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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 III - w/Etoposide/Platinum; BRIEF: The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone. ; DRUG USED: Yervoy; DRUG CLASS: Biologic; INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), Immune System; THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: - Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) - Eastern Cooperative Oncology Group (ECOG) of 0 or 1 Exclusion Criteria: - Prior systemic therapy for lung cancer - Symptomatic Central Nervous System (CNS) metastases - History of autoimmune disease ; PRIMARY OUTCOME: Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy; SECONDARY OUTCOME 1: Overall Survival in All Randomized Participants[/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 - PALISADE Follow-On (ARC004); BRIEF: The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed the ARC003 study. ; DRUG USED: Palforzia; DRUG CLASS: Biologic; INDICATION: Food Allergies; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Aimmune Therapeutics, Inc.; CRITERIA: Key Inclusion Criteria: - Completion of the ARC003 study - Written informed consent and/or assent from subjects/guardians as appropriate - Use of effective birth control by sexually active female subjects of child-bearing potential Key Exclusion Criteria: - Early discontinuation from the ARC003 study - Meets any longitudinally applicable ARC003 study exclusion criteria - (Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 study Exit DBPCFC - Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety ; PRIMARY OUTCOME: Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE); SECONDARY OUTCOME 1: Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)[/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 - Renal and Vascular Function; BRIEF: The purpose of this study was to evaluate the effect of celecoxib on the efficacy and safety of amlodipine besylate on renal and vascular function in subjects with existing hypertension requiring antihypertensive therapy. Kitov Pharma Ltd. (Kitov) is developing KIT-302, an oral fixed combination drug product (FCDP) consisting of the calcium channel blocker amlodipine besylate and the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, as a convenience reformulation FCDP to facilitate and improve patient compliance with the once a day (qd) administration of its individual components, amlodipine and celecoxib. The formulation of KIT-302 consists of amlodipine besylate and celecoxib co-formulated in a single immediate release tablet. However, for this study (KIT-302-03-02), commercial celecoxib capsules (Celebrex®) and commercial amlodipine besylate tablets (Norvasc®) were separately over-encapsulated (OE) and matched placebos were used to allow for blinding. Kitov completed a phase 3 pivotal trial in subjects with newly diagnosed hypertension (KIT-302-03-01) demonstrating that the amlodipine + celecoxib combination was statistically non-inferior to amlodipine monotherapy with regard to reduction of blood pressure. Further, trends towards superior blood pressure lowering effects and improved renal function were observed for the combination. This study (KIT-302-03-02) was conducted to quantify the beneficial renovascular effects noted in the prior study in subjects with existing hypertension requiring antihypertensive therapy. On May 31, 2018, the United States (US) Food and Drug Administration (FDA) approved KIT-302, under the brand name Consensi® (amlodipine and celecoxib) tablets [New Drug Application (NDA) 210045] for the following indication: patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ; DRUG USED: Consensi; DRUG CLASS: Non-NME; INDICATION: Hypertension (Systemic); TARGET: Calcium Channel, Cyclooxygenase 2 (COX2) / Prostaglandin-Endoperoxide Synthase 2 (PTGS2); THERAPY: Monotherapy; LEAD SPONSOR: Kitov Pharma Ltd; CRITERIA: Inclusion Criteria: 1. Adult 40 to 75 years of age 2. Existing hypertension that is being treated using pharmacological therapy with a single agent that is not a calcium channel blocker 3. SBPday > 135 and ≤ 169 mmHg and average daytime (9:00 to 21:00) ambulatory diastolic blood pressure (DBPday) ≤ 110 mmHg at Day 0 (after the 10- to 14-day washout from prior blood pressure medication) 4. Body Mass Index of 18.5 to 34.9 kg/m2 5. Healthy (other than hypertension) as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests 6. A negative pregnancy test at initial screening visit 7. If woman of childbearing potential, agree to use a highly effective form of birth control while on study (from Screening through final study visit) 8. Able to comprehend and sign an informed consent form. Exclusion Criteria: 1. Resting SBP > 169 mmHg or a resting DBP > 110 mmHg at initial screening visit while on their standard antihypertensive therapy (where resting is defined as supine for at least 10 minutes with minimal interaction) 2. Weight < 55 kg 3. Fragile health 4. Evidence of clinically significant findings on screening evaluations (clinical, laboratory, and ECG) which, in the opinion of the Investigator would pose a safety risk or interfere with appropriate interpretation of safety data 5. Current or recent history (within four weeks prior to initial screening visit) of a clinically significant bacterial, fungal, or mycobacterial infection 6. Current clinically significant viral infection 7. History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin 8. Major surgery within four weeks prior to initial screening visit 9. Presence of a malabsorption syndrome possibly affecting drug absorption (e.g., Crohns disease or chronic pancreatitis) 10. Active peptic ulceration or history of gastrointestinal bleeding 11. History of myocardial infarction, congestive heart failure, or stroke 12. Any current cardiovascular disease (other than hypertension) 13. History of psychotic disorder 14. History of alcoholism or drug addiction or current alcohol or drug use that, in the opinion of the Investigator, will interfere with the subjects ability to comply with the dosing schedule and study evaluations 15. History of any illicit drug use within one year prior to initial screening visit 16. Positive drug screen at initial screening visit. A positive drug screen for opiates only (with all other drug tests negative) will not be a basis for exclusion if the subject took over-the-counter narcotics as indicated on the product label within 24 hours prior to the drug screen 17. Current treatment or treatment within 30 days prior to first dose of study drugs with another investigational drug or current enrollment in another clinical trial 18. Known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C 19. Known hypersensitivity to amlodipine or celecoxib 20. Known hypersensitivity to the inactive ingredients in the over-encapsulated (OE) study drugs 21. Asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic type reactions after taking acetylsalicylic acid or NSAIDs including cyclooxygenase-2 inhibitors 22. Subjects who, in the opinion of the Investigator, are unable or unlikely to comply with the dosing schedule and study evaluations 23. Pregnant or lactating 24. Unable to correctly use ambulatory blood pressure monitor after instruction on its use 25. Subjects with Child-Pugh Class B or C cirrhosis 26. Subjects currently taking a calcium channel blocker or any NSAID for any reason will be excluded. Subjects will not be withdrawn from these drugs to be enrolled in the trial 27. Subjects that took a calcium channel blocker in the past for any indication 28. Creatinine clearance < 50 ml/min as estimated by the Cockroft-Gault equation 29. Known cytochrome P450 2C9 poor metabolizer 30. Subjects with allergy or hypersensitivity to sulfonamides ; PRIMARY OUTCOME: Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday); SECONDARY OUTCOME 1: Change in Body Weight[/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 - REFLECT (Italy); BRIEF: The purpose of this study was, starting from the Italian clinical practice in liver transplantation, to optimize the immunosuppressive therapy, considering specific patient characteristics as alcoholic cirrhosis, hepatitis C virus (HCV), hepatocellular carcinoma (HCC), and short/long-term implications. Then efficacy and safety of a calcineurin inhibitor (CNI)-withdrawal regimen was evaluated in comparison with a CNI-minimization regimen. ; DRUG USED: Zortress; DRUG CLASS: New Molecular Entity (NME); INDICATION: Liver Transplant Rejection; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria at Baseline: - Male and female liver transplant recipients who are ≥ 18 years of age, treated with a tacrolimus-based immunosuppressive regimen, who have received an induction therapy or i.v. steroids as per local clinical practice. - Recipients of a full-size or technically modified liver allograft will be eligible at 4 weeks (± 7 days) after liver transplantation. - Allograft is functioning at an acceptable level by the time of Baseline as defined by the AST, ALT, total bilirubin levels ≤ 3 times ULN and INR < 1.5 times ULN. - Abbreviated MDRD-4 eGFR ≥ 30 mL/min/1.73m2. Serum creatinine results obtained within 5 days prior to Baseline are acceptable. Inclusion criteria at Randomization: - Effective tacrolimus minimization, confirmed by stable blood trough levels in the two months prior to randomization, i.e. verification of last two tacrolimus blood trough level ≤ 5 ng/mL in the two months prior to randomization. Investigators should make adjustments in tacrolimus dosing to continue to target trough levels ≤ 5 ng/mL prior to randomization. - Abbreviated MDRD-4 eGFR ≥ 30 mL/min/1.73m2. Serum creatinine results obtained within 5 days prior to Visit 5 are acceptable. Exclusion criteria at Baseline: - Patients who are recipients of multiple solid organ transplants, (e.g., multivisceral or combined liver-kidney transplants), or have previously received an organ or tissue transplanted, or who received an AB0 incompatible transplant. - Patients who experienced more than one episode of treated biopsy proven acute rejection (BANFF ≥ 3 or RAI ≥ 7) or one steroid-resistant acute rejection. - Patients who require renal replacement therapy. - Patients with a confirmed spot urine protein/creatinine ratio that indicates ≥1.0 g/24 hrs of proteinuria. - History of malignancy of any organ system within the past 5 years whether or not there is evidence of local recurrence or metastases, other than non-metastatic basal or squamous cell carcinoma of the skin or HCC. Exclusion criteria at Randomization: - Patients who experienced more than two episodes of treated biopsy proven acute rejection (BANFF ≥ 3 or RAI ≥ 7) since transplantation or one steroid-resistant acute rejection during the run-in period. - Patients with a confirmed spot urine protein/creatinine ratio that indicates ≥ 3.0 g/24 hrs of proteinuria. ; PRIMARY OUTCOME: Renal Function Assessed by Estimated Glomerular Filtartion Rate (eGFR); SECONDARY OUTCOME 1: Percentage of Participants With Treated Biopsy Proven Acute Rejection (tBPAR) Acute Rejection (AR), Graft Loss (GL) or Death (D)[/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 - 009 (vs. Gardasil); BRIEF: Primary objective: • To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL. Secondary objectives: - To evaluate the tolerability of V503 in 9-15 year-old girls. - To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or GARDASIL. ; DRUG USED: Gardasil 9; DRUG CLASS: Vaccine; INDICATION: Human papillomavirus (HPV) Prevention (Antiviral, Vaccines); TARGET: Human Papillomavirus (HPV), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Female from 9 to 15 years old. - Good physical health. Exclusion Criteria: - Known allergy to any vaccine component. - History of severe allergic reaction. - Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections. - Pregnant subject. - Immunocompromised or immunodeficient subject. - Splenectomy. - Receipt of medication / vaccine that may interfere with study assessment. - Fever - History of a positive test for HPV, prior receipt of HPV vaccine or prior participation to HPV trial. - Any condition that might interfere with study assessment. ; PRIMARY OUTCOME: Geometric Mean Titers (GMTs) to HPV Types 16 and 18; SECONDARY OUTCOME 1: GMTs to HPV Types 6 and 11[/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 - Chinese Patients; BRIEF: The purpose of this study is to determine the efficacy and safety of the study drug ixekizumab in Chinese participants with moderate-to-severe plaque psoriasis. ; DRUG USED: Taltz; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Present with chronic plaque Ps based on a confirmed diagnosis of chronic Ps vulgaris for at least 6 months prior to baseline. - Have ≥10% BSA involvement at screening and baseline. - Have both an sPGA score ≥3 and PASI score ≥12 at screening and baseline. - Are candidates for phototherapy and/or systemic therapy. Exclusion Criteria: - Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline. - Drug-induced psoriasis. - Ongoing use of prohibited treatments. - Have previously completed or withdrawn from this study, or have previously exposed to ixekizumab or any other biologic drug directly targeting interleukin-17 (IL-17) (such as secukinumab) or the IL-17 receptor. - Have concurrent or recent use of any biologic agent within washout periods or <5 half-lives prior to baseline, whichever is longer. - 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 human chorionic gonadotropin (hCG) laboratory test. ; PRIMARY OUTCOME: Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement; SECONDARY OUTCOME 1: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission)[/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 - FREEDOM-1; BRIEF: A randomized controlled study to evaluate the safety, efficacy, and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation. ; DRUG USED: FCR001; DRUG CLASS: Biologic; INDICATION: Kidney Transplant Rejection; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Talaris Therapeutics Inc.; CRITERIA: Main Inclusion Criteria: - Recipient age ≥18 years. - Donor age ≥18 and ≤60 years at time of signing informed consent. - Recipients of a first or second living donor kidney transplant - Donor willing to undergo mobilization, apheresis and 12-month safety follow-up and meet all local standard eligibility criteria to donate stem cells for allogeneic transplantation. - Recipient meets all local standard eligibility criteria for allogeneic stem cell transplant. - Donors must be deemed eligible as per the requirements of 21CFR1271. Main Recipient and Donor Exclusion Criteria: - Recipient and donor who are identical twins. - Recipient or donor with history of malignancy or premalignant syndrome (e.g., myelodysplastic syndrome, monoclonal gammopathy of renal significance [MGRS], monoclonal gammopathy of unknown significance [MGUS]) of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. - Recipient or donor with known bone marrow aplasia. Main Recipient-only Exclusion Criteria: - Multi-organ or stem cell transplant recipient. - Calculated panel reactive antibodies >80%. - Recipient is blood type ABO incompatible with donor. - Presence of donor-specific antibodies (DSA) (positive result) at any time pre-transplant. - Recipient who is human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) positive. - Recipient with any baseline condition requiring or anticipated will require chronic or intermittent use of systemic steroids or other IS (eg, autoimmune disease, asthma) throughout the course of the study. - Recipient with a BMI < 18 or > 35 kg/m2. - Recipient requiring systemic anticoagulation, (eg, for hyper-coagulation disorders, deep vein thrombosis, atrial fibrillation) that cannot be temporarily interrupted which would preclude renal biopsy. Main Donor-only Exclusion Criteria: - Biologically unrelated (i.e., no genetic relationship) female donor transplant to male recipient. ; PRIMARY OUTCOME: Proportion of FCR001 recipients who are free from immunosuppression (IS), without biopsy proven acute rejection (BPAR) at 24 months post-transplant; SECONDARY OUTCOME 1: Change in renal function by Modification of Diet in Renal Disease (MDRD4) from post-transplant baseline (Month 1) to Month 24 in FCR001 recipients[/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 - ATALANTE-1; BRIEF: The aim of this study is to determine if the Investigational Medicinal Product Tedopi (OSE2101) is more effective than standard treatment in treating patients with stage IIIB NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment after failure of immune checkpoint-inhibitor regimens. ; DRUG USED: Tedopi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: OSE Immunotherapeutics; CRITERIA: Inclusion Criteria: 1. Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment. 2. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. 3. Female or male, 18 years of age or older. 4. Histologically or cytologically proven diagnosis of NSCLC that is locally advanced (stage III) unsuitable for radiotherapy or metastatic (stage IV) according to the 8th edition of tumor, node, metastasis (TNM) in Lung Cancer published by the International Union Against Cancer and the American Joint Committee on Cancer. 5. Subjects with disease recurrence or progression After therapy with an immune checkpoint inhibitor and platinum-based chemotherapy i) either 1st line chemotherapy followed by 2nd line checkpoint inhibitor, or ii) 1st line combination of checkpoint inhibitor and chemotherapy Patients with progression during or within 12 months after the end of ICI as sequential or concomitant platinum-based chemotherapy ± radiation for locally advanced disease (stage III) are eligible 6. Subjects with measurable or non-measurable lesions. 7. Subjects must express HLA-A2 phenotype as assessed serologically. 8. Subjects must be considered suitable for chemotherapy with either single-agent pemetrexed or docetaxel. 9. Subjects with brain metastases are eligible if treated (whole brain radiotherapy, stereotaxic radiotherapy, surgery) at least 3 weeks prior to initiation of study treatment and have no symptoms related to brain metastases for at least 2 weeks before initiation of study treatment and are not taking any forbidden medications. 10. Any prior chemotherapy, immunotherapy, hormonal therapy, radiation therapy or surgeries must have been completed at least 3 weeks prior to initiation of study treatment. 11. Any toxicity from prior therapy must have recovered to ≤ Grade 1 (except alopecia). 12. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 13. Adequate organ function as defined by all the following criteria: - Albuminemia > 25g/L - Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 1.5 x upper limit of normal (ULN) with alkaline phosphatase ≤ 2.5 x ULN, or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to liver metastases - Total serum bilirubin ≤ 1.5 x ULN - Absolute neutrophil count (ANC) ≥ 1500/L - Platelets ≥ 100000/L - Hemoglobin ≥ 9.0 g/dL (in the absence of transfusion within 2 weeks before randomization) - Creatinine clearance (based on modified Cockcroft-Gault formula) ≥ 45 ml/min. Exclusion Criteria: 1. Small-cell lung cancer/mixed NSCLC with small cell component or other neuroendocrine lung cancers (typical and atypical carcinoids, large-cell neuroendocrine carcinomas). 2. Patients with squamous cell carcinoma histology, and who had docetaxel as part of his prior chemotherapy. 3. Current or previous treatment with investigational therapy in another therapeutic clinical trial (interrupted less than 4 weeks before study treatment initiation). 4. Patients whose tumor harbors EGFR gene mutation that sensitizes tumors to Tyrosine-Kinase Inhibitor (TKI) (EGFR exon 18-21) or Anaplastic Lymphoma Kinase (ALK) rearrangement. 5. Ongoing immunotherapy (checkpoint inhibition, antigen immunotherapy that would be scheduled to continue concomitantly to the study). 6. Spinal cord compression (unless treated with the patient attaining good pain control and stable or recovered neurologic function), carcinomatous meningitis, or leptomeningeal disease 7. Patients with squamous cell histology or non-squamous cell histology previously treated by pemetrexed with a contraindication for docetaxel with grade ≥ 2 neuropathy or hypersensitivity reaction to medications formulated with polysorbate 80 (Tween 80) as they could be randomly assigned to Arm B. 8. Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications. 9. Treatment with corticosteroids in the last 3-week period before inclusion, except for topical, ocular, intra-articular, intranasal, and inhaled corticosteroids with minimal systemic absorption (e.g. with a dose ≤ 500 microgram beclomethasone equivalent for inhaled steroids), or steroid doses ≤ 10 mg daily prednisone equivalent which are permitted. 10. A recognized immunodeficiency disease including human immunodeficiency virus (HIV) infection (and other cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary, congenital or acquired immunodeficiencies). 11. Patients with auto-immune disease, with the exception of type I diabetes or treated hypothyroidism. 12. Patients with interstitial lung disease. 13. Patients with active B or C hepatitis. 14. Other malignancy: patients will not be eligible if they have evidence of other active invasive cancer(s) (other than NSCLC) within 5 years prior to screening (except appropriately treated non-melanoma skin cancer or localized cervical cancer, or other local tumors considered cured (e.g.localized and presumed cured prostate cancer). 15. Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study. 16. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. 17. Male patients sexually active with a woman of childbearing potential must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator. 18. Breastfeeding women. 19. Women with a positive pregnancy test. ; PRIMARY OUTCOME: Overall Survival time (OS); SECONDARY OUTCOME 1: Disease Control Rate (DCR) at 6 months[/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 - ZEAL-1L (w/Pembrolizumab); BRIEF: This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line platinum-based induction chemotherapy with pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free survival (PFS) and Overall survival (OS). ; DRUG USED: Zejula; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Combination; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion criteria: - Participant must be >=18 years of age. - Has a histologically or cytologically confirmed diagnosis of NSCLC without known targetable driver alteration (either non-squamous or squamous histology; mixed histology is allowed for which an approved targeted therapy is available in the 1L induction/maintenance therapy setting). - Has advanced (Stage IIIB or Stage IIIC, not amenable to definitive chemoradiotherapy) or metastatic (Stage IV) or metastatic (Stage IV) NSCLC. - Has completed at least 4 but no more than 6 cycles of standard of care first-line platinum-based induction chemotherapy with pembrolizumab. - Has SD, PR, or CR of the NSCLC per Investigators assessment after completion of 4 to 6 cycles of standard of care first-line platinum-based induction chemotherapy with pembrolizumab. - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Has a life expectancy of at least 12 weeks. - Has adequate organ and bone marrow function. - Must submit tumor specimens. - Must be able to swallow and retain orally administered study treatment. - A female is eligible to participate if she is not pregnant or breastfeeding, and must follow contraceptive guidance during the treatment period and 180 days afterwards. - A male is eligible to participate if he agrees to contraceptive guidance and refrains from sperm donation during the intervention period and for at least 90 days after the last dose of study treatment. - Is able to understand the study procedures and agrees to participate in the study by providing written informed consent. Participants must be informed that their participation is voluntary. Participants will be required to sign a statement of informed consent to participate in the study. Exclusion criteria: - Has mixed small cell lung cancer or sarcomatoid variant NSCLC. - Has received prior Poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor(s) in prior lines of treatment. - Has systolic blood pressure (BP) >140 millimeters of mercury (mmHg) or diastolic BP >90 mmHg. - Has any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels. - Has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiographic signs of CNS hemorrhage. - Has received colony-stimulating factors (granulocyte macrophage colony-stimulating factor or recombinant erythropoietin) within 4 weeks prior to the first dose of study treatment. - Has an active or previously documented autoimmune or inflammatory disorder. - Is receiving chronic systemic steroids (prednisone >20 mg per day) other than intermittent use of bronchodilators, inhaled steroids, or local steroid. - Has other active concomitant malignancy that warrants systemic, biologic, or hormonal therapy. - Is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and/or for up to 180 days after the last dose of study treatment. - Has a known history of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML). - Has a known history of active tuberculosis. - Has current active pneumonitis within 90 days of planned start of the study or a known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis requiring steroid treatment. ; PRIMARY OUTCOME: Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 in overall population; SECONDARY OUTCOME 1: PFS assessed by BICR using RECIST v 1.1 in non-squamous histology (NSQ) 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 III - 008 (EU, Infants); BRIEF: This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine. This study will also determine whether the immune response to V419 is similar to that of participants who received a licensed vaccine control. The primary hypothesis is that participants who receive PR5I at 2, 4, and 11 to 12 months have an acceptable response rate to all PR5I-contained antigens at one month after the Toddler dose of PR5I. ; DRUG USED: Vaxelis; DRUG CLASS: Vaccine; INDICATION: Hepatitis B Prevention (Vaccines, Antiviral); TARGET: Hepatitis B/HBV, Immune System; THERAPY: Combination; LEAD SPONSOR: MCM Vaccines B.V.; CRITERIA: Inclusion Criteria: - Healthy infant able to attend all study visits - Parent(s)/legal representative are able to read, understand, and complete study questionnaires Exclusion Criteria: - History of congenital or acquired immunodeficiency - Received or is expected to receive immunosuppressive agents or systemic immunomodulatory steroids - History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder - Hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines - Has any chronic illness that could interfere with study conduct or completion - Received any immune globulin, blood, or blood-derived products since birth - Received a dose of hepatitis B vaccine prior to study entry - Vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus vaccine, or combination thereof - Fever within 24 hours prior to enrollment - Received any non-study vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrolment - Has a coagulation disorder - Has developmental delay or neurological disorder - Participant or his/her mother has a medical history of hepatitis B surface antigens (HBsAg) seropositivity - History of Haemophilus influenzae type b, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus gastroenteritis, or invasive pneumococcal infection ; PRIMARY OUTCOME: Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age); SECONDARY OUTCOME 1: Non-inferiority of Antibody (Ab) Response Rate to Haemophilus Influenzae Type b (PRP) One Month After the 2nd Dose of PR5I (4 Months of Age) as Compared With INFANRIX Hexa[/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 - CARAVAGGIO; BRIEF: Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study ; DRUG USED: Eliquis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Venous Thromboembolism (VTE); TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Fadoi Foundation, Italy; CRITERIA: Inclusion Criteria: - Consecutive patients with a newly diagnosed, objectively confirmed: symptomatic or unsuspected, proximal lower-limb DVT or symptomatic PE or unsuspected PE in a segmental or more proximal pulmonary artery; - Any type of cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intracerebral metastasis and acute leukemia); - Signed and dated informed consent of the patient, available before the start of any specific trial procedure. Exclusion Criteria: - age <18 years; - ECOG Performance Status III or IV; - life expectancy of less than 6 months; Related to anticoagulant treatment: - administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization; - 3 or more doses of a vitamin K antagonist before randomization; - thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode; - indication for anticoagulant treatment for a disease other than the index VTE episode; Related to bleeding risk: - thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy; - active bleeding or a high risk of bleeding contraindicating anticoagulant treatment; - recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery - hemoglobin level lower than 8 g/dL (5.0 mmol/L) or platelet count <75x10^9/L or history of heparin induced thrombocytopenia; - creatinine clearance < 30 ml /min based on the Cockcroft Gault equation; - acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range; - uncontrolled hypertension (systolic BP> 180 mmHg or diastolic BP > 100 mmHg despite antihypertensive treatment); - concomitant use of strong inhibitors or inducers of both cytochrome P-450 3A4 and P-Glycoprotein; Standard criteria: - bacterial endocarditis; - hypersensitivity to the active substance or to any of the excipients of study drug; - patients participation in other pharmaco therapeutic program with an experimental therapy that is known to effect the coagulation system; - childbearing potential without proper contraceptive measures, pregnancy, or breast feeding; - any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study. ; PRIMARY OUTCOME: Recurrent venous thromboembolism; 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 - MANIFEST-2 (w/Ruxolitinib); BRIEF: A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins. ; DRUG USED: Pelabresib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelofibrosis (MF); TARGET: BET Proteins/Bromodomains; THERAPY: Combination; LEAD SPONSOR: Constellation Pharmaceuticals; CRITERIA: Inclusion Criteria: - Aged ≥ 18 years - Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia) - Adequate hematologic, renal, and hepatic function - Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the MFSAF v4.0 - Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system - Spleen volume of ≥ 450 cm^3 - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Exclusion Criteria: - Splenectomy or splenic irradiation in the previous 6 months - Chronic or active conditions and/or concomitant medication use that would prohibit treatment - Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm ; PRIMARY OUTCOME: Splenic response at Week 24; SECONDARY OUTCOME 1: Total Symptom Score response at Week 24[/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 - DURATION-8 (w/Dapagliflozin); BRIEF: Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin. ; DRUG USED: Bydureon; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion criteria - Has a diagnosis of T2DM. - Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2. - Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to Screening. Exclusion criteria - FPG ≥280 mg/dL (15.6 mmol/L). - Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening) - Clinically significant abnormal free T4 values or patients needing initiation or adjustment of thyroid treatment according to the investigator. - Abnormal thyroid stimulating hormone (TSH) value at Screening will be further evaluated by free T4.Patients with clinically significant abnormal free T4 values will be excluded. - Known active proliferative retinopathy. - History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1 - History or presence of inflammatory bowel disease or other severe GI diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis. - History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded. ; PRIMARY OUTCOME: Change in HbA1c From Baseline to Week 28; SECONDARY OUTCOME 1: Change in Body Weight From Baseline to Week 28[/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 - 501; BRIEF: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT. ; DRUG USED: Caplyta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine 2 (D2) Receptor, Serotonin 5-HT2A receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Intra-Cellular Therapies, Inc.; CRITERIA: Inclusion Criteria: 1. Male or female patients between the ages of 18 and 65 years, inclusive; 2. Meets DSM-5 criteria for MDD as confirmed by using the MINI and meets all of the following criteria: 1. The start of the current major depressive episode (MDE) is at least 8 weeks but not more than 18 months prior to Screening; 2. Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline; 3. Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening and at Baseline; 4. Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥14 at Screening and at Baseline; 5. and the current MDE is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning. 3. Currently having an inadequate response to ADT (less than 50% improvement) as confirmed by the Investigator and taking at least the minimum effective dose (per package insert) of one of the following antidepressants as monotherapy treatment for at least 6 weeks duration: 1. citalopram/escitalopram 2. fluoxetine 3. paroxetine 4. sertraline 5. duloxetine 6. levomilnacipran/milnacipran (if locally approved for MDD) 7. venlafaxine/desvenlafaxine 8. buproprion 9. vilazodone 10. vortioxetine Exclusion Criteria: 1. Within the patients lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including: 1. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder; 2. Bipolar Disorder; 2. Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including: 1. Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary diagnoses. 2. Eating disorder; 3. Substance use disorders (excluding nicotine); 4. Personality disorder of sufficient severity to have a major impact on the patients psychiatric status; 5. Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment; 3. The patient experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline; 4. The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline; 5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or: 1. At Screening, the patient scores yes on Suicidal Ideation Items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening, or at Baseline, the patient scores yes on Suicidal Ideation Items 4 or 5 since the Screening Visit; 2. At Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening; 3. At Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or 4. The patient is considered to be in imminent danger to him/herself or others. 6. The patient has a first MDE at age 60 years or older. ; PRIMARY OUTCOME: Montgomery-Åsberg Depression Rating Scale; SECONDARY OUTCOME 1: Clinical Global Impression Scale-Severity[/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 - AZALEA (Open-Label Safety); BRIEF: This open-label study is designed to evaluate the safety of suprachoroidally administered triamcinolone acetone injectable suspension, CLS-TA, in patients with non-infectious uveitis with and without macular edema. ; DRUG USED: Xipere; DRUG CLASS: Non-NME; INDICATION: Uveitis (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Clearside Biomedical, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of active or inactive non-infectious uveitis (pan, anterior, intermediate and posterior) - ETDRS BCVA score of ≥ 5 letters read in the study eye Exclusion Criteria: - Any active ocular disease or infection in the study eye other than uveitis - Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye; patients with IOP of 22 or less in the study eye not excluded with no more than 2 IOP-lowering medications. - Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study - Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline. ; PRIMARY OUTCOME: Adverse Events; SECONDARY OUTCOME 1: Mean Intraocular Pressure in the Study Eye[/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 - Comparative Pain Study (SQ Auto-Injector); BRIEF: To demonstrate that Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) delivered subcutaneously via auto-injector is associated with less pain as compared to intramuscular injections of Makena® ; DRUG USED: Makena; DRUG CLASS: Non-NME; INDICATION: Preterm Labor; TARGET: Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: AMAG Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Female subjects aged 50 to 75 years of age, inclusive, at Screening Visit. 2. Follicle stimulating hormone (FSH) levels greater than 40 mIU/mL. 3. Naturally or surgically postmenopausal with or without an intact uterus. Exclusion Criteria: 1. Have history of or positive test results for HIV or hepatitis B or C. 2. A significant history or current evidence of chronic infectious disease, organ dysfunction especially cardiovascular, renal, or hepatic disorders or other medical condition. 3. Receiving or have received chronic opioid therapy within 12 months. 4. Unwilling to stop taking/using: - pain medication. - topical analgesic or anti-inflammatory treatment. Topical analgesics must be washed out by at least 72 hours in the areas to be treated before randomization. 5. History of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse in the last 12 months. 6. Currently taking any estrogen/progesterone hormone replacement therapy (HRT). 7. History of allergy or sensitivity to hydroxyprogesterone caproate, castor oil or any of the constituents of the study medications or history of any drug hypersensitivity or intolerance. 8. Poorly controlled diabetes (Hgb A1C >8). 9. Current or history of thrombosis or thromboembolic disorders. 10. Known or suspected breast cancer, other hormone-sensitive cancer or tumor, or history of these conditions within the last 5 years. 11. Any current or recent (within previous 12 months) vaginal bleeding. 12. Uncontrolled hypertension. 13. A chronic pain condition (i.e. chronic back pain) that may confound the assessments of injection pain. ; PRIMARY OUTCOME: Comparison of Average Pain Intensity; SECONDARY OUTCOME 1: Clinician Assessment of Ease of Injection Technique[/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 - CR012781; BRIEF: The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety of subcutaneous (SC) golimumab injections following transition from IV golimumab infusions will also be evaluated. ; DRUG USED: Simponi Aria (IV); DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Centocor, Inc.; CRITERIA: Inclusion Criteria: - Must have a diagnosis of active rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ARA (American Rheumatism Association) with at least 4 swollen and 4 tender joints for at least 3 months prior to screening - Have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg per week for at least 3 months prior to screening - Have been on a stable MTX dose of greater than or equal to 15 mg per week and less than or eual to 25 mg per week for at least 4 weeks prior to screening - If using non steroidal anti-inflammatory agents (such as naproxen) or other pain relievers for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent Exclusion Criteria: - Participants having known hypersensitivity (severe allergy) to human immunoglobulin proteins or other components of golimumab - Having known clinically serious adverse reaction to a biologic anti-TNF agent - Have had history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to screening ; PRIMARY OUTCOME: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14; SECONDARY OUTCOME 1: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24[/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 - STRIDE 3; BRIEF: The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID). ; DRUG USED: EYSUVIS; DRUG CLASS: Non-NME; INDICATION: Dry Eye (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Kala Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Have a documented clinical diagnosis of dry eye disease in both eyes Exclusion Criteria: - Known hypersensitivity or contraindication to the investigational product(s) or components - History of glaucoma, IOP>21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye. - Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within 30 days prior to screening. - In the opinion of the Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops. ; PRIMARY OUTCOME: Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15); SECONDARY OUTCOME 1: Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)[/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 - CheckMate 914; BRIEF: The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney. ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy - Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0 - Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features - Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 - Women must agree to follow methods of contraception, if applicable Exclusion Criteria: - Participants with an active known or suspected autoimmune disease - Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways - Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation - History of allergy or hypersensitivity to study drug components - Participants with a condition requiring systemic treatment with corticosteroids - Participants who have received a live/attenuated vaccine within 30 days of first treatment Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Disease-free survival (DFS) as assessed by BICR (Part A and Part B); SECONDARY OUTCOME 1: Overall Survival (OS) (Part A and Part B)[/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 - CORE II (EU); BRIEF: This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period. After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules. ; DRUG USED: Uceris; DRUG CLASS: Non-NME; INDICATION: Ulcerative Colitis (UC); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Bausch Health Americas, Inc.; CRITERIA: Inclusion Criteria: - Patients fulfilling the following criteria at the screening visit are eligible for participation in the study: - Male and female patients, 18-75 years old, suffering from ulcerative colitis for at least 6 months. - Diagnosis of ulcerative colitis in active phase, of mild or moderate entity with Ulcerative Colitis Disease Activity Index (UCDAI) ≥ 4 and ≤ 10 according to Sutherland. - All females of child-bearing potential must have a negative serum pregnancy test immediately prior to enrollment. In addition, all females of child-bearing potential must agree to be completely abstinent or be using an accepted form of contraception throughout the entire study period. Accepted forms of contraception are defined as those with a failure rate <1% when properly applied and include: combination oral pill, some intra-uterine devices, and a sterilised partner in a stable relationship. Female subjects must also not be actively breast-feeding through the entire study period. - Ability to comprehend the full nature and purpose of the study, including possible risks and side effects. - Ability to co-operate with the investigator and to comply with the requirements of the entire study. - Must be able to understand and voluntarily sign written informed consent prior to inclusion in the study. Exclusion Criteria: - Patients who meet any of the following criteria at screening visit are to be excluded from study participation: - Patients with limited distal proctitis (from anal verge up to 15 cm above the pectineal line). - Patients with severe ulcerative colitis (UCDAI >10). - Patients with infectious colitis. - Evidence or history of toxic megacolon. - Severe anaemia, leucopaenia or granulocytopaenia. - Use of oral or rectal steroids in the last 4 weeks. - Use of immuno-suppressive agents in the last 8 weeks before the study. - Use of anti tumour necrosis factor alpha (anti-TNFα) agents in the last 3 months. - Concomitant use of any rectal preparation. - Concomitant use of antibiotics. - Concurrent use of cytochrome P450 3A4 (CYP3A4) inducers or CYP3A4 inhibitors. - Patients with verified, presumed or expected pregnancy or ongoing lactation. - Patients with liver cirrhosis, or evident hepatic or renal disease or insufficiency, and/or severe impairment of the bio-humoural parameters (i.e. 2 x upper limit of normal for alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT) or creatinine). - Patient with severe diseases in other organs and systems. - Patients with local or systemic complications or other pathological states requiring a therapy with corticosteroids and/or immuno-suppressive agents. - Patients diagnosed with type 1 diabetes. - Patients diagnosed with, or with a family history of, glaucoma. - All patients with known hepatitis B, hepatitis C or with human immunodeficiency virus (HIV), according to the local privacy policy. - Participation in experimental therapeutic studies in the last 3 months. (Note: patients who participated in observational only studies are not excluded). - Any other medical condition that in the principal investigators opinion would make the administration of the study drug or study procedures hazardous to the subject or obscure the interpretation of adverse events (AEs). ; PRIMARY OUTCOME: Clinical and Endoscopic Remission.; SECONDARY OUTCOME 1: Clinical Improvement.[/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 - Acute vs. Placebo (P06124); BRIEF: A multicenter, randomized, parallel-group, double-blind, fixed dose, 6-week trial of the efficacy and safety of asenapine compared with placebo in participants with an acute exacerbation of schizophrenia. ; DRUG USED: Saphris; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Alpha 2 Adrenergic Receptor, Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Organon and Co; CRITERIA: Inclusion Criteria: - current diagnosis of schizophrenia of paranoid, disorganized, catatonic, or undifferentiated (295.90) subtype - minimum Positive and Negative Syndrome Scale (PANSS) total score of 60 at screening and Baseline. - participant had a score of at least 4 in two or more of 5 items in the positive subscale of the PANSS at Screening and Baseline. - participant confirmed by the investigator to be experiencing an acute exacerbation of schizophrenia as evidenced by ALL of the following: - at the screening test, the duration of the current episode was no more than 2 months; - current symptoms represented a dramatic and substantial change compared to the participants symptomatic state prior to the emergence of the current episode; - participant was in need of changing medication or dosage to treat newly appeared or worsened positive symptoms. - participant had a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at Baseline; - responded positively to an antipsychotic medication in a prior episode. - discontinued the use of all prohibited concomitant medications, with last dose taken no later than the evening prior to the baseline visit (For depot neuroleptic, discontinuation must have occurred more than 3 months prior to randomization). - participants must agree to inpatient status for screening period and for up to 42 days of dosing and, for out-patient phase, had a caregiver or an identified responsible person (e.g., family member, social worker, case worker, or nurse) whom the investigator accepts and who has agreed to provide support to the participant to ensure compliance with study treatment, out-patient visits, and protocol procedures. Exclusion Criteria: - not be treatment-refractory defined by the following criteria: (1) had been treated with at least two different atypical anti-psychotic agents at dosages equivalent to or greater than 600 mg/day of chlorpromazine (12 mg /day of haloperidol) for more than 4 weeks, each without clinical response, or (2) has received clozapine for 12 weeks immediately preceding the screening. - not have received treatment with 3 or more antipsychotic drugs, or dose-equivalents higher than 18 mg/day of haloperidol (equivalent 900 mg/day of chlorpromazine) within one month prior to randomization. - not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophreniform disorder, or schizophrenia with course specifiers continuous, single episode in partial remission, or single episode in full remission - not have a concurrent psychiatric disorder other than schizophrenia coded on Axis I; not have a primary diagnosis other than schizophrenia - not have had a known diagnosis of borderline personality disorder, mental retardation or organic brain disorder. - not have a 20% or greater decrease in PANSS total score from screening to baseline - not have an imminent risk of self-harm or harm to others, in the investigators opinion. - not have a substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse - not be currently under involuntary in-patient confinement. - not been previously treated with asenapine. ; PRIMARY OUTCOME: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.; SECONDARY OUTCOME 1: Change From Baseline in PANSS Positive Symptom 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 III - contRAst-2 (201791); BRIEF: This study [contRAst 2 (201791: NCT03970837)] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csDMARD(s). Participants who, in investigators judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study [contRAst X (209564: NCT04333147)]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase. ; DRUG USED: Otilimab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: Granulocyte-Macrophage CSF (GM-CSF); THERAPY: Combination; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Key inclusion criteria - >=18 years of age - Has had RA for >=6 months and was not diagnosed before 16 years of age - Has active disease, as defined by having both* - >=6/68 tender/painful joint count (TJC), and - >=6/66 swollen joint count (SJC) - Has at least 1 bone erosion present on hand/wrist or foot radiographs - Has had an inadequate response to one or two of the csDMARDs: - methotrexate (MTX) 15-25 mg/week** oral or injected - hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day - sulfasalazine up to 3000 mg/day - leflunomide up to 20 mg/day*** - bucillamine up to 100 mg/day (or up to 300 mg/day if permitted per local requirement) - iguratimod up to 50 mg/day - If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC. - A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement. - Concomitant use of leflunomide and methotrexate is not allowed, for safety reasons. Key exclusion criteria - History of other inflammatory rheumatologic or systemic autoimmune disorder, other than Sjögrens syndrome secondary to RA, that may confound the evaluation of the effect of the study intervention. - Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections. - Has received prior treatment with an antagonist of GM-CSF or its receptor or Janus kinase (JAK) inhibitors (either experimental or approved). ; PRIMARY OUTCOME: Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo (Global Cohort); SECONDARY OUTCOME 1: Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Less Than or Equal to (<=)10 [CDAI Low Disease Activity (LDA)] at Week 12 (Global Cohort)[/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 - MTI-107 (Long-Term Safety); BRIEF: Study of the long term safety of serlopitant for the treatment of pruritus in adults. ; DRUG USED: Serlopitant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pruritus; TARGET: Neurokinin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Vyne Therapeutics Inc.; CRITERIA: Inclusion Criteria: - Male or female, age 18 years or older at consent. - Pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis. - Female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug. - Willing and able to comply with study visits and study related requirements including providing written informed consent. Exclusion Criteria: - Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies). - Any known major psychiatric diagnosis, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder, which may confound the assessment of serlopitant safety or efficacy, or interfere with the subjects ability to comply with protocol-mandated activities, within 3 years prior to enrollment. - Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease, or history of thyroid malignancy; or the prescense of any medical condition or disability, that could interfere with the assessment of safety in this study or compromise the safety of the subject. - Investigational therapy within 4 weeks or 5-half-lives prior to enrollment (whichever is longer) or expected participation in another clinical study involving an investigational product or device during the subjects participation in this study. - Treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant, fosaprepitant, rolapitant) within 4 weeks. - Treatment with strong cytochrome P450 3A4 inhibitors within 4 weeks. - Currently pregnant or breastfeeding or planning to become pregnant during the study. ; PRIMARY OUTCOME: Number of Subjects With Treatment-emergent Adverse Events; 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 - DYNAGITO; BRIEF: The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD. ; DRUG USED: Stiolto Respimat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Male or female patients, 40 years of age or older. - Diagnosis of COPD with a documented post-bronchodilator Forced expiratory volume in one second (FEV1)< 60% of predicted normal and a post-bronchodilator FEV1/ forced vital capacity (FVC) <70% at Visit 1 - Documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization. - Symptomatically stable as defined by: no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of change in their usual COPD medication 4 weeks prior to visit 1. - Current or ex-smokers with a smoking history of more than 10 pack years. Exclusion criteria: - Significant disease other than COPD. - Clinically relevant abnormal baseline haematology, blood chemistry or creatinine > x2 ULN will be excluded regardless of clinical condition. ( A repeat laboratory evaluation can be conducted if deemed necessary by the investigator.) - Current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma - A diagnosis of thyrotoxicosis - A history of myocardial infarction within 6 months of screening visit. - Life-threatening cardiac arrhythmia. - Known active tuberculosis. - Any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed). - A history of cystic fibrosis. - Clinically relevant bronchiectasis. - Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening - A history of significant alcohol or drug abuse in the opinion of the investigator. - Patients who have undergone thoracotomy with pulmonary resection - Patients being treated with oral or patch ß-adrenergics. - Patients being treated with oral corticosteroid medication at unstable doses - Patients being treated with antibiotics for any reasons within 4 weeks of screening visit - Patients being treated with PDE4 inhibitors within 3 months of screening visit - Patients who have taken an investigational drug within one month or six half-lives - Pregnant or nursing women. - Women of childbearing potential not using a highly effective method of birth control. ; PRIMARY OUTCOME: Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period.; SECONDARY OUTCOME 1: Number of Patients With at Least One Moderate to Severe COPD Exacerbation During the Actual 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 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 III - DYSCOVER; BRIEF: The primary objective of this study was to examine the effect of levodopa-carbidopa intestinal gel (LCIG) compared with optimized medical treatment (OMT) on dyskinesia in participants with advanced Parkinsons disease (PD). ; DRUG USED: Duopa; DRUG CLASS: Non-NME; INDICATION: Parkinsons Disease (PD); TARGET: Aromatic L-amino acid decarboxylase (AADC), Dopamine Receptor - Unspecified; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Participants must have a diagnosis of idiopathic Parkinsons disease (PD) according to the United Kingdom Parkinsons Disease Society (UKPDS) Brain Bank Criteria - Participants with advanced levodopa-responsive PD and persistent motor fluctuations who have not been controlled with optimized medical treatment (OMT: the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected with regard to any additional manipulations of levodopa and/or other antiparkinsonian medication based on the Investigators clinical judgment) - Unified Dyskinesia Rating Scale (UDysRs) Total score ≥ 30 at Visit 3 Exclusion Criteria: - Participant(s) treated with levodopa-carbidopa intestinal gel (LCIG) previously - Participants PD diagnosis is unclear or there is a suspicion that the subject has a parkinsonian syndrome such as secondary parkinsonism (e.g. caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), parkinson-plus syndrome (e.g. Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body disease) or other neurodegenerative disease that might mimic the symptoms of PD - Participant(s) has undergone neurosurgery for the treatment of Parkinsons disease. - Participant(s) has contraindications to levodopa (e.g. narrow angle glaucoma, malignant melanoma) - Participant(s) experiencing clinically significant sleep attacks or clinically significant impulsive behavior (e.g. pathological gambling, hypersexuality) at any point during the three months prior to the Screening evaluation as judged by the Principal Investigator ; PRIMARY OUTCOME: Mean Change From Baseline to Week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score; SECONDARY OUTCOME 1: Mean Change From Baseline to Week 12 in ON Time Without Troublesome Dyskinesia[/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 - Menstrually Related Migraine; BRIEF: This is a multicenter study to test the hypothesis that telcagepant is superior to placebo in preventing perimenstrual migraines as measured by mean monthly headaches during the entire treatment period. This study will also evaluate the safety and tolerability of telcagepant for female migraine participants. ; DRUG USED: Telcagepant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Participant who has had regular menstrual cycles monthly (22 to 32 days) for at least the last 3 cycles - Participant experiences headache during menstrual period in at least 2 out of last 3 cycles - Participant has history of migraine for ≥ 3 months and with ≥ 2 migraine attacks per month in the 2 months prior to screening - Participant agrees to use an effective method of birth control through the duration of the study Exclusion Criteria: - Participant has basilar or hemiplegic migraine headache - Participant has taken medication for acute headache on more than 15 days per month in the 3 months prior to screening - Participant is taking prophylactic medication for migraine and daily dose has changed within 4 weeks prior to screening - Participant has history of significant liver disease - Participant has had cardiac surgery or symptoms within 3 months of screening - Participant has confounding pain syndromes, psychiatric conditions, dementia, or major neurological disorders other than migraine - Participant has history of neoplastic disease ≤ 5 years prior to signing informed consent - Participant has history of gastric or small intestinal surgery - Participant consumes 3 or more alcoholic drinks per day ; PRIMARY OUTCOME: Number of Participants With Clinical Adverse Events (AEs); SECONDARY OUTCOME 1: Mean Monthly Headache Days During Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline[/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 - 329 - Rollover Ext.; BRIEF: This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489. ; DRUG USED: Vyvanse; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine, Norepinephrine (Noradrenaline); THERAPY: Combination; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: - Subject has completed 1 of the respective short-term antecedent SPD489 MDD studies and did not experience any clinically significant AEs in the antecedent study that would preclude exposure to SPD489. Exclusion Criteria: - Subject has any current co-morbid Axis I or Axis II psychiatric disorder (including a lifetime history of psychosis) which was not present or recognized at entry into the antecedent study or has a concurrent chronic or acute illness or unstable medical condition that may deteriorate that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol ; PRIMARY OUTCOME: Columbia-Suicide Severity Rating Scale (C-SSRS); SECONDARY OUTCOME 1: Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET[/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 - ARISER; BRIEF: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether monoclonal antibody therapy is effective in treating kidney cancer. PURPOSE: This randomized phase III trial is studying monoclonal antibody therapy to see how well it works in treating patients who have undergone surgery for nonmetastatic primary kidney cancer. ; DRUG USED: Rencarex; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC); TARGET: Carbonic Anhydrase; THERAPY: Monotherapy; LEAD SPONSOR: Heidelberg Pharma AG; CRITERIA: DISEASE CHARACTERISTICS: - Histologically confirmed primary clear cell renal cell carcinoma - Meets 1 of the following high risk criteria: - T3a, N0/NX, M0 OR T3b, N0/NX, M0 OR T3c, N0/NX, M0 OR T4, N0/NX, M0 - Any T stage and N + disease and M0 - T1b, N0/NX, M0 OR T2, N0/NX, M0, each with grade ≥ 3 (Fuhrman or any other nuclear grading system with at least 3 grades) - Prior nephrectomy (total or partial) of primary renal cell carcinoma with documented clear cell histology within the past 12 weeks - No evidence of macroscopic or microscopic residual disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Platelet count > 100,000/mm^3 - WBC > 3,000/mm^3 - Hemoglobin > 10 g/dL Hepatic - AST and ALT < 3 times upper limit of normal (ULN) - Bilirubin < 1.5 times ULN - Hepatitis B surface antigen (HbsAg) negative - Hepatitis C antibody negative Renal - Creatinine < 2.0 times ULN Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV I and II negative - No concurrent unrelated illness which can significantly jeopardize patients clinical status - No active infection - No inflammation - No medical condition or laboratory abnormalities that would preclude study participation - No other malignancies within the past 5 years except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - More than 5 years since prior immunotherapy - No prior murine or chimeric antibody therapy Chemotherapy - More than 5 years since prior chemotherapy Endocrine therapy - No concurrent corticosteroids above Cushing dose for another disease - Physiologic corticosteroid replacement therapy allowed at discretion of the primary investigator Radiotherapy - More than 5 years since prior radiotherapy Surgery - See Disease Characteristics - No prior organ transplantation Other - No concurrent immunosuppressive agents (e.g., cyclosporine or tacrolimus) ; PRIMARY OUTCOME: Disease-free Survival; SECONDARY OUTCOME 1: Quality of Life - Global Health Status[/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 - RAPID-AxSpA; BRIEF: The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA). ; DRUG USED: Cimzia; DRUG CLASS: Biologic; INDICATION: Axial Spondyloarthritis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: UCB BIOSCIENCES GmbH; CRITERIA: Inclusion Criteria: - Documented diagnosis of adult-onset axial Spondyloarthritis (SpA) of at least 3 months duration as defined by the specified Assessment of Spondyloarthritis International Society (ASAS) criteria - Active disease as defined by: - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 - Back pain ≥ 4 on a 0 to 10 Neurobehavioral Rating Scale (NRS) (from BASDAI item 2) - C-Reactive Protein (CRP) > ULN (Upper Limit of Normal) and/or current evidence (ie, within the last 3 months from Screening) for Sacroiliitis on Magnetic Resonance Imaging (MRI) as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria - Intolerance to or inadequate response to at least 1 Nonsteroidal Anti-Inflammatory Drug (NSAID) Exclusion Criteria: - Presence of total Spinal Ankylosis (bamboo spine) - Diagnosis of any other Inflammatory Arthritis - Prior treatment with any experimental biological agents for treatment of Axial Spondyloarthritis (SpA) - Exposure to more than 1 TNF-antagonist or to more than 2 previous biological agents for Axial Spondyloarthritis (SpA) - History of or current chronic or recurrent infections - High risk of infection - Recent live vaccination - Concurrent malignancy or a history of malignancy - Class