on urine testing. - Positive test for hepatitis B, hepatitis C, HIV1 or HIV2. - Loss of more than 400 mL blood during the 3 months before the study, e.g. as a blood donor. ; PRIMARY OUTCOME: Safety of YF476; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Advanced Cancer; BRIEF: The purpose of this study is to determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug. ; DRUG USED: Aliqopa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Age >/= 18 years. - Histological or cytological documentation of non-hematologic, malignant solid tumor, excluding primary brain or spinal tumors, or history of central nervous system metastases - At least one measurable lesion or evaluable disease - Life expectancy of at least 12 weeks - ECOG Performance Status of 0, 1 or 2 - PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists]. Low-dose aspirin is permitted (</= 100 mg daily). - Adequate bone marrow, liver and renal function - Ability to understand and to sign an informed consent form; a signed informed consent must be obtained prior to any study specific procedures Exclusion Criteria: - History of cardiac disease congestive heart failure (CHF) > NYHA Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or Digoxin are permitted). - Current diagnosis of type I or II diabetes mellitus or fasting blood glucose level >125 mg/dL at screening, or HbA1c 7% - Active clinically serious infections > Grade 2 (NCI-CTCAE Version 3.0) - History of having received allogeneic organ transplant - Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital) is not allowed throughout the entire study. - Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management ; PRIMARY OUTCOME: Characterize safety, tolerability + pharmacokinetics, to determine the maximum tolerated dose of BAY80-6946 administered 1x weekly for 3 weeks, every 4weeks, as a 1h-intravenous infusion. Evaluate biomarkers that may be predictive of tumor response.; SECONDARY OUTCOME 1: Determine the effects of BAY80-6946 on blood glucose and insulin, and its safety in patients with type I or II diabetes.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - INSIGHT 2; BRIEF: This study will assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC). ; DRUG USED: Tepmetko; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Hepatocyte growth factor receptor (c-Met, HGFR); THERAPY: Combination; LEAD SPONSOR: EMD Serono Research & Development Institute, Inc.; CRITERIA: Inclusion Criteria: - Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) histology (confirmed by either histology or cytology) with documented activating Epidermal Growth Factor Receptor (EGFR) mutation - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a minimum life expectancy of 12 weeks - Acquired resistance on previous first-line osimertinib. Participants must meet both of the following 2 criteria: - Radiological documentation of disease progression on first-line osimertinib - Objective clinical benefit documented during previous osimertinib therapy, defined by either partial or complete radiological response, or durable stable disease (SD) (SD should last greater than (>) 6 months after initiation of osimertinib - Have received only first-line osimertinib as a prior line of therapy in the non curative advanced or metastatic NSCLC setting - MET amplification as determined by either FISH testing (central or local) on tumor tissue (TBx) or central blood-based next generation sequencing (LBx). Tumor and blood samples must be collected following progression on prior first-line osimertinib at Prescreening - Submission of tumor tissue and blood sample obtained after progression on first-line osimertinib, is mandatory for all patients for MET amplification testing - Submission of tumor tissue during Prescreening or Screening is mandatory for patients with tumor tissue tested by local FISH, to confirm MET amplification status. Central confirmation is not mandated prior to the start of study treatment - Other protocol defined inclusion criteria could apply Exclusion Criteria: - Spinal cord compression or brain metastasis unless asymptomatic, stable or not requiring steroids for at least 2 weeks prior to start of study intervention - Any unresolved toxicity Grade 2 or more according to National cancer institute common terminology criteria for adverse events( NCI-CTCAE) version 5, from previous anticancer therapy with the exception of alopecia - Inadequate hematological, liver and renal function - Impaired cardiac function - History of interstitial lung disease(ILD) or interstitial pneumonitis including radiation pneumonitis that required steroid treatment - Hypertension uncontrolled by standard therapies (not stabilized to < 150/90 millimeter of mercury (mmHg) - Contraindication to the administration of osimertinib - Other protocol defined exclusion criteria could apply. ; PRIMARY OUTCOME: Safety run-in: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version (NCI-CTCAE v 5.0); SECONDARY OUTCOME 1: Objective Response According to RECIST Version 1.1 as per IRC for Combined Therapy in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Solids/Urothelial; BRIEF: This study will be conducted in adult subjects diagnosed with any form of an advanced or metastatic solid tumors including urothelial carcinoma for which standard therapy is no longer effective or is intolerable. This is a phase 1, multi-center, open label study designed to assess safety and tolerability of IK-175 as a single agent and in combination with nivolumab, to determine the recommended phase 2 dose (RP2D). Disease response, pharmacokinetics (PK), pharmacodynamics, and response biomarkers will also be assessed. ; DRUG USED: IK-175; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Aryl hydrocarbon receptor (AhR); THERAPY: Monotherapy; LEAD SPONSOR: Ikena Oncology; CRITERIA: Inclusion Criteria: 1. Adult patients ≥18 years of age. 2. Patients with confirmed solid tumors (including urothelial carcinoma) who have locally recurrent or metastatic disease that has progressed on or following all standard of care therapies or who is not a candidate for standard treatment. 3. For patients with urothelial carcinoma to be enrolled in the Combination Treatment arm, patients must have confirmation of urothelial carcinoma and have unresectable locally recurrent or metastatic disease that has progressed on or following all standard of care therapies, or who is not a candidate for standard treatment. Checkpoint inhibitor therapy with anti-PD-1 or anti-PD-L1 does not necessarily need to directly precede the study, but patients must have progressed on or within 3 months of receiving the last infusion/dose anti-PD-(L)1 therapy for inclusion in the Combination Treatment arm only. 4. Have measurable disease. 5. Accessible tumor that can be safely accessed for multiple core biopsies and patient is willing to provide tissue from newly obtain biopsies before and during treatment. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 7. Adequate organ function. 8. Highly effective birth control. 9. Time since the last dose of prior therapy to treat underlying malignancy (including other investigational therapy): 9a. Systemic cytotoxic chemotherapy: ≥ the duration of the most recent cycle of the previous regimen (with a minimum of 2 weeks for all, except 6 weeks for systemic nitrosourea or systemic mitomycin-C). 9b. Biologic therapy (eg, antibodies): ≥ 3 weeks or their dosing interval if shorter than 3 weeks (e.g. q2w therapy would require a 2-week washout). 9c. Small molecule therapies: ≥ 5 × half-life. 9d. Investigational Agent: ≥4 weeks or ≥5 × half-life, whichever is shorter Exclusion Criteria: 1. Untreated symptomatic central nervous system (CNS) tumors or brain metastasis. Patients are eligible if CNS metastases are asymptomatic and do not require immediate treatment or have been treated and patients have neurologically returned to baseline (residual signs or symptoms related to the CNS treatment are permitted). In addition, patients must have been either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to entering the Treatment period (Day 1). 2. Patients who have not recovered to ≤ Grade 1 or baseline from all adverse events (AEs) due to previous therapies 3. Has an active autoimmune disease that has required systemic treatment in past 2 years with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs; nonsteroidal anti-inflammatory drugs (NSAIDs) are permitted. Patients with type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. 4. Any condition requiring continuous systemic treatment with either corticosteroids (>10mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks prior to first dose of study treatment (Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalent are permitted in the absence of active clinically significant [ie, severe] autoimmune disease.). 5. Any other concurrent antineoplastic treatment or investigational agent except for allowed local radiation of lesions for palliation and hormone ablation. 6. Uncontrolled or life-threatening symptomatic concomitant disease (including known symptomatic human immunodeficiency virus (HIV) positive with an AIDS defining opportunistic infection within the last year, or a current CD4 count <350 cells/uL, symptomatic active hepatitis B or C checked at screening, or active tuberculosis). Patients with HIV are eligible if: 6a. they have received antiretroviral therapy (ART) for at least 4 weeks prior to entering the Treatment period as clinical indicated while enrolled on study; 6b. they continue on ART as clinically indicated while enrolled on study; 6c. CD4 counts and viral load are monitored per standard of care by a local health care provider. 7. Patients that have undergone a major surgery within 3 weeks of starting trial treatment or has inadequate healing or recovery from complications of surgery prior to starting trial treatment. 8. Prior radiotherapy within 2 weeks of start of study treatment. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had severe radiation pneumonitis. A 1-week washout is permitted for palliative radiation [≤ 2 weeks of radiotherapy] to non-CNS disease. 9. Prior AHR inhibitor treatment without Sponsor permission. 10. Potentially life-threatening second malignancy requiring systemic treatment within the last 3 years or which would impede evaluation of treatment response. Hormone ablation therapy is allowed within the last 3 years. Patients with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible. 11. Recent or current significant cardiovascular disease (e.g. stroke, heart attack, heart failure, or arrhythmia). 12. Medical issue that limits oral ingestion or impairment of gastrointestinal function that is expected to significantly reduce the absorption of IK-175. 13. Clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or the presence of any condition that can increase proarrhythmic risk (eg, hypokalemia, bradycardia, heart block) including any new, unstable, or serious cardiac arrhythmia requiring medication, or other baseline arrhythmia that might interfere with interpretation of ECGs on study (eg, bundle branch block). Patients with QTcF >450 msec for males and >470 msec for females on screening ECG are excluded. Any patients with a bundle branch block will be excluded with QTcF >450 msec. Males who are on stable doses of concomitant medication with known prolongation of QTcF (eg, Selective Serotonin Reuptake Inhibitor Antidepressants) will only be excluded for QTcF >470 msec. 14. History of life-threatening toxicity related to prior immune therapy (eg. anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg. hormone replacement after adrenal crisis). 15. Has an active infection requiring systemic therapy. 16. Treatment with any live/attenuated vaccine within 30 days of first study treatment. 17. A woman of child-bearing potential (WOCBP) who has a positive pregnancy test or is breastfeeding prior to treatment. ; PRIMARY OUTCOME: To determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD), and to characterize the dose-limiting toxicities (DLTs) of IK-175 as a single agent and in combination with nivolumab.; SECONDARY OUTCOME 1: Pharmacokinetics of IK-175: half-life (t1/2)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - A24; BRIEF: This protocol is designed to serve as a pre-screening study for subjects who are potentially eligible for Alzheimers Disease (AD) therapeutic trials that require tau imaging for inclusion by means of a flortaucipir F18 Positron Emission Tomography (PET) scan. ; DRUG USED: Tauvid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease - Imaging; TARGET: Tau proteins; THERAPY: Monotherapy; LEAD SPONSOR: Avid Radiopharmaceuticals; CRITERIA: Inclusion Criteria: 1. Patients with gradual and progressive change in memory function reported by the patient or informant for ≥6 months 2. Patients who have a mini-mental status exam (MMSE) score between 20-28 inclusive 3. Patients who are willing to undergo a PET scan using flortaucipir F 18 4. Patients who give informed consent or have a legally authorized representative (LAR) available to consent at the time of enrollment 5. A study partner who must be available if the patient enters the treatment trial Exclusion Criteria: 1. Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant (negative serum β-HCG [beta human chorionic gonadotropin] at screening and negative urine β-HCG prior to flortaucipir F 18 injection) or breastfeeding at screening. Females should agree to avoid becoming pregnant by refraining from sexual activity or using reliable contraceptive methods for 24 hours following administration of flortaucipir F 18 injection; 2. Patients who lack, in the investigators opinion, adequate premorbid literacy, adequate vision, or adequate hearing to complete the required psychometric testing; 3. Have significant neurological disease affecting the central nervous system (CNS), other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinsons disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures); 4. Patients with any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessment, or affect the patients ability to complete the study [Patients with history of schizophrenia or other chronic psychosis are excluded.]; 5. Have a current serious or unstable illness including, cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigators opinion, could interfere with the analyses in this study; or has a life expectancy of <24 months; 6. Has a history of cancer within the last 5 years, with the exception of nonmetastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer, or other cancers with low risk of recurrence or spread; 7. Have a past history (suspected or confirmed) of Hepatitis B or Hepatitis C; 8. Are clinically judged by the investigator to be at serious risk for suicide as assessed by medical history, examination, or the Columbia-Suicide Severity Rating Scale (C-SSRS). 9. Have a history of alcohol or drug disorder (except tobacco use disorder) within 2 years before the screening visit; 10. Have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis) 11. Have known positive serologic findings for human immunodeficiency virus (HIV) antibodies. Local laws and regulations may apply to whether testing is required. 12. Has previous MRI evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the patients ability to safely participate in the study; 13. Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker; 14. Have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, ECG, or clinical laboratory test results that could be detrimental to the patient, could compromise the study, or show evidence of other etiologies for dementia. 15. Has hypersensitivity to flortaucipir F 18 or any of its excipients; 16. Intend to use drugs known to significantly prolong the QT interval within 14 days or 5 half-lives, whichever is longer, of a scheduled screening/baseline flortaucipir F 18 PET scan, or have medical history of risk factors for torsades de pointes. 17. Have an ECG corrected QT (QTcF) interval measurement >450 msec (men) or >470 msec (women) at screening (as determined at the investigational site). 18. Have poor venous access; 19. Contraindication to PET; 20. Present or planned exposure to ionizing radiation that, in combination with the planned administration of study PET ligands, would result in a cumulative exposure that exceeds local recommended exposure limits; 21. Patients that are currently enrolled in any other interventional clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study 22. Have participated, within the last 30 days in a clinical trial involving an investigational product. If the previous investigational product is scientifically or medically incompatible with this study and has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed prior to screening (Participation in observational studies may be permitted upon review of the observational study protocol and approval by the sponsor). 23. Are investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as spouse, parent, child, or sibling whether biological or legally adopted; 24. Are Lilly employees or are employees of third-party organizations (TPOs) involved in a study that requires exclusion of their employees; 25. In the opinion of the investigator, are otherwise unsuitable for a study of this type. 26. Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than 1 months [If a patient has recently stopped an AChEI and/or memantine, he or she must have discontinued treatment at least 1 months prior]. 27. Have changes in concomitant medications that could potentially affect cognition and their dosing should be stable for at least 1 month before screening, (does not apply to medications with limited duration of use, such as antibiotics). 28. Have received active immunization agents for the treatment of Alzheimers Disease 29. Have known allergies to LY3303560, related compounds, or any components of the formulation; or history of significant atopy 30. Have allergies to either monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone; 31. Are receiving Immunoglobulin G therapy (also known as gamma globulin or intravenous immunoglobulin [IVIG]) ; PRIMARY OUTCOME: Flortaucipir Qualitative Results (Visual Reads); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 004 - PK; BRIEF: This study is a single-center, open-label, 3-group, fixed-sequence drug-drug interaction study to assess the effect of coadministration of multiple-dose itraconazole or diltiazem on the single-dose PK of AZD3293 and the effects of coadministration of single- and multiple-dose AZD3293 on the single-dose PK of midazolam. The study will also evaluate the safety and tolerability of single and multiple oral doses of AZD3293, alone and in combination with itraconazole, diltiazem, and midazolam in healthy young subjects.AZD3293 is being developed for the treatment of Alzheimers disease ; DRUG USED: Lanabecestat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Beta-secretase (BACE); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Provision of signed, written, and dated informed consent prior to any study-specific procedures Male and nonfertile female healthy subjects, aged 18 to 55 years at the time of consent - Body weight ≥50 to ≤100 kg and body mass index (BMI) ≥19 to ≤30 kg/m2 - Clinically normal findings on physical examination in relation to age, as judged by the Investigator - Male healthy subjects must be willing to use barrier contraception, ie, condoms, even if their partners are post-menopausal, surgically sterile, or using accepted contraceptive methods, from the first day of dosing until 3 months after the last dose of investigational product (IP) Exclusion Criteria: - Participation in any prior study of AZD3293 - History of any clinically significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, may influence the results, or may limit the subjects ability to participate in the study - History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs - History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), as assessed by the Mini-International Neuropsychiatric Interview (MINI) ; PRIMARY OUTCOME: The effect of multiple-dose co-administration of CYP3A4 inhibitors on the single-dose PK of AZD3293 measured by assessment of area under the curve over the time (AUC) and maximum concentration; SECONDARY OUTCOME 1: Safety profile in terms of Adverse events assessment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - CL-201 (Axillary Hyperhidrosis); BRIEF: To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis. ; DRUG USED: Sofpironium Bromide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dermatology; TARGET: Muscarinic acetylcholine receptor, Sweat gland activation; THERAPY: Monotherapy; LEAD SPONSOR: Botanix Pharmaceuticals; CRITERIA: Inclusion Criteria: - Primary axillary hyperhidrosis of at least 6 monthss duration - Hyperhidrosis disease severity score of 3 or 4 at baseline - Gravimetric test at baseline indicating at least 50 mg of sweat production at rest in each axilla, in 5 minutes (room temperature) - Willing to refrain from using any other antiperspirant agent for the duration of the study. - Females of childbearing potential must agree to use a medically acceptable method of contraception while participating in the study. Exclusion Criteria: - Any skin or subcutaneous tissue conditions in the axilla or near the axillary area, other than hyperhidrosis. - Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe, including: 1. Botulinum toxin to the axillary area within 1 year of the baseline visit. 2. Axillary iontophoresis within 12 weeks of baseline visit. 3. Axillary thermolysis, sympathectomy or surgical procedures of the axillary area at any time in the past. - Use of systemic and/or topical anticholinergic treatment within 30 days of the baseline visit. - Subjects with hyperhidrosis symptoms initiated or exacerbated with their menopause. - Subjects with history of diabetes mellitus, renal impairment, hepatic impairment, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, benign prostatic hyperplasia (BPH), neurological conditions, psychiatric conditions, Sjögrens syndrome, Sicca syndrome, or cardiac abnormalities that may alter normal sweat production or may be exacerbated by the use of anticholinergics. - Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components of the topical formulation. - Pregnant or lactating women. - Use of an investigational drug within 30 days prior to the baseline visit. - Prior treatment with the study drug in a previous trial. - Any major illness within 30 days before the screening examination. - Any other condition or laboratory abnormality that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study. ; PRIMARY OUTCOME: Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4; SECONDARY OUTCOME 1: Proportion of Subjects Achieving at Least 1-point Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/Rituxan - MCL; BRIEF: The goal of this clinical research study is to find the highest tolerable dose of the drug lenalidomide (Revlimid, lenalidomide) that can be given with Rituxan® (rituximab) in the treatment of relapsed mantle cell lymphoma. The safety and effectiveness of this combination treatment will also be studied in both mantle cell lymphoma and diffuse large B-cell non-Hodgkins lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma). ; DRUG USED: Revlimid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Mantle Cell Lymphoma - NHL; TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Combination; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: 1. Phase I and Phase II: Confirmed diagnosis of mantle cell lymphoma with CD20 positivity in tissue biopsy. Patients must have previously treated relapsed and/or refractory MCL. Or for Phase II: Confirmed diagnosis of previously treated relapsed and/or refractory diffuse large B-cell lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma). 2. Understand and voluntarily sign an Institutional Review Board (IRB) approved informed consent form. 3. Age equal to or greater than 18 years at the time of signing the informed consent. 4. Patients must have bi-dimensional measurable disease (bone marrow only involvement is acceptable). 5. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. 6. Serum bilirubin <1.5 mg/dl and serum creatinine < 2.0 mg/dl; platelet count >75,000/mm^3 and absolute neutrophil count (ANC) > 1,000/mm^3. AST (SGOT) and ALT (SGPT) < 2 x upper limit of normal or < 5 x upper limit of normal if hepatic metastases are present. 7. Disease free of prior malignancies of equal to or greater than 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other malignancies in remission (including prostate cancer patients in remission from radiation therapy, surgery or brachytherapy), not actively being treated, with a life expectancy > 3 years. 8. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test 10-14 days prior to therapy and repeated within 24 hours of starting study drug and must either commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. 9. Continuation from # 8 : (HIGHLY EFFECTIVE METHODS - Intrauterine device (IUD), hormonal (birth control pills, injections, implants), tubal ligation, partners vasectomy. ADDITIONAL EFFECTIVE METHOD-latex condom, diaphragm, cervical cap) while on study drug. 10. WCBP must agree to have pregnancy tests every week for the first 4 weeks of treatment, then every 4 weeks if her menstrual cycles are regular or every 2 weeks if her cycles are irregular, while on study drug, and 4 weeks after the last dose of study drug. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. 11. Patients may have 1 to 4 lines of prior therapy for MCL (projected median 2 prior lines of therapy). Patient may or may not have received an anthracycline-based chemotherapy regimen. 12. Patients must be willing to receive transfusions of blood products. 13. Past stem cell (autologous or allogenic) transplantation is acceptable. 14. Patients may have prior therapy with rituximab. Exclusion Criteria: 1. Any serious medical condition including but not limited to, uncontrolled hypertension, diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active infection, active hemorrhage, laboratory abnormality, or psychiatric illness that places the patient at unacceptable risk and would prevent the subject from signing the informed consent form. Patients with history of cardiac arrythmias should have cardiac evaluation and clearance. 2. Pregnant or lactating females. 3. Use of any standard/experimental anti-lymphoma drug therapy, including steroids, within 3 weeks of initiation of the study or use of any experimental non-drug therapy (e.g., donor leukocyte/mononuclear cell infusions) within 56 days of initiation of the study drug treatment. 4. Known hypersensitivity to thalidomide or rituximab; including the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide. 5. Prior use of lenalidomide. 6. Known HIV infection. Patients with active hepatitis B infection (not including patients with prior hepatitis B vaccination; not including patients with positive serum Hepatitis B antibody). Known hepatitis C infection is allowed as long as there is no active disease and is cleared by GI consultation. 7. All patients with history of central nervous system lymphoma. 8. Patients with peripheral blood involvement with white blood cell count (WBC) > 20,000 are EXCLUDED for the Phase I component of the study. 9. Patients with >/= Grade 3 neuropathy. 10. Patients with active pulmonary embolism or deep vein thrombosis (30 days within diagnosis). 11. Patients with severe bradycardia (heart rate <40 bpm, hypotension, light-headedness, syncope). ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With Rituximab; SECONDARY OUTCOME 1: Response of Participants Treated at Lenalidomide 20 mg[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 13-009; BRIEF: The purpose of this study is to evaluate the effect of brexpiprazole, via functional magnetic resonance imaging (fMRI), on the right ventrolateral prefrontal cortex (VLPFC) activated by impulsive behavior. ; DRUG USED: Rexulti; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Dopamine 2 (D2) Receptor, Norepinephrine (Noradrenaline), Serotonin 5-HT1A receptor, Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Are 18 to 65 years of age, inclusive, at the time of informed consent (outpatients only), with a diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and confirmed by both the M.I.N.I. for Schizophrenia and Psychotic Disorders Studies, and an adequate clinical psychiatric evaluation. - Have a CGI-S score of ≤ 4 (moderately ill) at screening and baseline. - Have a score of ≤ 4 (moderate) on PANSS item G8 (uncooperativeness) at screening and baseline. - Have a BIS-11 score of ≥ 50 at screening and baseline. - Willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period. - Are stable on their current oral antipsychotic medication (no changes within the last month) and are able to meet protocol-required washouts of their current antipsychotic medication. - Have received previous outpatient antipsychotic treatment at an adequate dose (at least minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and showed a previous good response to such antipsychotic treatment (other than clozapine) in the last 12 months, according to the investigators opinion. - Subjects with eyesight that is sufficient to be able to see visual displays, or correctable with magnet-compatible glasses or contact lenses. - Subjects fluent in English Exclusion Criteria: - Are presenting with schizophreniform or with a first episode of schizophrenia based on the clinical judgment of the investigator. - Have been hospitalized for psychotic symptoms within the previous 6 months. - Have a current DSM-IV-TR Axis I primary diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, major depressive disorder, bipolar disorder, post-traumatic