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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 - IPATential150; BRIEF: The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC). ; DRUG USED: Ipatasertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Eastern Collaborative Oncology Group (ECOG) performance status of 0 or 1 at screening - Adequate hematologic and organ function within 28 days before the first study treatment - Ability to comply with the study protocol, in the investigators judgment - Willingness and ability of participants to use the electronic device to report selected study outcomes; Caregivers and site staff can assist with patient diary input but patient must be able to independently comprehend and answer the questionnaires - Life expectancy of at least 6 months - Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm - For enrollment into the China extension cohort, residence in the Peoples Republic of China Disease-specific Inclusion Criteria: - Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small-cell features - Consent to provide a formalin-fixed paraffin-embedded (FFPE) tissue block (preferred) or a minimum of 15 (20 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue accompanied by an associated pathology report (with tumor content information, Gleason score, and disease staging) for PTEN IHC and NGS testing and for other protocol-mandated secondary and exploratory assessments. If only 12-14 slides are available, the patient may still be eligible for the study, after discussion with and approval by the Medical Monitor. Cytologic or fine-needle aspiration samples are not acceptable. Tumor tissue from bone metastases is not acceptable - A valid PTEN IHC result (testingcentral laboratory tested with results directly sent to IxRS) (e.g., participants with an invalid or failed PTEN IHC result are not permitted to enroll) - Metastatic disease documented prior to randomization by clear evidence of bone lesions on bone scan and/or measurable soft tissue disease by computed tomography (CT) and/or magnetic resonance imaging (MRI) (at least one target lesion) according to RECIST v1.1 - Asymptomatic or mildly symptomatic form of prostate cancer - Progressive disease before initiating study treatment - Ongoing androgen deprivation with gonadotropin-releasing hormone (GnRH) analog or bilateral orchiectomy, with serum testosterone <= 50 ng/dL (<= 1.7 nmol/L) within 28 days before randomization Exclusion Criteria: - Inability or unwillingness to swallow whole pills - History of malabsorption syndrome or other condition that would interfere with enteral absorption - Clinically significant history of liver disease consistent with Child-Pugh Class B or C, including cirrhosis, current alcohol abuse, or current known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) - Need of more than 10 mg/day of prednisone or an equivalent dose of other anti-inflammatory corticosteroids as a current systemic corticosteroid therapy to treat a chronic disease (e.g., rheumatic disorder) - Active infection requiring intravenous (IV) antibiotics within 14 days before Day 1, Cycle 1 - Immunocompromised status because of current known active infection with HIV or because of the use of immunosuppressive therapies for other conditions - Major surgical procedure or significant traumatic injury within 28 days prior to Day 1, Cycle 1, or anticipation of the need for major surgery during study treatment - History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), untreated coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), myocardial infarction or atrial thrombotic events within the past 6 months, severe unstable angina, New York Heart Association Class III and IV heart disease or depressed left ventricular ejection fraction (LVEF; previously documented LVEF < 50% without documentation of recovery), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome - History of another malignancy within 5 years prior to randomization, except for either adequately treated non-melanomatous carcinoma of the skin, adequately treated melanoma in situ, adequately treated non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta, and low grade T1 tumors), or other malignancies where the patient has undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to have a recurrence rate of <5% at 5 years - Any other diseases, cardiovascular, pulmonary, or metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participants at high risk from treatment complications. Disease-Specific Exclusion Criteria: - Pathologic findings consistent with small-cell or neuroendocrine carcinoma of the prostate - Any therapy including chemotherapy (e.g., docetaxel) or biological therapy (e.g., vaccine, immunotherapy) for the treatment of castration-resistant prostate cancer. Previous treatment with flutamide, steroidal anti-androgens, androgens, estrogens, bicalutamide, nilutamide, or 5-α reductase inhibitor is permitted. - Use of opioid medications for cancer-related pain, including codeine and dextropropoxyphene, currently or any time within 4 weeks of Day 1, Cycle 1 - Prior treatment with abiraterone or other known potent CYP17 inhibitors (e.g., ketoconazole, orteronel) or investigational agents that block androgen synthesis. Previous treatment with itraconazole and fluconazole is permitted. - Prior treatment with enzalutamide or other potent androgen-receptor blockers, approved or experimental (e.g., ARN-509, ODM-201, or galeterone) - Prior treatment with flutamide (Eulexin®), steroidal anti-androgens (e.g., cyproterone acetate, chlormadinone acetate), androgens, or estrogens treatment within 4 weeks of Cycle 1, Day 1 - Prior treatment with bicalutamide (Casodex®) or nilutamide (Nilandron®) within 6 weeks of Cycle 1, Day 1 - Prior treatment with 5-alpha reductase inhibitors within 4 weeks of Cycle 1, Day 1 - Prior treatment with systemic radiopharmaceuticals (e.g., radium-223 and strontium-89). Radiopharmaceuticals for the purpose of imaging are permitted. Focal palliative radiation to treat cancer-related pain is permitted provided that the last treatment with radiation is at least 14 days prior to Cycle 1, Day 1. - Prior treatment with approved or experimental therapeutic agents with known inhibition of the PI3K pathway, including PI3K inhibitors, AKT inhibitors, and mTOR inhibitors - Administration of an investigational therapeutic agent within 28 days of Cycle 1, Day 1 - Known untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsant medications or corticosteroids for symptomatic control); a CT or MRI scan of the brain will be performed at screening if required by the local health authority - Any chronic therapy or use of food supplements that are strong CYP3A4/5 inducers or inhibitors or sensitive substrates of CYP3A or CYP2D6 with a narrow therapeutic window Abiraterone-Specific Exclusion Criteria: - Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg) - History of pituitary or adrenal dysfunction - Any ongoing cardiac arrhythmias (including atrial fibrillation) that require medical therapy Ipatasertib-Specific Exclusion Criteria: - Type 1 or Type 2 diabetes mellitus requiring insulin at study entry - History of inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis), active bowel inflammation (e.g., diverticulitis) ; PRIMARY OUTCOME: Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (PTEN Loss Population); SECONDARY OUTCOME 1: Overall Survival (OS)[/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 - OASIS-3 (Extension); BRIEF: The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis. ; DRUG USED: Mirikizumab; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participant must have completed the last visit of an eligible study period of originating study. - Participant must be willing to follow the birth control measures during and after study treatment if woman of childbearing potential. Exclusion Criteria: - Participant must not have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal lab results, that the study investigator thinks makes it unsafe or inappropriate for the participant to participate in this study. - Participant must not have stopped taking mirikizumab during a previous study or if the study investigator thinks restarting mirikizumab would create an unacceptable risk to the participant. ; PRIMARY OUTCOME: Percentage of Participants With a Static Physicians Global Assessment Among Those Who Entered the Study With a sPGA of 0,1; SECONDARY OUTCOME 1: Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)[/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 - Triple Therapy (Oral Treprostinil, Ambrisentan, Tadalafil); BRIEF: This is a multicenter, randomized (2:1 oral treprostinil: placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are currently receiving background dual therapy (ambrisentan, tadalafil) for at least 30 days at randomization for their PAH. Once randomized, subjects will return for 5 study visits up to Week 28 during the blinded period. After the Week 28 Visit, eligible subjects will transition to the open-label period of the study for up to 20 weeks. ; DRUG USED: Orenitram; DRUG CLASS: Non-NME; INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Prostacyclin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: United Therapeutics; CRITERIA: Inclusion Criteria: 1. Between 18 and 79 years of age, inclusive 2. PAH that is idiopathic / heritable, PAH associated with connective tissue disease, HIV infection, repaired congenital systemic-to-pulmonary shunts (repaired > 1 year), or appetite suppressant / toxin use 3. Receiving dual therapy (ambrisentan and tadalafil) 4. Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH Exclusion Criteria: 1. Nursing or pregnant 2. PAH due to conditions other than noted in the above inclusion criteria 3. Received PAH-specific drug therapy for >2 years 4. History of uncontrolled sleep apnea, severe liver disease, severe renal impairment, left sided heart disease, uncontrolled systemic hypertension 5. Participated in an investigational drug or device study within 90 days prior to signing consent. ; PRIMARY OUTCOME: Change in 6-Minute Walk Distance (6MWD); SECONDARY OUTCOME 1: Compare the effects of triple therapy versus dual therapy on the time to clinical worsening[/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 - 3074 (Adjunctive Ext; Depression); BRIEF: The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder. ; DRUG USED: Nuvigil; DRUG CLASS: Non-NME; INDICATION: Bipolar Disorder; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Cephalon; CRITERIA: Key Inclusion Criteria: - The patient has completed 8 weeks of treatment in a Cephalon-sponsored Phase 3, double-blind study of armodafinil treatment in patients with major depression associated with bipolar I disorder. - The patient met criteria for enrollment in the previous double-blind study and, in the opinion of the investigator, is in need of continued treatment for depression. - During the previous double-blind study, the patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium; valproic acid; olanzapine; quetiapine; aripiprazole; lamotrigine; risperidone; ziprasidone, (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met: 1. The mood stabilizers must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation. 2. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine. 3. The patient must be judged by the investigator to be compliant with treatment with the mood stabilizer(s). 4. The patient must be willing to continue treatment with the same protocol-allowed mood stabilizer(s) at dosages considered appropriate by the investigator. - The patient has a Young Mania Rating Scale (YMRS) total score of 14 or less at the enrollment visit. Patients who have a YMRS score of 12 through 14 must be discussed with the medical monitor to determine their suitability for enrollment. Key Exclusion Criteria: - The patient has any Axis I or Axis II disorder apart from bipolar I disorder that became the primary focus of treatment during the double-blind study. - The patient has psychotic symptoms or had psychosis during the double-blind study. - The patient has current active suicidal ideation, is at imminent risk of self harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present. - The patient met criteria for alcohol or substance abuse or dependence (with the exception of nicotine dependence) during the double-blind study. - The patient has any history of homicidal ideation or significant aggression or currently has homicidal or significant aggressive ideation. ; PRIMARY OUTCOME: Participants With Treatment-Emergent Adverse Events (TEAE); SECONDARY OUTCOME 1: Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)[/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 - Japan (vs. Placebo); BRIEF: This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and safety of liraglutide in combination with insulin therapy compared to insulin alone in Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial insulin therapy. ; DRUG USED: Victoza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Combination; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months - Current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in addition to diet and exercise therapy for at least 12 weeks prior to trial start. Their therapy is stable and fluctuation of total daily insulin dose is within plus/minus 20% for at least 12 weeks prior to trial start and current total daily insulin dose equal to or greater than 10 (I)U/day - Glycosylated haemoglobin (HbA1c) between 7.5 and 11.0% (both inclusive) - Body Mass Index (BMI) below 45.0 kg/m^2 Exclusion Criteria: - Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as, but not limited to systemic corticosteroids, beta-antagonists or monoamine oxidase (MAO) inhibitors - Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months - Known proliferative retinopathy or maculopathy requiring treatment according to the investigator - Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist within 12 weeks prior to screening - Treatment with any oral antidiabetic drugs (OADs) within 12 weeks prior to screening ; PRIMARY OUTCOME: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16; SECONDARY OUTCOME 1: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36[/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 - Flexible-Dose (Adolescents); BRIEF: To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia ; DRUG USED: Rexulti; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Dopamine 2 (D2) Receptor, Norepinephrine (Noradrenaline), Serotonin 5-HT1A receptor, Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Male & female subjects 13-17 years of age, inclusive. - Subjects who turn 18 during trial 331-10-234 are permitted in this trial. - Subjects with a current primary diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by the K-SADS-PL completed at time of entry into Trial 331-10-234. For de novo subjects who did not participate in Trial 331-10-234, the initial diagnosis of schizophrenia must be made and documented, and the diagnosis confirmed by the K-SADS-PL at screening. - Subjects who, in the investigators judgment, require treatment with antipsychotic medication(s). Exclusion Criteria: - Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening - Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (e.g., medication, illicit drug use). - History of failure of clozapine treatment or response to clozapine treatment only. - History of neuroleptic malignant syndrome ; PRIMARY OUTCOME: Frequency & Severity of Adverse Events (AE) [Safety]; SECONDARY OUTCOME 1: Mean change from baseline and incidence of clinically significant abnormalities in clinical laboratory tests [Safety][/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 - Europe; BRIEF: Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction. Core decompression is currently the treatment of choice for early stage osteonecrosis of the femoral head. This method consists in decompressing the rigid intra-osseous chamber to promote revascularization, thus halting progression of the disease and stimulating repair. Still this treatment remains highly controversial, since the success rates of the first studies have not been repeated. The exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated. Several hypotheses have been evoked, including fat embolism, trabecular bone microfractures, microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells recruitment. Three studies have indicated the potential clinical benefits of cell-based approaches for the treatment of osteonecrosis (Hernigou 1997, Hernigou & Beaujean 2002, Gangji et al. 2004). This is on the basis of these observations that a proprietary population of autologous osteoblastic cells (PREOB®) has been developed. This Phase 3 study aims at demonstrating the efficacy and safety of PREOB® in the treatment of early stage osteonecrosis of the femoral head. More specifically, the purpose of the study is to demonstrate that core decompression/PREOB® implantation into the necrotic lesion is superior to core decompression/placebo implantation in relieving hip symptoms and halting (or reverting) radiological progression of the disease. ; DRUG USED: PREOB; DRUG CLASS: Biologic; INDICATION: Osteonecrosis; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Bone Therapeutics S.A; CRITERIA: Inclusion Criteria: - Men or women between 18 and 70 years (inclusive) with a diagnosis of ARCO Stage I or II non-traumatic osteonecrosis of the femoral head, confirmed by central imaging analysis based on X-ray and MRI. - Ability to provide a written, dated, and signed informed consent prior to any study related procedure and to understand and comply with study requirements - Diagnosis of Osteonecrosis: 1. ARCO stage I associated with WOMAC® VA3.1 pain score ≥20 mm and necrotic angle sum ≥190° based on sagittal and coronal MRI views or 2. ARCO stage II associated with WOMAC® VA3.1 pain score ≥20 mm if necrotic angle sum <190° based on sagittal and coronal MRI views or 3. ARCO stage II associated or not with pain if necrotic angle sum is ≥190° based on sagittal and coronal MRI views 4. Associated with corticosteroid and/or with alcohol abuse and/or idiopathic - Normal haematology function, defined as leukocytes ≥3000/mm3, absolute neutrophils count ≥1500/mm3, platelets ≥140,000/mm3, and haemoglobin concentration ≥10g/dl (peripheral blood test) Exclusion Criteria: Current symptoms and/or signs related to the disease under study - Exclusively diaphyseal or metaphyseal osteonecrotic lesion - Traumatic or hyperbaric osteonecrosis, or osteonecrosis associated with hemoglobinopathy or coagulopathy (e.g., thalassemia, sickle cell disease,…), or Gauchers disease - Any other focal or diffuse bone marrow lesion - Osteoarthritis at the target hip defined as Kellgrens stage ≥2, as assessed by the Central Radiologist - Patients suffering from any medical conditions interfering with patients pain evaluation of the hip under evaluation, such as knee arthritis. - Bone fracture or bone infection at hip under evaluation. - Patients who are candidates for any predictable joint replacement on the hip that is evaluated Current or previous diagnoses, signs and/or symptoms - Active hepatitis B (defined as positive HBs Ag and/or positive PCR), or active hepatitis C (defined as positive PCR), positive serology for HIV, or Syphilis, or HTLV-1, and any other tests that may be required by the authorities in case of a new disease outbreak that can affect the safety of the physicians and operators at the time of patient screening. - Presence, or previous history, of risks factors for diseases caused by prions, and recipients of grafts of cornea, sclera, and dura mater - History of blood loss exceeding 450 ml (incl. donations) within 1 month of screening - Renal impairment defined by an estimated creatinine clearance value < 30 ml per min, calculated with the Cockcroft-Gault formula - Hepatic impairment, defined as alanine aminotransferase or aspartate aminotransferase ≥ 3 times the upper limit of normal - Poorly controlled diabetes mellitus, defined as HbA1C > 9% - Global sepsis - Allergy to gentamicin or porcine collagen or any substance or device the patient might be exposed to in the context of the study related interventions (i.e., bone marrow harvesting and implantation), as judged by the Investigator - History of hypersensitivity to human biological material, including blood and blood derived products, documented clinically or by laboratory tests - Current or past history of solid or haematological neoplasia (except for basal cell carcinoma of the skin and for carcinoma in situ of the cervix that has been treated with no evidence of recurrence) - History of bone marrow transplantation - Patients with a life expectancy less than 2 years, as judged by the Investigator Current or previous treatment - Patients having participated in another clinical trial within 3 months of screening - Patients previously treated with PREOB® - Patients treated by core decompression of the hip under evaluation within 6 months of screening - Treatment with doses of prednisolone ≥15 mg per day (or equivalent) within 1 month from screening, and patients with anticipated needs of daily corticoid doses ≥15 mg prednisone (or equivalent) in the 6 -month period following PREOB/Placebo implantation - Illicit drug or alcohol abuse interfering with patients ability to understand and comply with study requirements, as judged by the Investigator Safety aspects concerning female patients of childbearing potential - Pregnancy - Breast-feeding - Women with childbearing potential not willing or able to use reliable contraceptive method for at least 6 weeks prior to screening and during the whole study period. Reliable contraceptive methods include orally administered hormonal contraceptives, surgical intervention (e.g., tubal ligation), and intrauterine device (IUD). Other exclusion criteria: - Body Mass Index (BMI) ≥ 35 kg/m2 - Patients unable to undergo MRI, e.g. patients with pace-maker, intra-ocular or intra-cerebral metallic foreign bodies, and mechanical artificial heart valves - Patients unable to undergo general anaesthesia or surgical intervention ; PRIMARY OUTCOME: Percentage of Treatment Responders; 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 - ProstACT; BRIEF: This multinational, multicenter, prospective, randomized, controlled, open label Phase 3 study is designed to investigate and confirm the benefits and risks associated with the PSMA-targeted antibody, 177Lu DOTA rosopatamab administered together with Standard of Care (SoC), as compared to the best SoC alone. The phase 3 will be conducted in patients with metastatic castration-resistant PC (mCRPC) that expresses PSMA and has progressed despite prior treatment with a novel androgen axis drug (NAAD). ; DRUG USED: ATL101; DRUG CLASS: Biologic; INDICATION: Prostate Cancer; TARGET: Prostate-specific Membrane Antigen (PSMA), Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Telix International Pty Ltd; CRITERIA: Inclusion Criteria: 1. Be a male, at least 18 years old, with metastatic adenocarcinoma of the prostate defined by histological / pathological confirmation of PC. 2. Be of ECOG Performance Status 0, 1, or 2 and have an estimated life expectancy of ≥6 months. 3. Have metastatic disease (≥1 metastatic lesions present on baseline CT, MRI, or bone scan imaging). 4. Have castration-resistant PC (defined as disease progressing despite castration by orchiectomy or ongoing use of luteinizing hormone-releasing hormone [LHRH]) and must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L). 5. In the mCRPC setting, must have received a minimum of 12 weeks of prior therapy with a NAAD, either enzalutamide or abiraterone plus prednisone. 6. Should have received one line of prior taxane therapy or have refused or be ineligible for taxanes 7. Have a disease that is progressing at study entry, despite a castrate testosterone level (<50 ng/dL or <1.7 nmol/L), by the demonstration of at least one of the following: 1. Rising PSA values done in sequence at least 1 week apart and with a minimal starting value of 2.0 ng/mL. 2. Progressive disease or new lesion(s) in the viscera or lymph nodes as per RECIST1.1 or in bone as per Prostate Cancer Working Group 3 [PCWG3; Scher et al., 2016]). Any ambiguous results are to be confirmed by other imaging modality (e.g., CT or MRI scan). 8. Have disease that is PSMA positive, as demonstrated by a 68Ga-PSMA11 PET/CT scan and confirmed as eligible by the Sponsors central reader (patient must have at least one site of metastatic disease with SUVmax ≥1.5 times the SUV of normal liver). If the disease meets the criteria for PSMA positivity, but there is one or more soft tissue lesion of ≥ 2 cm that is not PSMA positive, then the patient is to be excluded on the grounds that there is substantial disease which might not respond to the therapy. 9. Must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e., surgery, local radiotherapy, NAAD, chemotherapy, etc.). 10. Can be receiving a bisphosphonate or denosumab regimen provided that the patient has been receiving and tolerating this treatment for ≥30 days prior to randomization. 11. Have adequate organ function at Screening: a. Bone marrow: i. Platelets ≥150×109/L. ii. Absolute neutrophil count >1.5×109/L. iii. Hemoglobin ≥10g/dL (no red blood cell transfusion in the previous 4 weeks). b. Liver function: i. Total bilirubin < 1.5×the upper limit of normal (ULN). For patients with known Gilberts Syndrome <3×ULN is permitted. ii. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <3×ULN OR <5×ULN for patients with liver metastases. c. Renal function: i. Serum/plasma creatinine <1.5×ULN or creatinine clearance ≥50 mL/min determined using the Cockcroft & Gault formula. 12. Have the capacity to understand the study and be able and willing to comply with all protocol requirements. 13. Patients must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution in order to protect their contacts and the general public, especially if a female partner of the patient is or could be pregnant. 14. Must agree to practice adequate precautions to prevent pregnancy in a partner and to avoid potential problems associated with radiation exposure to the unborn child (Refer to Clinical Trials Facilitation Group, 2020: Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1, CTFG, 2020). Exclusion Criteria: 1. Are unable to understand or are unwilling to sign a written informed consent document or to follow investigational procedures in the opinion of the Investigator. 2. Have PC associated with pathological findings consistent with small cell or any histology other than adenocarcinoma of the prostate. If there are minor elements of neuroendocrine histology, this is acceptable. 3. Uncontrolled pain. 4. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease-free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, and superficial bladder cancer. 5. Are at increased risk of hemorrhage or bleeding, or with a recent history of a thrombolytic event (e.g., deep vein thrombosis [DVT]/ pulmonary embolism [PE]) and have been administered long-term anti-coagulant or anti-platelet agents. 6. Have received prior treatment with monoclonal antibody (mAb) J591 or HuJ591 or any other PSMA targeted therapy. 7. Have known allergies, hypersensitivity, or intolerance to the investigational drug or its excipients. 8. Have received prior systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, or biological therapy) and/or radiation therapy within 4 weeks of randomization OR if any significant AEs have not resolved to National Cancer Institute (NCI) AE Criteria ≤2; OR are receiving other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy. 9. Have received prior treatment with radioisotopes, including but not limited to: 89Strontium, 153Samarium, 186Rhenium, 188Rhenium, 223Radium, or hemi-body irradiation within 6 months prior to randomization. 10. Have received other investigational therapy within 4 weeks of randomization. 11. Have known brain metastases or hepatic metastases. 12. Have a history of seizure and/or stroke within past 6 months. 13. Have clinical or radiologic findings indicative of impending cord compression or experience symptomatic cord compression. 14. Have a serious active or sub-clinical infection or angina pectoris (New York Heart Association [NYHA] Class III or IV), significantly prolonged QT interval or other serious illness(es) involving the cardiac, respiratory, central nervous system, renal, hepatic or hematological organ systems, which might impair the ability to complete this study or could interfere with determination of causality of any adverse effects experienced in this study, or which require treatment that could interact with study treatment, particularly with enzalutamide. 15. Have received treatment with any PARP inhibitors (i.e., Olaparib) or with any platinum based anti-neoplastic drugs. 16. Have a known alteration in breast cancer genes (BRCA) BRCA1, BRCA2, or Ataxia Telangiectasia Mutated Gene (ATM) gene and are eligible to receive Olaparib therapy according to their institutions SoC ; PRIMARY OUTCOME: Comparison of radiographic progression-free survival (rPFS); SECONDARY OUTCOME 1: Overall survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - DUAL VII (vs. Basal-Bolus Therapy); BRIEF: This trial is conducted globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus. ; DRUG USED: Xultophy; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor, Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening - HbA1c (glycosylated haemoglobin) 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis - Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening - Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive - Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening - Body mass index (BMI) below or equal to 40 kg/m^2 Exclusion Criteria: - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening - Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids) - Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times upper limit of normal - Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Screening calcitonin at least 50 ng/L - History of pancreatitis (acute or chronic) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 ; PRIMARY OUTCOME: Change in HbA1c (Glycosylated Haemoglobin); SECONDARY OUTCOME 1: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.