III or IV congestive heart failure - New York Heart Association (NYHA) - Demyelinating disease of the central nervous system - Female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product - Subjects with any other condition which, in the investigators judgment, would make the subject unsuitable for inclusion in the study ; PRIMARY OUTCOME: Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12; SECONDARY OUTCOME 1: Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24[/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 - Study 1502 (Study 1 - EU/Australia); BRIEF: ; DRUG USED: Fintepla; DRUG CLASS: Non-NME; INDICATION: Dravet Syndrome (Epilepsy); TARGET: Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: ; CRITERIA: ; PRIMARY OUTCOME: ; 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/III - Generation S2; BRIEF: The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid. ; DRUG USED: CNP520; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Beta-secretase (BACE); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - consent to receive disclosure of their risk estimates to develop clinical symptoms of AD based on their APOE genotype and, if Heterozygotes, evidence of elevated brain amyloid. - Male or female, age 60 to 75 years inclusive. Females must be considered post-menopausal and not of child bearing potential - Cognitively unimpaired as evaluated by memory tests performed at screening. - Participants willingness to have a study partner. - Carrier of at least one APOE4 gene if Heterozygotes, elevated brain amyloid (as measured by CSF Abeta or amyloid PET imaging). Exclusion Criteria: - Any disability that could have prevented the participants from completing all study requirements. - - Current medical or neurological condition that could have impacted cognition or performance on cognitive assessments. - Advanced, severe progressive or unstable disease that could have interfered with the safety, tolerability and study assessments, or put the participant at special risk. - History of malignancy of any organ system, treated or untreated, within the past 60 months. - Indication for, or current treatment with ChEIs and/or another AD treatment (e.g. memantine). - Contraindication or intolerance to MRI. - Brain MRI results showing findings unrelated to AD that, in the opinion of the Investigator might be a leading cause to future cognitive decline, could have posed a risk to the participant, or could have prevented a satisfactory MRI assessment for safety monitoring. - Suicidal Ideation in the past six months, or Suicidal Behavior in the past two years. - A positive drug screen at Screening, if, in the Investigators opinion, was is due to drug abuse. - Significantly abnormal laboratory results at Screening, not as a result of a temporary condition. - Current clinically significant ECG findings. - Clinically relevant depigmenting or hypopigmenting conditions (e.g. albinism, vitiligo) or active / history of chronic urticaria in the past year. ; PRIMARY OUTCOME: Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimers Disease (AD)); SECONDARY OUTCOME 1: Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score[/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 - Lu AA21004_311 (EU); BRIEF: The purpose of this study is to evaluate the efficacy and safety of vortioxetine, once daily (QD), in adults with Generalized Anxiety Disorders. ; DRUG USED: Trintellix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Generalized Anxiety Disorder (GAD); TARGET: Serotonin 5-HT1A receptor, Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor , Serotonin 5-HT3 receptor, Serotonin 5-HT7 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: - Suffers from a primary diagnosis of Generalized Anxiety Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. - Has a Hamilton Anxiety Scale total score ≥20 at Screening and Baseline. - Has a Hamilton Anxiety Scale score ≥2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline. - Has a Montgomery-Åsberg Depression Rating Scale total score ≤16 at Screening and Baseline. - Male and females of childbearing potential who are sexually active agree to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication. Exclusion Criteria: - Has received any investigational compound <30 days before Screening or 5 half-lives prior to Screening. - Has received Lu AA21004 in a previous clinical study or as a therapeutic agent. - Has 1 or more of the following: - Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR. - Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR. - Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. - Presence or history of a clinically significant neurological disorder (including epilepsy). - Neurodegenerative disorder (Alzheimers disease, Parkinsons disease, multiple sclerosis, Huntington disease, etc). - Any Axis II disorder that might compromise the study. - Is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study including: - Nonsteroidal anti-inflammatory drugs - Rifampin - Macrolide antibiotics - Hormones - Hypoglycemic agents and Insulin - Systemic steroids - Antineoplastics - Antiobesity agents - Antidiarrheal agents (episodic use allowed) - Antifungal agents (episodic topical use allowed) - Antihistamines (episodic use of loratadine, desloratadine, cetirizine allowed) - Cough/cold agents (episodic use allowed but preparations containing pseudoephedrine and narcotics are NOT allowed) - Diuretics (episodic use allowed) - Has a significant risk of suicide according to the investigators opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months. - Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors. - Has received electroconvulsive therapy within 6 months prior to Screening. - Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study. - Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. - Has an alanine aminotransferase, aspartate aminotransferase or bilirubin level >1.5 times the upper limits of normal. - Has a serum creatinine of >1.5 times the upper limits of normal. - Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include those participants with basal cell or stage I squamous cell carcinoma of the skin. - Has clinically significant abnormal vital signs as determined by the investigator. - Has 1 or more laboratory values outside the normal range, based on the blood or urine samples taken at Screening, that are considered by the investigator to be clinically significant. - Has thyroid stimulating hormone value outside the normal range at Screening and is deemed clinically significant by the investigator. - Has an abnormal electrocardiogram as determined by the central reader and confirmed as clinically significant by the investigator. - Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy. - Has previously participated in this study. ; PRIMARY OUTCOME: Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8; SECONDARY OUTCOME 1: Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8[/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 - ROCKET 2; BRIEF: Evaluation of the ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution ; DRUG USED: Rhopressa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter, Rho GTPase/Rho Kinase; THERAPY: Monotherapy; LEAD SPONSOR: Aerie Pharmaceuticals; CRITERIA: Subject inclusion criteria 1. 0-2 years of age and 18 years or greater 2. Diagnosis of open angle glaucoma or ocular hypertension 3. Unmedicated (post-washout) intraocular pressure (IOP) >20 mm Hg and < 27 mm Hg in the study eye at 2 qualification visits 4. Corrected visual acuity in each eye equivalent to 20/200 5. Able and willing to give signed informed consent (parent or guardian consent for pediatric patient) and follow study instructions Subject exclusion criteria Ophthalmic: 1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable. 2. Intraocular pressure ≥27 mm Hg (unmedicated) in both eyes or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combinations count as two medications. 3. Known hypersensitivity to any component of the formulations to be used (benzalkonium chloride, etc.), to topical anesthetics or beta-adrenoceptor antagonists. 4. Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye 5. Refractive surgery in either eye. 6. Ocular trauma in either eye within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening. 7. Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or zoster keratitis at screening in either eye. 8. Ocular medication in either eye of any kind within 30 days of screening. 9. Clinically significant ocular disease in either eye (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe. 10. Central corneal thickness in either eye greater than 600 µm at screening. 11. Any abnormality in either eye preventing reliable applanation tonometry of either eye. Systemic: 12. Clinically relevant abnormalities (as determined by the investigator) in laboratory tests at screening which may impact the study. 13. Known hypersensitivity or contraindication to beta-adrenoceptor antagonists (e.g., chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third degree heart block or congestive heart failure; severe diabetes). 14. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study. 15. Participation in any investigational study within 30 days prior to screening. 16. Changes of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening, or anticipated during the study. 17. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must not intend to become pregnant during the study.. ; PRIMARY OUTCOME: Intraocular Pressure (IOP); SECONDARY OUTCOME 1: Extent of Exposure[/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 - STRIDE (HR+/HER2-); BRIEF: EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the indication of breast cancer following the clinical hold on the investigational new drug application for tecemotide (L-BLP25). ; DRUG USED: Tecemotide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Immune System, Mucin 1 (MUC-1); THERAPY: Combination; LEAD SPONSOR: EMD Serono; CRITERIA: Inclusion Criteria: - Postmenopausal women as defined in the protocol - Estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive, histologically or cytologically confirmed primary carcinoma of the breast - Expressing at least one of the following five human leukocyte antigen (HLA) haplotypes, as centrally assessed by HLA genotyping from whole blood: HLA-A2, -A3, -A11, -B7, or -B35 - Locally advanced, recurrent, or metastatic breast cancer (Subject must have at least one lesion not located in bone) - Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST), and inoperable - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate hematologic, hepatic, and renal function within two weeks prior to initiation of therapy, as defined by the protocol - Other protocol-defined inclusion criteria may apply Exclusion Criteria: Disease Status - PD either during hormonal therapy for early breast cancer (adjuvant therapy) or within 48 months from the initiation of such therapy - Human epidermal growth factor receptor 2-positive (HER2+) breast cancer as defined in the protocol - Autoimmune disease that in the opinion of the investigator could compromise the safety of the subject in this study (Exception will be granted for well-controlled Type I diabetes mellitus) - Recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; hereditary or congenital immunodeficiencies - Past or current history of malignant neoplasm other than breast cancer (BRCA), except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least five years - Known active Hepatitis B infection or carrier state and/or Hepatitis C infection, known Human Immunodeficiency Virus infection, or any other infectious process that in the opinion of the investigator could compromise the subjects ability to mount an immune response or could expose her to the likelihood of more and/or severe side effects Pre-therapies - Receipt of immunotherapy (for example [e.g.], interferons; tumor necrosis factor; interleukins; growth factors granulocyte macrophage-colony stimulating factor [GM-CSF], granulocyte-colony stimulating factor [G-CSF], macrophage-colony stimulating factor [M-CSF], or monoclonal antibodies), or chemotherapy, within four weeks (28 days) prior to randomization. Note: Subjects who have received monoclonal antibodies for imaging are eligible - Prior receipt of investigational systemic drugs (including off-label use of approved products) or any kind of systemic treatment (chemotherapy, or immunotherapy), with the exception of hormonal therapy (HT) when given for a period not exceeding 4 weeks (28 days) prior to randomization, for treatment of inoperable, locally advanced, recurrent, or metastatic breast cancer - Prior radiotherapy to the site of cancer, if only one site will be used for evaluation of tumor response Prior use of bisphosphonates or concurrent use while on study treatment is allowed Physiological Function - Central nervous system disease or brain metastases, as documented by computed tomography (CT) or magnetic resonance imaging (MRI) - Medical or psychiatric conditions that would interfere with the ability to provide informed consent, communicate side effects, or comply with protocol requirements - Clinically significant cardiac disease, e.g., cardiac failure of New York Heart Association (NYHA) classes III-IV; uncontrolled angina pectoris, uncontrolled arrhythmia, uncontrolled hypertension, or myocardial infarction in the previous six months, as confirmed by an electrocardiogram (ECG) - Splenectomy Standard Criteria - Need for concurrent treatment with a non-permitted therapy (e.g., concurrent chemotherapy, radiotherapy, systemic immunosuppressive drugs, use of herbal medicines or botanical formulations intended to treat cancer) while on protocol therapy. Palliative radiation to painful bone lesions is allowed - Participation in another clinical study within 30 days prior to randomization - Known hypersensitivity to the study drugs - Known alcohol or drug abuse - Legal incapacity or limited legal capacity - Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such. - Subject who could be regarded as vulnerable according to International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines (e.g., the subjects willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate, plus persons kept in detention; persons in nursing homes; subjects in emergency situations; homeless persons; and nomads) - Any other reason that, in the opinion of the investigator, precludes the subject from participating in this study ; PRIMARY OUTCOME: Progression-Free Survival (PFS); SECONDARY OUTCOME 1: Overall Survival (OS) Time[/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 - INN-CB-024; BRIEF: This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty to evaluate postoperative analgesia. ; DRUG USED: XaraColl; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Innocoll; CRITERIA: Inclusion Criteria - Has a body mass index of 18-35 kg/m2. - Must qualify for a planned (nonemergency) abdominoplasty with rectus sheath plication, with an incision that does not extend beyond the umbilicus, to be performed using standard surgical technique under general anesthesia. - Has the ability and willingness to comply with all study procedures including being domiciled for at least 72 hours after surgery. - Is willing to use opioid analgesia, if needed. Exclusion Criteria - Has a known hypersensitivity to amide-type local anesthetics, fentanyl, morphine, oxycodone, acetaminophen, NSAIDs, or bovine products. - Is scheduled for other significant concurrent surgical procedures (eg, gastrointestinal resection or additional cosmetic procedures concurrent with abdominoplasty). - Has used an opioid analgesic on an extended daily basis (≥5 mg oral morphine equivalents per day for 3 or more days a week) within 4 weeks before surgery and/or chronically uses pain medication. - Has any chronic painful condition (eg, fibromyalgia), as determined by the investigator, that may confound the assessment of pain associated with the abdominoplasty procedure ; PRIMARY OUTCOME: SPI24; SECONDARY OUTCOME 1: The secondary objective is to assess the safety and tolerability of INL 001 implants after placement[/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 - SHP621-303; BRIEF: This is a continuation study of Budesonide Oral Suspension (BOS) in adults and adolescents with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-302 extension study. The purpose of this study is to see if BOS is safe and well tolerated over the long-term in adolescents and adults with EoE. ; DRUG USED: Eohilia; DRUG CLASS: Non-NME; INDICATION: Esophagitis; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: - Participant completed the SHP621-302 (NCT02736409) extension study and is considered by the investigator to potentially benefit from continued BOS investigational treatment. - Participant is able to provide written informed consent (participant, parent or legal guardian and, as appropriate, participant assent) to participate in the study before completing any study-related procedures. - Females of childbearing potential must agree to continue acceptable birth control measures (example (e.g.): abstinence, surgically sterile male partner, stable oral contraceptives, or double-barrier methods) throughout study participation. - Participant is willing and has an understanding and ability to fully comply with study procedures and restrictions as defined in protocol. Exclusion Criteria: - Participant has changes in medications or diet during the SHP621-302 (NCT02736409) study that could affect participation in this continuation study. - Participant anticipates using swallowed topical corticosteroid for EoE or systemic corticosteroid for any condition during the treatment period; any temporary use (less than or equal to [≤] 7 days) or initiation of new steroid treatment during the study should be documented and discussed with the medical monitor prospectively but should be avoided within 4 weeks of the scheduled esophagogastroduodenoscopy (EGDs). - Participant anticipates use of Cytochrome P450 3A4 inhibitors (e.g., ketoconazole, grapefruit juice) during the continuation study. - Participant has an appearance at the EGD at the final treatment evaluation visit of SHP621-302 (NCT02736409) (Visit 8) of an esophageal stricture (high grade), as defined by the presence of a lesion that does not allow passage of a diagnostic adult upper endoscope (e.g., with an insertion tube diameter of greater than (>) 9 millimeter [mm]). - Participant has presence of esophageal varices at the EGD at the final treatment evaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study. - Participant has any current disease of the gastrointestinal tract, aside from EoE, including eosinophilic gastritis, enteritis, colitis, or proctitis, inflammatory bowel disease, or celiac disease. - Participant has other diseases causing or associated with esophageal eosinophilia, including hypereosinophilic syndrome, collagen vascular disease, vasculitis, achalasia, or parasitic infection. - Participant has oropharyngeal or esophageal candidiasis that failed to respond to previous treatment. Diagnosis with oropharyngeal or esophageal candidiasis at or since the final treatment evaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study is not an exclusion as long as the participant is expected to respond to treatment. - Participant has a potentially serious acute or chronic infection or immunodeficiency condition, including tuberculosis, fungal, bacterial, viral/parasite infection, ocular herpes simplex, or chicken pox/measles. - Participant has upper gastrointestinal bleeding identified at the EGD at the final treatment evaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study. - Participant has evidence of active infection with Helicobacter pylori. - Participant has evidence of unstable asthma. - Participant is female and pregnant or nursing. - Participant has a history of intolerance, hypersensitivity, or idiosyncratic reaction to budesonide (or any other corticosteroids), or to any other ingredients of the study medication. - Participant has a history or high risk of noncompliance with treatment or regular clinic visits. ; PRIMARY OUTCOME: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious 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 - ORION-9 (Heterozygous FH Subjects); BRIEF: This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international. ; DRUG USED: Leqvio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: The Medicines Company; CRITERIA: Inclusion Criteria: Participants may be included if they meet all of the following inclusion criteria prior to randomization: 1. Male or female participants ≥18 years of age. 2. History of HeFH with a diagnosis of HeFH by genetic testing; and/or a documented history of untreated LDL-C of >190 mg/dL, and a family history of familial hypercholesterolemia, elevated cholesterol or early heart disease that may indicate familial hypercholesterolemia. 3. Serum LDL-C ≥2.6 millimoles (mmol)/liter (L) (≥100 mg/dL) at screening. 4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening. 5. Participants on statins should be receiving a maximally tolerated dose. 6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins. 7. Participants on lipid-lowering therapies (such as a statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation. Exclusion Criteria: Participants will be excluded from the study if any of the following exclusion criteria apply immediately prior to randomization: 1. New York Heart Association (NYHA) class IV heart failure. 2. Uncontrolled cardiac arrhythmia 3. Uncontrolled severe hypertension 4. Active liver disease 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion: 1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) AND more than 55 years of age. 2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization. 3. Women who are surgically sterilized at least 3 months prior to enrollment. 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (condom with spermicide). 7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer. 8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9. The above information is not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Percent Change in LDL-C From Baseline To Day 510; SECONDARY OUTCOME 1: Absolute Change in LDL-C From Baseline to Day 510[/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 - Study 095 (CRPC); BRIEF: The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo ; DRUG USED: Yervoy; DRUG CLASS: Biologic; INDICATION: Prostate Cancer; TARGET: Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Metastatic prostate cancer - Asymptomatic or minimally symptomatic - Progression during hormonal therapy - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 Exclusion Criteria: - Liver, lung or brain metastases - Prior immunotherapy or chemotherapy for metastatic prostate cancer - Autoimmune disease - HIV, Hepatitis B, or Hepatitis C infection ; PRIMARY OUTCOME: Overall Survival (OS) Time; SECONDARY OUTCOME 1: Progression-Free Survival (PFS) Time[/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 - 8591A-018; BRIEF: This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension. ; DRUG USED: Islatravir; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: Reverse Transcriptase; THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Is HIV-1 positive with plasma Human Immunodeficiency Virus 1 (HIV-1) RNA <50 copies/mL at screening. - Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen. - Female is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Exclusion Criteria: - Has HIV-2 infection. - Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection. - Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposis sarcoma. - Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies. - Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period. - Has a documented or known virologic resistance to DOR. - Female expects to conceive or donate eggs at any time during the study. ; PRIMARY OUTCOME: Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 RNA) ≥50 Copies/mL at Week 48; SECONDARY OUTCOME 1: Participants With HIV-1 RNA ≥50 Copies/mL at Week 96[/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 - JAVELIN Renal 101; BRIEF: This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma ; DRUG USED: Bavencio; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed advanced or metastatic RCC with clear cell component - Availability of a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: 1) the biopsy or resection was performed within 1 year of randomization AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and randomization onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then, 15 unstained slides (10 minimum) will be acceptable - Availability of an archival FFPE tumor tissue from primary tumor resection specimen (if not provided per above). If an FFPE tissue block cannot be providedas per documented regulations 15 unstained slides (10 minimum) will be acceptable - At least one measureable lesion as defined by RECIST version 1.1 that has not been previously irradiated - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Adequate bone marrow function, renal and liver functions Exclusion Criteria: - Prior systemic therapy directed at advanced or metastatic RCC - Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment. - Prior immunotherapy with IL-2, IFN-α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways - Prior therapy with axitinib and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitors - Newly dignosed or active brain metastasis - Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011) - Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack - Any of the following in the previous 6 months: deep vein thrombosis or symptomatic pulmonary embolism - Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines) ; PRIMARY OUTCOME: Progression Free Survival (PFS) in PD-L1 positive patients; SECONDARY OUTCOME 1: Overall Survival (OS) in unselected patients[/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 - ADMIRAL; BRIEF: The purpose of this study is to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who are refractory to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy, and to determine the efficacy of ASP2215 therapy as assessed by the rate of complete remission and complete remission with partial hematological recovery (CR/CRh) in these participants. This study will also determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy. ; DRUG USED: Xospata; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Anaplastic lymphoma kinase (ALK), Axl Receptor Tyrosine Kinase, FMS-like tyrosine kinase 3 (FLT-3) ; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Astellas Pharma Global Development, Inc.; CRITERIA: Inclusion Criteria: - Participant has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification (2008) as determined by pathology review at the treating institute. - Participant is refractory to or relapsed after first-line AML therapy (with or without hematopoietic stem cell transplant (HSCT)). - Refractory to first-line AML therapy is defined as: 1. Participant did not achieve complete remission/complete remission with incomplete hematologic recovery/complete remission with incomplete platelet recovery (CR/CRi/CRp) under initial therapy. A Participant eligible for standard therapy must receive at least one cycle of an anthracycline containing induction block in standard dose for the selected induction regimen. A Participant not eligible for standard therapy must have received at least one complete block of induction therapy seen as the optimum choice of therapy to induce remission for this subject. - Untreated first hematologic relapse is defined as: 1. Participant must have achieved a CR/CRi/CRp (criteria as defined by [Cheson et al, 2003], see Section 5.3) with first line treatment and has hematologic relapse. - Participant is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab. A Participant with rapidly proliferative disease and unable to wait for the central lab results can be enrolled based on a local test performed after completion of the last interventional treatment. Participants can be enrolled from a local test result if they have any of the following FLT3 mutations: FLT3 internal tandem duplication (ITD), FLT3 tyrosine kinase domain (TKD)/D835 or FLT3- TKD/I836. - Participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. - Participant is eligible for pre-selected salvage chemotherapy. - Participant must meet the following criteria as indicated on the clinical laboratory tests: - Serum aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN) - Serum total bilirubin ≤ 1.5 x ULN - Serum creatinine ≤ 1.5 x ULN or an estimated glomerular filtration rate of > 50 mL/min as calculated by the Modification of Diet in Renal Disease equation. - Participant is suitable for oral administration of study drug. - Female Participant must either: - Be of non-child bearing potential: 1. post-menopausal (defined as at least 1 year without any menses) prior to Screening, or 2. documented as surgically sterile (at least 1 month prior to Screening) - Or, if of childbearing potential, 1. Agree not to try to become pregnant during the study and for 180 days after the final study administration 2. And have a negative urine pregnancy test at Screening 3. And, if heterosexually active, agree to consistently use highly effective contraception per locally accepted standards in addition to a barrier method starting at Screening and throughout the study period and for 180 days after the final study drug administration. - Female Participant must agree not to breastfeed at Screening and throughout the study period and for 60 days after the final study drug administration. - Female Participant must not donate ova starting at Screening and throughout the study period and for 180 days after the final study drug administration. - Male Participant and their female partners who are of childbearing potential must be using highly effective contraception per locally accepted standards in addition to a barrier method starting at Screening and continue throughout the study period and for 120 days after the final study drug administration. - Male Participant must not donate sperm starting at Screening and throughout the study period and 120 days after the final study drug administration. - Participant agrees not to participate in another interventional study while on treatment. Exclusion Criteria: - Participant was diagnosed as acute promyelocytic leukemia (APL). - Participant has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis). - Participant has AML secondary to prior chemotherapy for other neoplasms (except for MDS). - Participant is in second or later hematologic relapse or has received salvage therapy for refractory disease - Participant has clinically active central nervous system leukemia. - Participant has been diagnosed with another malignancy, unless disease-free for at least 5 years. Participants with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Participants with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed or treated with definitive radiotherapy. - Participant has received prior treatment with ASP2215 or other FLT3 inhibitors (with the exception of sorafenib and midostaurin used in first-line therapy regimen as part of induction, consolidation, and/or maintenance). - Participant has clinically significant abnormality of coagulation profile, such as disseminated intravascular coagulation (DIC). - Participant has had major surgery within 4 weeks prior to the first study dose. - Participant has radiation therapy within 4 weeks prior to the first study dose. - Participant has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or Participant with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ≥ 45%. - Participant requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A. - Participants with mean of triplicate Fridericia-corrected QT interval (QTcF) > 450 ms at Screening based on central reading. - Participants with Long QT Syndrome at Screening. - Participants with hypokalemia and hypomagnesemia at Screening (defined as values below lower limit of normal [LLN]). - Participant requires treatment with concomitant drugs that are strong inhibitors or inducers of P glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject. - Participant requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject. - Participant has an active uncontrolled infection. - Participant is known to have human immunodeficiency virus infection. - Participant has active hepatitis B or C, or other active hepatic disorder. - Participant has any condition which makes the Participant unsuitable for study participation. - Participant has active clinically significant GVHD or is on treatment with systemic corticosteroids for GVHD. - Participant has an FLT3 mutation other than the following: FLT3-ITD, FLT3-TKD/D835 or FLT3-TKD/I836. ; PRIMARY OUTCOME: Duration of Overall Survival (OS); SECONDARY OUTCOME 1: Duration of Event-Free Survival (EFS)[/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 - LELANTOS-2; BRIEF: To evaluate the efficacy and safety of pamrevlumab versus placebo in combination with systemic corticosteroids administered every 2 weeks in ambulatory participants with Duchenne muscular dystrophy (DMD) (age 6 to <12 years). ; DRUG USED: Pamrevlumab; DRUG CLASS: Biologic; INDICATION: Duchenne Muscular Dystrophy (DMD); TARGET: Connective Tissue Growth Factor (CTGF); THERAPY: Monotherapy; LEAD SPONSOR: FibroGen; CRITERIA: Inclusion Criteria: Age, and consent: 1. Males at least 6 to <12 years of age at screening initiation 2. Written consent by participant and/or legal guardian as per regional/ country and/or Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements DMD diagnosis: 3. Medical history includes diagnosis of DMD and confirmed Duchenne mutation, including status of exon 44 using a validated genetic test. Pulmonary criteria: 4. Average (of screening and Day 0) percent predicted forced vital capacity (FVC) above 45% 5. On a stable dose of systemic corticosteroids for a minimum of 6 months, with no substantial change in dosage for a minimum of 3 months (except for adjustments for changes in body weight) prior to screening. Corticosteroid dosage should be in compliance with the DMD Care Considerations Working Group recommendations (for example, prednisone or prednisolone 0.75 mg/kg per day or deflazacort 0.9 mg/kg per day) or stable dose. A reasonable expectation is that dosage and dosing regimen would not change significantly for the duration of the study. Performance criteria: 6. Able to complete 6-minute walking distance (6MWD) test with a distance of at least 270 meters but no more than 450 meters on two occasions within 3 months prior to randomization with ≤10% variation between these two tests. 