stress disorder, obsessive-compulsive disorder (OCD) or panic disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, antisocial personality disorders, or mental retardation. - Have worsening of ≥ 20% in total PANSS score between the screening and baseline assessments. - Experiencing a deterioration in clinical status or an acute exacerbation of schizophrenia in the opinion of the Investigator. - Experiencing acute onset of clinically significant depressive symptoms within the past 30 days, according to the investigators opinion. - Answer Yes on the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4 occurred within the last 6 months, OR Answer Yes on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting criteria for this C-SSRS Item 5 occurred within the last 6 months OR Answer Yes on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR who, in the opinion of the investigator, present a serious risk of suicide. - Have a history of stroke. - Contraindications to magnetic resonance imaging (MRI) such as metal prostheses, pacemakers, claustrophobia, movement disorders, waist circumference more than 56 inches or head circumference more than 29 inches, color blindness, significant tremors, or history of head injury or prolonged unconsciousness ; PRIMARY OUTCOME: Change From Baseline Brain Activation in the Ventrolateral Prefrontal Cortex (VLPFC) Based on Change From Baseline to Week 6 in fMRI Blood Oxygen-level Dependent (BOLD) Activation Score in the Right VLPFC During Performance of the Go/No-go Task; SECONDARY OUTCOME 1: Change From Baseline to Week 3 in fMRI BOLD Activation Score in the Right VLPFC, Scanned by fMRI During Performance of Tasks Associated With Impulsivity (SSRT Task, Go/No-go Task)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib - MAD (Healthy Volunteers); BRIEF: This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203 in healthy volunteers conducted at one study center in the United States ; DRUG USED: Telacebec; DRUG CLASS: New Molecular Entity (NME); INDICATION: Tuberculosis; TARGET: Mitochondrial Electron Transport Chain, Tuberculosis; THERAPY: Monotherapy; LEAD SPONSOR: Qurient Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol. 2. Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age, inclusive, at screening. Exclusion Criteria: 1. Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. 2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI. 3. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study. ; PRIMARY OUTCOME: Safety assessment through adverse event, vital signs, ECG, laboratory results, and telemetry monitoring; SECONDARY OUTCOME 1: Pharmacokinetic analysis: Area under the curve[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - PRISMS; BRIEF: PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) alteplase in participants with mild acute ischemic strokes that do not appear to be clearly disabling. Participants will be randomized in a 1:1 ratio to receive within 3 hours of last known well time either 1) one dose of IV alteplase and one dose of oral aspirin placebo or 2) one dose of IV alteplase placebo and one dose of oral aspirin 325 milligrams (mg). ; DRUG USED: Activase; DRUG CLASS: Biologic; INDICATION: Ischemic Stroke; TARGET: Fibrin (Coagulation Factor Ia) , Plasminogen, Tissue Plasminogen Activator (TPA); THERAPY: Monotherapy; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Mild ischemic stroke defined as the most recent pre-treatment NIHSS score of less than or equal to(</=) 5 and determined as not clearly disabling by the investigator - Study treatment initiated within 3 hours of last time participant seen normal Exclusion Criteria: - Computed tomography (CT) or magnetic resonance imaging (MRI) findings of one of the following: 1. CT with clear large hypodensity that is greater than (>) one-third middle cerebral artery (MCA) territory (or >100 cubic centimeter [cc] if not in MCA territory) 2. MRI with clear large hyperintensity on concurrent diffusion-weighted (DW) and fluid-attenuated inversion recovery (FLAIR) that is greater than one-third MCA territory (or greater than 100 cc if not in MCA territory), 3. Imaging lesion consistent with acute hemorrhage, or 4. Evidence of intraparenchymal tumor - Disability prior to the presenting stroke - Standard contraindications to IV alteplase within 3 hours of symptom onset, including: 1. Head trauma, myocardial infarction, or previous stroke within the previous 3 months 2. Gastrointestinal or urinary tract hemorrhage within the previous 21 days 3. Major surgery within the previous 14 days 4. Arterial puncture at non-compressible site within the previous 7 days 5. Any history of ICH with the exception of those less than (<) 5 chronic microbleeds on MRI 6. Elevated blood pressure defined by systolic blood pressure >185 millimeters of mercury (mm Hg) or diastolic blood pressure >110 mm Hg, or treatments requiring aggressive measures to achieve acceptable levels 7. Treatment with unfractioned heparin within past 48 hours and activated partial thromboplastin time outside normal range 8. Blood glucose <50 milligrams per deciliter (mg/dL) 9. International normalized ratio >1.7 10. Platelet count <100,000 per cubic millimeter (/mm^3) 11. Treatment with a direct thrombin inhibitor (dabigatran) or a factor Xa inhibitor (apixaban, rivaroxaban, edoxaban) within the last 48 hours - Allergic reaction to study drug, aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) - Females of childbearing age who are known to be pregnant and/or lactating - Inability to swallow, which would prevent oral intake of aspirin or aspirin placebo tablet - Other serious, advanced, or terminal illness that would confound the clinical outcome at 90 days - Current or recent (within 3 months) participation in another investigational drug treatment protocol - Anticipated inability to obtain 3-month follow-up assessments - Previous enrollment in PRISMS - Any other condition deemed by the investigator that would pose hazard to the participant with alteplase treatment ; PRIMARY OUTCOME: Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90; SECONDARY OUTCOME 1: Distribution of Participants Across the Ordinal mRS[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - TRIAC-1; BRIEF: This therapeutical trial will be conducted in patients with the Allan-Herndon-Dudley Syndrome (AHDS), which is mutations in MCT8. MCT8 is a thyroid hormone (TH) transporter which is crucial for the transport of TH from the blood into different tissues. Dysfunction of MCT8 results in a lack of TH (hypothyroidism) in tissues that depend on MCT8 for TH uptake. This local hypothyroidism in the brain of these patients causes severe psychomotor retardation. In addition, TH serum parameters are highly abnormal in AHDS: high T3, low T4 and normal TSH levels. The high serum T3 levels cause local hyperthyroidism in tissues that do not depend on MCT8 for cellular transport of TH, resulting in a low body weight and reduced muscle mass. Currently, no adequate treatment is available for the AHDS. A T3 analog that does not depend on MCT8 for its cellular entry could, at least partially, restore the abnormalities found in AHDS. Several in vivo, in vitro and animal studies have shown that the T3 analog Triac is a very promising candidate: 1. Triac binds to the same TH receptors as T3; 2. Cellular uptake of Triac does not depend on functional MCT8. Hence, in AHDS patients Triac will also be available in tissues that require functional MCT8 for TH uptake, e.g. the brain; 3. In vitro studies have shown that neuronal cells differentiate equally well in the presence of either Triac or T3; 4. In Mct8 deficient mice, Triac is taken up by the brain and suppresses serum TSH levels; consequently, serum T3 and T4 levels were lowered; 5. Triac is the treatment of choice in patient with the resistance to thyroid hormone (RTH) syndrome. Patient with RTH have high serum TSH and thyroid hormone levels, which shows strong similarities to the profile found in AHDS patients; the longstanding experience with Triac in RTH indicates its safety and tolerability . Thus, Triac treatment could result in normalization of the abnormal serum TH values in AHDS patients. Furthermore, Triac could replace the function of T3 in tissues that depend on MCT8 for TH uptake (e.g. brain). The current trial will investigate if Triac treatment in ADHS patients 1. reduces the toxic effects of the high T3 levels 2. restores the local TH deficiency in brain. ; DRUG USED: Emcitate; DRUG CLASS: New Molecular Entity (NME); INDICATION: Endocrine Disorder; TARGET: Thyroid stimulating hormone receptor (TSHR); THERAPY: Monotherapy; LEAD SPONSOR: Erasmus Medical Center; CRITERIA: Inclusion Criteria: - clinically relevant mutation in the MCT8 gene, resulting in the clinical phenotype of AHDS. Exclusion Criteria: - Major illness or recent major surgery (within 4 weeks) unrelated to AHDS - Patients who are participating in ongoing RCTs of therapeutic interventions (including clinical trials of investigational medicinal products); - Known allergy to components in Triac tablets; - Patients that have any contra-indication for Triac treatment. ; PRIMARY OUTCOME: serum T3 concentrations; SECONDARY OUTCOME 1: Heart rate[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Vemlidy; BRIEF: The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir soproxil plus tenofovir alafenamide (TAF) or commercially available nucleoside/nucleotide (NUC) in adults with chronic hepatitis B (CHB), to evaluate the antiviral activity of 12 weeks of inarigivir soproxil plus TAF versus TAF alone in viremic CHB participants (Groups 1-3, 5), and to evaluate the antiviral activity of 12 weeks of inarigivir soproxil with commercially available NUC(s) in virally suppressed CHB participants (Group 4). ; DRUG USED: Inarigivir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: RIG-I (retinoic acid-inducible gene-I), RIG-I-like Receptors (RLR): RIG-I, MDA5, and LGP2; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Groups 