[/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 - IRONS; BRIEF: This is a multicenter, randomized (2:1; oral treprostinil:placebo), double-blind, placebo-controlled event-driven (time to pulmonary hypertension [PH] clinical worsening) study in subjects with PH associated with sickle cell disease (SCD). Once enrolled, subjects will be evaluated at Weeks 6, 12, 24, and then every 12 weeks for the duration of the study. Subjects will be permitted to enter a 48-week open-label extension period if they experience a PH clinical worsening event. ; DRUG USED: Orenitram; DRUG CLASS: Non-NME; INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Prostacyclin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: United Therapeutics; CRITERIA: Inclusion Criteria: 1. The subject must have a diagnosis of SCD confirmed by hemoglobin electrophoresis. 2. The subject has a diagnosis of symptomatic World Health Organization (WHO) Group 5.1 chronic hemolytic anemia PH. 3. The subject must have a Baseline 6MWD greater than 150 meters, in the absence of a concurrent injury, illness, or other confounding factor. 4. The subject has pulmonary function tests conducted within 6 months of Screening or during the Screening period. 5. The subject must be on stable doses of other medical therapy for at least 30 days prior to randomization with no dose adjustments, additions, or discontinuations. 6. The subject must be optimally treated with conventional PH therapy for at least 10 days prior to randomization with no additions, discontinuations, or dose changes. 7. Subjects receiving an endothelin receptor antagonist (ERA) must have been receiving therapy for greater than 90 days, and have reached and maintained a stable dose for a minimum of 30 days prior to randomization. 8. Subjects receiving calcium channel blockers must have been on a stable dose for a minimum of 3 months prior to randomization. Exclusion Criteria: 1. The subject is pregnant or lactating. 2. The subject has previously received oral treprostinil or is receiving a phosphodiesterase type 5 inhibitor (PDE5-I). 3. The subject has received a prostacyclin within 30 days prior to start of the study, or had previous intolerance or significant lack of efficacy to any prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to titrate that therapy effectively. 4. The subject has had any other background conventional therapies for PH added, removed, or doses adjusted within 10 days prior to randomization. 5. The subject has any disease associated with pulmonary arterial hypertension (PAH). 6. The subject has had a vaso-occlusive crisis, acute chest syndrome event, or unscheduled transfusion within 30 days of randomization. 7. The subject has a history of ischemic heart disease, including a previous myocardial infarction or symptomatic coronary artery disease, within 6 months prior to Screening or a left ventricular ejection fraction less than 40% assessed by either multigated angiogram (MUGA), angiography, or echocardiogram. 8. The subject has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels 3 times or greater than the upper limit of normal, clinically significant liver disease/dysfunction, or known Child-Pugh Class B or C hepatic disease at Screening. 9. The subject has chronic renal insufficiency, as defined by the requirement for dialysis. 10. The subject has a musculoskeletal disorder, any disease that is likely to limit ambulation, or is connected to a machine that is not portable. 11. The subject has an unstable psychiatric condition or is mentally incapable of understanding the objectives, nature, or consequences of the study, or has any condition which in the Investigators opinion would constitute an unacceptable risk to the subjects safety. 12. The subject is receiving an investigational drug, has an investigational device in place, or has participated in an investigational drug or device study within 30 days prior to Screening. ; PRIMARY OUTCOME: Effect of oral treprostinil compared with placebo on time to first adjudicated PH clinical worsening (morbidity or mortality) event in subjects with PH associated with SCD; SECONDARY OUTCOME 1: Effect of oral treprostinil compared with placebo on exercise capacity as assessed by 6-Minute Walk Distance (6MWD)[/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 - 14376 (Japan); BRIEF: The purpose of the study is to assess the efficacy and safety of duloxetine in participants with Chronic Low Back Pain (CLBP). ; DRUG USED: Cymbalta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Low Back Pain (CLBP); TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participants with CLBP present for the preceding 6 months or longer - Participants used nonsteroidal anti-inflammatory drugs for CLBP for more than 14 days on average per month in the past 3 months and more than 14 days in one month prior to screening - Participants having a score of ≥4 on Brief Pain Inventory (BPI) average pain score before randomized - Female participants having child-bearing potential must test negative (-) on a pregnancy test Exclusion Criteria: - Participants have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication - Participants having a history of low back surgery - Participants having received epidural steroids, facet block, nerve block or other invasive procedures aimed to reduce low back pain within one month prior to screening - Participants who have any difficulties to fulfill diary appropriately - Participants having any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder - Participants having major depressive disorder as determined using depression module of the Mini-International Neuropsychiatric Interview - Participants having primary painful condition due to other than CLBP - Participants being anticipated by the investigator to require use of nonsteroidal anti-inflammatory drugs and includes acetaminophen, opioid analgesics, or other excluded medication for the duration of the study - Participants being considered as inappropriate for participation to the study for any medical or other reason as judged by the investigator - Participants answering yes to any of the questions about active suicidal ideation/intent/behaviors occurring within the past month (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section) - Participants having a positive urine drug screen for any substances of abuse or excluded medication - Participants having alanine aminotransferase or aspartate aminotransferase higher than 100 International Units per Liter (IU/L) or total bilirubin higher than 1.6 milligram per deciliter (mg/dL) - Participants having serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or receiving renal dialysis - Participants having uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension - Participants have had previous exposure to duloxetine or completed / withdrawn from any study investigating duloxetine - Participants having serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychiatric conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study - Participants have known hypersensitivity to multiple medications - Participants having diagnosis seronegative spondyloarthropathy or rheumatoid arthritis - Participants taking any excluded medications that cannot be discontinued - Participants treating with a monoamine oxidase inhibitor (MAOI) within 14 days or the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug - Participants are non-ambulatory or require the use of crutches or a walker - Participants having a history of substance abuse or dependence within the past year, excluding nicotine and caffeine - Pregnant participants or participants were breast-feeding, or wished to be pregnant during the clinical trial period - Participants cannot use appropriate contraceptive method or do not want to use that from screening until one month after the end of administration of the investigational drug ; PRIMARY OUTCOME: Change From Baseline to Week 14 in Brief Pain Inventory (BPI) 24-Hour Average Pain Severity Item; SECONDARY OUTCOME 1: Patient Global Impression of Improvement (PGI-I) at Week 14[/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 - Patients <U>></U>12 years old; BRIEF: This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study ; DRUG USED: QVAR RediHaler; DRUG CLASS: Non-NME; INDICATION: Asthma; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: - Severity of Disease: The patient has persistent asthma, with an forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) reference values at screening visit (SV) (Hankinson et al 1999). - Current asthma therapy: The patient is currently being treated with 1 of the following: 1) inhaled corticosteroids (ICSs) at a stable daily dose of less than or equal to 220 mcg/day fluticasone propionate via metered dose inhaler (MDI) or equivalent for a minimum of 4 weeks (28 days) before screening visit, or 2) a stable daily dosage of non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones, or short-acting beta-2 agonists (SABAs) alone or in combination for a minimum of 4 weeks (28 days) before screening visit (SV). - Reversibility of disease: The patient has demonstrated at least 15% and at least 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at SV or on retesting. - Other criteria apply, please contact the investigator for more information Exclusion Criteria: - The patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures. - The patient is a pregnant or lactating female or plans to become pregnant. - The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation. - The patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient may not have used tobacco products within the past year. - The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before SV, or has had any hospitalization for asthma within 2 months before SV. - The patient has historical or current evidence of a clinically significant disease. Significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study. - Other criteria apply, please contact the investigator for more information ; PRIMARY OUTCOME: Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 12 Weeks (AUEC(0-12wk)) by Actual Treatment Received; SECONDARY OUTCOME 1: Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 12-Week Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CEDAR; BRIEF: This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration. ; DRUG USED: Darpin; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Diagnosis of age-related macular degeneration in at least 1 eye - Best corrected visual acuity of 20/40 to 20/320 in the study eye - Best corrected visual acuity of 20/200 or better in the non-study eye Exclusion Criteria: - History of vitrectomy, macular surgery, or glaucoma surgery in the study eye - Cataract or refractive surgery in the study eye within the last 3 months ; PRIMARY OUTCOME: Percentage of Participants With Stable Vision at Week 52; SECONDARY OUTCOME 1: Mean Change From Baseline in BCVA in the Study Eye at Week 52[/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 - REACH-2 (Acute vs. BAT); BRIEF: Assess the efficacy and safety of ruxolitinib compared to Best Available Therapy (BAT) in patients with corticosteroid-refractory acute graft vs. host disease (aGvHD) after allogeneic stem cell transplantation. ; DRUG USED: Jakafi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Graft vs. Host Disease (GVHD) - Treatment; TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Have undergone Allogeneic Stem Cell Transplanttaion (alloSCT) from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non- myeloablative, myeloablative, and reduced intensity conditioning are eligible - Clinically diagnosed Grades II to IV acute GvHD as per standard criteria occurring after alloSCT requiring systemic immune suppressive therapy. Biopsy of involved organs with aGvHD is encouraged but not required for study screening. - Confirmed diagnosis of steroid refractory aGvHD defined as patients administered high-dose systemic corticosteroids (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]), given alone or combined with calcineurin inhibitors (CNI) and either: - Progressing based on organ assessment after at least 3 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD, OR - Failure to achieve at a minimum partial response based on organ assessment after 7 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD,OR - Patients who fail corticosteroid taper defined as fulfilling either one of the following criteria: - Requirement for an increase in the corticosteroid dose to methylprednisolone ≥2 mg/kg/day (or equivalent prednisone dose ≥2.5 mg/kg/day) , OR - Failure to taper the methylprednisolone dose to <0.5 mg/kg/day (or equivalent prednisone dose <0.6 mg/kg/day) for a minimum 7 days. Exclusion Criteria: - Has received more than one systemic treatment for steroid refractory aGvHD. - Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. - Evidence of uncontrolled viral infection including Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Human Herpes Virus-6 (HHV-6), Hepatitis Virus (HBV), or Hepatitis C Virus (HCV) based on assessment by the treating physician. - Presence of relapsed primary malignancy, or who have been treated for relapse after the alloHSCT was performed, or who may require rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse. ; PRIMARY OUTCOME: Overall Response Rate (ORR) at Day 28; SECONDARY OUTCOME 1: Durable Overall Response Rate (DORR) (Key Secondary Endpoint) at Day 56[/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 - SEAM-PsA (w/Methotrexate); BRIEF: The purpose of this study is to learn more about the role of etanercept alone or in combination with methotrexate on disease activity in adults with psoriatic arthritis. ; DRUG USED: Enbrel; DRUG CLASS: Biologic; INDICATION: Psoriatic Arthritis (PA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Amgen; CRITERIA: Key Inclusion Criteria: - Subject must have a diagnosis of psoriatic arthritis (PsA) by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria. - Subject has ≥ 3 tender and ≥ 3 swollen joints at screening and at baseline. - Subject has an active psoriatic skin lesion - Subject is naïve to etanercept and any other biologic for the treatment for PsA or psoriasis. - Subject has no prior use of methotrexate for PsA. - Subject has no history of tuberculosis - Subject has a negative test for tuberculosis, hepatitis B and C. Exclusion Criteria: - Subject has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or immunodeficiency syndromes, including human immunodeficiency virus (HIV) infection. - Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to the first dose of investigational product. - Subject has a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first dose of investigational product. ; PRIMARY OUTCOME: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24; SECONDARY OUTCOME 1: Percentage of Participants With a Minimal Disease Activity (MDA) 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 - CR108134; BRIEF: The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric participants is consistent with that in adults (part 1) and to assess efficacy (event-free survival [EFS]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, and idarubicin (RVICI) background therapy compared to RICE or RVICI background therapy alone (part 2). ; DRUG USED: Imbruvica; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Brutons Tyrosine Kinase (BTK), Interleukin-2-inducible