7. Able to rise (TTSTAND) from floor in <10 seconds (without aids/orthoses) at screening visit. 8. Able to undergo magnetic resonance imaging (MRI) test for the lower extremities vastus lateralis muscle. Vaccination: 9. Agreement to receive annual influenza vaccinations during the conduct of the study. Laboratory criteria: 10. Adequate renal function: cystatin C ≤1.4 mg/liter (L) 11. Adequate hematology and electrolytes parameters: 1. Platelets >100,000/microliter (μL) 2. Hemoglobin >12 grams (g)/deciliter (dL) 3. Absolute neutrophil count >1500/μL 4. Serum calcium (Ca), potassium (K), sodium (Na), magnesium (Mg) and phosphorus (P) levels are within a clinically accepted range for DMD participants 12. Adequate hepatic function: 1. No history or evidence of liver disease 2. Gamma glutamyl transferase (GGT) ≤3x upper limit of normal (ULN) 3. Total bilirubin ≤1.5xULN Exclusion Criteria: General Criteria: 1. Concurrent illness other than DMD that can cause muscle weakness and/or impairment of motor function 2. Severe intellectual impairment (for example, severe autism, severe cognitive impairment, severe behavioral disturbances) preventing the ability to perform study assessments in the Investigators judgment 3. Previous exposure to pamrevlumab 4. Body mass index (BMI) ≥40 kg/square meter (m^2) or weight >117 kg 5. History of 1. allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies 2. hypersensitivity to study drug or any component of study drug 6. Exposure to any investigational drug (for DMD or not), in the 30 days prior to screening initiation or use of approved DMD therapies (for example, eteplirsen, ataluren, golodirsen, casimersen) within 5 half-lives of screening, whichever is longer with the exception of the systemic corticosteroids, including deflazacort Pulmonary and Cardiac criteria: 7. Requires ≥16 hours continuous ventilation 8. Poorly controlled asthma or underlying lung disease such as bronchitis, bronchiectasis, emphysema, recurrent pneumonia that in the opinion of the investigator might impact respiratory function 9. Hospitalization due to respiratory failure within the 8 weeks prior to screening 10. Severe uncontrolled heart failure (New York Heart Association [NYHA] Classes III-IV) or renal dysfunction, including any of the following: 1. Need for intravenous diuretics or inotropic support within 8 weeks prior to screening 2. Hospitalization for a heart failure exacerbation or arrhythmia within 8 weeks prior to screening 3. Participants with glomerular filtration rate (GFR) of less than 30 mL/minute (min)/1.73 m^2 or with other evidence of acute kidney injury as determined by investigator 11. Arrhythmia requiring anti-arrhythmic therapy 12. Any other evidence of clinically significant structural or functional heart abnormality Clinical judgment: 13. The Investigator judges that the participant will be unable to fully participate in the study and complete it for any reason, including inability to comply with study procedures and treatment, or any other relevant medical, surgical or psychiatric conditions ; PRIMARY OUTCOME: Change From Baseline in North Star Ambulatory Assessment (NSAA) Total Score at Week 52; SECONDARY OUTCOME 1: Change From Baseline in 4-Stair Climb Velocity (4SCV) Assessment at Week 52[/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 - KEYNOTE-679/ECHO-302; BRIEF: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC. ; DRUG USED: Epacadostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: IDO (Indoleamine 2,3-dioxygenase); THERAPY: Combination; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Histologic confirmation of locally advanced or metastatic RCC with a clear-cell component with or without sarcomatoid features. - Must not have received any prior systemic therapy for their mRCC. - Measurable disease based on RECIST v1.1. - Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion as required. - Karnofsky performance status ≥ 70%. - Adequate organ function per protocol-defined criteria. Exclusion Criteria: - Use of protocol-defined prior/concomitant therapy. - Currently receiving or has received an investigational treatment as part of a study of an investigational agent or has used an investigational device within 4 weeks before randomization. - History of severe hypersensitivity reaction to study treatments or their excipients. - Active autoimmune disease that has required systemic treatment in past 2 years. - Known additional malignancy that has progressed or has required active treatment in the last 3 years. - Known active central nervous system metastases and/or carcinomatous meningitis. - History of (noninfectious) pneumonitis that required steroids or current pneumonitis. - History or presence of an abnormal electrocardiogram that, in the investigators opinion, is clinically meaningful. - Significant cardiac event within 12 months before Cycle 1 Day 1. ; PRIMARY OUTCOME: Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC); SECONDARY OUTCOME 1: Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing 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/III - BOND; BRIEF: The use of a designed viral vector that can destroy cancer cells while leaving normal cells largely unharmed. The virus also stimulates an immunological response by producing a special factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. It forms the hypothesis that this regimen may be used for people who have failed current forms of treatment and are recommended for cystectomy. It is with hope that this novel therapy will be able to delay or potentially avoid cystectomy for this patient population. Bladder instillation of this agent causes little long lasting side effects and may drastically improve the stimulation of the immune system for local cancer cell death as well as destroying those tumor cells that may have travelled to regional lymph nodes or distant organs. ; DRUG USED: CG0070; DRUG CLASS: Biologic; INDICATION: Bladder Cancer; TARGET: Granulocyte Macrophage Colony-Stimulating Factor Receptor (GM-CSFR)/CD116, Immune System, Oncolytic Virus Therapy; THERAPY: Monotherapy; LEAD SPONSOR: CG Oncology, Inc.; CRITERIA: Inclusion Criteria: 1. Patients must be considered high risk, with pathologically confirmed high grade disease (HG) WHO 2004 2. Patients must have pathologically-proven unresectable, primary, secondary or concurrent carcinoma in situ disease, defined by having either Ta and/or T1 with CIS, or CIS 3. Patients must have no evidence of muscle invasive disease 4. Patient need to sign a specific informed consent acknowledging that a delay of cystectomy may lead to an increase chance of progression and/or metastasis with serious or sometimes fatal consequences. 5. Patients must have received at least two or more prior courses of intravesical therapy. BCG must have been one of the prior therapies administered. Patients can have either failed BCG induction therapy within a six month period or have been successfully treated with BCG, but subsequently found to have recurrence. The standard course of intravesical therapy must include six weekly treatments (allowable range of instillations per course is 4-9). The second course of BCG can consist of three weekly treatments 6. 18 years of age or older 7. Residual disease at accrual 8. Pathologically diagnosed transitional cell (urothelial) bladder cancer (further details in 10.) patients where radical cystectomy with curative intent is indicated for superficial bladder cancer that is resistant to treatment. 9. Patients must be able to enter into the study within five weeks of their most recent diagnostic procedure, which is usually a diagnostic biopsy, a transurethral resection of bladder tumor (TURBT) procedure or other diagnostic scanning such as CT and PET procedures. 10. Histopathologically confirmed, transitional cell (urothelial) carcinoma. Urothelial tumors with mixed histology (but with <50% variant) are eligible. 11. No evidence of urethral or renal pelvis TCC by upper tract radiological imaging (e.g., intravenous pyelogram, CT urogram, or retrograde pyelogram) within the past 2 years. 12. Eastern Cooperative Oncology Group (ECOG) performance status <2. 13. Not pregnant or lactating 14. Patients with child bearing potential must agree to use adequate contraception 15. Agree to study specific informed consent and HIPAA authorization for release of personal health information 16. Adequate baseline CBC, renal and hepatic function. Renal parameters as detailed above. Absolute lymphocyte count ≥ 1,000/μL before all doses of CG0070 17. Patient to provide a tumor specimen for determination of RB pathway status Exclusion Criteria: 1. Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior immunotherapy or intravesical (administered within the bladder) chemotherapy for superficial disease is acceptable 2. No bladder cancer residual disease, such as patients that are rendered disease free by TURBT 3. History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products, clinically meaningful allergic reactions or any known hypersensitivity or prior reaction to any of the formulation excipients in the study drugs. 4. Known infection with HIV, HBV or HCV. 5. Anticipated use of chemotherapy, radiotherapy, or other immunotherapy not specified in the study protocol while on study 6. Any underlying medical condition that, in the Investigators opinion, will make the administration of study vaccine hazardous to the patient, would obscure the interpretation of adverse events, or surgical resection. Anticipated use of chemotherapy, radiotherapy, or other immunotherapy not specified in the study protocol while on study 7. Systemic treatment on any investigational clinical trial within 28 days prior to registration. 8. Concurrent treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (exception: inhaled or topically applied steroids, and acute and chronic standard dose NSAIDs, are permitted). Use of a short course (i.e., ≤ 1 day) of a glucocorticoid is acceptable to prevent a reaction to the IV contrast used for CT scans. 9. Immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry. 10. History of prior experimental cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine) 11. History of partial cystectomy in the setting of bladder cancer primary tumor. 12. History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products, clinically meaningful allergic reactions or any known hypersensitivity or prior reaction to any of the formulation excipients in the study drugs. 13. History of stage III or greater cancer, excluding urothelial cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer, must have been adequately treated and have been disease-free for ≥ 3 years at the time of registration. 14. Concomitant active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis) 15. Progressive viral or bacterial infection 16. All infections must be resolved and the patient must remain afebrile for seven days without antibiotics prior to being placed on study 17. Any underlying medical condition that, in the Investigators opinion, will make the administration of study vaccine hazardous to the patient, would obscure the interpretation of adverse events, or not permit adequate surgical resection. 18. Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel ; PRIMARY OUTCOME: Complete Response Proportion (CR); SECONDARY OUTCOME 1: Progression rate to muscle invasive disease[/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 - Pro-Feiba; BRIEF: The objective of this study is to assess whether prophylactic therapy with an activated prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number of bleeds in patients with hemophilia and persistent high responding inhibitors. ; DRUG USED: FEIBA NF; DRUG CLASS: Biologic; INDICATION: Hemophilia A and B - General Clotting Products; TARGET: Coagulation Factor VIII; THERAPY: Monotherapy; LEAD SPONSOR: Tulane University School of Medicine; CRITERIA: Inclusion Criteria: - hemophilia A, any severity, with documented history of high-titer inhibitor (>5BU); current use of bypassing agents (PCCs, aPCCs or rFVIIa) for treatment of bleeds; >/= 6 bleeds requiring bypassing therapy in the previous 6 months Exclusion Criteria: - concomitant immune tolerance therapy; clinically symptomatic liver disease, platelet count less than 100,000 ; PRIMARY OUTCOME: Number of Bleeds During 6 Month Treatment Period; 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 - 3004; BRIEF: Multiple Sclerosis (MS) is an acquired inflammatory demyelinating disease of the central nervous system (CNS) that is regarded as the foremost cause of non-traumatic neurologic disability in adults in North America. Spasticity is a common complication in MS and occurs in up to 84% of patients. The main sign of spasticity is resistance to passive limb movement characterized by increased resistance to stretching, clonus, and exaggerated deep reflexes. Osmotica Pharmaceutical is currently developing arbaclofen extended-release tablets (AERT) for the treatment of spasticity in patients with MS. ; DRUG USED: Ontinua ER; DRUG CLASS: Non-NME; INDICATION: Multiple Sclerosis (MS); TARGET: GABA-B Receptor; THERAPY: Monotherapy; LEAD SPONSOR: RVL Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria Includes: - Subjects 18 to 65 years of age, inclusive. - An established diagnosis of MS that manifests a documented history of spasticity. - If receiving disease-modifying medications (eg, interferons approved for MS, glatiramer acetate, natalizumab, fingolimod, or mitoxantrone), there must be no change in dose for at least 3 months prior to Visit 1 (Screening), and the subject must be willing to maintain this treatment dose for the duration of the study. If receiving AMPYRA® (dalfampridine, fampridine, 4-amino puridine), subject must be at a stable dose for at least 3 months prior to Visit 1. - Stable regimen for at least 3 months prior to Visit 2 for all medications and non-pharmacological therapies that are intended to alleviate spasticity. - Absence of infections, peripheral vascular disease, painful contractures, advanced arthritis, or other conditions that hinder evaluation of joint movement. - Use of a medically highly effective form of birth control (see Section 7.8) during the study and for 3 months thereafter for women of child-bearing potential (including female subjects and female partners of non-sterile male subjects). - Willing to sign the informed consent form (ICF). Exclusion Criteria Includes: - Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subjects level of spasticity. - Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables. - Pregnancy, lactation, or planned pregnancy during the course of the study and for 3 months after the final study visit. - Subject has clinically significant abnormal laboratory values, in the opinion of the investigator, at Visit 1 or Visit 2. - Current malignancy or history of malignancy that has not been in remission for more than 5 years, except effectively treated basal cell skin carcinoma. - Any other significant disease, disorder, or significant laboratory finding which, in the opinion of the investigator, puts the subject at risk because of participation, influences the result of the study, or affects the subjects ability to participate. ; PRIMARY OUTCOME: Change From Baseline in Total Numeric-transformed Modified Ashworth Scale Score of the Most Affected Limb (TNmAS-MAL); 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 - Study 007; BRIEF: This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis. ; DRUG USED: Parsabiv; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperparathyroidism (Secondary); TARGET: Protein Kinase C (PKC); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Subject understands the study procedures and agrees to participate in the study by giving written informed consent. - Subject is 18 years of age or older. - Subject agrees to not participate in another study of an investigational agent during the study. - Subject must be receiving hemodialysis 3 times weekly for at least 3 months - Other Inclusion Criteria may apply Exclusion Criteria: - Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening. - Other investigational procedures while participating in this study are excluded. - Anticipated or scheduled parathyroidectomy during the study period. - Subject has received a parathyroidectomy within 3 months prior to dosing. - Anticipated or scheduled kidney transplant during the study period. - Subject has known sensitivity to any of the products or components to be administered during dosing. - Subject has participated in a prior clinical trial of AMG 416 - Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator. - Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject. - Other Exclusion Criteria may apply ; PRIMARY OUTCOME: Percentage of Participants With > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase; SECONDARY OUTCOME 1: Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase[/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 - Phallcon (vs. Imatinib, Ph+ ALL); BRIEF: In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib. The main aim of this study is to compare the number of participants on each treatment that show no signs of disease. Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study. ; DRUG USED: Iclusig; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: BCR-ABL Fusion Protein, Fibroblast Growth Factor Receptor (FGFR) , FMS-like tyrosine kinase 3 (FLT-3) , RET, VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2017 national comprehensive cancer network (NCCN) guidelines. 2. Eastern Cooperative Oncology Group (ECOG) performance status of <=2. Exclusion Criteria: 1. With a history or current diagnosis of chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML). 2. Prior/current treatment with any systemic anticancer therapy (including but not limited to any tyrosine kinase inhibitor [TKI]) and/or radiotherapy for ALL, with the exception of an optional prephase therapy or chemotherapy induction (no more than 1 cycle), which should be discussed with the sponsors medical monitor/designee. 3. Currently taking drugs that are known to have a risk of causing prolonged corrected QT (QTc) or torsades de pointes (TdP) (unless these can be changed to acceptable alternatives or discontinued). 4. Taking any medications or herbal supplements that are known to be strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4 within at least 14 days before the first dose of study drug. 5. Uncontrolled active serious infection that could, in the investigators opinion, potentially interfere with the completion of treatment according to this protocol. 6. Major surgery within 28 days before randomization (minor surgical procedures such as catheter placement or BM biopsy are not exclusionary criteria). 7. Known human immunodeficiency virus (HIV) seropositivity, known active hepatitis B or C infection. 8. History of acute pancreatitis within 1 year of study screening or history of chronic pancreatitis. 9. Uncontrolled hypertriglyceridemia (triglycerides >450 milligram per deciliter [mg/dL]). 10. Diagnosed and treated for another malignancy within 5 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 11. History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinsons disease, cerebellar disease, organic brain syndrome, or psychosis. 12. Clinical manifestations of CNS or extramedullary involvement with ALL other than lymphadenopathy or hepatosplenomegaly. 13. Autoimmune disease with potential CNS involvement. 14. Known significant neuropathy of Grade >=2 severity. 15. Clinically significant, uncontrolled, or active cardiovascular, cerebrovascular, or peripheral vascular disease, or history of or active venous thrombotic/embolic event (VTE) disease. 16. Have a significant bleeding disorder unrelated to ALL. ; PRIMARY OUTCOME: Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase; SECONDARY OUTCOME 1: Event-free Survival (EFS)[/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 - LUX-Lung 3; BRIEF: This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients. ; DRUG USED: Gilotrif; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor), ErbB3/HER3, ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology. - Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of tumour biopsy material. - Measurable disease according to RECIST 1.1. - Eastern Cooperative Oncology Group score of 0 or 1. - Age >/= 18 years. - Life expectancy of at least three months. - Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice guidelines. Exclusion criteria: - Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation. - Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies. - Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation. - Active brain metastases - Any other current malignancy or malignancy diagnosed within the past five years - Known pre-existing interstitial lung disease. - Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom. - History or presence of clinically relevant cardiovascular abnormalities. - Any other concomitant serious illness or organ system dysfunction. - Adequate absolute neutrophil count and platelet count - Adequate liver and kidney function - Active hepatitis B infection, active hepatitis C infection or known HIV carrier. ; PRIMARY OUTCOME: Progression-Free Survival (PFS) Time; SECONDARY OUTCOME 1: Percentage of Patients With Objective Response (OR)[/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 - AdvanTIG-302 (w/Tislelizumab); BRIEF: The purpose of the study is to compare progression-free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab in combination with placebo) as assessed by investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and to compare overall survival (OS) between Arm A and Arm B. ; DRUG USED: BGB-A1217; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, TIGIT; THERAPY: Combination; LEAD SPONSOR: BeiGene; CRITERIA: Key Inclusion Criteria: 1. Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous NSCLC. 2. No prior systemic treatment for metastatic NSCLC. 3. Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available). 4. Tumors with PD-L1 expressed in ≥ 50% tumor cells. 5. At least 1 measurable lesion as defined per RECIST v1.1. 6. ECOG Performance Status ≤ 1. Key Exclusion Criteria: 1. Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1. 2. Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways. 3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis. 4. Active autoimmune diseases or history of autoimmune diseases that may relapse. Note: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Progression-free Survival (PFS) As Assessed By Investigators; SECONDARY OUTCOME 1: PFS As Assessed By A Blinded Independent Review Committee[/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 - JANUS 2; BRIEF: This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer. ; DRUG USED: Jakafi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pancreatic Cancer; TARGET: JAK/STAT ; THERAPY: Combination; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the pancreas. - Advanced adenocarcinoma of the pancreas that is inoperable or metastatic. - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 - Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy). - ≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities. - Radiographically measurable or evaluable disease - An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below: - Criteria: 1. mGPS of 1: C-reactive protein (CRP) > 10 mg/L and albumin ≥ 35 g/L 2. mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L Exclusion Criteria: - Received more than 1 prior regimen for advanced or metastatic disease. - Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment - Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization). - Current or previous other malignancy within 2 years of study entry without sponsor approval - Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), ruxolitinib, or any of their excipients. - Prior treatment with a JAK inhibitor for any indication. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression Free Survival (PFS)[/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 - Dapa-CKD; BRIEF: The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease. ; DRUG USED: Farxiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Nephropathy; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Provision of signed informed consent prior to any study specific procedures - Female or male aged ≥18 years at the time of consent - eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1 - Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200 and ≤5000 mg/g at visit 1 - Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated, Exclusion Criteria: - Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis - Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment - History of organ transplantation - Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor - Type 1 diabetes mellitus - New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment - MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment ; PRIMARY OUTCOME: Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.; SECONDARY OUTCOME 1: Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.[/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 - SPIRIT 1; BRIEF: The purpose of this study is to determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain. ; DRUG USED: Orgovyx; DRUG CLASS: New Molecular Entity (NME); INDICATION: Endometriosis; TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Combination; LEAD SPONSOR: Myovant Sciences GmbH; CRITERIA: Key Inclusion Criteria: 1. Is a premenopausal female aged 18 to 50 years old (inclusive) on the day of signing of the informed consent form. 2. Has agreed to use only study-specified analgesic medications during the study and is not known to be intolerant to these. 3. Has a diagnosis of endometriosis and has had, within 10 years prior to signing the informed consent form, surgical or direct visualization and/or histopathologic confirmation of endometriosis, for example, during a laparoscopy or laparotomy. 4. During the Run-In Period (35 to 70 days prior to treatment period) has a dysmenorrhea NRS score ≥ 4.0 on at least 2 days and 1. Mean NMPP NRS score ≥ 2.5, or 2. Mean NMPP NRS score ≥ 1.25 and NMPP NRS score ≥ 5.0 on ≥ 4 days. Key Exclusion Criteria: 1. Has a history of chronic pelvic pain that is not caused by endometriosis. 2. Has any chronic pain or frequently recurring pain condition, other than endometriosis that is treated with opioids or requires analgesics for ≥ 7 days per month. 3. Has had surgical procedures for treatment of endometriosis within the 3 months prior to the Screening visit. 4. Has a history of or currently has osteoporosis or other metabolic bone disease. 