1-3 and 5: - Individuals not taking any prescribed hepatitis B virus (HBV) NUC treatment - Group 4: - HBV deoxyribonucleic acid (DNA) ≤ 20 IU/mL at Screening by Central Lab. - Have been on a commercially available HBV NUC treatment(s) Key Exclusion Criteria: - Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV). - Extensive bridging fibrosis or cirrhosis - Evidence of hepatocellular carcinoma on imaging - Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage). - Chronic liver disease of a non-HBV etiology - Current alcohol or substance abuse Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1-3 and 5); SECONDARY OUTCOME 1: Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1 Through 3 and 5)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - INDUCE-3; BRIEF: The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) >=1 R/M HNSCC. ; DRUG USED: Feladilimab; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: Cluster of Differentiation 28 (CD28) /ICOS and B7RP-1 Pathway; THERAPY: Combination; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Capable of giving signed informed consent - Male or female, age >=18 years - Histological or cytological documentation of Head and Neck Squamous Cell Carcinoma (HNSCC) that is considered incurable by local therapies - Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx - No prior systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy given as part of multimodal treatment for locally advanced disease) - Measurable disease per RECIST version 1.1 guidelines - ECOG Performance PS score of 0 or 1 - Adequate organ function - Life expectancy of at least 12 weeks - Female participants: must not be pregnant, not breastfeeding, and at least one of the following conditions apply: 1. Not a woman of childbearing potential (WOCBP) 2. A WOCBP who agrees to use a method of birth control from 30 days prior to randomization and for at least 120 days after the last dose of study treatment - Male participants with female partners of child-bearing potential: must agree to use a highly effective contraception while receiving study treatment and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period - Provide tumor tissue from excisional or core biopsy (fine needle aspirates and bone biopsies are not acceptable) acquired within 2 years prior to randomization for PD-L1 immunohistochemistry (IHC) testing by central laboratory - Have PD-L1 Immunohistochemistry (IHC) CPS 1 status by central laboratory testing - Have results from testing of Human Papilloma Virus (HPV) status for oropharyngeal cancer Exclusion Criteria: - Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent - Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter - Major surgery 28 days prior to randomization - Has high risk of bleeding - Toxicity related to prior treatment that has not resolved to <=Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be<= Grade 2) - Received transfusion of blood products or administration of colony stimulating factors within 14 days prior to randomization - Central nervous system (CNS) metastases, with the following exception: Participants with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to randomization - Invasive malignancy or history of invasive malignancy other than disease under study within the last 3 years, except as noted below: a. Any other invasive malignancy for which the participant was definitively treated, has been disease-free for 3 years and in the opinion of the principal investigator and GSK Medical Monitor will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy, may be included in this clinical study - Autoimmune disease or syndrome that required systemic treatment within the past 2 years - Has a diagnosis of immunodeficiency or is receiving systemic steroids (≥10 mg oral prednisone per day or equivalent) or other immunosuppressive agents within 7 days prior to randomization - Receipt of any live vaccine within 30 days prior randomization - Prior allogeneic/autologous bone marrow or solid organ transplantation - Has current pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents - Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions - Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess - Recent history of allergen desensitization therapy within 4 weeks of randomization - History or evidence of cardiac abnormalities within the 6 months prior to randomization - Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice - Active infection requiring systemic therapy - Known HIV infection, or positive test for hepatitis B active infection (presence of hepatitis B surface antigen), or hepatitis C active infection - History of severe hypersensitivity to monoclonal antibodies or any ingredient used in the study treatment formulations - Known history of active tuberculosis - Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participants safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator - Is currently participating in (unless in follow-up phase and 4 weeks have elapsed from last dose of prior investigational agent), or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to date of randomization - Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study ; PRIMARY OUTCOME: Overall Survival (OS) in the Programmed Death Receptor-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Population; SECONDARY OUTCOME 1: PFS Per Immune-based RECIST (iRECIST) in the PD-L1 CPS ≥1 Population[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - LOTUSS (SSc-ILD); BRIEF: PSSc-001 (LOTUSS) This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in participants with systemic sclerosis-related interstitial lung disease (SSc-ILD). ; DRUG USED: Esbriet; DRUG CLASS: New Molecular Entity (NME); INDICATION: Scleroderma; TARGET: p38 MAP kinase (MAPK); THERAPY: Monotherapy; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: 1. Diagnosis of systemic sclerosis-related (SSc) confirmed by the American College of Rheumatology classification criteria of systemic sclerosis (Masi 1980); duration of diagnosis less than (<) 7 years 2. Diagnosis of SSc-ILD based on an high-resolution computed tomography (HRCT) scan 3. Screening forced vital capacity (FVC) greater than equal to (>=) 50 percent (%) of the predicted value, and screening carbon monoxide diffusing capacity (DLCO) >=40% of the predicted value 4. At study entry, the participant either was not taking SSc-ILD medication or was taking cyclophosphamide or mycophenolate Exclusion Criteria: 1. Clinically significant pulmonary hypertension 2. Known underlying liver disease 3. Clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux 4. History of clinically significant asthma or chronic obstructive pulmonary disease 5. Active infection 6. Diagnosis of another connective tissue disorder 7. Evidence of a malignancy that is likely to result in significant disability or require significant medical or surgical intervention 8. History of unstable or deteriorating cardiac or pulmonary disease (other than SSc-ILD) 9. Pregnancy or lactation 10. Creatinine clearance <40 milliliters per minute (mL/min) 11. Prior use of pirfenidone 12. Unsuitable for enrollment or unlikely to comply with study requirements ; PRIMARY OUTCOME: Percentage of Participants With Treatment-Emergent Adverse Events (AEs); SECONDARY OUTCOME 1: University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PISCES (Preference vs. Sunitinib); BRIEF: This is a randomised, double-blind, cross-over study of pazopanib versus sunitinib in patients with locally advanced or metastatic renal cell carcinoma (mRCC) who have received no prior systemic therapy for advanced or metastatic RCC. Approximately 160 eligible patients will be stratified based on the ECOG performance status (0 vs. 1) and number of metastatic sites of disease (0 and 1 vs. >=2). The study consists of two treatment periods of 10 weeks with a 2-week wash-out period between the two treatment periods. Patients will receive pazopanib and sunitinib treatment sequentially in a double-blinded fashion. The primary objective of the study is to assess how the tolerability and safety differences between pazopanib and sunitinib translate into patient preference, defined by the patients stated preference for which drug they may prefer to continue treatment with at end of study. The secondary objectives are to evaluate the reason for patient preference as assessed by a patient preference questionnaire; to evaluate fatigue as assessed by FACIT-Fatigue and quality of life as assessed by EuroQoL EQ-5D; to evaluate dose modifications and time to dose modification; and to evaluate safety. ; DRUG USED: Votrient (Oral); DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients must provide written informed consent prior to performance of any study-specific procedures or assessments and must be willing to comply with treatment and follow up. Procedures conducted as part of the patients routine clinical management (e.g. blood count, imaging study) and obtained prior to signing of informed consent may be utilised for screening or baseline purposes provided these procedures are conducted as specified in the protocol. - Received no prior systemic therapy (including interleukin-2, interferon-alpha, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic RCC. Patients who received adjuvant treatment with a cancer vaccine are eligible. - Locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic renal cell carcinoma of any histology (equivalent to Stage IV RCC according to AJCC staging). Patients with non-measurable disease are allowed if metastatic disease can be confirmed. - ECOG PS of 0 or 1 - Age >= 18 years - A female is eligible to enter and participate in this study if she is of: Non-childbearing potential (i.e. physiologically incapable of becoming pregnant) Childbearing potential, including any female who has had a negative serum pregnancy test within two weeks prior to the first dose of study treatment, preferably as close to the first