T-cell kinase (ITK); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Participants with 1 to less than (<) 18 years of age (Part 1 only), or 1 to 30 years of age, inclusive, if initial diagnosis of mature B-cell non-Hodgkin lymphoma (NHL) occurred at <18 years of age (Part 2 only) - Participants must be in first recurrence and have received only one prior line of therapy or have disease that is primarily refractory to conventional therapy - Participants must have at least 1 of the following: 1 site of measurable disease greater than (>) 1 centimeter (cm) in the longest diameter and >1 cm in the shortest diameter by radiological imaging; bone marrow involvement; cerebrospinal fluid with blasts present - Participants with lansky-Karnofsky score of greater than or equal to (>=) 50 - Adolescent women/young women of childbearing potential must have a negative highly sensitive serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at Screening before enrollment/randomization. Adolescent/young women who are pregnant or breastfeeding are ineligible for this study Exclusion Criteria: - Participants with ongoing anticoagulation treatment with warfarin or equivalent vitamin K antagonists (example phenprocoumon), or ongoing treatment with agents known to be strong CYP3A4/5 inhibitors, or has taken any disallowed therapies as noted in Section 8.2, Prohibited Medications, before the planned first dose of study drug - Participants with inherited or acquired bleeding disorders - Participants with clinically significant arrhythmias, complex congenital heart disease, or left ventricular ejection fraction (LVEF) <50 percent (%) or shortening fraction (SF) <=28% - Participants with known history of human immunodeficiency virus (HIV) or active Hepatitis B or C virus - Participants with any condition that could interfere with the absorption or metabolism of ibrutinib including malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel - Participants with known allergies, hypersensitivity, or intolerance to ibrutinib or its excipients (refer to Investigators Brochure) - A diagnosis of post-transplant lymphoproliferative disease (PTLD) - Participants who are within 6 months of an allogeneic bone marrow transplant - Participants who have had prior exposure to ibrutinib ; PRIMARY OUTCOME: Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib; SECONDARY OUTCOME 1: Part 1 and Part 2: Number of Participants With Adverse Events as Measure of Safety and Tolerability[/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 - Infacort 003; BRIEF: The study will be conducted in a total of 24 subjects before their 6th birthday, requiring replacement therapy for adrenal insufficiency due to either CAH, primary adrenal failure or hypopituitarism. The study will consist of three consecutive cohorts. Cohort 1 will include 12 subjects aged between 2 and < 6 years. If no safety concerns emerge, then 6 subjects aged 28 days to <2 years will be enrolled (Cohort 2). A review of accumulated data will be undertaken and only if again no safety concerns emerge, then 6 neonates aged from birth to <28 days will be enrolled (Cohort 3). The decision to continue after each cohort will be based on the recommendation of an Independent Data Monitoring Committee (IDMC). ; DRUG USED: Alkindi Sprinkle; DRUG CLASS: Non-NME; INDICATION: Congenital Adrenal Hyperplasia (CAH); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Diurnal Limited; CRITERIA: Inclusion Criteria: 1. Male and female children less than 6 years of age. 2. A diagnosis of adrenal insufficiency as confirmed by an inappropriately low cortisol usually with other supporting tests. 3. Receiving appropriate adrenocortical replacement therapy (hydrocortisone with/without fludrocortisone). 4. Adequately hydrated and nourished. 5. Ability of parents/carers to understand and give written Informed Consent Exclusion Criteria: 1. Clinically evident acute adrenal insufficiency (adrenal crisis). 2. Inability of the child to take oral therapy. 3. Concomitant therapy (other than that required to treat adrenal insufficiency, Vitamin D, Fluoride, Thyroxine and growth hormone). 4. Subjects with clinical signs of acute infection or fever on Day 1. 5. Any surgical or medical condition which in the opinion of the investigator may place the subject at higher risk from his/her participation in the study. 6. Parents/carers of subjects unwilling to consent to saving and propagation of pseudonymised medical data for study reasons. 7. Subjects who are dependent on the investigator or the sponsor. ; PRIMARY OUTCOME: Serum Cortisol Concentration up to 240 Minutes; SECONDARY OUTCOME 1: Serum Cortisol Concentration up to 6 Hours[/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 - NEI (laser, triamcinolone); BRIEF: The purpose of the study is to find out which is a better treatment for diabetic macular edema (DME): laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections, with or without laser treatment, are better than just laser by itself. It is possible that one or both of the types of injections, with or without laser treatment, will improve vision more often than will laser without injections. However, even if better vision outcomes are seen with injections, side effects may be more of a problem with the injections than with laser. Therefore, this study is conducted to find out whether the benefits of the injections will outweigh the risks. ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Jaeb Center for Health Research; CRITERIA: General Inclusion Criteria To be eligible, the following inclusion criteria (1-5) must be met: - Age >= 18 years - Diagnosis of diabetes mellitus (type 1 or type 2) - At least one eye meets the study eye criteria - Fellow eye (if not a study eye) meets criteria - Able and willing to provide informed consent General Exclusion Criteria A subject is not eligible if any of the following exclusion criteria are present: - Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. - 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). - Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry. - Known allergy to any component of the study drug. - Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). - Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months. - Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization. - Systemic anti-vascular growth factor (anti-VEGF) or pro-VEGF treatment within 4 months prior to randomization. - For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months. - Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 12 months of the study. Study Eye Inclusion Criteria The subject must have one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below. A subject may have two study eyes only if both are eligible at the time of randomization. - Best corrected electronic Early Treatment Diabetic Retinopathy (E-ETDRS) visual acuity letter score <= 78 (i.e., 20/32 or worse) and >= 24 (i.e., 20/320 or better) within 8 days of randomization. - On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula. - Ocular coherence tomography (OCT) central subfield >=250 microns within 8 days of randomization. - Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs. - If prior macular photocoagulation has been performed, the investigator believes that the study eye may possibly benefit from additional photocoagulation. Study Eye Exclusion Criteria The following exclusions apply to the study eye only (i.e., they may be present for the nonstudy eye): - Macular edema is considered to be due to a cause other than diabetic macular edema. - An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition). - An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.) - Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal). - History of treatment for diabetic macular edema at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment). - History of panretinal (scatter) photocoagulation (PRP) within 4 months prior to randomization. - Anticipated need for PRP in the 6 months following randomization. - History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization. - History of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to randomization. - Aphakia. - Intraocular pressure >= 25 mmHg. - History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: history of angle-closure glaucoma is not an exclusion criterion). - History of steroid-induced intraocular pressure (IOP) elevation that required IOP-lowering treatment. - History of prior herpetic ocular infection. - Exam evidence of ocular toxoplasmosis. - Exam evidence of pseudoexfoliation. - Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis. ; PRIMARY OUTCOME: Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity; SECONDARY OUTCOME 1: Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year[/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 - JAGS; BRIEF: The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as baricitinib in participants with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate therapy. ; DRUG USED: Olumiant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have a diagnosis of adult-onset RA as defined by the ACR/European League Against Rheumatism (EULAR) 2010 Criteria for the Classification of RA. - Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints. - Have a CRP (or hsCRP) measurement ≥ 6 mg/liter (L) based on the most recent data (if available). - Have had regular use of MTX for at least the 12 weeks prior to study entry at a dose that, in accordance with local clinical practice, is considered acceptable to adequately assess clinical response. The dose of MTX must have been a stable, unchanging oral dose of 7.5 to 25 mg/week (or the equivalent injectable dose) for at least the 8 weeks prior to study entry. The dose of MTX is expected to remain stable throughout the study and may be adjusted only for safety reasons. Exclusion Criteria: - Are currently receiving corticosteroids at doses >10 mg of prednisone per day (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization. - Have started treatment with NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization. - Are currently receiving concomitant treatment with MTX, hydroxychloroquine, and sulfasalazine or combination of any 3 conventional disease modifying anti-rheumatic drugs (cDMARDs). - Are currently receiving or have received cDMARDs (for example, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 8 weeks prior to study entry. - Have received leflunomide in the 12 weeks prior to study entry (or within 4 weeks prior to study entry if the standard 11 days of cholestyramine is used to washout leflunomide). - Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry. - Have ever received any biologic DMARD (such as tumor necrosis factor (TNF), interleukin-1, interleukin-6 (IL-6), or T-cell- or B-cell-targeted therapies). - Have received any parenteral corticosteroid administered by intramuscular or intravenous injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study. - Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization. - Have a diagnosis of any systemic inflammatory condition other than RA such as, but not limited to, juvenile chronic arthritis, spondyloarthropathy, Crohns disease, ulcerative colitis, psoriatic arthritis, active vasculitis or gout. - Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of <40 milliliters/minute/1.73 meters squared (m^2). - Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal (ULN) or the most recent available total bilirubin 1.5 times the ULN. - Have a current or recent (<30 days prior to study entry) clinically serious viral, bacterial, fungal, or parasitic infection. - Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). - Have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB. - Have evidence of active TB or have previously had evidence of active TB and did not receive appropriate and documented treatment. - Are pregnant or nursing at the time of study entry. - Are females of childbearing potential who do not agree to use 2 forms of highly effective birth control when engaging in intercourse while enrolled in the study and for at least 28 days following the last dose of orally administered investigational product. - Are males who do not agree to use 2 forms of highly effective birth control while engaging in sexual intercourse with female partners of childbearing potential while enrolled in the study and for at least 28 days following the last dose of orally administered investigational product. - Have previously been randomized in this study or any other study investigating baricitinib. - Have received prior treatment with an oral janus kinase inhibitor. ; PRIMARY OUTCOME: Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20); SECONDARY OUTCOME 1: Change From Baseline to Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) 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 - A2324 (Moderate/Severe Plaque Psoriasis); BRIEF: The purpose of this study is to assess secukinumab high dose (every 2 weeks) vs standard dose (every 4 weeks) in heavy body weight subjects with moderate to severe plaque psoriasis. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Written informed consent must have been obtained before any assessment was performed. Where relevant, a legal representative will also have signed the informed study consent according to local laws and regulations. - Subjects must have been able to understand and communicate with the investigator and comply with the requirements of the study. - Men or women at least 18 years of age at time of screening. - Body weight of ≥ 90 kg at the time of randomization. - Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization. - Moderate to severe psoriasis as defined at randomization by: - Psoriasis Area and Severity Index (PASI) score of 12 or greater, and - Investigators Global Assessment (IGA) mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and - Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater. - Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by: - topical treatment and/or, - phototherapy and/or, - previous systemic therapy. Key Exclusion Criteria: - Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or Randomization. - Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit ultraviolet (UV) light exposure (e.g., sunbathing and / or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited. Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited. - Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting Interleukin-17 (IL-17) or the IL-17 receptor. - Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 4 weeks until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations. - Pregnant or nursing (lactating) women - History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowens disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed). - History of hypersensitivity to any of the study drug constituents. ; PRIMARY OUTCOME: Percentage of Subjects Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set); SECONDARY OUTCOME 1: Percentage of Subjects Who Achieve Investigator Global Assessment (IGA Modified 2011) Score of 0 or 1 - Week 16 (Full Analysis Set)[/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 - B2302 (Familial Chylomicronemia); BRIEF: The purpose of this study is to determine whether LCQ908 is effective and safe in lowering triglycerides in subjects with Familial Chylomicronemia Syndrome (FCS) (Hyperlipoproteinemia [HLP] type I). Data from this study will be used to support a registration submission of LCQ908 20 mg and 40 mg as treatment of chylomicronemia in subjects with FCS (HLP Type 1). ; DRUG USED: LCQ908; DRUG CLASS: New Molecular Entity (NME); INDICATION: Familial Chylomicronemia Syndrome (FCS)/Lipoprotein Lipase Deficiency (LPLD); TARGET: Diglycerol Acyltransferase (DGAT); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: 1. Written informed consent given before any assessment was performed for Period I. 2. Male and female patients ages at least 18 years of age. 3. Fasting triglyceride ≥ 8.4 mmol/L (750 mg/dL) at Screening. 