5. Has a clinically significant gynecologic condition, other than endometriosis, identified during Screening or Run-In period transvaginal ultrasound or endometrial biopsy. ; PRIMARY OUTCOME: Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or End Of Treatment (EOT); SECONDARY OUTCOME 1: Change From Baseline In The Endometriosis Health Profile (EHP)-30 Pain Score At Week 24[/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/III - GALAXI 1; BRIEF: The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohns disease. ; DRUG USED: Tremfya; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Have Crohns disease (CD) or fistulizing Crohns disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy - Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohns Disease (SES-CD) - Have screening laboratory test results within the protocol specified parameters - A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline - Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD Exclusion Criteria: - Current diagnosis of ulcerative colitis or indeterminate colitis - Has complications of Crohns disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation - Unstable doses of concomitant Crohns disease therapy - Receipt of Crohns disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol - Any medical contraindications preventing study participation ; PRIMARY OUTCOME: Phase 2: Change from Baseline in the Crohns Disease Activity Index (CDAI) Score at Week 12; SECONDARY OUTCOME 1: Phase 2: Clinical Remission 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 IIb/III - HPTN 083 (Cisgender Men/Transgender Women); BRIEF: This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW). ; DRUG USED: Vocabria; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV Prevention; TARGET: HIV Integrase; THERAPY: Monotherapy; LEAD SPONSOR: National Institute of Allergy and Infectious Diseases (NIAID); CRITERIA: Inclusion Criteria: - MSM and TGW, 18 years or older at the time of screening (male at birth) - Willing to provide informed consent for the study - At high risk for sexually acquiring HIV infection based on self-report of at least one of the following: - Any condomless receptive anal intercourse in the 6 months prior to enrollment (condomless anal intercourse within a monogamous HIV seronegative concordant relationship does not meet this criterion) - More than five partners in the 6 months prior to enrollment (regardless of condom use and HIV serostatus, as reported by the enrollee) - Any stimulant drug use in the 6 months prior to enrollment - Rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to enrollment - SexPro score of less than or equal to 16 (U.S. sites only) - In general good health, as evidenced by the following laboratory values, which must be from specimens obtained within 45 days prior to study enrollment: - Non-reactive / negative HIV test results. More information on this criterion can be found in the protocol. - Hemoglobin greater than 11 g/dL, - Absolute neutrophil count greater than 750 cells/mm^3 - Platelet count greater than or equal to 100,000/mm^3 - Calculated creatinine clearance greater than or equal to 60 mL/minute using the Cockcroft-Gault equation (use sex at birth for calculation) - Although not protocol exclusionary, sites should carefully consider the advisability of enrolling participants with calculated creatinine clearance between 60-70 mL/min, as limited changes in creatinine clearance during study conduct will lead to protocol-mandated product holds and may alter the risk-benefit considerations of study participation - Alanine aminotransferase (ALT) less than 2 times the upper limit of normal (ULN) - Total bilirubin less than or equal to 2.5 times ULN - Hepatitis B virus (HBV) surface antigen (HBsAg) negative - Hepatitis C virus (HCV) Ab negative - No Grade 3 or higher laboratory abnormalities on any laboratory tests obtained at screening, including tests obtained as part of a panel of tests ordered to obtain the protocol-required laboratory test results. - No medical condition that, in the opinion of the study investigator, would interfere with the conduct of the study (e.g., provided by self-report, or found upon medical history and examination or in available medical records) - Willing to undergo all required study procedures Exclusion Criteria: - One or more reactive or positive HIV test result at Screening or Enrollment, even if HIV infection is not confirmed - Active or recent use of any illicit intravenous drugs (recent defined as in the 90 days prior to enrollment) - Co-enrollment in any other interventional research study or other concurrent studies that may interfere with this study (as provided by self-report or other available documentation. Exceptions may be made if appropriate after consultation with the CMC.) - Past or current participation in HIV vaccine trial. An exception will be made for participants that can provide documentation of receipt of placebo (not active arm). Note: Past participation in a monoclonal antibody study is not exclusionary, effective as of Version 1.0 of HPTN 083. - Clinically significant cardiovascular disease, as defined by history/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease - Inflammatory skin conditions that compromise the safety of intramuscular (IM) injections, per the discretion of the Investigator of Record. Mild skin conditions may not be exclusionary at the discretion of the Investigator of Record (IoR) or designee in consultation with the CMC - Has a tattoo or other dermatological condition overlying the buttock region which in the opinion of the IoR or designee, in consultation with the CMC, may interfere with interpretation of injection site reactions - Current or chronic history of liver disease (e.g., non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome, asymptomatic gallstones, or cholecystectomy) - Coagulopathy (primary or iatrogenic) which would contraindicate IM injection (concomitant anticoagulant or anti-platelet therapy use should be discussed with the CMC) - Active or planned use of prohibited medications as described in the Investigators Brochure or listed in the Study Specific Procedures (SSP) Manual (provided by self-report, or obtained from medical history or medical records). In particular, future use of TDF/FTC at any point during the study. - Known or suspected allergy to study product components (active or placebo), including egg or soy products (egg and soy products are contained in Intralipid) - Surgically-placed or injected buttock implants or fillers, per self-report. Contact the CMC for guidance regarding questions about individual cases. - Alcohol or substance use that, in the opinion of the study investigator, would jeopardize the safety of the participant on study (e.g., provided by self-report, or found upon medical history and examination or in available medical records). - History of seizure disorder, per self-report - QTc interval (B or F) greater than 500 msec ; PRIMARY OUTCOME: Number of Participants With Documented Incident HIV Infections During Steps 1 and 2; SECONDARY OUTCOME 1: Number of Participants With Documented Incident HIV Infections in Step 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 III - CR013012; BRIEF: The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on treatment of partial onset seizures. ; DRUG USED: Comfyde; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: Unknown; THERAPY: Combination; LEAD SPONSOR: SK Life Science, Inc.; CRITERIA: Inclusion Criteria: - Male or Female, 16 year or older - Clinical diagnosis of focal epilepsy for at least 1 year - History of poor response to at least 1 anti-epileptic drug in the past - Current treatment with 1 or 2 anti-epileptic drugs - Should have at least 3 seizures per month Exclusion Criteria: - Generalized epilepsy - Cannot count your seizures - Unstable medical disease, such as a recent heart attack or uncontrolled diabetes - Major psychiatric illness - Recent drug or alcohol abuse - Unable to swallow pills ; PRIMARY OUTCOME: The primary outcome is the change in seizure frequency of all simple partial motor, complex partial, or secondarily generalized seizures from the pretreatment baseline phase compared with the double-blind treatment phase.; SECONDARY OUTCOME 1: The key secondary outcome is the change in the Seizure Severity Questionnaire score.[/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 - BERSON (T2D w/atorvastatin); BRIEF: The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with hyperlipidemia or mixed dyslipidemia. ; DRUG USED: Repatha; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Males and females with type 2 diabetes (receiving pharmacologic treatment for at least 6 months or longer) with stable diabetes therapy - Lipid-lowering therapy must be unchanged for at least 4 weeks or more - Subjects receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 100 mg/dL - Subjects not receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 130 mg/dL Exclusion criteria: - New York Heart Association (NYHA) class III or IV heart failure - Uncontrolled cardiac arrhythmia - Uncontrolled hypertension - Type 1 diabetes or poorly controlled type 2 diabetes - Uncontrolled hypothyroidism or hyperthyroidism. ; PRIMARY OUTCOME: Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12; SECONDARY OUTCOME 1: Change From Baseline in LDL-C at the Mean of Weeks 10 and 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 - ALLIANCE (NCI) (Age >=65); BRIEF: This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether rituximab with bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia. ; DRUG USED: Imbruvica; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Brutons Tyrosine Kinase (BTK), Interleukin-2-inducible T-cell kinase (ITK); THERAPY: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - PRE-REGISTRATION (STEP 0) - All patients are REQUIRED to be pre-registered to A041202 in order to submit peripheral blood to the Alliance Hematologic Malignancy Biorepository (HEME) for central Zap-70 methylation. This specimen submission is mandatory prior to registration as results will be used for stratification - REGISTRATION (STEP 1) - Patients must be diagnosed with CLL in accordance with International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria that includes all of the following: - >= 5 x 10^9 B lymphocytes (5000/uL) in the peripheral blood - On morphologic review, the leukemic cells must be small mature lymphocytes, and prolymphocytes must not exceed 55% of the blood lymphocytes - CLL cells on immunophenotype (performed locally) must reveal a clonal B-cell population, which express the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5; patients with bright surface immunoglobulin expression or lack of CD23 expression in > 10% of cells must lack t(11;14) translocation by interphase cytogenetics - Patients must be intermediate or high-risk Rai stage CLL - Intermediate risk (formerly Rai stage I/II) is defined by lymphocytosis plus enlarged lymph nodes at any site, with or without hepatomegaly or splenomegaly - High risk (formerly Rai stage III/IV) is defined by lymphocytosis with or without enlarged nodes and spleen plus disease-related anemia (hemoglobin < 11 g/dL) or thrombocytopenia (platelet count < 100 x 10^9/L) that is not attributable to autoimmune hemolytic anemia or thrombocytopenia - Patients must meet criteria for treatment as defined by IWCLL 2008 guidelines which includes at least one of the following criteria: - Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia) - Massive (>= 6 cm below the costal margin), progressive or symptomatic splenomegaly - Massive nodes (>= 10 cm) or progressive or symptomatic lymphadenopathy - Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy - Constitutional symptoms, which include any of the following: - Unintentional weight loss of 10% or more within 6 months - Significant fatigue - Fevers > 100.5 degrees F for 2 weeks or more without evidence of infection - Night sweats > 1 month without evidence of infection - Age >= 65 years - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Patients with active hepatitis B defined by hepatitis B surface antigen positivity or core antibody positivity in the presence of hepatitis B DNA are not eligible for this study; patients with a positive hepatitis B core antibody but with negative hepatitis B DNA may participate, but must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician - Intravenous immunoglobulin (IVIG) can cause a false positive hepatitis B serology; if patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, but should have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician - Patients with class III or class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible - Patients who have had a myocardial infarction, intracranial bleed, or stroke within the past 6 months are not eligible - Patients with known human immunodeficiency virus (HIV) are eligible if their CD4 count is >= 350 cells/mm^3 and if they are not taking prohibited CYP-interacting medications - Patients may not have had major surgery within 10 days of enrollment, or minor surgery within 7 days of enrollment; examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint; the decision about whether a surgery is major or minor can be made at the discretion of the treating physician - Absolute neutrophil count (ANC) >= 1,000/uL unless due to bone marrow involvement - Aspartate aminotransferase (AST) or alanine aminotransferase (AST) =< 2.5 x upper limits of normal except if due to disease infiltration of the liver - Bilirubin =< 1.5 x upper limits of normal (unless due to liver involvement, hemolysis, or Gilberts disease) - Creatinine clearance >= 40 mL/min - To be calculated by modified Cockcroft-Gault formula - Platelet count (untransfused) >= 30,000/uL Exclusion Criteria: - Prior treatment - Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids) - Treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment; palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration - Patients must not be receiving active systemic anticoagulation with heparin or warfarin; patients must be off warfarin therapy for at least 30 days prior to enrollment - Patients must not have any history of Richters transformation or prolymphocytic leukemia (prolymphocytes in blood > 55%) - Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily - Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics - Patients must not have continued requirement for therapy with a strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitor or inducer - Patients must not have a known allergy to mannitol - Patients must not have prior significant hypersensitivity to rituximab (not including infusion reactions) ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: Progression Free Survival (PFS) Rate at 2 Years[/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 - RAP-MD-04 (Relapse Prevention); BRIEF: This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in participants with Major Depressive Disorder (MDD). ; DRUG USED: Rapastinel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: NMDA Receptor - Glycine Site; THERAPY: Monotherapy; LEAD SPONSOR: Naurex, Inc, an affiliate of Allergan plc; CRITERIA: Inclusion Criteria: - Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD - Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Screening - Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant - If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test. Exclusion Criteria: - DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Screening - Lifetime history of meeting DSM-5 criteria for: - Schizophrenia spectrum or other psychotic disorder - Bipolar or related disorder - Major neurocognitive disorder - Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participants ability to consent, follow study directions, or otherwise safely participate in the study - Dissociative disorder - Posttraumatic stress disorder - MDD with psychotic features - Significant suicide risk, as judged by the Investigator. ; PRIMARY OUTCOME: Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period; SECONDARY OUTCOME 1: Time to First Relapse During the Entire Double-Blind Treatment Period[/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 - IXORA-S; BRIEF: The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis. ; DRUG USED: Taltz; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Chronic plaque psoriasis for at least 6 months before baseline - Failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy) - Psoriasis Area Severity Index (PASI) score at least 10 at screening and at baseline - Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 15 weeks after stopping treatment Exclusion Criteria: - Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis - History of drug-induced psoriasis - Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks before baseline and during the study - Have received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks of baseline, or have had topical psoriasis treatment within the 2 weeks of baseline - Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days; infliximab, adalimumab, or alefacept <60 days; golimumab <90 days; rituximab <12 months; or any other biologic agent <5 half-lives prior to baseline - Have prior use of ustekinumab, or have any condition or contraindication to ustekinumab that would preclude the participant from participating in this protocol - Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, have participated in any study investigating other interleukin (IL)-17 or IL-12/23 antagonists, or have received treatment with other IL-17 or IL-12/23 antagonists - Have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study - Have had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months of baseline or intend to have vaccination with BCG during the course of the study or within 12 months of completing treatment in this study - Have a known allergy or hypersensitivity to latex - Have had any major surgery within 8 weeks of baseline or will require such during the study - Have active or history of malignant disease within 5 years prior to baseline - Significant uncontrolled disorder - Ongoing infection or serious infection within 12 weeks of baseline; serious bone or joint infection within 24 weeks of baseline - Are women who are lactating or breast-feeding ; PRIMARY OUTCOME: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline; SECONDARY OUTCOME 1: Percentage of Participants With a ≥75% Improvement in PASI (PASI 75) From Baseline[/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 - CheckMate-026 (First-Line); BRIEF: The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1 - Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy - Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria - PD-L1+ on immunohistochemistry testing performed by central lab - Men and women, ages ≥ 18 years of age Exclusion Criteria: - Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy - Known anaplastic lymphoma kinase (ALK) translocations - Untreated central nervous system (CNS) metastases - Previous malignancies - Active, known or suspected autoimmune disease ; PRIMARY OUTCOME: Progression-Free Survival in Participants With PD-L1 Expression >= 5%; SECONDARY OUTCOME 1: Progression-Free Survival in All Randomized Participants[/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 - EHS (Saudi Arabia); BRIEF: A double-blind, parallel study of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) compared to current Standard of Care (SOC) for EHS. ; DRUG USED: Ryanodex; DRUG CLASS: Non-NME; INDICATION: Neurology - Other; TARGET: Ryanodine Receptor (RyRs); THERAPY: Monotherapy; LEAD SPONSOR: Eagle Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: Core body temperature of greater than or equal to 40.0 degrees C (104 degrees F); recent history of exertional activity; GCS score less than 13; tachycardia - Exclusion Criteria: clinical severe infection; hyperthermia secondary to another condition; endotracheal intubation;; sedative drugs administered prior to or at time of study entry; likelihood of head trauma within 6 months pre-study; positive pregnancy test; history of myocardial infection within 30 days; history of seizure disorder or epilepsy; concomitant or prior use of calcium channel blockers. - ; PRIMARY OUTCOME: Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization]; SECONDARY OUTCOME 1: Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) Greater Than or Equal to 13 Over the Course of the Study [Time Frame: Study Duration][/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 - Study 302; BRIEF: This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen. ; DRUG USED: Halaven; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion: Subjects must meet all of the following criteria to be included in this study: 1. Histologically or cytologically confirmed diagnosis of NSCLC. 2. Documented evidence of advanced NSCLC not amenable to surgery or radiotherapy. 3. Confirmation of the presence or absence of EGFR mutations prior to study enrolment in all subjects. 4. Subjects must have received at least two prior regimens for advanced NSCLC, which should have included a platinum-based regimen and, in all subjects with tumors harbouring EGFR mutations, an EGFR TKI. 5. Radiographic evidence of disease progression on, or after, the last anti-cancer regimen prior to study entry. 6. Presence of measurable disease. 7. ECOG performance status of 0, 1, or 2. 8. Adequate bone marrow 9. Adequate renal function. 10. Adequate liver function. 11. Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. 12. Male subjects and their female partners who are of child-bearing potential must agree to use two forms of highly effective contraception. 13. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol. 14. Males or females aged at least 18 years (or any age greater than 18 years as determined by country legislation) at the time of informed consent. Exclusion: Subjects who meet any of the following criteria will be excluded from this study: 1. Subjects who have received any anti-cancer therapy within 14 days, or five half-lives of the drug (whichever is longer), prior to randomization. 2. Subjects who have not recovered from toxicities as a result of prior anti-cancer therapy to less than Grade 2. 3. Subjects who have previously been treated, or participated in a study with eribulin, whether treated with eribulin or not. The TPC option must not include the same agent which the subject received in a prior regimen. 4. Peripheral neuropathy more than CTCAE Grade 2. 5. Significant cardiovascular impairment. 6. Subjects with a high probability of Long QT Syndrome, or QTc interval >500 ms. 7. Subjects with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and do not require treatment or have been adequately treated by local therapy. 8. Any serious concomitant illness. 9. Known HIV positive, or have an infection requiring treatment. 10. Any malignancy that required treatment, or has shown evidence of recurrence (except for NSCLC, non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in-situ) during the 5 years prior to study entry. 11. Female subjects must not be pregnant, and must not be breastfeeding. 12. Hypersensitivity to either HalB or HalB chemical derivatives or both, or to any of the excipients of the eribulin formulation. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST)[/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 - vs. Gardasil - Ages 9-14 (France); BRIEF: The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule of 0, 2, 6 months in 9-14 years old healthy females. ; DRUG USED: Cervarix; DRUG CLASS: Vaccine; INDICATION: Human papillomavirus (HPV) Prevention (Antiviral, Vaccines); TARGET: Human Papillomavirus (HPV), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who the investigator believes can and will comply with the requirements of the protocol and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the requirements of the protocol. - A female between, and including, 9 and 14 years of age at the time of the first vaccination. - Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, if capable, the subject should sign and personally date a written informed assent. - Healthy subjects as established by medical history and clinical examination before entering into the study. - Female subjects of non-childbearing potential may be enrolled in the study. - Female subjects of childbearing potential may be enrolled in the study, if the subject: - has practiced adequate contraception for 30 days prior to vaccination, and - has a negative pregnancy test on the day of vaccination, and - has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series. Exclusion Criteria: - Pregnant or breastfeeding. - A woman planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose. - Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than those foreseen in the protocol. - Child in care. - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 36). - Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. - History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines. - Cancer or autoimmune disease under treatment. - Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window. - Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). - Previous administration of vaccine components. - Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - Family history of congenital or hereditary immunodeficiency. - Major congenital defects or serious chronic illness. - Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine. - Acute disease and/or fever at the time of enrolment. - Drug and/or alcohol abuse. ; PRIMARY OUTCOME: Number of Seroconverted Subjects for Anti-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity; SECONDARY OUTCOME 1: Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA[/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 - evolutionRMS 2 (vs. Aubagio); BRIEF: The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period. ; DRUG USED: Evobrutinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany; CRITERIA: Inclusion Criteria: - Participants are diagnosed with RMS (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS] with relapses) in accordance with 2017 Revised McDonald criteria (Thompson 2018) - Participants with one or more documented relapses within the 2 years before Screening with either: a. one relapse which occurred within the last year prior to randomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to randomization - Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening and Baseline (Day 1). Participants with an EDSS score <= 2 at Screening and Baseline (Day 1) are only eligible for participation if their disease duration (time since onset of symptoms) is no more than 10 years - Participants are neurologically stable for >= 30 days prior to both screening and baseline (Day 1) - Female participants must be neither pregnant nor breast-feeding or must lack child-bearing potential (as defined by either: post-menopausal or surgically sterile), or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure - Male participants must refrain from donating sperm and/or abstain from intercourse with women of child-bearing potential or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure - Participants have given written informed consent prior to any study-related procedure - Other protocol defined inclusion criteria could apply. Exclusion Criteria: - Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a). Participants with Primary Progressive MS. b) Participants with secondary progressive MS without evidence of relapse - Disease duration more than (>) 10 years in participants with an EDSS =< 2.0 at screening and Baseline (Day 1) - Immunologic disorder other than MS, or any other condition requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid disease - Other protocol defined exclusion criteria could apply. ; PRIMARY OUTCOME: DBTP: Annualized Relapse Rate (ARR); SECONDARY OUTCOME 1: DBTP: Time to First Occurrence of 12-Week Confirmed Disability Progression (CDP) as measured by Expanded Disability Status Scale (EDSS) Progression[/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 - 4202-HEM-301; BRIEF: This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of etavopivat and test how well etavopivat works compared to placebo to improve the amount of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when the blood vessels become blocked and cause pain). ; DRUG USED: Etavopivat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sickle Cell Anemia; TARGET: Pyruvate kinase (PK); THERAPY: Monotherapy; LEAD SPONSOR: Forma Therapeutics, Inc.; CRITERIA: Key Inclusion Criteria: - Provision of consent - Patient has a confirmed diagnosis of sickle cell disease - At least 2 episodes of vaso-occlusive crises in the past 12 months - Hemoglobin ≥ 5.5 and ≤ 10.5 g/dL (≥ 55 and ≤ 105 g/L) during screening - Patients taking hydroxyurea, must demonstrate a stable dose for at least 90 days prior to start of study treatment - Patients on crizanlizumab or L-glutamine treatment at the time of consent must be on a stable dose for ≥ 12 months and must be ≥ 80% compliant with the planned regimen at the time of consent and meet the VOC eligibility criteria - Female patients of childbearing potential must use highly effective methods of contraception, male patients are willing to use barrier methods of contraception Key Exclusion Criteria: - More than 10 vaso-occlusive crises within the past 12 months - Female who is breastfeeding or pregnant - Hepatic dysfunction characterized by: - Alanine aminotransferase (ALT) > 4.0 × upper limit of normal (ULN) - Direct bilirubin > 3.0 × ULN - Known HIV positivity - Active hepatitis B or hepatitis C infection - Severe renal dysfunction or on chronic dialysis - History of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to consent including but not limited to the following: - Unstable angina pectoris or myocardial infarction or elective coronary intervention - Congestive heart failure requiring hospitalization - Uncontrolled clinically significant arrhythmias - Symptomatic pulmonary hypertension - History of overt clinical stroke within previous 2 years or any history of an intracranial hemorrhage - History of deep venous thrombosis requiring systemic anti-coagulation therapy for ≥ 6 weeks, occurring within 6 months prior to Day 1 of study treatment. Prior/Concomitant Therapy - Patients receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) - Receiving or use of concomitant medications that are strong inducers of CYP3A4/5 within 2 weeks of starting study treatment or anticipated need for such agents during the study - Use of voxelotor within 28 days prior to starting study treatment or anticipated need for this agent during the study - Use of an experimental selectin antagonist (eg, monoclonal antibody or small molecule) within 28 days of starting study treatment or anticipated need for such agents during the study - Use of erythropoietin or other hematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study - Receipt of prior cellular-based therapy (eg, hematopoietic cell transplant, gene modification therapy) ; PRIMARY OUTCOME: Hemoglobin response rate; SECONDARY OUTCOME 1: Hemoglobin[/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 - SGTP-002; BRIEF: Safety and efficacy study of SANGUINATE on reduction of delayed graft function (DGF) in patients who will be recipients of a donation after brain death (DBD) donor kidney. ; DRUG USED: SANGUINATE; DRUG CLASS: Biologic; INDICATION: Delayed Graft Function (DGF); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Prolong Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Able to understand and provide written informed consent. 2. Male or female subject at least 18 years of age. 3. Dialysis-dependent renal failure initiated at least 3 months prior to transplantation. 4. Subject is to be the recipient of a first kidney transplant from a deceased donor (brain death criteria). 5. Is able to receive intravenous infusions of study drug. 6. Anticipated donor organ cold ischemia time < 30 hours. 7. A calculated prediction of DGF risk of least 25%. 8. Females of childbearing potential must agree to use 2 forms of effective birth control regimen (at least one-barrier method) during the initial 30-day study period. 9. Male subjects must agree to use condoms or other suitable means of pregnancy prevention. Exclusion Criteria: 1. Has received a blood transfusion of packed red blood cells (PRBC), other than with leukocyte-poor blood, within the 90-day period prior to screening. 2. Recipient of a live donor kidney or a kidney from a donation after cardiac death (DCD) donor. 3. Recipient of donor kidney preserved with normothermic machine perfusion. 4. Is scheduled to undergo multi-organ transplantation. 5. Has planned transplant of kidney(s) from a donor < 6 years of age. 6. Has planned transplant of kidneys that are implanted en bloc (dual kidney transplant). 7. Has planned transplant of dual kidneys (from the same donor) transplanted not en bloc. 8. Body Mass Index (BMI) > 38 kg/m2 9. Is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy (under another Investigational New Drug) for ischemic/reperfusion injury immediately prior to organ recovery. 10. Is scheduled to receive an blood type-incompatible donor kidney. 11. Has undergone desensitization to remove antibodies prior to transplantation. 12. Total bilirubin > 1.5 mg per dL, transaminase more than twice the upper limit of normal or evidence of hepatic insufficiency 13. Has participated in an investigational study within the last 30 days or received an investigational product within 5 half-lives of the study drug administration, whichever is longest. Potential subjects participating in a strictly observational study or a study involving approved treatments should be discussed with the Medical Monitor. 14. Has a history of human immunodeficiency virus (HIV) 15. History or presence of active substance abuse (illicit drugs or alcohol) in the previous 6 months, as believed by the Investigator 16. Presence of ECG-based evidence of acute myocardial infarction, unstable angina, decompensated heart failure, third degree heart block or cardiac arrhythmia associated with hemodynamic instability 17. History or presence of any disease or psychiatric condition that in the Investigators assessment that would increase the risk to subjects associated with study participation, drug administration or interpretation of results 18. History of biopsy-confirmed malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ skin lesions, carcinoma of the cervix in situ, or early detected prostate cancer. 