dose as possible and agrees to use adequate contraception. - Adequate organ system functions - Total serum calcium concentration <12.0mg/dL - Left ventricular ejection fraction (LVEF) >=lower limit of institutional normal (LLN) as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan. The same modality used at baseline must be applied for subsequent evaluations. - Patient is able to swallow and retain oral tablets Exclusion Criteria: - Poor MSKCC risk group - History of another malignancy. Note: Patients who have had another malignancy and have been disease-free for 3 years or patients with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible. - History or clinical evidence of central nervous system (CNS) metastases. Note: Patients who have previously-treated CNS metastases (surgery +/- radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible: - Are asymptomatic, - Have had no evidence of active CNS metastases for >=6 months prior to enrolment , - Have no requirement for steroids or enzyme-inducing anticonvulsants (EIAC). - Any clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding or affect absorption of investigational product including, but not limited to: - Malabsorption syndrome - Major resection of the stomach or small bowel that could affect the absorption of study drug - Active peptic ulcer disease - Inflammatory bowel disease - Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation - History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment. - Presence of uncontrolled infection. - Corrected QT interval (QTc) >480 msecs using Bazetts formula - History of one or more of the following cardiovascular conditions within the past 6 months: - Cardiac angioplasty or stenting - Myocardial infarction - Unstable angina - Coronary artery bypass graft surgery - Symptomatic peripheral vascular disease - Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) - Poorly controlled hypertension (defined as systolic blood pressure (SBP) of > 150mmHg or diastolic blood pressure (DBP) of > 90mmHg) at baseline. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour within a visit. The mean SBP/DBP values from each blood pressure assessment must be <=150/90mmHg in order for a patient to be eligible for the study. - History of cerebrovascular accident (CVA) including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Patients with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible. - Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major). - Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels. - Evidence of active bleeding or bleeding diathesis. - Significant haemoptysis within 6 weeks prior to first dose of study drug. - Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patients safety, obtaining informed consent or compliance to the study. - Use any prohibited medications within 14 days of the first dose of study medication. - Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug. - Radiation therapy, surgery or tumour embolisation within 14 days prior to the first dose of study treatment. - Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or sunitinib. - Pregnant or lactating female Female patients who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug. ; PRIMARY OUTCOME: Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ); SECONDARY OUTCOME 1: Change From Period Baseline (BL) in Fatigue as Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - PK/PD (SC vs. Syringe Driver); BRIEF: The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single subcutaneous (SC) dose of rozanolixizumab administered to healthy participants by manual push (MP) versus (vs) syringe driver. ; DRUG USED: Rozanolixizumab; DRUG CLASS: Biologic; INDICATION: Immune Thrombocytopenic Purpura (ITP); TARGET: Neonatal Fc Receptor; THERAPY: Monotherapy; LEAD SPONSOR: UCB Biopharma SRL; CRITERIA: Inclusion Criteria: - Study participant must be 18 to 65 years of age, inclusive - Study participants who are overtly healthy in the opinion of the investigator as determined by medical evaluation including medical history, a general clinical examination, including physical examination and laboratory tests, and cardiac monitoring - Study participant has blood pressure (BP) and pulse within normal range in a supine position after 5 minutes of rest (systolic BP: 90 to 140 mmHg, diastolic BP: 50 to 90 mmHg, pulse: 40 to 90 beats per minute (bpm)) - Study participant has clinical laboratory test results within the reference ranges of the testing laboratory or not clinically significant if outside the specified ranges, in the opinion of the investigator - Study participants electrocardiogram (ECG) is considered normal or abnormal but clinically nonsignificant (as interpreted by the investigator) - Study participants may be male or female - Participant has a body mass index of 18 to 32 kg/m^2, with a minimum body weight of 35 kg Exclusion Criteria: - History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders. Has active neoplastic disease or history of neoplastic disease within the previous 5 years of entry in the clinical study (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care approaches). Has a history of a major organ transplant or hematopoietic stem cell/marrow transplant - Symptomatic herpes zoster within 3 months prior to Screening - Allergies to humanized monoclonal antibodies - Female who is pregnant or lactating - Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions - Evidence of active or latent tuberculosis (TB) as documented by medical history and examination - Predicted inability to comply with being free of caffeine and ethanol from 72 hours prior to clinic admission and during the In-Clinic Period of the study - Known hypersensitivity to oral paracetamol (acetaminophen) - History of known inflammatory bowel disease, active diverticular disease, or a history of confirmed duodenal, gastric, or esophageal ulceration in the previous 6 months - History of hyperprolinemia, since L-proline is a constituent of rozanolixizumab. - Twelve-lead ECG with abnormalities considered to be clinically significant upon medical review - Renal impairment, defined as a creatinine concentration in serum of ≥1.4 mg/dL (≥123 μmol/L) for female participants and ≥1.5 mg/dL (≥132 μmol/L) for male participants - Known viral hepatitis (B and C) or human immunodeficiency virus 1/2 antibodies or has a past medical history or family history of primary immunodeficiency or antibodies to human immunodeficiency virus type 1 and/or type 2 at Screening - Participant has a positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in reverse transcriptase-polymerase chain reaction on admission to the unit - Participant has clinical signs and symptoms consistent with SARS-CoV-2 (eg, fever, dry cough, dyspnea, sore throat, fatigue) or confirmed infection by appropriate laboratory test within the previous 14 days prior to Screening or on admission - Participant has active infection or is symptomatic with SARS-CoV-2 or is currently in quarantine (has been in contact with a SARS-CoV-2 positive individual in the last 14 days) - Participant has had a severe course of SARS-CoV-2 (eg, requiring extracorporeal membrane oxygenation, mechanical ventilation, or hospitalization) - Past or intended use of over-the-counter or prescription medication (including herbal medications) within 14 days prior to dosing until Day 57 - Live vaccine(s) within 8 weeks prior to Screening or plans to receive such vaccines during the study or is within a dosing cycle to receive a second dose of a coronavirus disease-19 (COVID-19) vaccine, or within 2 weeks of having received a COVID-19 vaccine - Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing - Exposure to more than 3 new chemical entities within 12 months prior to dosing - Has previously been assigned to treatment in a clinical study of rozanolixizumab - Participated in another study of an investigational medicinal product (IMP) (or a medical device) within the previous 90 days or 5 half-lives prior to Day -1 (whichever is longer) or is currently participating in another study of an IMP (or a medical device) - Immunoglobulin G <7g/L or >16g/L at the Screening Visit - Participant is splenectomized or has had an active clinically significant infection within the last 6 weeks - Donated or lost >500 mL of blood or blood products in the 3 months preceding the start of dosing or plans to donate blood during the clinical study - Employee or direct relative of an employee of the contract research organization (CRO) or UCB - History of alcohol and/or drug abuse up to 12 months before Screening - Smoked on average >5 cigarettes/day (or equivalent) during the last 3 months and is not able to stop smoking during the In-Clinic Period - Excessive consumption of beverages or food containing xanthine bases (including caffeinated drinks, coffee, chocolate, etc.), equating to >400 mg caffeine per day ; PRIMARY OUTCOME: Incidence of treatment-emergent adverse events (TEAEs); SECONDARY OUTCOME 1: Maximum plasma concentration (Cmax) of a single dose rozanolixizumab[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - GIGVHD; BRIEF: The objectives of this trial were to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in participants with acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI) tract. ; DRUG USED: ALXN1007; DRUG CLASS: Biologic; INDICATION: Graft vs. Host Disease (GVHD) - Treatment; TARGET: C5a Receptor, Complement component 5 (C5), Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Participants must be males or females age 18 years or older. - Participants with Stage 1 to 4 (per the Modified Keystone Grading Schema) acute GVHD of the lower GI tract, without signs of chronic GVHD, at the time of diagnosis, which developed in the first 180 days following allogeneic hematopoietic cell transplantation (HCT) using bone marrow, peripheral blood, or cord blood; or after preplanned donor lymphocyte infusion. - Participants are willing to undergo or must