4. An established diagnosis of FCS (HLP Type I) confirmed through ultracentrifugation or by documented medical history of a fasting triglyceride ≥ 8.4 mmol/L (750 mg/dL) and by documentation of any of the following at Screening or during the Screening Period: - Confirmed homozygote or compound heterozygote for known loss-of-function mutations in Type I-causing genes (such as LPL, apo C II, GPIHBP1, or LMF1) - Post heparin plasma LPL activity of ≤ 20% of normal - Confirmed presence of LPL inactivating antibodies 5. History of pancreatitis. Key Exclusion Criteria: 1. Current pancreatitis, pancreatitis was required to be inactive for at least 1 week prior to the screening Visit. 2. Treatment with fish oil preparations within 4 weeks prior to randomization. 3. Treatment with bile acid binding resins (i.e., colesevelam, etc.) within 4 weeks prior to randomization. 4. Treatment with fibrates within 4 weeks prior to randomization. 5. Glybera [alipogene tiparvovec (AAV1-LPLS447X)] gene therapy exposure within the two years prior to screening. 6. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 7. Any surgical or medical conditions, acute or unstable chronic disease which may, based on the investigators opinion, jeopardize the patient in case of participation in the study or might significantly alter the absorption, distribution, metabolism or excretion of the study drug. 8. History of drug or alcohol abuse within the 12 months prior to randomization or evidence of such abuse at screening. 9. Evidence of liver disease or liver injury as indicated by abnormal liver function tests such as aspartate aminotransferase (AST) and alanine aminotransferase (ALT), or serum bilirubin. 10. Estimated glomerular filtration rate (eGFR) <30mL/min/1.73m2 or history of chronic renal disease. 11. Participation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, or any other limitation of participation based on local regulations. 12. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. 13. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG laboratory test. 14. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 100 days after discontinuation of investigational study drug. ; PRIMARY OUTCOME: Percent Change in Fasting Triglycerides From Baseline to 12 Weeks; SECONDARY OUTCOME 1: Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline or Final Fasting TG < 8.4 mmol/L (750 mg/dL)[/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 - FALCON; BRIEF: This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 850 patients will be enrolled. ; DRUG USED: Bardoxolone Methyl; DRUG CLASS: New Molecular Entity (NME); INDICATION: Polycystic Kidney Disease; TARGET: KEAP1 (Kelch-like ECH-associated protein 1), STAT3 Transcription Factor; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Inclusion Criteria: - Male and female patients 12 ≤ age ≤ 70 upon study consent; - Diagnosis of ADPKD by modified Pei-Ravine criteria: 1) at least 3 cysts per kidney by sonography or at least 5 cysts by CT or MRI with family history of ADPKD or 2) at least 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history; - Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 to≤ 90 mL/min/1.73 m2 (18 to 55 years) or ≥ 30 to ≤ 44 mL/min/1.73 m2 (56 to 70 years): 1) Patients with either screening eGFR ≥ 60 to ≤ 90 mL/min/1.73 m2 or age 56 to 70 years, must have evidence of ADPKD progression (i.e., eGFR decline of ≥ 2.0 mL/min/1.73 m2 per year, based on historical eGFR data and medical monitor discretion); 2)The two eGFR values collected at Screen A and Screen B visits used to determine eligibility must have a percent difference ≤ 25%; - Albumin to creatinine ratio (ACR) ≤ 2500 mg/g at Screen B visit; - Systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at Screen A visit after a period of rest. Exclusion Criteria: - History of administration of polycystic kidney disease-modifying agents (somatostatin analogues) within 3 months prior to the Screen A visit; - B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit; - Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit; - Serum albumin < 3 g/dL at Screen A visit; - History of intracranial aneurysms; - Kidney or any other solid organ transplant recipient or a planned transplant during the study; - Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening; - History of clinically significant left-sided heart disease and/or clinically significant cardiac disease; - Systolic BP < 90 mm Hg at Screen A visit after a period of rest; - BMI < 18.5 kg/m2 at the Screen A visit; - History of malignancy within 5 years prior to Screen A visit, with the exception of localized skin or cervical carcinomas; - Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study; - Untreated or uncontrolled active bacterial, fungal, or viral infection; - Participation in other interventional clinical studies within 30 days prior to Day 1; - Unwilling to practice acceptable methods of birth control (both males who have partners of child-bearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested; - Women who are pregnant or breastfeeding; - Concomitant use of tolvaptan is excluded. Patients previously treated with tolvaptan must have discontinued drug for at least 3 months prior to Screen A visit ; PRIMARY OUTCOME: Change in eGFR from baseline (108 weeks); SECONDARY OUTCOME 1: Change in eGFR from baseline (100 weeks)[/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 - MINISTONE-2 (Pediatric, Ages 1 to 11); BRIEF: This study will evaluate the safety, pharmacokinetics, and efficacy of baloxavir marboxil compared with oseltamivir in a single influenza episode in otherwise healthy pediatric participants (i.e., 1 to <12 years of age) with influenza-like 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: - Aged 1 to < 12 years at randomization (Day 1). - Written informed consent/assent for study participation obtained from participants parents or legal guardian, with assent as appropriate by the participant, depending on the patients level of understanding - Participant able to comply with study requirements, depending on the patients level of understanding - Participant with a diagnosis of influenza virus infection confirmed by the presence of all of the following: - Fever ≥ 38 degree celsius (tympanic temperature) at screening - At least one respiratory symptom (either cough or nasal congestion) - The time interval between the onset of symptoms and screening is ≤ 48 hours Exclusion Criteria: - Severe symptoms of influenza virus infection requiring inpatient treatment - Concurrent infections requiring systemic antiviral therapy at screening - Require, in the opinion of the investigator, any of the prohibited medication during the study - Previous treatment with peramivir, laninamivir, oseltamivir, zanamivir, or amantadine within 2 weeks prior to screening - Immunization with a live/attenuated influenza vaccine in the 2 weeks prior to randomization - Concomitant treatment with steroids or other immuno-suppressant therapy - Known HIV infection or other immunosuppressive disorder - Uncontrolled renal, vascular, neurologic, or metabolic disease (e.g., diabetes, thyroid disorders, adrenal disease), hepatitis, cirrhosis, or pulmonary disease or participants with known chronic renal failure. - Active cancer at any site - History of organ transplantation - Known allergy to either study drug (i.e., baloxavir marboxil and oseltamivir) or to acetaminophen - Females with child-bearing potential - Participation in a clinical trial within 4 weeks or five half-lives of exposure to an investigational drug prior to screening, whichever is longer ; PRIMARY OUTCOME: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MET56 (Age 15+); BRIEF: The aim of the study was to describe the safety and antibody response to booster administration with Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine in participants who received their first quadrivalent meningococcal Conjugate vaccine dose in the past 4-10 years. Primary Objective: - To demonstrate the non-inferiority of the vaccine seroresponse of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of MenACYW Conjugate vaccine compared to those observed following the administration of a booster dose of Menactra® in participants who were first vaccinated with 1 dose of a quadrivalent meningococcal vaccine 4 to 10 years before the booster dose. Secondary Objectives: - To evaluate the vaccine seroresponse of meningococcal serogroups A, C, Y, and W measured using human serum bactericidal assay (hSBA) in serum specimens collected 6 days after vaccination in a subset of 120 participants. - To evaluate the antibody responses (geometric mean titers) to serogroups A, C, Y, and W measured using hSBA on Day 0 (pre-vaccination) and Day 30 after vaccination. Observational Objectives: - To describe the antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA assessed at Day 0, Day 6, and Day 30 days after vaccination. - To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days after vaccination with MenACYW Conjugate vaccine or Menactra® measured by rabbit serum bactericidal assay (rSBA) in a subset of participants. - To describe the safety profile of MenACYW Conjugate vaccine compared to that of a licensed Menactra® after booster vaccination. ; DRUG USED: MenQuadfi; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Groups A, C, Y, and W-135; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi Pasteur, a Sanofi Company; CRITERIA: Inclusion Criteria: - Aged >= 15 years on the day of inclusion. - Participant has documented record of having received 1 dose of a quadrivalent meningococcal conjugate vaccine 4 to 10 years prior to study vaccination. - Participant aged 15 to < 18 years: assent form signed and dated by the participant and informed consent form (ICF) signed and dated by the parent or guardian. - Participant aged >=18 years: ICF signed and dated by the participant. - Participants aged 15 to < 18 years: both the participant and parent / guardian were able to attend all scheduled visits and to comply with all trial procedures. - Participants aged >= 18 years: able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: - Participant was pregnant, lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination). - Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. - Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine before Day 30 visit except for influenza vaccination, which may be received at least 2 weeks before study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. - Previous vaccination against meningococcal disease with either an investigational or approved meningococcal B vaccine. - Receipt of immune globulins, blood or blood-derived products in the past 3 months. - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). - History of meningococcal infection, confirmed either clinically, serologically, or microbiologically. - At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease). - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances. - Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine. - Personal history of Guillain-Barré syndrome. - Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the Investigators opinion. - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigators opinion. - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. - Current alcohol abuse or drug addiction. - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion. - Moderate or severe acute illness/infection (according to the Investigators judgment) on the day of vaccination or febrile illness (temperature >= 100.4°Fahrenheit [F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. - Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. - 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 (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. ; PRIMARY OUTCOME: Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine; SECONDARY OUTCOME 1: Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine at Day 6 After Vaccination[/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 - Post-Hip Surgery; BRIEF: The purpose of this study is to test in patients who have had hip replacement surgery the effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503 compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to assess the safety of the drug for 9 days after patients completed the double blind period. ; DRUG USED: Nucynta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Pain; TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter, Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; CRITERIA: Inclusion Criteria: - Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to degenerative joint disease (arthritis), not due to some inflammatory process, (eg. infection) - Baseline pain intensity >= 4 on an 11-point (0 to 10) Pain Intensity rating scale, rated within 30 minutes before randomization - Women must be postmenopausal, surgically sterile, or practicing or agree to practice an effective method of birth control throughout the study Exclusion Criteria: - Patients will be excluded from the study if they have a history of seizure disorder or epilepsy - history of malignancy within the past 2 years before starting the study - history of alcohol or drug abuse - evidence of active infections that may spread to other areas of the body - clinical laboratory values reflecting moderate or severe kidney insufficiency - currently treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or selective norepinephrine reuptake inhibitor (SNRI), (selective serotonin reuptake inhibitor [SSRI] treatments are allowed if taken for at least 30 days before the screening period of the study at an unchanged dose) ; PRIMARY OUTCOME: Sum of Pain Intensity Difference Over 48 Hours (SPID48); SECONDARY OUTCOME 1: Time to First Rescue Pain Medication.