19. Female subject who is pregnant or breast feeding. ; PRIMARY OUTCOME: Reduction of delayed graft function (DGF); SECONDARY OUTCOME 1: Proportion of subjects requiring dialysis for any reason in the first 7 days 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 - CRISTALLO (w/Obinutuzumab); BRIEF: This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale [CIRS]/score of ≤6 and a normal creatinine clearance of ≥70 mL/min) with previously untreated CLL without DEL(17P) or TP53 mutation requiring treatment. Eligible participants will be randomly assigned in a 1:1 ratio to receive either VEN + G (Arm A) or FCR/BR (Arm B). ; DRUG USED: Venclexta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: B-cell lymphoma 2 (Bcl-2)/Bcl-2 Family; THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Ability to comply with the study protocol, in the investigators judgment - Aged 18 years or older - Have previously untreated documented Chronic Lymphocytic Leukemia (CLL) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria - CLL requiring treatment according to the iwCLL criteria - Cumulative Illness Rating Scale (CIRS) score ≤ 6 and creatinine clearance (CrCl) ≥ 70 mL/min - Hematology values within the following limits, unless cytopenia is caused by the underlying disease (i.e., no evidence of additional bone marrow (BM) dysfunction; e.g., myelodysplastic syndrome, hypoplastic BM): - Absolute neutrophil count ≥ 1.0 x 109/L, unless there is BM involvement - Platelet count ≥ 75 x 109/L and more than 7 days since last transfusion, or ≥ 30 x 109/L if there is BM involvement - Adequate liver function as indicated by a total bilirubin, aspartate aminotransferase, and Alanine transaminase ≤ 2 times the institutional upper limit of normal (ULN) value, unless directly attributable to the participants CLL - Life expectancy >6 months - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm Exclusion Criteria: - Transformation of CLL to aggressive Non-Hodgkins Lymphoma (NHL) - Participants with Small Lymphocyclic Lymphoma (SLL) only - Known central nervous system involvement - Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML) - Detected del(17p) or TP53 mutation (valid test within 6-months from screening is required for randomisation) - An individual organ/system impairment score of 4 as assessed by the Cumulative Illness Rating Scale (CIRS) definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system - Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia - History of prior malignancy - Participants with infections requiring IV treatment (Grade 3 or 4) within the last 8 weeks prior to enrollment - Evidence of other clinically significant uncontrolled conditions including but not limited to active or uncontrolled systemic infection (e.g., viral, bacterial, or fungal) - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products - Hypersensitivity to fludarabine, bendamustine, cyclophosphamide, rituximab, obinutuzumab, or venetoclax or to any of the excipients (e.g., trehalose) - Pregnant women and nursing mothers - Vaccination with a live vaccine ≤ 28 days prior to randomization - Prisoners or participants who are institutionalized by regulatory or court order or persons who are in dependence to the Sponsor or an investigator - History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigators judgment - Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg] serology) - Positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology testing) - Participants with known infection with HIV or Human T-Cell Leukemia Virus 1 (HTLV-1) - Any serious medical condition or abnormality in clinical laboratory tests that, in the investigators judgment, precludes the participants safe participation in and completion of the study - Received any of the following agents within 28 days prior to the first dose of study treatment: - Immunotherapy - Radiotherapy - Hormone therapy - Any therapies intended for the treatment of lymphoma/leukemia whether approved or experimental - Participants who have received the following agents: - Strong and moderate CYP3A inhibitors/inducers within 7 days prior to the initiation of study treatment - Steroid therapy for anti-neoplastic intent with the exception of inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids within 7 days prior to the first dose of study drug administration - Consumed grapefruit, grapefruit products, Seville oranges(including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study drug and throughout venetoclax administration - Inability to swallow a large number of tablets. ; PRIMARY OUTCOME: Minimal Residual Disease (MRD) Response Rate Using Next-generation Sequencing (NGS); SECONDARY OUTCOME 1: Progression-free Survival (PFS)[/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 - US-014; BRIEF: This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinsons Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinsons medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinsons disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group. ; DRUG USED: Nourianz; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Adenosine A2a Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Kyowa Hakko Kirin Pharma, Inc.; CRITERIA: Inclusion Criteria: - 30 years of age or older. - UK Parkinsons Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD - PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale. - On levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit - Taking at least 400mg levodopa combination daily and on stable regimen of any other anti-Parkinsonian drugs (MAO-B, COMT, DA) for at least 2 weeks prior to randomization - Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization - Documented end-of-dose wearing-off and levodopa-induced dyskinesia - Have an average of two hours of OFF time per day Exclusion Criteria: - Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion. - Subject who have had neurosurgical operation for PD - Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers - Subjects who smoke > 5 cigarettes/day ; PRIMARY OUTCOME: Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12; SECONDARY OUTCOME 1: Total Hours of ON Time Per Day Without Troublesome Dyskinesia[/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 - KEYNOTE-672/ECHO-307 (w/Pembrolizumab) ; BRIEF: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma. ; DRUG USED: Epacadostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bladder Cancer; TARGET: IDO (Indoleamine 2,3-dioxygenase); THERAPY: Combination; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Histologically or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra. - Measurable disease based on RECIST v1.1. - Be considered ineligible to receive cisplatin-based combination therapy, based on protocol-defined criteria. - Have provided tissue for PD-L1 analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. - Have received no prior systemic chemotherapy for advanced/unresectable (inoperable) or metastatic urothelial cancer. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 14 days prior to randomization. - Adequate organ function per protocol-defined criteria. Exclusion Criteria: - Disease that is suitable for local therapy administered with curative intent. - Known additional malignancy that is progressing or has required active treatment within the past 3 years. - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. - Active autoimmune disease that has required systemic treatment in past 2 years. - Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority. - Known history of or is positive for active hepatitis B (hepatitis B surface antigen [HBsAg] reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility. - History of a gastrointestinal condition that in the opinion of the Investigator may affect oral drug absorption. - History or presence of an abnormal electrocardiogram (ECG) that, in the investigators opinion, is clinically meaningful. - Use of protocol-defined prior/concomitant therapy. ; PRIMARY OUTCOME: Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo; SECONDARY OUTCOME 1: Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Experiencing 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 III - TEMPO-3 (Flexible Dose, Late Stage); BRIEF: The purpose of this study is to assess the effect of tavapadon on the change from baseline in total daily hours of on time without troublesome dyskinesia in L-Dopa-treated participants with Parkinsons Disease (PD) who are experiencing motor fluctuations. ; DRUG USED: Tavapadon; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Dopamine 1 (D1) Receptor, Dopamine 5 (D5) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Cerevel Therapeutics, LLC; CRITERIA: Key Inclusion Criteria: - Male and female participants aged 40 to 80 years, inclusive, at the time of signing the informed consent form (ICF). - Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment. - Participants who are capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. - Participants with a diagnosis of PD that is consistent with the UK Parkinsons Disease Society Brain Bank diagnostic criteria, with bradykinesia and motor asymmetry. - Participants with modified Hoehn and Yahr stage 2, 2.5, or 3 in the on state. - Participants with a good response to levodopa (L-Dopa) in the judgment of the investigator. - Participants who return a completed self-reported home diary for motor function status (Hauser diary) during the screening period (after diary training and concordance testing has occurred), with recordings for 2 consecutive days (ie, 2 consecutive 24-hour periods) showing at least 2 and half hours of off time on each of the 2 days. - Participants who are on a stable dose of L-Dopa for at least 4 weeks prior to screening and are taking a minimum total daily dose of 400 milligram (mg) divided in at least 4 doses per day of standard carbidopa/levodopa or divided in at least 3 doses per day of extended-release carbidopa/levodopa capsules. The carbidopa/levodopa dose and frequency must be maintained for the duration of the trial. - Prior and concurrent use of catechol-O-methyl transferase (COMT) inhibitors, monoamine oxidase B (MAO-B) inhibitors, amantadine, istradefylline or anticholinergic drugs are permitted if the use was initiated greater than (>) 90 days before the baseline visit and the dosage will remain stable for the duration of the trial (ie, no change in the COMT, MAO-B inhibitor, amantadine, istradefylline or anticholinergic dose is permitted during the trial). Key Exclusion Criteria: - Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supranuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or poststroke parkinsonism). - Participants with a history of nonresponse or insufficient response to L-Dopa at therapeutic dosages. - Participants with a history or current diagnosis of a clinically significant impulse control disorder (Disruptive, Impulse Control, and Conduct Disorder per DSM-5). - Participants with the presence of or history of brain tumor, hospitalization for severe head trauma, epilepsy (as defined by the International League Against Epilepsy), or seizures. - Participants with a history of psychosis or hallucinations within the previous 12 months. - Participants who answer yes on the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting the criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR Participants who 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 the criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide. - Participants with substance abuse or dependence disorder, including alcohol, benzodiazepines, and opioids, but excluding nicotine, within the past 6 months (180 days). - Participants with dementia or cognitive impairment that, in the judgement of the investigator, would exclude the participant from understanding the ICF or participating in the trial. - Participants with any condition that could possibly affect drug absorption, including bowel resections, bariatric weight loss surgery, or gastrectomy (this does not include gastric banding). - Participants who have a positive result for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) antibodies at screening. - Participants with a history of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias that are not controlled with medical and/or surgical intervention; second- or third-degree atrioventricular block; sick sinus syndrome; severe or unstable angina; or congestive heart failure within the last 12 months. A recent (less than or equal to [<=12] months) history of myocardial infarction with secondary arrhythmias is exclusionary regardless of the therapeutic control. - Participants with a history of neuroleptic malignant syndrome. - Participants who are currently receiving moderate or strong CYP3A4 inducers or CYP3A4 inhibitors (except for topical administration). - Participants with a positive urine drug screen for illicit drugs are excluded and may not be retested or rescreened. Participants with a positive urine drug screen resulting from use of marijuana (any tetrahydrocannabinol-containing product), prescription, or over-the-counter medications or products that, in the investigators documented opinion, do not signal a clinical condition that would impact the safety of the participant or interpretation of the trial results may continue evaluation for the trial following consultation and approval by the medical monitor - Participants with a Montreal Cognitive Assessment (MoCA) score <26. - Participants with clinically significant orthostatic hypotension (eg, syncope). - Participants with a 12-lead ECG demonstrating a QTcF interval >450 msec. - Participants with moderate or severe renal impairment (creatinine clearance as estimated by Cockcroft-Gault formula <30 mL/min or on dialysis). - Participants with any of the following abnormalities in clinical laboratory tests at the Screening Visit, as assessed by the central laboratory and confirmed by a single repeat measurement, if deemed necessary: - Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >=3 × Upper Limit Normal (ULN). - Total bilirubin >=1.5 × ULN. Participants with a history of Gilberts syndrome may be eligible provided they have a value <ULN for direct bilirubin - Participants with other abnormal laboratory test results, vital sign results, or ECG findings unless, in the judgment of the investigator, the findings are not medically significant and would not impact the safety of the participants or the interpretation of the trial results. ; PRIMARY OUTCOME: Change From Baseline in the Total On Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary); SECONDARY OUTCOME 1: Change From Baseline in Total Daily Off Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)[/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 - vs. FP/SAL+TIO; BRIEF: Asthma is a common, chronic respiratory disease affecting 1-18 percent of the population. It is accepted that much of the uncontrolled asthma is due to poor adherence and asthma outcomes in such cases may improve simply by increasing adherence to available treatments. GlaxoSmithKline (GSK) has developed a sensor, which clips on to the ELLIPTA® dry powder inhaler (DPI). This will inform subjects if/when they have taken their medication that is in the ELLIPTA inhaler, as well as other information, including: asthma management strategies, tracking of symptoms, asthma triggers, medication reminders and daily asthma forecasts. The sensors, application (app), and provider portal that provide data are subsequently described as the CIS. The combination of once-daily FF/UMEC/VI with the CIS will improve the disease management and adherence. Thus, this study is designed to study the effectiveness and adherence of single inhaler triple therapy (SITT) of FF/UMEC/VI with the CIS as compared to multiple inhaler triple therapy (MITT) of the combination of FP/SAL plus TIO without CIS in subjects with inadequately controlled asthma. The study randomization will be stratified by pre-study inhaled corticosteroids (ICS) dosage strength (mid- or high-dose). Subjects will be randomized in a 1:1 ratio to receive either FF/UMEC/VI delivered via the ELLIPTA DPI with the CIS or FP/SAL delivered via the DISKUS® DPI (with sensor only) plus TIO delivered via the RESPIMAT inhaler (without sensor). The maximum study duration will be approximately 29 weeks, which comprised of prescreen/ screening/ randomization period of up to 4 weeks, 24-week treatment period and a 1-week follow-up period. Approximately 1006 subjects will be randomized in the study. ELLIPTA and DISKUS are registered trademarks of GlaxoSmithKline (GSK) group of companies. ; DRUG USED: Trelegy Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR), Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects must have their own Android or iPhone operating system (IOS) mobile device (example given [e.g.] smart phone or tablet) and a data package suitable for the installation and running of the app and sending and receiving data. Data used by the CIS is approximately 1 megabyte (MB) per month as a maximum; this is less data than a 1 minute video streamed from YouTube (2MB). - Subjects must be willing and able to download the app on their personal mobile device and keep it turned on for the duration of the study. This will also require Bluetooth to be turned on for duration of the study. Subjects will also have to turn on mobile data for the app for the duration of study; unless travelling and when extra data roaming costs could be incurred. - Subjects must be 18 years of age or older at the time of signing the informed consent. - Subjects with a documented diagnosis of asthma by a respiratory physician or subjects with a documented asthma diagnosis by their general practitioner (GP) are required to have spirometry consistent with the diagnosis of asthma (e.g., reduced FEV1, reduced FEV1/forced vital capacity (FVC), or variable airflow obstruction) at or before Visit 0. - Subjects who are able to perform spirometry that conforms to American Thoracic Society/ European Respiratory Society(ATS/ERS) technical standards at Visit 0 or Visit 1. - Subjects are eligible if they require daily ICS/ long-acting beta-agonist (LABA) therapy (with a stable total daily dose of ICS of >250 microgram per day [mcg/day] FP, or equivalent) for at least 4 weeks prior to screening. Dosing regimen (once or twice daily to equal the total daily dose) should be restricted to the current local product labels/treatment guidelines. - Subjects with inadequately controlled asthma (ACT total score <20) despite ICS/LABA maintenance therapy at Visit 1. - Male or Female subjects will be included in the study. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 5 days after the last dose of study treatment. The Investigator is responsible for ensuring that subject understands how to properly use these methods of contraception. - Capable of giving signed informed consent. Exclusion Criteria: - Subjects with current evidence of pneumonia, active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases including chronic obstructive pulmonary disease (COPD) or abnormalities other than asthma. - Subjects with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation (e.g. very low body mass index [BMI] or severely malnourished), or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. - Subjects with any of the following at screening would be excluded: myocardial infarction or unstable angina in the last 6 months; unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association (NYHA) Class IV Heart failure. - Moderate or severe hepatic impairment in subjects receiving high dose ICS. - Subjects with a history of allergy or hypersensitivity to any corticosteroid, anticholinergic/ muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate are excluded from participation in this study. - Subjects with a medical condition such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy or bladder neck obstruction should only be included if in the opinion of the Investigator the benefit outweighs the risk and that the condition would not contraindicate study participation. - Subjects with active uncontrolled psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study. - 30 days or within 5 drug half-lives of the investigational drug (whichever is longer). - Subjects who are medically unable to withhold their albuterol/salbutamol for the 6-hour period required prior to spirometry testing at each study visit. - Smokers will be excluded as follows: current smokers (defined as subjects who have used inhaled tobacco products within the 12 months prior to screening [that is {i.e.}, cigarettes, e-cigarettes/vaping, cigars or pipe tobacco]); former smokers with a smoking history of >=10 pack years (e.g., >=20 cigarettes/day for 10 years). - Subjects unable to comply with the study procedures due to infirmity, disability, or geographic location. - Study Investigators, sub-Investigators, study coordinators, employees of a participating Investigator or study site, or immediate family members of the aforementioned that is involved with this study. - In the opinion of the Investigator, any subject who is unable to read and/or would not be able to complete study related materials. - Subjects who have taken part in more than 1 clinical trial in the 12 months prior to Visit 1 and/or subjects who have taken part in any of the following clinical trials in the 12 months prior to Visit 1: a clinical trial including audio and/or visual reminders for the subject to take their study treatment; any clinical trial during the 4 weeks prior to Visit 1;GSK study 207040. ; PRIMARY OUTCOME: Percentage of subjects who have an asthma control test (ACT) total score of >=20; SECONDARY OUTCOME 1: Annualized rate of moderate and/or severe asthma exacerbations[/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 - Protocol W (Diabetic Retinopathy Clinical Research Network); BRIEF: Multiple studies have implicated vascular endothelial growth factor VEGF as a major causative factor in human eye diseases characterized by neovascularization including proliferative diabetic retinopathy (PDR) and vascular permeability including diabetic macular edema (DME). While there is strong evidence that PDR outcomes are markedly reduced in eyes that are treated with monthly anti-VEGF therapy (A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus: RIDE/RISE) and moderately reduced in eyes that received fairly frequent dosing during the 1st year of treatment (Diabetic Retinopathy Clinical Research Network protocol I), it is unknown whether or not an earlier but less frequent dosing regimen would result in similar, favorable anatomic outcomes, and whether favorable anatomic outcomes subsequently would result in favorable visual acuity outcomes. If this study demonstrates that intravitreous aflibercept treatment is effective and safe for reducing the onset of PDR or center involved- DME (CI-DME) in eyes that are at high risk for these complications, a new strategy to prevent vision threatening complications of diabetes will be available for patients. The application of intravitreous aflibercept earlier in the course of disease (i.e., at the time when an eye has baseline severe non-proliferative diabetic retinopathy) could help to reduce future potential treatment burden in patients, at the same time resulting in similar or better long-term visual outcomes, if PDR and DME are prevented. The primary objectives of this protocol are to 1) determine the efficacy and safety of intravitreous aflibercept injections versus sham injections (observation) for prevention of PDR or CI-DME in eyes at high risk for development of these complications and 2) compare long-term visual outcomes in eyes that receive anti-VEGF therapy early in the course of disease with those that are observed initially, and treated only if high-risk PDR or CI-DME with vision loss develops. Secondary objectives include: - Comparing other visual acuity outcomes between treatment groups, such as proportion of eyes with at least 10 or at least 15 letter loss from baseline, or gain or loss of at least 5 letters at the consecutive study visit just before and at the 2- or 4-year visit - Comparing optical coherence tomography (OCT) outcomes, such as mean change in OCT central subfield thickness and volume from baseline - Comparing proportion of eyes with at least 2 and 3-step worsening or improvement of diabetic retinopathy severity level (scale for individual eyes) by central reading center from baseline - Comparing associated treatment and follow-up exam costs between treatment groups - Comparing safety outcomes between treatment groups ; DRUG USED: Eylea; DRUG CLASS: Biologic; INDICATION: Diabetic Retinopathy (Ophthalmology); TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Jaeb Center for Health Research; CRITERIA: Inclusion Criteria: 1. Age >= 18 years 2. Diagnosis of diabetes mellitus (type 1 or type 2) • Any one of the following will be considered to be sufficient evidence that diabetes is present: 1. Current regular use of insulin for the treatment of diabetes 2. Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes 3. Documented diabetes by American Diabetes Association and/or World Health Organization criteria 3. Able and willing to provide informed consent. Meets all of the following ocular criteria in at least one eye: 1. Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity letter score ≥79 (approximate Snellen equivalent 20/25 or better) 2. Severe non-proliferative diabetic retinopathy (NPDR) (based on the 4:2:1 rule) evident on clinical examination and on digital imaging as judged by the investigator. Reading center grading of less than ETDRS level 43 or greater than 53 is an exclusion. Severe NPDR is defined as: 1. All 4 midperipheral quadrants show severe hemorrhages or microaneurysms (at least as great as Standard photograph 2A, approximately 20 dot and blot hemorrhages), or 2. At least 2 fields of definite venous beading in the midperipheral quadrants or at least 1 field at least as severe as Standard photograph 6A, or 3. At least 1 field of moderate intraretinal microvascular abnormalities (IRMA) in the midperipheral quadrants, at least as severe as Standard photograph 8A 3. No evidence of neovascularization on clinical exam including active neovascularization of the iris (small iris tufts are not an exclusion) or angle neovascularization (if the angle is assessed). 4. No evidence of neovascularization (NV) on fluorescein angiography within the 7-modified ETDRS fields, confirmed by the central Reading Center prior to randomization. • The widest method of imaging available at the site must be used to document whether there is NV present in the periphery; however, presence of NV outside of the 7-modified ETDRS fields on ultrawide field imaging will not be an exclusion provided treatment is not planned. 5. No center-involved diabetic macular edema (CI-DME) on clinical exam and optical coherence tomography (OCT) central subfield thickness must be below the following gender and OCT-machine specific thresholds: 1. Zeiss Cirrus: 290 µm in women and 305 µm in men 2. Heidelberg Spectralis: 305 µm in women and 320 µm in men 3. Investigator and potential participant are comfortable withholding treatment for DME until there is at least a 10% increase in OCT central subfield thickness with confirmed visual acuity loss (10 letter loss at a single visit or 5 to 9 at two consecutive visits). 6. Prompt panretinal photocoagulation (PRP) or anti-vascular endothelial growth factor (anti-VEGF) treatment not required AND investigator and potential participant are willing to wait for development of high-risk characteristics (defined in protocol) to treat PDR. 7. Media clarity, pupillary dilation, and study participant cooperation sufficient to obtain adequate fundus photographs, fluorescein angiogram, and OCT. - Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality (including segmentation line placement) Exclusion Criteria: 1. History of chronic renal failure requiring dialysis or kidney transplant. 2. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control). 3. Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months. 4. Participation in an investigational trial that involved treatment within 30 days of randomization with any drug that has not received regulatory approval for the indication being studied. • Note: study participants cannot participate in another investigational trial that involves treatment with an investigational drug while participating in the study. 5. Known allergy to any component of the study drug or any drug used in the injection prep (including povidone iodine prep). 6. Known allergy to fluorescein dye. 7. Blood pressure > 180/110 (systolic above 180 or diastolic above 110). • If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible. 8. Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization. • These drugs should not be used during the study. 9. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 2 years. • Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed. 10. Individual is expecting to move out of the area of the clinical center to an area not covered by another Diabetic Retinopathy Clinical Research Network certified clinical center during the next 2 years. Individual has any of the following ocular characteristics in the eye(s) being evaluated: 1. Exam or photographic evidence of vitreous hemorrhage or preretinal hemorrhage presumed to be from PDR. 2. History of prior vitreous hemorrhage or preretinal hemorrhage presumed to be from PDR. 3. History of prior PRP (defined as ≥100 burns outside of the posterior pole). 4. An ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g., retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, vitreomacular traction, etc.). 5. History of DME or diabetic retinopathy treatment with laser or intraocular injections of medication within the prior 12 months and no more than 4 prior intraocular injections at any time in the past. • Enrollment will be limited to a maximum of 25% of the planned sample size with any history of treatment for DME and/or diabetic retinopathy. Once this number of eyes has been enrolled, any history of treatment for DME and/or diabetic retinopathy will be an exclusion criterion. 6. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization. 7. Any history of vitrectomy. 8. History of yttrium aluminum garnet capsulotomy performed within 2 months prior to randomization. 9. Aphakia. 10. Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis. 11. Evidence of uncontrolled glaucoma. - Intraocular pressure must be <30, with no more than one topical glaucoma medication, and no documented glaucomatous field loss for the eye to be eligible. ; PRIMARY OUTCOME: Development of PDR and/or DME (Whichever Came First); SECONDARY OUTCOME 1: Change in Visual Acuity From Baseline[/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 - VOYAGE 1; BRIEF: The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis. ; DRUG USED: Tremfya; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent - Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline - Have an Investigators Global Assessment (IGA) score >=3 at Screening and at Baseline - Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline - Must be a candidate for either systemic therapy or phototherapy for psoriasis Exclusion Criteria: - Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) - Participants who have ever received guselkumab or adalimumab - History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances - Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments - Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug ; PRIMARY OUTCOME: Percentage of Participants Who Achieved an Investigators Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16; SECONDARY OUTCOME 1: Percentage of Participants Who Achieved an Investigators Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48[/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 - HERMIONE (HER2+); BRIEF: This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physicians choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting. ; DRUG USED: MM-302; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), DNA, DNA synthesis, HER2/neu or ErbB-2, Topoisomerase II (DNA gyrase); THERAPY: Monotherapy; LEAD SPONSOR: Merrimack Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients must have histologically or cytologically confirmed invasive cancer of the breast - Patients must have documented locally advanced/metastatic disease, defined by the investigator, which is not amenable to resection with curative intent. - Patients must have HER2-positive breast cancer as defined by ASCO/CAP 2013 guidelines that is confirmed by a Sponsor-designated central laboratory - Patients must have progressed on, or be intolerant to pertuzumab in the LABC/MBC setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting. - Patients must have progressed on, or be intolerant to ado-trastuzumab emtansine in the LABC/MBC setting - Patients must have been previously treated with trastuzumab in any setting (which may have been previously administered with or without pertuzumab) - ECOG Performance Status of 0 or 1 Exclusion Criteria: - Patients who have previously been treated with doxorubicin, liposomal doxorubicin, epirubicin, mitoxantrone, or any other anthracycline derivative - Subjects with central nervous system (CNS) metastases, unless they have been treated and are stable without symptoms for 4 weeks after completion of treatment and must be off steroids for at least 4 weeks prior to enrollment - Patients with any class of New York Heart Association (NYHA) CHF or heart failure with preserved ejection fraction (HFPEF) - Patients with a history of known coronary artery disease or a myocardial infarction within the last 12 months - Patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia) - Patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity - Patients with a history of LVEF decline to below 50% during or after prior trastuzumab/lapatinib or other HER2 directed therapy. ; PRIMARY OUTCOME: Independently assessed progression-free survival according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; SECONDARY OUTCOME 1: Locally assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1[/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 - ARTEST (ER+/HER2-); BRIEF: To demonstrate the efficacy of enobosarmin the treatment of androgen receptor positive (AR+) and estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS). ; DRUG USED: Enobosarm; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: Veru Inc.; CRITERIA: Inclusion Criteria: - Provide informed consent - Be able to communicate effectively with the study personnel - Aged ≥18 years - For Female Subjects - Menopausal status - Be postmenopausal as defined by the National Comprehensive Cancer Network as either: - Age ≥55 years and one year or more of amenorrhea - Age <55 years and one year or more of amenorrhea, with an estradiol assay <20 pg/mL - Age <55 years and surgical menopause with bilateral oophorectomy - Be premenopausal or perimenopausal on ovarian suppression with LHRH agonist for at least 4 months, with an estradiol assay <20 pg/mL and a negative urine pregnancy test. - If subject is of child bearing potential, the subject must agree to use acceptable methods of contraception: - If female study participant could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization of male partner (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository} - If female study participant has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used - If female study participant has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used - For Male Subjects - Subject must agree to use acceptable methods of contraception: - If the study subjects partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/ film/cream/suppository [i.e., barrier method of contraception], surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) - If female partner of a study subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used - If female partner of a study subject has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used - Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 - Documented evidence of ER+/HER2- metastatic breast cancer - Measurable disease is required as per RECIST 1.1 (NOTE: Bone only metastatic disease is acceptable but requires a measurable component - Have androgen receptor nuclei staining ≥40% as assessed by central laboratory - Received at least 2 prior lines of treatment in MBC setting which must have included both an AI (monotherapy or combination) and fulvestrant (monotherapy or combination); at least one must have been given in combination with a CDK 4/6 inhibitor. - Previously responded (without disease progression for at least 6 months) to one of the following treatments: fulvestrant monotherapy or fulvestrant plus CDK 4/6 inhibitor or nonsteroidal aromatase inhibitor monotherapy or nonsteroidal aromatase inhibitor plus CDK 4/6 inhibitor for metastatic breast cancer. - Subject is willing to comply with the requirements of the protocol through the end of the study Exclusion Criteria: - Known hypersensitivity or allergy to enobosarm - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 X upper limit of normal (ULN) or total bilirubin >ULN (an elevated total bilirubin up to 1.5 X ULN attributed to a previously confirmed diagnosis of Gilberts disease is acceptable if all other eligibility criteria are met). In patients with documented metastases to the liver, the limits for inclusion are ALT or AST >5.0 X ULN or total bilirubin >1.5 X ULN. - Patients with biliary catheter. - Creatinine clearance < 30 mL/min as measured using the Cockcoft Gault formula (patients with mild and moderate renal failure are not excluded from participation in this study) - Previously received >1 course of systemic chemotherapy (not including immunotherapies or targeted therapies) for the treatment of metastatic breast cancer. Note: Subjects may have received 1 course of chemotherapy in the adjuvant or neoadjuvant setting would not count as a line of therapy. - Subjects with radiographic evidence of central nervous system (CNS) metastases as assessed by CT or MRI that are not well-controlled (symptomatic or requiring control with continuous corticosteroid therapy [e.g., dexamethasone]) Note: Subjects with CNS metastases are permitted to participate in the study if the CNS metastases are medically well-controlled and stable for at least 30 days after receiving local therapy (irradiation, surgery, etc.) - Radiotherapy within 14 days prior to randomization except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to randomization. Subjects must have recovered from radiotherapy toxicities prior to randomization - Any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, severe renal impairment, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk - Treatment with any investigational product within < 4 half-lives for each individual investigational product OR within 30 days prior to randomization - Major surgery within 30 days prior to randomization - Treatment with testosterone, methyltestosterone, oxandrolone (Oxandrin®), oxymetholone, danazol, fluoxymesterone (Halotestin®), testosterone-like agents (such as dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or antiandrogens (enzalutamide, abiraterone, bicalutamide, apalutamide, or darolutamide). Previous therapy with testosterone and testosterone-like agents is acceptable with a 30-day washout (if previous testosterone therapy was long term depot within the past 6 months, the site should contact the Medical Monitor) or any other androgenic agent. - Treatment with any of the following hormone replacement therapies for metastatic breast cancer. Prior use in the adjuvant or neoadjuvant setting is allowed if the treatment is, discontinued greater than 30 days prior to randomization - Estrogens - Megesterol acetate - Testosterone - All other concurrent anticancer treatments (including, but not limited to, all SERMs unless randomized to the Control Treatment Group with a SERM as the control treatment, AIs unless randomized to Control Treatment Group (exemestane or exemestane plus everolimus) with the AI containing treatment as the control treatment, and all CDK 4/6 inhibitors) - An abnormal ECG result which, based on the investigators clinical judgment, would place the subject at increased risk - Has a known additional, invasive, malignancy that is progressing or required active treatment in the last 5 years [note: subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal breast carcinoma in situ, bladder cancer (superficial treated), or cervical carcinoma in situ that have undergone potentially curative therapy are not excluded] - Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment ; PRIMARY OUTCOME: To demonstrate the efficacy of Enobosarm in the treatment of androgen receptor positive (AR+) and estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS).; SECONDARY OUTCOME 1: Objective Response Rate (ORR)[/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 - DISCOVER-1 (vs. Vancomycin); BRIEF: The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial skin or skin structure infection. ; DRUG USED: Dalvance; DRUG CLASS: New Molecular Entity (NME); INDICATION: Skin and Skin-Structure Infections (Antibacterial); TARGET: Cell wall synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Durata Therapeutics Inc., an affiliate of Allergan plc; CRITERIA: Inclusion Criteria: 1. Male or female patients 18 - 85 years of age. 2. Signed and dated informed consent document. 3. Major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by Gram-positive bacteria. 4. At least two (2) local signs and symptoms of ABSSSI and at least one (1) systemic sign of infection. 5. Requires a minimum of 3 days of IV therapy. 6. Patient willing and able to comply with study procedures. Exclusion Criteria: Patients presenting with any of the following: 1. A contra-indication to any required study drug. 2. Pregnant or nursing females. 3. Sustained shock. 4. Participation in another study of an investigational drug or device within 30 days. 5. Receipt of a systemically or topically administered antibiotic within 14 days prior to randomization, except receipt of a single dose of a short-acting antibacterial drug 3 or more days prior to randomization. 6. Infection due to a dalbavancin or vancomycin-resistant organism. 7. Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis, and/or endovascular infection. 8. Exclusively gram-negative bacterial or a fungal ABSSSI. 9. Venous catheter infection. 10. Infection of a diabetic foot ulcer or a decubitus ulcer. 11. Device-related infections. 12. Gram-negative bacteremia. 13. Infected burns. 14. Infected limb with critical ischemia. 15. Superficial/simple skin and skin structure infections. 16. Concomitant condition requiring non-study antibacterial therapy. 17. ABSSSI requiring therapy for longer than 14 days. 18. Adjunctive therapy with hyperbaric oxygen. 19. More than 2 surgical interventions for ABSSSI anticipated. 20. Chronic inflammatory condition precluding assessment of clinical response. 21. Absolute neutrophil count < 500 cells/mm3. 22. Human immunodeficiency virus (HIV) infection with a CD4 cell count < 200 cells/mm3. 23. Recent bone marrow transplant, > 20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation. 24. Regular, chronic antipyretic use in patients unable to modify during the first three days of study drug therapy. 25. Life expectancy less than 3 months. 26. Conditions that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results. 27. Prior participation in the study. ; PRIMARY OUTCOME: Early Clinical Efficacy; SECONDARY OUTCOME 1: >= 20% Reduction in Lesion Area[/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 - COMPASS (HTG); BRIEF: The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia. ; DRUG USED: Waylivra; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Apolipoprotein C-III (apoCIII, apo-CIII, apo-C3); THERAPY: Monotherapy; LEAD SPONSOR: Ionis Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Body mass index (BMI) ≤ 45 kg/m2 2. Fasting Triglycerides (TG) ≥ 500 mg/dL (≥ 5.7 mmol/L) at Screening. 3. If on statin or fibrate, participants must be on stable, labeled dose for at least 3 months prior to screening. Participants not receiving these drugs within 4 weeks prior to screening are also eligible. Exclusion Criteria: 1. Type 1 diabetes mellitus 2. Newly diagnosed type 2 diabetes mellitus (within 12 weeks of screening) or HbA1c ≥ 9.0% at Screening 3. Acute pancreatitis within 3 months of screening 4. Acute Coronary Syndrome within 6 months of screening 5. Major surgery within 3 months of screening 6. Prior exposure to ISIS 304801 7. Have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study ; PRIMARY OUTCOME: Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3; SECONDARY OUTCOME 1: Absolute Change in Fasting TG From Baseline to Month 3[/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 - CENTERSTONE; BRIEF: Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 1 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms. ; DRUG USED: Xofluza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Influenza (excluding vaccines); TARGET: Influenza Virus, Polymerase Acidic Protein (PA), RNA, RNA polymerase; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: INCLUSION CRITERIA: Index Patients (IPs): - Able to comply with the study protocol per investigator judgment. - Diagnosed with acute influenza infection by investigator. - Polymerase chain reaction [PCR] (+) or Rapid Influenza Diagnostic Test [RIDT] (+) for influenza A/B based on cobas® SARS-CoV-2 and influenza A/B or other point-of-care / local laboratory results. - PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 and Influenza A/B test or other point-of-care / local laboratory result - Presence of (a) fever (>=38.0 °C per tympanic or rectal thermometer; >=37.5 °C per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue). - The time interval between the onset of fever or influenza symptoms and the pre-dose examinations is 48 hours or less. - IP lives in a household where: (1) No HHC is known to have been diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional (HCP) in the past 4 weeks; (2) All HHCs are expected to meet the key HHC inclusion criteria; (3) >=1 HHCs are expected to participate in the full study who have not received the influenza vaccine within 6 months prior to screening. - Women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures specified in the protocol All HHCs (Part 1): - PCR (-) or RIDT (-) based on cobas® SARS-CoV-2 and influenza A/B or other local point-of-care / local laboratory result. - PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 and Influenza A/B or other POC / local laboratory result. - HHC lives with no HHC who will be present in the home at any time during the study and who meets any HHC exclusion criteria. - HHC lives with no HHC who does not meet HHC inclusion criteria (part 1). - HHC lives in a household where ≥1 HHCs meet all of the following: Start screening within 24 hours after IP randomization; Have NOT received the influenza vaccine within 6 months prior to screening; and Fulfill full study HHC inclusion criteria part 2. Full study HHCs (part 2) intended for full study must meet the following additional criteria for study entry: - Agree to participate in the full study. - Able to comply with the study protocol per investigator judgment - No influenza symptoms within 7 days prior to screening. Alternatively, mild symptoms are permissible if determined by the investigator to be due to a preexisting condition. - Temperature <38.0 °C (tympanic). - Will reside in the index patients house for at least 7 of the next 9 days and will be present for scheduled study visits. - Willing and able to measure and record temperature, or have another household member perform the task on his or her behalf. Furthermore, a responsible adult will assume responsibility to oversee or perform this task on behalf of minors. - In the 6 months prior to screening: a) Has not been diagnosed with influenza by a healthcare professional b) Has not received BXM, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, favipiravir or amantadine. - Does not have a moderate or worse active infections OR infections requiring systemic (e.g., oral or intravenous) or otherwise internally administered (e.g., inhaled, intrathecal) antibiotic/antiviral/antifungal therapy, (topical therapies for mild external infections allowed). EXCLUSION CRITERIA: IPs: - IPs with severe influenza virus infection requiring inpatient treatment. - IPs judged by the investigator to be at high risk for complications of influenza. - IP is ≥12 years old and unable to swallow tablets (not applicable to IPs 5 to 11 year olds who will receive oral suspension). - Women who are breastfeeding or have a positive pregnancy test in the pre-dose examinations. - IPs with concurrent (non-influenza) infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations. - IPs who have received baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, favipiravir or amantadine, or an investigational drug, within 30 days or 5 drug-elimination half-lives, whichever is longer, prior to screening. - IPs who have received an investigational monoclonal antibody for a viral disease in the last year. - Known hypersensitivity to baloxavir marboxil or the drug product excipients. - IP previously included in the study - IP lives with an HHC who, based on available information, meets the HHC exclusion criteria HHC: - Pregnant or within 2 weeks post-partum at screening. - Immunocompromised. - Less than 2 years old. - Who have received an investigational therapy within the 30 days or 5 drug elimination half-lives, whichever is longer, prior to screening. - Diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional in the past 4 weeks. - HHC who plans to arrive home after 24 hours post IP randomization to Day 9 and is not willing to be consented as soon as possible upon arrival. - HHC previously included in the study. ; PRIMARY OUTCOME: Virological Transmission by Day 5; SECONDARY OUTCOME 1: Symptomatic Transmission by Day 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 III - LUX-Lung 8 (vs. Erlotinib); BRIEF: This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients. ; DRUG USED: Gilotrif; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor), ErbB3/HER3, ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Diagnosis of advanced stage NSCLC squamous histology. 2. Platinum-based doublet chemotherapy as 1st line treatment of Stage IIIB/IV NSCLC. 3. Eligible to receive 2nd line therapy in the opinion of the investigator. 4. Measurable disease according to RECIST 1.1. 5. Adequate Performance Status. 6. Availability of tumour tissue material for correlative studies. Archived tumour tissue is acceptable. 7. Adequate organ function. 8. Age = 18 years and above. 9. Written informed consent that is consistent with International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines. Exclusion criteria: 1. Prior treatment with Epidermal Growth Factor Receptor (EGFR) directed small molecules or antibodies. 2. Radiotherapy within 4 weeks prior to randomization. 3. Active brain metastases . 4. Any other current malignancy or malignancy diagnosed within the past three (3) years (other than basal-cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer). 5. Known pre-existing interstitial lung disease. 6. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom 7. Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug. 8. Women of child-bearing potential and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended. 9. Female patients of childbearing potential (see Section 4.2.3.3) who: 1. are nursing or 2. are pregnant or 3. are not using an acceptable method of birth control, or do not plan to continue using this method throughout the study and/or do not agree to submit to pregnancy testing required by this protocol. 10. Active hepatitis B infection (defined as presence of Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier. 11. Known or suspected active drug or alcohol abuse in the opinion of the investigator. 12. Any contraindications for therapy with afatinib or erlotinib. 13. Known hypersensitivity to erlotinib, afatinib or the excipients of any of the trial drugs. 14. Major surgery within 4 weeks of starting study treatment. 15. Prior participation in an afatinib clinical study, even if not assigned to afatinib. 16. Use of any investigational drug within 4 weeks of randomisation (unless a longer time period is required by local regulations or by the guidelines for the investigational product). 17. Patients without Progression of their lung cancer. ; PRIMARY OUTCOME: Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1; SECONDARY OUTCOME 1: Overall Survival[/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 - CIT; BRIEF: Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of avatrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of ovarian, lung (small cell and non-small cell) and bladder cancer. ; DRUG USED: Doptelet; DRUG CLASS: New Molecular Entity (NME); INDICATION: Thrombocytopenia; TARGET: Thrombopoietin Receptor (TPO-R, c-Mpl, CD110); THERAPY: Monotherapy; LEAD SPONSOR: Sobi, Inc.; CRITERIA: Inclusion Criteria: - Men and women greater than or equal to 18 years of age; - A diagnosis of ovarian, lung (small cell or non-small cell) or bladder cancer requiring systemic chemotherapy - Participant receiving a chemotherapy regimen given in a 21 or 28-day cycle, including 1 or more of the following agents or class of agents: - Nucleoside analog, including gemcitabine and fluorouracil; - Carboplatin or cisplatin; - Anthracycline; or - Alkylating agent; - Participant experienced severe thrombocytopenia, defined as 2 platelet counts <50 x 109/L measured at least 24 hours apart, during the qualifying chemotherapy cycle, of their current chemotherapy regimen - ECOG performance status <=2 Exclusion Criteria: - Participant has experienced >=Grade 2 CIT other than during the current chemotherapy treatment regimen within 6 months of Screening; - Participant has any history of hematologic malignancies, including leukemia, myeloma, myeloproliferative disease, lymphoma, or myelodysplastic diseases; - Participant has received >2 previous lines of chemotherapy or is receiving whole brain radiation during the study treatment period; - Participant has a known medical history of genetic prothrombotic syndromes - Participant has a history of arterial or venous thrombosis within 3 months of screening; - Use of vitamin K antagonists; - Participant has previously received a thrombopoietin receptor agonist or recombinant human thrombopoietin for the treatment of CIT within 3 months of screening ; PRIMARY OUTCOME: Percentage of Subjects Who do Not Require Platelet Transfusion, Dose Reduction in Chemotherapy by 15%, or Chemotherapy Delay by >=4 Days; SECONDARY OUTCOME 1: Duration of Severe Thrombocytopenia Defined as a Platelet Count <50 x 10^9/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 III - VAT00008 (Global); BRIEF: The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a booster injection of a CoV2 preS dTM-AS03 vaccine, in adults 18 years of age and older. A total of approximately 21 046 participants are planned to be enrolled (5080 per study intervention group in Stage 1 and 5443 per study intervention group in Stage 2). Initial, double-blind, primary series study design is planned for 365 days post-last Initial injection (ie, approximately 386 days total) for each participant. Based on decisions of the Study Oversight Group, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows: - For participants who initially received vaccine: 12 months post-booster (ie, approximately 18 to 24 months) - For participants who initially received placebo: ≥ 4 months post-last dose of the primary series + 12 months post-booster (ie, approximately 28 to 34 months) - For participants who do not consent to continue in the unblinded Crossover / Booster part of the study, all study procedures will be stopped and participants will be discontinued from the study. ; DRUG USED: Coronavirus Vaccine (Sanofi/GSK); DRUG CLASS: Vaccine; INDICATION: COVID-19 Prevention; TARGET: Immune System, SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi Pasteur, a Sanofi Company; CRITERIA: Inclusion Criteria: - Aged 18 years or older on the day of inclusion. - For persons living with human immunodeficiency virus (HIV), stable HIV infection determined by participant currently on antiretrovirals with CD4 count > 200/mm3. - SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies. - Does not intend to receive an authorized/approved COVID-19 vaccine despite encouragement by the Investigator to receive the authorized vaccine available to them at the time of enrollment. - Informed consent form has been signed and dated - Able to attend all visits and to comply with all study procedures - Covered by health insurance, only if required by local, regional or national regulations - A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: - is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile, or - is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 12 weeks after the second study intervention administration. A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours before any dose of study intervention. Exclusion Criteria: - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. - Dementia or any other cognitive condition at a stage that could interfere with following the study procedures based on Investigator?s judgment. - Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator?s judgment - Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator?s judgment. - Unstable acute or chronic illness that in the opinion of the Investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures. - Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ? 38.0 C [? 100.4 F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. - Receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention. - Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome). - Receipt of solid-organ or bone marrow transplants in the past 180 days. - Receipt of anti-cancer chemotherapy in the last 90 days. - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. - Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. - Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. ; PRIMARY OUTCOME: Occurrences of symptomatic COVID-19; SECONDARY OUTCOME 1: Occurrences of SARS-CoV-2 infection[/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 - MEASURE 2; BRIEF: This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Axial Spondyloarthritis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male or non-pregnant, non-lactating female patients - Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS (1984) - Patients should have been on NSAIDs with an inadequate response - Patients who were regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose - Patients who had been on an anti-TNFα agent (not more than one) must have experienced an inadequate response Exclusion Criteria: - Chest X-ray (or MRI) with evidence of ongoing infectious or malignant process - Patients with total ankylosis of the spine - Patients previously treated with any biological immunomodulating agents except for those targeting TNFα - Previous treatment with any cell-depleting therapies ; PRIMARY OUTCOME: Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16; SECONDARY OUTCOME 1: Percentage of Participants Achieving ASAS 40 (SpondyloArthritis International Society Criteria) Response[/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 - 2016-002 (Ext.); BRIEF: This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556) ; DRUG USED: Cequa; DRUG CLASS: Non-NME; INDICATION: Dry Eye (Ophthalmology); TARGET: Calcineurin phosphatase ; THERAPY: Monotherapy; LEAD SPONSOR: Sun Pharmaceutical Industries Limited; CRITERIA: Inclusion Criteria: - Completion of Study OTX-101-2016-001 Exclusion Criteria: - ; PRIMARY OUTCOME: Adverse Events; 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 - chAMP; BRIEF: The purpose of this clinical study (ChAMP - Comparability pharmacokinetics of Alpha-1 Modified Process) is to compare the pharmacokinetic, safety and tolerability of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP) and Prolastin in adult Alpha1-antitrypsin deficient patients. Patients will be infused intravenously with study drug on a weekly schedule for 24 weeks. ; DRUG USED: PROLASTIN-C; DRUG CLASS: Biologic; INDICATION: Alpha-1 Antitrypsin Deficiency (A1AD or AATD); TARGET: Alpha-1-antitrypsin (A1AT), Protease; THERAPY: Monotherapy; LEAD SPONSOR: Grifols Therapeutics LLC; CRITERIA: Inclusion Criteria: - Documented diagnosis of congenital Alpha1-antitrypsin deficiency - Must be receiving augmentation therapy with plasma-derived (human) Alpha1-Proteinase Inhibitor (Prolastin®) for at least one month prior to study entry. - Signed written informed consent prior to initiation of any study related procedures Exclusion Criteria: - Females who are pregnant, breast feeding, or if of child-bearing potential, unwilling to practice adequate contraception throughout the study - Use of systemic steroids within the 2 weeks prior to receiving study treatment (this does not include the use of inhaled steroids used on a routine or as needed basis). - Subjects who have had exacerbations of their disease within one month of trial entry. ; PRIMARY OUTCOME: Alpha-1 MP vs. Prolastin® of Area Under the Curve (AUC) From Day 0 to Day 7; 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 - SPIRE-1 (CV Outcomes); BRIEF: This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization, in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg /dL (2.6 mmol/L). ; 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: - Must be on background lipid lowering treatment. - Must be at high risk of a CV event. - Must have an LDL C >/=70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg/dL (2.6 mmol/L). Exclusion Criteria: - Planned coronary (PCI or CABG) or other arterial revascularization. - New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging. - Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD formula or with end state renal disease on dialysis. - History of hemorrhagic stroke. - Prior exposure to bococizumab or other investigational PCSK9 inhibitor. ; PRIMARY OUTCOME: Event Rate Per 100 Participant-Years For First Occurrence of Major Cardiovascular (CV) Event; SECONDARY OUTCOME 1: Event Rate Per 100 Participant-Years For First Occurrence of Composite Endpoint of Cardiovascular Death, Non-Fatal Myocardial Infraction, or Non-Fatal Stroke[/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 - KEYNOTE-426 (w/Pembrolizumab; First-Line); BRIEF: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with axitinib versus sunitinib monotherapy as a first-line treatment for participants with advanced/metastatic renal cell carcinoma (mRCC). The primary hypotheses of this study are: 1. The combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Progression-Free Survival (PFS) as assessed by blinded independent central imaging review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) 2. The combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Overall Survival (OS). ; DRUG USED: Inlyta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: Platelet-derived growth factor receptor (PDGFR), VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Has histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features - Has locally advanced/metastatic disease (i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer) or has recurrent disease - Has measurable disease per RECIST 1.1 as assessed by the investigator/site radiologist - Has received no prior systemic therapy for advanced RCC. - Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. - Has Karnofsky performance status (KPS) ≥ 70% as assessed within 10 days prior to randomization. - If receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to randomization. - Demonstrates adequate organ function. - Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug. - Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug. Exclusion Criteria: - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization. - Has had major surgery within 4 weeks, received radiation therapy within 2 weeks prior to randomization, or has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to prior treatment. - Has had prior treatment with any anti-programmed cell death (anti-PD-1), or programmed cell death ligand 1 (PD-L1), or PD-L2 agent or an antibody targeting any other immune-regulatory receptors or mechanisms. - Has received prior systemic anti-cancer therapy for RCC with vascular endothelial growth factor (VEGF)/VEGF receptors (VEGFR) or mechanistic target of rapamycin (mTOR) targeting agents. - Has a history of severe hypersensitivity reaction (e.g., generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to axitinib or sunitinib. - Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy exceeding physiologic corticosteroid dose or any other form of immunosuppressive therapy within 7 days prior to randomization, except in the case of central nervous system (CNS) metastases. - Has an active autoimmune disease requiring systemic treatment with in the past 2 years OR a documented history of clinically severe autoimmune disease. Note: Participants with vitiligo, Sjøgrens syndrome, Type 1 diabetes, resolved childhood asthma/atopy, hypothyroidism or adrenal or pituitary insufficiency who are stable on hormone replacement, are not excluded. - Has a known additional malignancy that has progressed or has required active treatment in the last 3 years. Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ such as breast cancer in situ are acceptable if they have undergone potentially curative therapy. - Has known active CNS metastases and/or carcinomatous meningitis. - Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. - Has an active infection requiring systemic therapy. - Has a known history of Human Immunodeficiency Virus (HIV). - Has known active Hepatitis B or Hepatitis C infection. - Has received a live virus vaccine within 30 days of randomization. - Has a clinically significant gastrointestinal (GI) abnormality including: - Malabsorption, total gastric resection - Or any condition that might affect the absorption of orally taken medication - Active GI bleeding, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy - Intraluminal metastatic lesion with suspected bleeding, inflammatory bowel disease, ulcerative colitis or other GI condition associated with increased risk of perforation - Has QT interval corrected for heart rate (QTc) ≥480 msec. - Has a history of any of the following cardiovascular conditions within 12 months of randomization: - Myocardial infarction - Unstable angina pectoris - Cardiac angioplasty or stenting - Coronary/peripheral artery bypass graft - Class III or IV congestive heart failure per New York Heart Association - Cerebrovascular accident or transient ischemic attack - Has a history of deep vein thrombosis or pulmonary embolism within 6 months of screening. - Has poorly controlled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and/or diastolic blood pressure (DBP) ≥90 mm Hg. - Has evidence of inadequate wound healing. - Has active bleeding disorder or other history of significant bleeding episodes within 30 days of randomization. - Has hemoptysis within 6 weeks prior to randomization. - Has current use (within 7 days of randomization) or anticipated need for treatment with drugs or foods that are known strong cytochrome P450 (CYP3A4/5) inhibitors. - Has current use (within 7 days of randomization) or anticipated need for treatment with drugs that are known strong CYP3A4/5 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. Johns wort; or drugs that are known with proarrhythmic potential. - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. - Has had a prior solid organ transplant. - Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug. ; PRIMARY OUTCOME: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review; SECONDARY OUTCOME 1: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review[/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 - SP583; BRIEF: The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 4 treatment arms receiving either fesoterodine (SPM 907) 4mg, fesoterodine 8mg, active control (tolterodine SR 4mg) or placebo during the Double-Blind Treatment Period. Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment. The most important safety variables included the assessment of adverse events, laboratory parameters, changes in ECG, physical exams and measurement of residual urine. ; DRUG USED: Toviaz; DRUG CLASS: New Molecular Entity (NME); INDICATION: Overactive Bladder (OAB); TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Overactive Bladder Syndrome Exclusion Criteria: - less than 8 micturitions in 24 hours ; PRIMARY OUTCOME: ; 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 - IFN-Free w/ABT-450/Ritonavir/ABT-267 +/- RBV (PEARL-IV); BRIEF: The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis. ; DRUG USED: Exviera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides); THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile - Chronic hepatitis C, genotype 1a-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening) - Subject has never received antiviral treatment for hepatitis C infection - No evidence of liver cirrhosis Exclusion Criteria: - Significant liver disease with any cause other than HCV as the primary cause - Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody - Positive screen for drugs or alcohol - Significant sensitivity to any drug - Use of contraindicated medications within 2 weeks of dosing - Abnormal laboratory tests ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses; SECONDARY OUTCOME 1: Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment[/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 - ALTERNATIVE (w/Trastuzumab/AI); BRIEF: A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC). ; DRUG USED: Tykerb; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor), HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria Subjects eligible for enrollment in the study must meet all of the following criteria: 1. Signed written informed consent. In Korea and Japan, subjects between >=18 and <20 years of age must also have a legal representative sign the written informed consent. 2. Post-menopausal female subjects >=18 years of age. Post-menopausal as defined by any of the following: - Subjects at least 60 years of age. - Subjects under 60 years of age and amenorrhic for at least 12 consecutive months AND follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range (utilizing ranges from the local laboratory facility). - Prior bilateral oophorectomy. - Prior radiation castration with amenorrhea for at least 6 months 3. Subjects must have a history of histologically confirmed breast cancer, with a clinically confirmed diagnosis of metastatic disease [confirmed by histology, cytology or other clinical means (e.g. CT, MRI)]. Subjects may have either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) 4. Tumors that are ER+ and/or PgR+ by local laboratory 5. Documentation of HER2 overexpression or gene amplification, in the invasive component of either the primary tumor or metastatic disease site as defined as: - 3+ by Immunohistochemistry (IHC) and/or - HER2/neu gene amplification by fluorescence, chromogenic or silver in situ hybridization [FISH, CISH or SISH; >6 HER2/neu gene copies per nucleus or a FISH, CISH or SISH test ratio (HER2 gene copies to chromosome 17 signals) of ≥2.0] 6. Subject must have received at least one prior regimen containing trastuzumab in combination with chemotherapy for breast cancer:. - Subject has ONLY received prior trastuzumab in combination with chemotherapy as neoadjuvant and/or adjuvant treatment. OR - Subject has received ONE prior trastuzumab-containing regimen for metastatic disease (and has progressed), and may or may not have received prior trastuzumab in combination with chemotherapy as neoadjuvant and/or adjuvant treatment. 7. Subject must have received prior endocrine therapy (such as aromatase inhibitors or selective estrogen receptor modulators). 8. Subjects who have a life expectancy of > 6 months as assessed by the treating investigator 9. Subjects must have baseline Left Ventricular Ejection Fraction (LVEF) ≥50% measured by echocardiography (ECHO) or multi-gated acquisition scan (MUGA) 10. Subject must have an ECOG performance status of 0-1 11. All prior treatment related toxicities must be CTCAE (Version 4.0) ≤ Grade 1 at the time of randomization 12. Completion of screening assessments 13. Adequate baseline organ function. 14. Subjects must meet all of the following criteria: - QTc <450msec or - QTc <480msec for subjects with bundle branch block The QTc is the QT interval corrected for heart rate according to either Bazetts formula (QTcB) or to Fridericias formula (QTcF), machine or manual over read, for males and females. The specific formula that will be used in a protocol should be determined prior to initiation of the study, and the formula used to determine inclusion and discontinuation should be the same throughout the study. The QTc should be based on single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period Exclusion criteria: 1. History of another malignancy. Exception: Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. 2. Subjects with extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or the disease is considered by the investigator to be rapidly progressing or life threatening (subjects who are intended for chemotherapy) 3. Serious cardiac illness or medical condition including but not confined to: - Uncontrolled arrhythmias - Uncontrolled or symptomatic angina - History of congestive heart failure (CHF) - Documented myocardial infarction <6 months from study entry 4. Known history of, or clinical evidence of, central nervous system (CNS) metastases or leptomeningeal carcinomatosis 5. Have acute or currently active/requiring anti-viral therapy hepatic or biliary disease (with the exception of subjects with Gilberts syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) 6. Have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subjects safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent) 7. Have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels 8. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the study agents or their excipients that, in the opinion of the Investigator or GSK medical monitor, contraindicates their participation 9. Any prohibited medication. 10. Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment. ; PRIMARY OUTCOME: PFS of Lapatinib+Trastuzumab+AI Combination vs. Trastuzumab+AI Combination; SECONDARY OUTCOME 1: PFS of Trastuzumab/AI vs. Lapatinib/AI and Trastuzumab/Lapatinib/AI vs. Lapatinib/AI[/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 - 301; BRIEF: The primary objective of this study is to compare the efficacy, safety and tolerability of IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris. ; DRUG USED: Altreno; DRUG CLASS: Non-NME; INDICATION: Acne; TARGET: Retinoic acid receptor (RARs); THERAPY: Monotherapy; LEAD SPONSOR: Valeant Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male or female at least 9 years of age and older - Written and verbal informed consent must be obtained. - Subject must have a score of moderate or severe on the Evaluators Global Severity assessment at the screening and baseline visit - Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits - Subjects must be willing to comply with study instructions and return to the clinic for required visits. Exclusion Criteria: - Any dermatological conditions on the face that could interfere with clinical evaluations - Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive - Subjects with a facial beard or mustache that could interfere with the study assessments - Concomitant use of potentially irritating over-the-counter products ; PRIMARY OUTCOME: Absolute change in inflammatory lesion count from baseline to Week 12; SECONDARY OUTCOME 1: Percent change in inflammatory lesion count from baseline to Week 4, 8, and 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 - CN138-165; BRIEF: The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy. ; DRUG USED: Abilify (Oral and IM); DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Alpha Adrenergic Receptors, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2C receptor; THERAPY: Combination; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Men and women, 18-65 years old who have experienced single or recurrent, non-psychotic episodes of Major Depressive Disorder, with the current episode of minimally 8 weeks in duration. - Treatment history of an inadequate response to at least one and no more than three adequate antidepressant trials. ; PRIMARY OUTCOME: Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS); SECONDARY OUTCOME 1: Mean Change in Sheehan Disability Scale (SDS) Mean 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 III - RUTH; BRIEF: The purpose of this study is to determine whether raloxifene compared with placebo lowers the risk of coronary events and reduces the risk of invasive breast cancer in postmenopausal women at risk for major coronary events. ; DRUG USED: Evista; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Endothelin Receptor Type B (EDNRB), Estrogen Receptor Alpha (ER1 or ER alpha); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Postmenopausal women with established coronary heart disease or at risk for a major coronary event. Exclusion Criteria: - Postmenopausal symptoms that required estrogen replacement therapy. - Suspected or known history of breast or endometrial carcinoma. - Known or probable history of deep venous thrombosis, pulmonary embolism, or retinal vein thrombosis. - New York Heart Association classes III or IV heart failure. ; PRIMARY OUTCOME: Time to first occurrence of coronary death, non-fatal myocardial infarction (MI), or hospitalized acute coronary syndrome other than MI combined after an expected 5 to 7.5 years of follow-up.; SECONDARY OUTCOME 1: After an expected 5 to 7.5 years of follow-up:[/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 - REVIVE-Safety (TA-314); BRIEF: This open-label study is being conducted to evaluate the long-term safety, tolerability, and efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400 subjects will be enrolled and treated with avanafil for up to 52 weeks. ; DRUG USED: Stendra; DRUG CLASS: New Molecular Entity (NME); INDICATION: Erectile Dysfunction (ED); TARGET: Phosphodiesterase 5 (PDE5); THERAPY: Monotherapy; LEAD SPONSOR: VIVUS LLC; CRITERIA: Inclusion Criteria: - Successfully completed the entire treatment period in a qualifying study (TA-301 [NCT00790751] or TA-302 [NCT00809471]); - Demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial; - Made at least 4 attempts at intercourse during the last treatment period of the qualifying trial; - Agree to make at least 4 attempts at intercourse each month through the course of this study; - Agree not to use any other treatments for erectile dysfunction during participation in this study. - Provide written informed consent; - Willing and able to comply with scheduled study visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: - Subjects who, in the opinion of the investigator, have developed one or more comorbidities during the qualifying study that would pose a safety concern to their continuation on treatment in study TA-314; - Subjects requiring treatment with an excluded medication. ; PRIMARY OUTCOME: Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.; 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 - DT or DF; BRIEF: This randomized phase III trial compares the effects, good and/or bad, of sorafenib tosylate in treating patients with desmoid tumors or aggressive fibromatosis. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. [Funding Source - FDA OOPD] ; DRUG USED: Nexavar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), Raf kinase, RET, Tyrosine Kinases, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Patients must have confirmation of DT/DF by local pathologist prior to registration - Patients may have been treated with locoregional therapies such as major surgery, radiation, radiofrequency ablation, or cryosurgery provided this has been completed at least 4 weeks prior to registration and recovered from therapy related toxicity to less than CTCAE grade 2 - Patients may have been treated with cytotoxic, biologic (antibody), immune or experimental therapy, tyrosine kinase inhibitors, hormone inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs) provided this has been completed at least 4 weeks prior to registration (6 weeks for mitomycin and nitrosoureas) and recovered from any therapy related toxicity to less than CTCAE grade 2 - Patients with prior or current treatment of sorafenib are excluded - No concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted; please note that drugs that strongly induce or inhibit cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or are associated with a risk of torsades are not allowed; chronic concomitant treatment of CYP3A4 inducers is not allowed (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. Johns wort); as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; the following drugs are strong inhibitors of CYP3A4 and are not allowed during the treatment with sorafenib: - Boceprevir - Indinavir - Nelfinavir - Lopinavir/ritonavir - Saquinavir - Telaprevir - Ritonavir - Clarithromycin - Conivaptan - Itraconazole - Ketoconazole - Mibefradil - Nefazodone - Posaconazole - Voriconazole - Telithromycin - Drugs with possible or conditional risk of torsades should be used with caution knowing that sorafenib could prolong the QT interval - Chronic daily NSAID use as treatment for controlling desmoid tumors is not allowed, and should be stopped >= 3 days prior to registration; NSAIDS are allowed when used for desmoid tumor-related pain or for symptoms that are unrelated to desmoid disease (eg. headache, arthritis) - Patients must have measurable disease - Patients have to meet one of the following criteria to be eligible: - Disease determined unresectable or entailing unacceptably morbid surgery based on 1 or more of the following characteristics: - Multifocal disease - Disease in which there is involvement or inadequate plane from: neurovascular bundle, bone, skin, or viscera - Large size in relationship to location OR multi-compartment involvement - Progression by radiographic imaging (10% increase in size by RECIST v1.1 within 6 months of registration) - Patients with symptomatic disease which meets the following criteria Brief Pain Inventory (BPI) score greater than or equal to 3 AND one of the following: - Inability to control pain with NSAIDs and considering addition of narcotics OR - > 30% increase in current use of narcotics OR - Addition of a new opioid narcotic - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 - Patients who are pregnant or nursing are not eligible - No patients with a history of cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); active coronary artery disease (CAD) (myocardial infarction or unstable angina within 6 months prior to study entry) - No patients with inadequately controlled hypertension (defined as a blood pressure of >= 150 mmHg systolic and/or >= 90 mmHg diastolic), or any prior history of hypertensive crisis or hypertensive encephalopathy - No patients with clinically significant gastrointestinal (GI) bleeding or bleeding diathesis within 30 days prior to registration - Absolute neutrophil count >= 1,500/mm^3 - Hemoglobin >= 8 g/dl - Platelets >= 75,000/mm^3 - Total bilirubin =< 1.5 x upper limits of normal (ULN) - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST])/serum glutamate pyruvate transaminase (SGPT) (aspartate aminotransferase [ALT]) =< 1.5 x ULN - Calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault equation ; PRIMARY OUTCOME: Progression-free Survival(PFS) Rate; SECONDARY OUTCOME 1: Incidence of Adverse Events, Using the Patient Reported Outcomes-Common Terminology Criteria in Adverse Events Version 4.0[/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 III - PROpel; BRIEF: The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage. ; DRUG USED: Lynparza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol. 2. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses. 3. For inclusion in i) the optional exploratory genetic research and ii) the optional biomarker research, patients must fulfill the following criteria: - Provision of informed consent for genetic research prior to collection of sample. - Provision of informed consent for biomarker research prior to collection of sample. If a patient declines to participate in the optional exploratory genetic research or the optional biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study. 4. Patients must be ≥18 years of age (or ≥19 years of age in South Korea) at the time of signing the informed consent form. For patients enrolled in Japan who are <20 years of age, written informed consent should be obtained from the patient and from his legally acceptable representative. 5. Histologically or cytologically confirmed prostate adenocarcinoma. 6. Metastatic status defined as at least 1 documented metastatic lesion on either a bone scan or a computed tomography(CT)/ magnetic resonance imaging (MRI) scan. 7. First-line metastatic castration-resistant prostate cancer (mCRPC). 8. Ongoing androgen deprivation with gonadotropin-releasing hormone analogue or bilateral orchiectomy, with serum testosterone <50 nanograms per decilitre (ng/dL) (<2.0 nanomoles per litre (nmol/L)) within 28 days before randomisation. Patients receiving androgen deprivation therapy (ADT) at study entry should continue to do so throughout the study. 9. Candidate for abiraterone therapy with documented evidence of progressive disease. 10. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment. 11. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, with no deterioration over the previous 2 weeks. 12. The participant has, in the opinion of the investigator, a life expectancy of at least 6 months. 13. Prior to randomisation, sites must confirm availability of either an archival formalin fixed, paraffin embedded (FFPE) tumour tissue sample, or a new biopsy taken during the screening window, which meets the minimum pathology and sample requirements in order to enable homologous recombination repair (HRR) status subgroup analysis of the primary endpoint radiographic progression-free survival (rPFS). If there is not written confirmation of the availability of tumour tissue prior to randomisation, the patient is not eligible for the study. 14. Male patients must use a condom during treatment and for 3 months after the last dose of olaparib+abiraterone when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. Exclusion Criteria: 1. Has a known additional malignancy that has had progression or has required active treatment in the last 5 years. 2. Patients with myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML) or with features suggestive of yelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML). 3. Clinically significant cardiovascular disease Association Class II-IV heart failure or cardiac ejection fraction measurement of <50% during screening as assessed by echocardiography or multigated acquisition scan. 4. Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure. 5. Prior revascularisation procedure (significant coronary, carotid, or peripheral artery stenosis). 6. Uncontrolled hypertension (systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or diastolic blood pressure (BP) ≥95 millimeters of mercury (mmHg)). 7. History of uncontrolled pituitary or adrenal dysfunction. 8. Active infection or other medical condition that would make prednisone/prednisolone use contraindicated. 9. Any chronic medical condition requiring a systemic dose of corticosteroid >10 milligrams (mg) prednisone/prednisolone per day. 10. Patients who are considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. 11. Persistent toxicities (Common Terminology Criteria for Adverse Events [CTCAEs] grade >2) caused by previous cancer therapy, excluding alopecia. 12. Patients with brain metastases. A scan to confirm the absence of brain metastases is not required. 13. Patients with spinal cord compression are excluded unless they are considered to have received definitive treatment for this and have evidence of clinically stable disease for 4 weeks. 14. Patients who are unevaluable for both bone and soft tissue progression 15. Patients who are unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication. 16. Immunocompromised patients 17. Patients with known active hepatitis infection (ie, hepatitis B or C). 18. Any previous treatment with Polyadenosine 5diphosphoribose [poly (ADP ribose)] polymerase (PARP) inhibitor, including olaparib. 19. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment. Patients who receive palliative radiotherapy need to stop radiotherapy 1 week before randomisation. 20. Any previous exposure to a Cytochrome P450 (CYP) 17 (17α-hydroxylase/C17,20-lyase) inhibitor (eg, abiraterone, orteronel). 21. Concomitant use of known strong Cytochrome P450 (CYP) 3A inhibitors (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks. 22. Concomitant use of known strong Cytochrome P450 (CYP) 3A inducers (eg, phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine or St Johns wort) or moderate Cytochrome P450 (CYP) 3A inducers (eg, bosentan, efavirenz or modafinil). The required period prior to starting study treatment is 5 weeks for phenobarbital and enzalutamide and 3 weeks for other agents. 23. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. 24. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT). 25. Participation in another clinical study with an investigational product or investigational medical devices within 1 month of randomisation. 26. History of hypersensitivity to olaparib or abiraterone, any of the excipients of olaparib or abiraterone, or drugs with a similar chemical structure or class to olaparib or abiraterone. 27. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and Merck staff and/or staff at the study site). 28. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. 29. Previous randomisation in the present study. ; PRIMARY OUTCOME: Number of Participants With Radiological Progression Free Survival (rPFS) Event by Investigator Assessment; SECONDARY OUTCOME 1: Number of Participants With Overall Survival (OS) Event[/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 - CALIMA (w/ High-Dose ICS-LABA) (52 weeks); BRIEF: The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers. ; DRUG USED: Fasenra; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures 2. Female and male aged 12 to 75 years, inclusively, at the time of Visit 1 3. History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250µg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1. 4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion. Exclusion criteria: 1. Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome) 2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, 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, haematology, clinical chemistry, or urinalysis during screening/run-in 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 ; PRIMARY OUTCOME: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL; SECONDARY OUTCOME 1: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL[/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 - LEAP-015; BRIEF: The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer. The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Has histologically and/or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic gastroesophageal adenocarcinoma - Is not expected to require tumor resection during the treatment course - Has gastroesophageal adenocarcinoma that is not HER-2/neu positive - Has measurable disease as defined by RECIST 1.1 by scan with IV contrast as determined by the local site investigator - Male participants agree to refrain from donating sperm and agree to either remain abstinent from heterosexual intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for ≥7 days after last dose of lenvatinib or 90 days after last dose of chemotherapy-whichever comes last - Female participants not pregnant or breastfeeding are eligible to participate if not a women of childbearing potential (WOCBP), or if a WOCBP they either use a contraceptive method that is highly effective OR remain abstinent from heterosexual intercourse as their preferred and usual lifestyle, and do not donate eggs (ova, oocytes) to others or freeze/store for their own use, and abstain from breastfeeding during the intervention period through 120 days after last dose of pembrolizumab, 30 days after last dose of lenvatinib, or 180 days after last dose of chemotherapy-whichever occurs last - Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of study treatment - Has adequately controlled blood pressure with or without antihypertensive medications - Has adequate organ function Exclusion Criteria: - Has had previous therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ) esophageal adenocarcinoma - Has had major surgery within 28 days prior to first dose of study interventions - Has had radiotherapy within 14 days of randomization - Has a known additional malignancy that is progressing or has required active treatment within the past 5 years - Has known CNS metastases and/or carcinomatous meningitis - Has severe hypersensitivity (≥Grade 3) to treatment with an monoclonal antibody (mAb) or known sensitivity or intolerance to any component of lenvatinib, pembrolizumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum containing products - Has had an allogeneic tissue/solid organ transplant - Has perforation risks or significant gastrointestinal (GI) bleeding - Has GI obstruction, poor oral intake (CAPOX participants), or difficulty in taking oral medication (CAPOX participants) - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor - Has received prior therapy with anti- vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor or anti-VEGF mAb - Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug - Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) - Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation - Has inadequate cardiac function - Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Has poorly controlled diarrhea - Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment. - Has peripheral neuropathy ≥Grade 2 - Has a known history of human immunodeficiency virus (HIV) or HIV 1/2 antibodies - Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection - Has weight loss of >20% within the last 3 months ; PRIMARY OUTCOME: Part 1: Number of Participants with Dose Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Part 2: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR in Participants with PD-L1 CPS ≥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 - COSMOS (MEA115661); BRIEF: This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care in subjects who have severe, refractory asthma and a history of eosinophilic inflammation. Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to consent for this study. ; DRUG USED: Nucala Lyophilized Powder Formulation; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. - Informed Consent: Prior to commencing any study related activities, subjects must be able and willing to provide written informed consent. - MEA115588 or MEA115575 study completion: Completion of the double-blind investigational product treatment during MEA115588 or MEA115575. - Current Anti-Asthma Therapy: Asthma is currently being treated with a controller medication (i.e., inhaled corticosteroids [ICS] or other asthma controlled medication) and the subject has been on a controller medication for the past 12 weeks. Subjects will be expected to continue controller therapy for the duration of the study. - Male or eligible female subjects: - To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control for the duration of the trial and for 4 months after the last study drug administration. - A serum pregnancy test is required of all females at the initial Baseline Visit (Visit 1). In addition, a urine pregnancy test will be performed for all females prior to enrollment, during each scheduled study visit prior to the injection of investigational product, and during the Follow-up Visit. Exclusion Criteria: - Hypersensitivity: Hypersensitivity reaction related to study medication during the MEA115588 or MEA115575 that led to patient withdrawal. Subjects who experienced a localized injection site reaction do not need to be excluded. - Health Status: Clinically significant change in health status during MEA115588 or MEA115575 which in the opinion of the investigator would make the subject unsuitable for participation in this long-term study. - Malignancy: A current malignancy or malignancy that developed during MEA115588 or MEA115575 (subjects that had localized carcinoma of the skin which was resected for cure will not be excluded). [Note for South Korea: Korean subjects with a diagnosis of malignancy within 5 years are excluded] - Prior SAE: A study related SAE in MEA115588 or MEA115575 that was assessed as possibly related to study medication by the investigator. - Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation. - ECG: Baseline ECG which has a clinically significant abnormality or which shows corrected QT interval with Fridericia (QTcF) >=450 millisecond (msec) or QTcF >=480 msec for subjects with Bundle Branch Block. - Smoking status: Current smokers - Liver Function: Liver function tests that meet any of the following during one of the last treatment visits in MEA115588 or MEA115575 : alanine transaminase (ALT) >=2 x upper limit of normal (ULN); aspartate transaminase (AST) >=2 x ULN; alkaline phosphatase >=2 x ULN; Bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35% - Hepatitis Status: Positive Hepatitis B Surface Antigen (HBsAg) screen at Visit 1 - ECG Over-read: Clinically significant abnormality identified during the central over-read during one of the last treatment visits in MEA115588 or MEA115575 ; PRIMARY OUTCOME: Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions; SECONDARY OUTCOME 1: Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies (NAb) at the Indicated Time Points[/INST]Yes</s>