have had an endoscopy of the upper and/or lower GI tract and biopsy to confirm GI GVHD. - Participants must be receiving systemic corticosteroids. - Participants with an absolute neutrophil count (ANC) >500/microliter (μL) at Screening. - Participants and spouse/partner who are of childbearing potential must be using high effective contraception consisting of 2 forms of birth control (at least 1 of which much be barrier method) starting at Screening and continuing through the entire study (for at least 3 months after the last dose of ALXN1007 if study treatment is stopped early or participant withdraws consent). - Male participants must not donate sperm during the Screening and Treatment periods, and for at least 3 months after the last dose of ALXN1007. - Stage of acute GVHD of the lower GI tract will be determined using the Modified Keystone Grading Schema. Exclusion Criteria: - Participants with a body weight > 140 kg (for Cohorts dosing 20 mg/kg of ALXN1007 and higher only). - Participants with signs and symptoms of chronic GVHD. - Participants with an active uncontrolled infection. - Participants who test positive for Clostridium difficile (C. difficile) at Screening. - Participants with relapsed/persistent malignancy requiring rapid immune suppression withdrawal. - Participants who received an unplanned (not part of the original transplant therapy plan) donor lymphocyte infusion. - Participants who received previous systemic treatment for acute GVHD, except for a maximum of 3 days (72 hours) of 2 mg/kg corticosteroid therapy. - Participants with unresolved veno-occlusive disease of the liver. - Participants with creatinine clearance <40 milliliters (mL)/minute at Screening, as calculated by the Cockcroft-Gault formula. - Participants known to be infected with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. - Participants known to have an uncontrolled thyroid disorder. - Participants who are pregnant, breast feeding, or sexually active and unwilling to use effective birth control for the duration of the study. - Participants who participated in any other investigational drug trial or had exposure to any other investigational agent, device, or procedure <4 weeks prior to Screening and throughout the entire trial, with the exception of investigational drugs administered prophylactically for cytomegalovirus (CMV) post allogeneic HCT. ; PRIMARY OUTCOME: Overall Acute Graft-Versus-Host Disease (GVHD) Response Rate At Day 28; SECONDARY OUTCOME 1: Pharmacokinetics (PK): Time To Maximum Observed Concentration In Plasma (Tmax) Of IV ALXN1007[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Liver Transplant Patients; BRIEF: The purpose of this study is to test the safety and efficacy of Civacir® to prevent the recurrence of Hepatitis C Virus (HCV) after liver transplant. ; DRUG USED: Civacir; DRUG CLASS: Biologic; INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Hepatitis C/HCV; THERAPY: Monotherapy; LEAD SPONSOR: Biotest Pharmaceuticals Corporation; CRITERIA: Inclusion Criteria: - Written informed consent obtained prior to any study-specific assessments and within 3 months (reconsent) of orthotopic liver transplantation (OLT). - HCV Genotype 1 through 6 Infection. - Subjects in the beginning of a new antiviral therapy regimen (regardless of prior treatment failures) for up to and including 24 weeks prior to the day of OLT. - Most recent evidence within the last 4 weeks that HCV RNA is <100 IU/mL. Subjects may be randomized based on local lab HCV RNA. - Male and female subjects (age 18-80 years). - Subject weight under 250 pounds. - Stable patient in a condition which in the opinion of the investigator would permit safe participation in the study. Exclusion Criteria: - Re-transplantation due to viral recurrence. - Positive HIV or HBV test within 90 days prior to transplantation. - Most recent PCR test indicating HCV RNA ≥100 IU/mL within 4 weeks of OLT. - Subjects having received organs from HCV positive donors. - Serum creatinine level >2.5 times the upper limit of normal or advanced renal disease at screening. - Pregnancy or single contraceptive measure or lactation period (females only). - Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction). - Known absolute Immunoglobulin A (IgA) deficiency. - Known intolerance to proteins of human origin. - Participation in another clinical trial within 90 days before signing Informed Consent Form (ICF) or during the study (observational/ non-interventional and 988 studies allowed), and/or previous participation in 988 study (except for Study 988 screen failures). - Active drug and/or alcohol abuse. - Inability or lacking motivation to participate in the study. ; PRIMARY OUTCOME: Determine the efficacy of Civacir® in preventing post-transplant HCV recurrence at 22 weeks post transplant; SECONDARY OUTCOME 1: Determine the efficacy of Civacir® in preventing post-transplant HCV recurrence at 4 and 34 weeks post transplant[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EKL001 (Korea); BRIEF: The purpose of this study was to observe the Efficacy and safety of 400 μg twice daily of aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD). ; DRUG USED: Tudorza Pressair; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Daewoong Pharmaceutical Co. LTD.; CRITERIA: Inclusion Criteria: - A diagnosis of stable moderate to severe COPD as defined by GOLD (the Global Initiative for Chronic Obstructive Lung Disease) guidelines(http://www.goldcopd.org); a postbronchodilator FEV1/forced vital capacity [FVC] ratio < 70% and FEV1 ≥ 30% to <80% of the predicted value. - Current or former cigarette smokers with a smoking history of at least 10 pack-years. Exclusion Criteria: - History or current diagnosis of asthma - Patients who have been hospitalized for an acute COPD exacerbation within 3 months prior to Visit 1 - Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1. - Patients with any clinically significant respiratory conditions other than COPD ; PRIMARY OUTCOME: Change from baseline to Week 12 in morning predose (trough) FEV1; SECONDARY OUTCOME 1: Change from baseline to Week 12 in peak FEV1[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - BORUS; BRIEF: This is an open-label, one sequence study to evaluate the steady-state comparative bioavailability of 100 mg Risperidone ISM® injectable every 4 weeks compared to once daily 4 mg oral risperidone in subjects with schizophrenia stabilized on oral risperidone treatment. ; DRUG USED: Doria; DRUG CLASS: Non-NME; INDICATION: Schizophrenia; TARGET: Alpha 1 Adrenergic Receptor , Alpha 2 Adrenergic Receptor, Dopamine 2 (D2) Receptor, Histamine H1 Receptor (HRH1), Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Rovi Pharmaceuticals Laboratories; CRITERIA: Subjects will be considered eligible to participate in this study if each one of the following inclusion criteria is satisfied at screening (or at baseline when specified): 1. Male or female aged ≥18 and <65 years with a body mass index (BMI) of ≥17 kg/m2 but ≤35 kg/m2 2. Current diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria 3. Outpatient; not hospitalized for worsening of schizophrenia within the last 3 months (hospitalization for social management within this time period is acceptable) 4. Medically stable over the last month and psychiatrically stable without significant symptom exacerbation over the last 3 months based on the investigators judgement 5. On oral risperidone 4 mg daily as maintenance therapy for at least the last 4 weeks prior to screening and on 4 mg oral risperidone once daily (QD) for at least one week prior baseline (Day1, Visit 2) 6. Agrees to taper off all prohibited medications prior to baseline 7. On a stable dosage of all permitted medications (with the exception of medication to be used on an as-needed basis) for at least 2 weeks prior to the baseline visit and for the duration of the study 8. Clinical Global Impression - Severity (CGI-S) score of ≤4 (moderately ill) 9. A female subject of childbearing potential who is sexually active and using a medically accepted contraceptive method. Acceptable methods include condoms (male or female) with or without spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device, and hormonal contraceptives. A female subject of childbearing potential who is not currently sexually active must agree that should she be so while participating in the trial, she will use a medically accepted method of contraception for the remainder of the study and for 1 month afterward. Female patients who have had a hysterectomy, bilateral tubal ligation, or bilateral salpingooophorectomy are considered surgically sterile and are thus are exempt from the requirement to use contraception. Female patients who are postmenopausal are considered not of childbearing potential and thus exempt from the contraception requirement; for the purpose of this study, postmenopausal is defined as the permanent cessation of menstruation for at least 12 months prior to screening in women ≥ 45 years of age. 10. Female subjects must have a negative pregnancy test at screening (serum test) and baseline (urine test) 11. Psychotherapy should not be started or changed during a patients participation in the study. It is acceptable for a patient already receiving psychotherapy to participate in the study 12. Able to speak, read, and understand sufficiently to allow completion of all study assessments 13. Must provide written informed consent prior to the initiation of any protocol-specific procedures Subjects will not be considered eligible to participate in this study if any one of the following exclusion criteria is satisfied at screening (or at baseline when specified): 1. Presence of an uncontrolled, unstable, clinically significant medical condition (eg, renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, or malignancy) that in the opinion of the investigator could have interfered with the interpretation of safety and PK evaluations 2. Presence of a clinically