[/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 - SAVE-ABDO; BRIEF: The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events (VTE) in patients undergoing major abdominal surgery. The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population. ; DRUG USED: Visamerin/Mulsevo; DRUG CLASS: Non-NME; INDICATION: Venous Thromboembolism (VTE); TARGET: Coagulation Factor X, Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion Criteria: - Patient undergoing major abdominal surgery (open surgery under general anesthesia lasting more than 45 minutes in the peritoneal and/or retroperitoneal space and/or pelvis). - Patient <60 years of age had to have one of the following additional risk factors for VTE: - History of VTE, - Obesity, - Chronic Heart failure, - Chronic Respiratory Failure, - Inflammatory Bowel Disease, - Cancer Surgery. Exclusion Criteria: - Any major orthopedic or general surgery in the 3 months prior to study start; - Clinical signs or symptoms of DVT or PE within the last 12 months or known post phlebitic syndrome; - Any contra-indications to the performance of venography; - High risk of bleeding; - Known hypersensitivity to heparin or Enoxaparin sodium; - End stage renal disease or patient on dialysis. The above information was not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death; SECONDARY OUTCOME 1: Percentage of Participants Who Experience major VTE or All-cause Death[/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 - SKYSCRAPER-08; BRIEF: The purpose of this study is to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin (PC) compared with atezolizumab matching placebo plus tiragolumab matching placebo plus PC as first-line treatment in participants with unresectable locally advanced, unresectable recurrent, or metastatic esophageal carcinoma (EC). Participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during induction phase: Arm A: Atezolizumab plus Tiragolumab and PC Arm B: Atezolizumab placebo plus Tiragolumab placebo and PC Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab matching placebo plus tiragolumab matching placebo (Arm B). ; DRUG USED: Tecentriq; DRUG CLASS: Biologic; INDICATION: Esophageal Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Key Inclusion Criteria: - Histologically confirmed EC - Unresectable locally advanced, unresectable recurrent, or metastatic disease - Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Adequate hematologic and end-organ function - Female participants must be willing to avoid pregnancy and refrain from donating eggs during the treatment period and for 90 days after the final dose - Male participants with partners of childbearing potential must commit to the use of two methods of contraception and must not donate sperm for the study duration and 90 days after the final dose Key Exclusion Criteria: - Palliative radiation treatment for EC within 4 weeks prior to initiation of study treatment - Evidence of complete esophageal obstruction not amenable to treatment - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases - Uncontrolled tumor-related pain, uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures - Active or history of autoimmune disease or immune deficiency or leptomeningeal disease - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis - Malignancies other than EC within 2 years prior to screening with a negligible risk of metastasis or death adequately treated with expected curative outcome - Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety - Positive test result for human immunodeficiency virus (HIV) - Active hepatitis B or hepatitis C - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies - Treatment with any investigational therapy prior to initiation of study treatment - Poor peripheral venous access - Prior allogeneic stem cell or solid organ transplantation - Concurrent participation in another therapeutic clinical trial ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Investigator-Assessed 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 - A2311 (6 to <18 Years of Age); BRIEF: This was an open-label, parallel-group, two-arm, multicenter study in pediatric subjects aged 6 years to less than 18 years, at randomization, with moderate to severe chronic plaque psoriasis. 84 subjects (most with moderate severity) were enrolled. Subjects were stratified by weight and disease severity. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Written informed assent and parental permission (age as per local law) obtained at screening before any assessment is performed. 2. Must be 6 to less than 18 years of age at the time of randomization 3. Moderate to Severe plaque psoriasis, defined as a PASI score ≥ 12, and IGA mod 2011 score of ≥ 3, and BSA involvement of ≥10%, at randomization. 4. Subject being regarded by the investigator to be a candidate for systemic therapy. Exclusion Criteria: 1. Forms of psoriasis other than chronic plaque-type active at randomization 2. Drug-induced psoriasis 3. Ongoing use of prohibited treatments 4. Female subjects of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing and for 16 weeks after stopping study treatment 5. Pregnant or nursing (lactating) females 6. Subjects with total WBC count <2,500/μL, or platelets <100,000/μL or neutrophils <1,500/μL or hemoglobin <8.5 g/dL at screening 7. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor ; PRIMARY OUTCOME: Number and Percentage of Participants With PASI 75 Response; SECONDARY OUTCOME 1: Number and Percentage of Participants With PASI 90 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 - CORAIL; BRIEF: Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the activity and safety of PM01183 versus PLD or topotecan as control arm in patients with platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B). ; DRUG USED: Zepzelca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: DNA; THERAPY: Monotherapy; LEAD SPONSOR: PharmaMar; CRITERIA: Inclusion Criteria: - Age >/= 18 years - Confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer. - Platinum-resistant disease (PFI: 1-6 months after last platinum-containing chemotherapy). - Evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria - No more than three prior systemic chemotherapy regimens - Eastern Cooperative Oncology Group (ECOG) performance status (PS) (ECOG PS) ≤ 2 - Adequate hematological, renal, metabolic and hepatic function Exclusion Criteria: - Concomitant diseases/conditions: cardiac disease, immunodeficiency, chronic active hepatitis or cirrhosis, uncontrolled infection, bowel obstruction, any other major illness - Prior treatment with PM01183, trabectedin, or with both PLD and topotecan. - Requirement of permanent or frequent (i.e., once per week) external drainages within two weeks prior to randomization ; PRIMARY OUTCOME: Progression-free Survival by Independent Review Committee; SECONDARY OUTCOME 1: Progression-free Survival by Investigators Assessment[/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 - BEACON; BRIEF: This study assesses the efficacy of bardoxolone methyl relative to placebo in delaying progression to end-stage renal disease (ESRD) and cardiovascular deaths in patients with Stage 4 Chronic Kidney Disease (CKD) and type 2 diabetes receiving standard of care. ; DRUG USED: Bardoxolone Methyl; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Nephropathy; TARGET: KEAP1 (Kelch-like ECH-associated protein 1), STAT3 Transcription Factor; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Inclusion Criteria: 1. Screening eGFR ≥ 15.0 and < 30.0 mL/min/1.73 m2; 2. A history of type 2 diabetes; diagnosis should have been made at ≥ 30 years of age; 3. Male or female at least 18 years of age; 4. Treatment with an angiotensin converting enzyme (ACE)inhibitor and/or an angiotensin II receptor blocker (ARB)for at least 6 weeks prior to and during screening. Stable dose 2 weeks prior to and during screening. Patients not taking an ACE inhibitor and/or ARB because of a medical contraindication must have discontinued treatment at least 8 weeks prior to Screening Visit A; 5. Mean systolic blood pressure (SBP) must be ≤ 160 mmHg and ≥ 105 mmHg and mean diastolic blood pressure (DBP) must be < 90 mm Hg during screening; both mean SBP and mean DBP (determined as the average of three readings) must be within this range at two separate time points measured at least 4 days apart during the screening period (blood pressure may be re-evaluated once during an unscheduled visit); 6. Willing to practice methods of birth control (both male and female patients) during the entire study period and for at least 30 days after the last dose of the study drug is ingested; 7. Serum magnesium level must be ≥ 1.3 mEq/L (0.65 mmol/L) at Screening Visit B or during subsequent unscheduled visit during screening (serum magnesium level may be re-evaluated once during an unscheduled visit); 8. Willing and able to cooperate with all aspects of the protocol; 9. Willing and able to give written informed consent for study participation and provide consent for access to medical data according to appropriate local data protection legislation, allowing authorization to access medical records and describe events captured in the endpoints Exclusion Criteria: 1. Type 1 diabetes mellitus (juvenile onset). If a history of diabetic ketoacidosis exists, a C-peptide level must confirm type 2 diabetes; 2. Known non-diabetic renal disease (e.g., polycystic kidney disease, focal segmental glomerulosclerosis) [nephrosclerosis superimposed on diabetic kidney disease is acceptable]; 3. Ongoing clinical evidence suggesting non-diabetic renal disease other than nephrosclerosis; 4. History of a renal transplant or a planned transplant from a living donor during the study; 5. Albumin to creatinine ratio (ACR) greater than 3500 mg/g (395.5 mg/mmol); 6. Hemoglobin A1c level > 11.0% (97 mmol/mol) during screening; 7. Acute dialysis or acute kidney injury within 12 weeks prior to screening or during screening; 8. Clinical signs and/or symptoms of uremia and expected need for renal replacement therapy within 12 weeks following randomization, as assessed by the investigator; 9. Recently active cardiovascular disease defined as: a. Unstable angina pectoris within 12 weeks before study randomization; b. Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 12 weeks before study randomization; c. Cerebrovascular accident, including transient ischemic attack within 12 weeks before study randomization; d. Current diagnosis of Class III or IV New York Heart Association (NYHA) congestive heart failure; 10. Clinical diagnosis of severe obstructive valvular heart disease or severe obstructive hypertrophic cardiomyopathy; 11. Atrioventricular block, 2o or 3o, not successfully treated with a pacemaker; 12. DAdministration of a contrast agent that may induce nephropathy within 30 days prior to study randomization or planned during the study; 13. Systemic immunosuppression for a total of > 2 weeks, cumulatively, within the 12 weeks prior to randomization or planned during the study; 14. Total bilirubin, aspartate aminotransaminase (AST) or alanine aminotransaminase (ALT) levels greater than the upper limit of normal (ULN), or alkaline phosphatase level greater than two times the ULN on ANY screening laboratory test result; 15. Female patients who are pregnant, intend to become pregnant during the study, or are nursing; 16. BMI < 18.5 g/m2 17. Known hypersensitivity to any component of the study drug; 18. Current history of drug or alcohol abuse as assessed by the investigator; 19. Clinically significant infection requiring intravenous administration of antibiotics or hospitalization within 6 weeks of screening or during screening; 20. Hepatitis B surface antigen positive; 21. Diagnosis or treatment of a malignancy in the past 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix or a condition highly likely to transform into malignancy during the course of the study; 22. A clinical condition that in the judgment of the investigator could potentially pose a health risk to the patient while involved in the study; 23. Participation in a clinical study involving any intervention within 30 days prior to randomization, concurrent participation in such a study, or participation in a prior clinical study involving bardoxolone methyl in any form; 24. Unable to communicate or cooperate with the investigator due to language problems, poor mental development or impaired cerebral function. ; PRIMARY OUTCOME: Time-to-first event of the composite endpoint; SECONDARY OUTCOME 1: Rate of change in estimated glomerular filtration rate (eGFR) over the duration of the study[/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 - IGSC 20% (US); BRIEF: The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD). ; DRUG USED: Gammagard (Subcutaneous); DRUG CLASS: Biologic; INDICATION: Primary Immunodeficiencies; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Baxalta now part of Shire; CRITERIA: Main Inclusion Criteria: - Documented diagnosis of a form of primary humoral immunodeficiency involving defective antibody formation and requiring gammaglobulin replacement as defined according to the IUIS Scientific Committee, 2011 and by diagnostic criteria according to Conley et al. (1999). The diagnosis must be confirmed by the Medical Director prior to first treatment with the investigational product (IP) in the study. - Participant is 2 years or older at the time of screening, and has a minimum body weight of 13 kg. - Written informed consent has been obtained from either the participant or the participants legally authorized representative prior to any study-related procedures and study product administration - Participant has been receiving a stable monthly equivalent dose of IgG at an average minimum dose equivalent to 300 mg/kg bodyweight (BW)/4 weeks and a maximum dose equivalent to 1.0 gram/kg BW/4 weeks, for a minimum of 12 weeks prior to first treatment with the IP in the study. - Serum trough level of IgG > 500 mg/dL at screening - Participant is willing and able to comply with the requirements of the protocol Main Exclusion Criteria: - Participant has known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for Hepatitis C virus(HCV), PCR for human immunodeficiency virus (HIV) Type 1/2 - Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent): - Persistent alanine aminotransferase (ALT) and aspartate amino transferase(AST) > 2.5 times the upper limit of normal for the testing laboratory - Persistent severe neutropenia (defined as an absolute neutrophil count [ANC] ≤500/mm^3) - Creatinine clearance (CLcr) value that is < 60% of normal for age and gender either measured, or calculated according to the Cockcroft-Gault formula - Malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix), unless the disease-free period prior to screening exceeds 5 years - Participant is receiving anti-coagulation therapy (low dose aspirin at ≤325 mg/day is permitted) or has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) or sickle cell disease with crisis within 12 months prior to screening or a history of thrombophilia - Abnormal protein loss (protein losing enteropathy, nephrotic syndrome) - Anemia that would preclude phlebotomy for laboratory studies according to standard practice at the site - Acute serious bacterial infection within 3 months prior to screening - Ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following intravenous immunoglobulin, subcutaneous immunoglobulin, and/or Immune Serum Globulin (ISG) infusions - Severe immunoglobulin A (IgA) deficiency (less than 0.07g/L) with known anti-IgA antibodies and a history of hypersensitivity - Participant is on continuous systemic antibacterial antibiotics at doses sufficient to treat or prevent bacterial infections, and, in the opinion of the investigator, cannot stop these for the duration of the study without putting the patient at risk of increased infections - Participant has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening - Bleeding disorder or thrombocytopenia