significant vital sign or physical examination finding that in the opinion of the investigator could potentially interfere with the ability to evaluate safety and tolerability of the trial medication or could impair the subjects ability to complete the trial 3. Presence of a clinically significant abnormality on blood or urine safety tests, which do not improve on retesting. In particular, laboratory and/or clinical evidence of clinically significant hepatic conditions, such as: - alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN) and total bilirubin > 2 × ULN; or - ALT or AST > 3 × ULN with the appearance of jaundice, worsening of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia 4. Corrected QT interval, Fridericias correction (QTcF) interval greater than 450 msec for males and 470 msec for females, or other clinically significant ECG abnormality on screening or baseline 5. If female, a positive serum pregnancy test, or planning to become pregnant between signing informed consent and 1 month after the last dose of trial medication, or is breastfeeding a child 6. Uncontrolled or unstable diabetes, or a clinically significant abnormal Hba1c blood level 7. Known or suspected (non-febrile) seizure disorder 8. Known serological evidence of human immunodeficiency (HIV) antibody 9. History of hepatitis B infection within the past year, or history of hepatitis C infection that has not been adequately treated and abnormal Liver Functional Tests (LFT) values 10. History of neuroleptic malignant syndrome 11. Current or past history of clinically significant tardive dyskinesia 12. Primary diagnosis other than schizophrenia diagnosis that is primarily responsible for current symptoms and functional impairment 13. Known or suspected diagnosis of mental retardation or organic brain disorder 14. Positive urine drug/alcohol (ethanol breathalyzer is also acceptable) screen finding, unless the positive finding can be accounted for by documented prescription use. Individuals who have positive results for alcohol, cannabis, or other psychotropic substances but are not dependent on or abusing these substances may be included at the investigators discretion, following a discussion between the investigator and the medical monitor 15. Heavy smoker (consumption of >40 cigarettes daily) 16. Fulfillment of the DSM-5 criteria for moderate or severe substance use disorder (excluding nicotine) within the past 6 months 17. Diagnosis of a psychotic disorder or a behavioral disturbance that is thought to be substance-induced or due to substance abuse 18. In the investigators opinion, at imminent risk of committing self-harm or harm to others, based on clinical interview and responses provided on the Columbia-Suicide Severity Rating Scale (C-SSRS). Individuals will be excluded if they report having suicidal ideation of Type 4 or 5 in the past 2 months, or suicidal behavior in the past 6 months, as measured by the C-SSRS at screening or baseline 19. On more than 1 antidepressant; or if on just one, a change in dose within the last 4 weeks prior to screen 20. Use of depot antipsychotics within the last 6 to 9 months 21. Use of electroconvulsive therapy (ECT) within the last 3 months 22. Use of moderate or strong cytochrome P450 3A4 (CYP3A4)enzyme inducers and inhibitors (carbamazepine, phenytoin, rifampicin, phenobarbital) or moderate or strong cytochrome P450 2D6 (CYP2D6) inhibitors (fluoxetine, paroxetine) (see Appendix 11.2) within 3 days or a time period of 5 half lives of the concerning drug, whichever is longer, prior to baseline 23. Unwilling to discontinue any of prohibited medications prior to the baseline visit; or, in the opinion of the investigator, is unable to safely taper off such medication without significant destabilization or increased risk of self-harm (suicide). Prohibited medications may include antipsychotics, phenobarbital, fluoxetine, fluoxetine combinations, paroxetine, benzodiazepines except lorazepam, diazepam, oxazepam, psychotropics, herbal drugs/dietary supplements for depression, anxiety, insomnia, rifampicin, and quinidine 24. Receipt of any investigational drugs within the last 3 months 25. Current participation in any other clinical trial 26. In the investigators opinion, medically non-compliant in the management of his or her disease 27. Known or suspected allergy or hypersensitivity to risperidone or any of the ISM® excipients 28. Previous non-responder to risperidone treatment 29. Currently under involuntary in-patient commitment ; PRIMARY OUTCOME: Area under the curve during the dosing interval (AUCtau); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - V98_08 (South Africa); BRIEF: This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women. ; DRUG USED: Group B Streptococcus Vaccine (GSK); DRUG CLASS: Vaccine; INDICATION: Group B Streptococcus; TARGET: Group B Streptococci, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Vaccines; CRITERIA: Inclusion Criteria: - Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive. - Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation) Exclusion Criteria: - Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive - Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive ; PRIMARY OUTCOME: The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.; SECONDARY OUTCOME 1: The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Pediatric NASH; BRIEF: The study was being conducted in order to assess the pharmacokinetics and the safety of elafibranor following once daily administration of two dose levels of elafibranor (80 milligrams [mg] and 120mg) during 3 months in children and adolescent population (8 to 17 years of age) with non alcoholic steatohepatitis (NASH). ; DRUG USED: Elafibranor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: PPAR alpha, PPAR delta; THERAPY: Monotherapy; LEAD SPONSOR: Genfit; CRITERIA: Inclusion Criteria: - Was male or female between 8 and 17 years of age (inclusive) at the time of Screening Visit (when consent for study participation is given) and at the time of Randomization; - Diagnosis of NASH confirmed by histological evaluation (with or without fibrosis) from a liver biopsy obtained within 24 months prior to Randomization; - Had an alanine aminotransferase (ALT) level greater than (>) 50 international units per liter (IU/L), at Screening; - Had a Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) greater than or equal to (>=) 5, at Screening; - Had a Body Mass Index z-score (BMI z-score) (also referred to as BMI-for-age percentile) >=85th percentile for age and gender at Screening; - Had a Hemoglobin A1C (HbA1c) less than or equal (<=) to 8.5%. If the participants had Type 2 diabetes and is taking anti-diabetic therapy (e.g., metformin or insulin), treatment must had been started at least 3 months prior to Screening and the dose must had been stable for at least 3 months prior to Screening and should remain stable through Randomization; - Sexually active female participants of childbearing potential must had agree to utilize a highly effective method of contraception per the Clinical Trial Facilitation Group Guidelines from Screening through 30 days after the last dose of study drug (1 month after the end of treatment), and agree to monthly pregnancy testing during the study up to and including end of study. Other inclusion criteria may apply Exclusion Criteria: - Had history of bariatric surgery or planned surgery during the study period; - Had known history of heart disease; - Had uncontrolled hypertension evidenced by sustained elevation in systolic blood pressure greater than140 mmHg or diastolic blood pressure greater than 90 mmHg despite treatment with antihypertensive therapy, prior to Randomization; - Had a known history of Type 1 diabetes; - Had a known history of acquired immunodeficiency syndrome or positive screening for human immunodeficiency virus antibodies at Screening Visit; - Had a documented weight loss of more than 5% during the 6-month period prior to Randomization; - Had a history of renal disease defined as an estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m^2 using the Schwartz Bedside GFR Calculator for Children or present at Screening Visit; - History of, significant alcohol consumption or inability to reliably quantify alcohol intake, and/or use of illicit drugs. - Had clinical and/or historical evidence of cirrhosis, included by not limited to: 1. Abnormal hemoglobin (with the exception of females with a documented history of a low hemoglobin during menstruation); 2. White blood cell count less than 3,500 cells/mm^3 of blood; 3. Platelet count less than150,000 cells/mm^3 of blood; 4. Direct bilirubin greater than 0.3 mg/dL; 5. Total bilirubin greater than 1.3 mg/dL unless the patient has a diagnosis of Gilbert disease in which case direct bilirubin, reticulocyte count and haemoglobin must be normal; 6. Serum albumin less than 3.5 g/dL; 7. International normalized ratio (INR) greater than 1.4; - Has evidence of chronic liver disease other than NASH, defined by any one of the following: 1. Biopsy consistent with histological evidence of autoimmune hepatitis; 2. Serum hepatitis A antibody positive; 3. Serum hepatitis B surface antigen positive; 4. Serum hepatitis C antibody positive; 5. Serum hepatitis E antibody positive; 6. History of or current positive Anti-Mitochondrial Antibody Test; 7. Known or current Iron/total iron binding capacity ratio (transferrin saturation) greater than 45% with histological evidence of iron overload; 8. Known or current Alpha-1-antitrypsin phenotype/genotype ZZ or SZ; 9. Diagnosis of Wilsons disease; - Had AST and/or ALT greater than 8 fold the upper limit of normal; - Was pregnant, lactating or is planning to become pregnant during the study; Other exclusion criteria may apply ; PRIMARY OUTCOME: Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Elafibranor and Its Active Metabolite (GFT1007); SECONDARY OUTCOME 1: Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113[/INST]No</s>