with a platelet count less than 20,000/μL, or who, in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of subcutaneous therapy - Total protein > 9 g/dL or myeloma or macroglobulinemia (IgM) or paraproteinemia - Severe dermatitis that would preclude adequate sites for safe product administration - Women of childbearing potential meeting any one of the following criteria: - Participant presents with a positive pregnancy test - Participant is breast feeding - Participant intends to begin nursing during the course of the study - Participant does not agree to employ adequate birth-control measures (e.g. intrauterine device, diaphragm or condom [for male partner] with spermicidal jelly or foam, or birth control pills/patches) throughout the course of the study - Participation in another clinical study and exposure to an investigational product or device within 30 days prior to study enrollment (exception: treatment in a previous Baxter immunoglobulin study) - Participant is scheduled to participate in another (non-Baxter) non-observational (interventional) clinical study involving an investigational product or device during the course of the study ; PRIMARY OUTCOME: Rate of Acute Serious Bacterial Infections Per Year (ASBI); SECONDARY OUTCOME 1: Annual Rate of All Infections Per Participant[/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 - Open Label; BRIEF: This study evaluates the safety and tolerability of PH94B with repeated dosing over a period of up to 12 months. Participating subjects will use PH94B up to 4 times a day when they encounter anxiety-provoking situations in daily life. Safety and tolerability of PH94B (≤ 4 doses per day up to 12 months) will be assessed and summarized during monthly visits from baseline (Visit 2) to end of treatment (Visit 14) in AEs, laboratory values, 12-lead ECGs, physical examinations, and vital sign assessments following exposure to PH94B. ; DRUG USED: PH-94B; DRUG CLASS: New Molecular Entity (NME); INDICATION: Social Anxiety Disorder (SAD); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: VistaGen Therapeutics, Inc.; CRITERIA: Most but not all patients will enter the study following completion of Palisade-1 (NCT047548020) and Palisade-2 (NCT05011396). Inclusion Criteria: 1. Male and female adults, 18 through 65 years of age, inclusive. 2. Women of childbearing potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study, and must also have a negative urine pregnancy test result at both Screening (Visit 1) (for subjects who attend Visit 1) and Baseline (Visit 2), prior to IP administration. Effective methods of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices. 3. Current diagnosis of social anxiety disorder 4. Clinician-rated HAM-D17 total score < 18 at study entry 5. LSAS score 50 or greater Exclusion Criteria: 1. Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, autism-spectrum disorder, or obsessive-compulsive disorder. Any other current Axis I disorder, other than SAD, which is the primary focus of treatment. Note that subjects with concurrent Generalized Anxiety Disorder are eligible for the study provided that Generalized Anxiety Disorder is not the primary diagnosis. 2. Subjects who meet criteria for moderate or severe alcohol or substance use disorder within the 1 year prior to study entry. 3. In the opinion of the Investigator, the subject has a significant risk for suicidal behavior during the course of their participation in the study. 4. Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, total anosmia, or nasal septum perforation that may have damaged the nasal chemosensory epithelium. 5. An acute or chronic condition, including an infectious illness, uncontrolled seasonal allergies at the time of the study, or significant nasal congestion that potentially could affect drug delivery to the nasal chemosensory epithelium. 6. Subjects using the following psychotropic medications: anticonvulsants, mood stabilizers, antipsychotic medications, gabapentin, pregabalin, opioids, naltrexone, esketamine, and ketamine at enrollment. Subjects using lower doses of atypical antipsychotics at Screening may be eligible after discussion with the Medical Monitor (e.g., quetiapine < 100 mg). In general, subjects using antidepressants or buspirone can continue to receive these provided that they have been taking them for a minimum of 2 months, and have been on a stable dose for a minimum of 1 month. 7. Use of anxiolytics, such as benzodiazepines or unapproved treatments such as beta blockers, within 30 days before study entry; concomitant use is prohibited during the study. Subjects who have been taking benzodiazepines daily for 1 month or longer at the time of Visit 1 are not eligible to participate. 8. Use of any over-the-counter product, prescription product, or herbal preparation for treatment of the symptoms of anxiety or social anxiety within 30 days before study entry; concomitant use is prohibited during the study. 9. Subjects with clinically significant abnormalities in hematology, blood chemistry, urinalysis, 12-lead ECG, or physical examination identified at the Screening visit or Baseline visit that in the clinical judgment of the Investigator, could place the subject at undue risk, interfere with study participation, or confound the results of the study. - ; PRIMARY OUTCOME: Adverse events and other safety measures; 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 - Adults and Elderly ; BRIEF: The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Southern hemisphere) in adults (18 to 60 years of age) and in the elderly (over 60 years of age). ; DRUG USED: Fluarix Quadrivalent; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - Written informed consent obtained from the subject prior to performing any study specific procedure. - A male or female aged 18 years or above at the time of vaccination. - Healthy subjects with well-controlled chronic diseases 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 2 months after completion of the vaccination series. Exclusion Criteria: - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the dose of study vaccine (Day -29 to Day 0), or planned use during the study period. - Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. - Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed. - Administration of long-acting immune-modifying drugs (e.g. rituximab, infliximab, etc.) within 6 months before study start, or planned administration during the study. - Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the study vaccination and during the entire study period. - Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period. - Administration of an influenza vaccine within the 6 months preceding the study start or planned use of such vaccines during the study period.. - 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 vaccine/product (pharmaceutical product or device). - Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). - Acute disease and/or fever at the time of enrolment. - Fever is defined as temperature ≥ 38.0°C/100.4°F, measured by any means. - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. - Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. - Chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insulin-dependent diabetes mellitus), not stabilised or clinically serious. - History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. - History of Guillain-Barré syndrome. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, including latex. - History of severe adverse reaction to a previous influenza vaccination. - Anaphylaxis following the administration of vaccine(s). - Pregnant or lactating female. - Female planning to become pregnant or planning to discontinue contraceptive precautions. ; PRIMARY OUTCOME: Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.; SECONDARY OUTCOME 1: Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.[/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 - Europe; BRIEF: The primary objective of this study will be to assess how effective Xilonix is in the treatment of patients with symptomatic colorectal cancer. By blocking a substance that helps tumours grow and spread, Xilonix therapy may not only slow tumour growth, but also may improve symptoms of muscle loss, fatigue, appetite loss, and pain in patients with colorectal cancer. The effectiveness of the therapy will be measured by assessing the change in these symptoms for patients treated with Xilonix versus those treated with placebo. Reversal of muscle loss will be assessed with a type of X-ray called a DEXA scanner. Improvement in pain, appetite loss, and fatigue will be measured with a questionnaire that is completed by patients enrolled on the trial. ; DRUG USED: Xilonix; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: IL-1 (Interleukin-1); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: 1. Subjects with pathologically confirmed colorectal carcinoma that is metastatic or unresectable and which is refractory to standard therapy. To be considered refractory, a subject must have failed both an oxaliplatin (oxaliplatin may have been in the adjuvant setting) and an irinotecan based regimen. 2. Symptomatic Disease: One symptom from each domain (metabolic and functional) must be present. - Evidence of metabolic dysfunction, defined as the presence of one or more of the following: - Any degree (up to 20%) of unintentional total body weight loss in the previous 6 months - Serum Interleukin 6 levels ≥10 pg/ml - Evidence of reduced function or presence of cancer related symptoms as determined by EORTC QLQ-C30. - Appetite reduction, with a score of >10 - Presence of fatigue, with a score of >10 - Presence of Pain, with a score of >10 - Decreased Role, Emotional and Social function, with a score of < 90. 3. Eastern Cooperative Oncology Group (ECOG) performance status 1 or 2. Exclusion Criteria: 1. Mechanical obstruction that would prevent adequate oral nutritional intake. 2. >20% total body weight loss in the previous 6 months. 3. Serious uncontrolled medical disorder, or active infection, that would impair the ability of the patient to receive protocol therapy. 4. Uncontrolled or significant cardiovascular disease, including: - A myocardial infarction within the past 6 months. - Uncontrolled angina within the past 3 months. - Congestive heart failure within the past 3 months, if defined as NYHC-II. - Diagnosed or suspected congenital long QT syndrome. - Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes). - Any history of second or third degree heart block (may be eligible if currently have a pacemaker). - Heart rate < 50 beats per minute on pre-entry electrocardiogram. - Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg diastolic). 5. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent. 6. Subjects who have not recovered from the adverse effects of prior therapy at the time of enrollment to ≤ grade 1; excluding alopecia and grade 2 neuropathy. 7. Subjects who have received extensive prior radiation therapy to the bone marrow. Extensive radiation therapy is defined as treatment of more than one axial bony metastasis. However for subjects with rectal cancer pelvic irradiation, in addition to treatment of one axial bony metastasis, is acceptable. 8. Immunocompromised subjects, including subjects known to be infected with human immunodeficiency virus (HIV). 9. Known hepatitis B surface antigen and/or hepatitis C antibody or known history of infection. 10. History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA). 11. Receipt of a live (attenuated) vaccine within 1 month prior to Randomization 12. Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition to Xilonix™ or any component of its formulations. 13. Women who are pregnant or breastfeeding. 14. WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to randomization, for the duration of the study, and for at least 3 months after the last dose of study medication. 15. History of progressive multifocal leukoencephalopathy or other demyelinating disease. 16. Subjects on immunosuppressive therapy, including transplant patients. 17. Subjects with known brain metastases. Subjects with symptoms of brain metastases during screening should undergo CT imaging prior to randomization. ; PRIMARY OUTCOME: Response Rate; 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 - SUSTAIN; BRIEF: The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subjects treatment allocation in the initial, core Phase 3 GED-0301 study. The GED-0301-CD-003 trial was not initiated; see detailed description. ; DRUG USED: GED 0301; DRUG CLASS: New Molecular Entity (NME); INDICATION: Crohns Disease; TARGET: Smad; THERAPY: Monotherapy; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria for Adult Subjects: Subjects must satisfy the following criteria to be screened and enrolled in the study: - Male or female ≥ 18 years of age. - Subject must have participated in the GED-0301-CD-002 or GED 0301 CD 003 study. - Subject must use protocol approved contraception. Inclusion Criteria for Adolescent Subjects: Adolescent subjects must satisfy the following criteria to be screened and enrolled in the study - Male or female 12 to 17 years of age. - Subject must have participated in the GED 0301 CD 003 study. - Subject is able to swallow the IP tablets. - Subject must use protocol approved contraception. Exclusion Criteria for Adult and Adolescent Subjects: The presence of any of the following will exclude a subject from screening and enrollment: - Subject had experienced a serious adverse event (SAE) related to the investigational product while participating in the previous Phase 3 GED-0301 study. - Subject has initiated biologic agents, such as TNF-α blockers or integrin antagonists. - Subject is pregnant or breastfeeding. - Subject has developed a known hypersensitivity to oligonucleotides, GED 0301 or any ingredient in the investigational product. ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208; 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 - 0002; BRIEF: The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model. ; DRUG USED: Zerviate; DRUG CLASS: Non-NME; INDICATION: Allergic Conjunctivitis (Ophthalmology); TARGET: Histamine H1 Receptor (HRH1); THERAPY: Monotherapy; LEAD SPONSOR: Aciex Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - positive bilateral conjunctival allergen challenge (CAC) reaction Exclusion Criteria: - known contraindications or sensitivities to the study medication or its components - any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters - use of disallowed medication during the period indicated prior to the enrollment or during the study ; PRIMARY OUTCOME: Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-Dose); SECONDARY OUTCOME 1: Ciliary Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ESA-naive; BRIEF: The objective of this study is to evaluate the safety and efficacy of ASP1517 in ESA-naive hemodialysis chronic kidney disease patients with anemia. ; DRUG USED: Roxadustat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Dependent; TARGET: Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH); THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Inc; CRITERIA: Inclusion Criteria: - Mean of the subjects two most recent Hb values during the Screening Period must be ≤10.0 g/dL with an absolute difference ≤1.0 g/dL between the two values - Either transferrin saturation (TSAT) ≥ 5% or serum ferritin ≥ 30 ng/mL during the screening period - Female subject must either: Be of non-childbearing potential: - post-menopausal (defined as at least 1 year without any menses) prior to Screening, or - documented surgically sterile Or, if of childbearing potential, - Agree not to try to become pregnant during the study and for 28 days after the final study drug administration - And have a negative pregnancy test at Screening - And, if heterosexually active, agree to consistently use two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and continued for 28 days after the final study drug administration. - Female subject must agree not to breastfeed starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration. - Female subject must not donate ova starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration. - Male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 12 weeks after the final study drug administration - Male subject must not donate sperm starting at Screening and throughout the study period and, for 12 weeks after the final study drug administration Exclusion Criteria: - Concurrent retinal neovascular lesion requiring treatment and macular edema requiring treatment - Concurrent autoimmune disease with inflammation that could impact erythropoiesis - History of gastric/intestinal resection considered influential on the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent gastroparesis - Uncontrolled hypertension - Concurrent congestive heart failure (NYHA Class III or higher) - History of hospitalization for treatment of stroke, myocardial infarction, or pulmonary embolism within 12 weeks before the screening assessment - Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibody at the screening assessment, or positive for human immunodeficiency virus (HIV) in a past test - Concurrent other form of anemia than renal anemia - Having received treatment with protein anabolic hormone, testosterone enanthate, or mepitiostane within 6 weeks before the screening assessment - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), or total bilirubin that is greater than the criteria, or previous or concurrent another serious liver disease at screening assessment - Previous or current malignant tumor (no recurrence for at least 5 years is eligible.) - Having undergone blood transfusion and/or a surgical procedure considered to promote anemia (excluding shunt reconstruction surgery for access to the blood) within 4 weeks before the screening assessment - Having undergone a kidney transplantation - Having a previous history of treatment with ASP1517. - History of serious drug allergy including anaphylactic shock - Participation in another clinical study or post-marketing clinical study (including that of a medical device) within 12 weeks before informed consent acquisition ; PRIMARY OUTCOME: Hemoglobin (Hb) Response rate; SECONDARY OUTCOME 1: Average Hb level from Week 18 to 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 - ENDURANCE-4 (GT 4-6, Renal Impaired); BRIEF: The purpose of this study is to evaluate the effect of response to treatment by evaluating the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12 weeks of treatment with ABT-493/ABT-530 and to evaluate the safety of the regimen in participants with chronic hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection. ; DRUG USED: Mavyret; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: 1. Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection. 2. Chronic HCV infection. 3. HCV treatment-naïve or treatment experienced (interferon [IFN] or pegylated interferon [pegIFN] with or without ribavirin [RBV]; sofosbuvir [SOF] plus RBV with or without pegIFN). 4. Non-cirrhotic participants. Exclusion Criteria: 1. History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs. 2. Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study. 3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. 4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). 5. Co-infection with more than one HCV genotype. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With On-treatment Virologic Failure[/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 - AVAIL (CF/MRSA); BRIEF: This is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis (CF). ; DRUG USED: AeroVanc; DRUG CLASS: Non-NME; INDICATION: Staphylococcal Vaccines and Other Staphylococcus-Specific Agents (Antibacterial); TARGET: Cell wall synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Savara Inc.; CRITERIA: Inclusion criteria 1. Participants ≥6 years of age at time of informed consent form or assent form signing. 2. Confirmed diagnosis of CF, determined by having clinical features consistent with the CF phenotype, plus one of the following: 1. Positive sweat chloride test (value ≥60 milliequivalent/L), 2. Genotype with 2 mutations consistent with CF (i.e., a mutation in each of the cystic fibrosis transmembrane conductance regulator genes). 3. Positive sputum culture or a throat swab culture for MRSA at Screening. 4. In addition to the Screening sample, have at least 2 prior sputum or throat swab cultures positive for MRSA, of which at least 1 sample is >6 months prior to Screening. At least 50% of all MRSA cultures (sputum or throat swab culture) collected from the time of the first positive culture (in the previous 1 year) must have tested positive for MRSA. (Note: Screening sample may count towards 50% positive count) 5. FEV1 ≥30% and ≤90% of predicted that is normal for age, gender, race, and height, using the Global Lung Function Initiative equation. 6. At least 1 episode of acute pulmonary infection treated with non-maintenance antibiotics within 12 months prior to the Baseline visit (initiation of treatment with intermittent inhaled anti-Pseudomonal therapy will not qualify as treatment with non-maintenance antibiotics). 7. If female of childbearing potential, an acceptable method of contraception must be used during the study and must be combined with a negative pregnancy test obtained during Screening; sexually active male subjects of reproductive potential who are non-sterile (i.e., male who has not been sterilized by vasectomy for at least 6 months, and were not diagnosed with infertility through demonstration of azoospermia in a semen sample and/or absence of vas deferens through ultrasound) must be willing to use a barrier method of contraception, or their female partner must use an acceptable method of contraception, during the study. For purposes of this study, the Sponsor defines acceptable methods of contraception as: 1. Oral birth control pills administered for at least 1 monthly cycle prior to administration of the study drug. 2. A synthetic progestin implanted rod (eg, Implanon®) for at least 1 monthly cycle prior to the study drug administration but not beyond the 4th successive year following insertion. 3. Intrauterine devices, inserted by a qualified clinician for at least 1 monthly cycle prior to study drug administration. 4. Medroxyprogesterone acetate (eg, Depo-Provera®) administered for a minimum of 1 monthly cycle prior to administration of the study drug and continuing through 1 month following study completion. 5. Hysterectomy or surgical sterilization. 6. Abstinence. 7. Double barrier method (diaphragm with spermicidal gel or condoms with contraceptive foam). Note: For subjects prescribed Orkambi: Orkambi may substantially decrease hormonal contraceptive exposure, reducing the effectiveness and increasing the incidence of menstruation-associated adverse reactions. Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with Orkambi. 8. Able and willing to comply with the protocol, including availability for all scheduled study visits and able to perform all techniques necessary to use the AeroVanc inhaler and measure lung function. 9. Agree not to smoke during any part of the clinical trial (Screening visit through end of study). 10. Participants with a Pseudomonas aeruginosa co-infection must either be stable on a regular suppression regimen of inhaled antibiotics or must be, in the opinion of the Investigator, stable despite the lack of such treatment. Exclusion criteria 1. Use of anti-MRSA treatments prescribed as maintenance therapy (intravenous [IV] or inhaled treatment within 28 days; oral treatment within 14 days) prior to the Baseline visit. 2. Use of non-maintenance antibiotic for pulmonary infection or extrapulmonary MRSA infection (IV or inhaled antibiotic within 28 days; oral antibiotic within 14 days) prior to the Baseline visit. 3. History of previous allergies or sensitivity to vancomycin, or other component(s) of the study drug or placebo except for a history of red-man syndrome. 4. Inability to tolerate inhaled products. 5. First time sputum culture or throat swab culture yielding Burkholderia cepacia, or nontuberculous Mycobacteria in the previous 6 months to Screening. 6. History of lung or other solid organ transplantation or currently on the list to receive lung or other solid organ transplantation. 7. Resistance to vancomycin at Screening (vancomycin resistant Staphylococcus aureus, or vancomycin intermediate resistant Staphylococcus aureus, with minimum inhibitory concentration ≥8 μg/mL). 8. Oral corticosteroids in doses exceeding 10 mg prednisone per day or 20 mg prednisone every other day, or equipotent doses of other corticosteroids. 9. Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications within 14 days, or changes in cystic fibrosis transmembrane conductance modulators within 28 days, prior to the Baseline visit. 10. Abnormal laboratory findings or other findings or medical history at Screening that, in the Investigators opinion, would compromise the safety of the subject or the quality of the study data. 11. Inability to tolerate inhalation of a short acting beta2 agonist 12. Oxygen saturation <90% at Screening. 13. Changes in physiotherapy technique or physiotherapy scheduled within 1 week of the Baseline visit. 14. Administration of any investigational drug or device within 4 weeks prior to the Screening visit and during the study 15. Female with positive pregnancy test result during Screening, pregnant (or intends to become pregnant), lactating or intends to breastfeed during the study. 16. Renal insufficiency, defined as creatinine clearance <50 mL/min using the Cockcroft-Gault equation for adults or Schwartz equation for children at the Screening visit. 17. Abnormal liver function, defined as ≥4x upper limit of normal of serum aspartate aminotransferase or serum alanine aminotransferase, or known cirrhosis at Screening. 18. Diagnosed with clinically significant hearing loss. 19. History of positive result for human immunodeficiency virus, hepatitis B virus or hepatitis C virus. 20. Planned hospitalizations for prophylaxis antibiotic treatment within 28 days prior to Baseline visit or during the double-blind period (Period 1). ; PRIMARY OUTCOME: Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted; SECONDARY OUTCOME 1: Frequency of Pulmonary 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 - 1503-SS01; BRIEF: This is an exploratory sub-study to ZX008-1503 [NCT02823145]. Subjects will be fitted with an Embrace seizure detection watch and seizures detected by the watch will be compared to those entered into an electronic seizure diary. ; DRUG USED: Fintepla; DRUG CLASS: Non-NME; INDICATION: Dravet Syndrome (Epilepsy); TARGET: Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.; CRITERIA: Inclusion Criteria: - Meeting all of the main study ZX008-1503 [NCT02823145] inclusion criteria - Subject is willing to wear the Embrace watch on the wrist (alternatively ankle, if needed for younger children). Subjects are asked to wear the watch for as many hours of the day as possible and for the entire night, if possible, for the duration of the sub-study. - Subjects parent/caregiver is willing to use the Alert App. - Subject/subjects caregiver is willing to ensure that the Embrace watch remains within close proximity of the paired iPod Touch running the Empatica Alert app. Exclusion Criteria: - Subject has a known hypersensitivity to any of the Embrace device materials. - Subject has a clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to Visit 1, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject. ; PRIMARY OUTCOME: Overall Usability of the Empatica Embrace Seizure Detection Watch System (Embrace) in Outpatients With Dravet Syndrome; 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 - BACH (BAP00089, EU); BRIEF: The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis. ; DRUG USED: Toctino; DRUG CLASS: Non-NME; INDICATION: Atopic Dermatitis (Eczema); TARGET: Retinoid Receptors (RAR and RXR); THERAPY: Monotherapy; LEAD SPONSOR: Basilea Pharmaceutica; CRITERIA: Inclusion Criteria: - Chronic hand dermatitis, all types including hyperkeratotic, vesicular, fingertip dermatitis - Lasting for 6 months since initial diagnosis - Rated severe - Refractory to standard therapy including non-medicated therapy and avoidance of irritants and allergens - Refractory to topical steroids Exclusion Criteria: - Female patients who are pregnant or want to become pregnant - Female patients of child bearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously - Patients whose disease is adequately controlled by standard non-medicated therapy and standard corticosteroid therapy ; PRIMARY OUTCOME: Physicians global assessment; SECONDARY OUTCOME 1: Response rate per treatment group[/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 - ACHIEVE 2/3; BRIEF: This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive. ; DRUG USED: Zalbin; DRUG CLASS: Biologic; INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Interferon Receptor; THERAPY: Combination; LEAD SPONSOR: Human Genome Sciences Inc.; CRITERIA: Key Inclusion Criteria: - Diagnosis of chronic hepatitis C. - Liver biopsy performed within 2 years of Day 0 or during screening. - Infected with hepatitis C virus genotype 2/3. - Interferon alfa treatment naïve (ie, have never been treated with an interferon product). - Subjects are eligible to enter the study if they (or their partners) are not pregnant or nursing, are sterile, or of non childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study and for 7 months after the last dose of ribavirin. - Have compensated liver disease. Key Exclusion Criteria: - Decompensated liver disease including those subjects with a past history or presence of ascites, bleeding varices or hepatic encephalopathy. - History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt. - Positive for human immunodeficiency virus (HIV-1) or hepatitis B surface antigen (HBsAG). - Clinical diagnosis of other causes of chronic liver disease including but not limited to hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, hemochromatosis, Wilsons Disease, or alpha 1-antitrypsin deficiency. - A history of immunologically mediated disease (eg, rheumatoid arthritis, inflammatory bowel disease, moderate/severe psoriasis, sarcoidosis, systemic lupus erythematosus). - Active seizure disorder within the last 2 years. - Organ transplant other than cornea and hair transplant. - Clinically significant hemoglobinopathy (eg, thalassemia, sickle cell anemia). - Cancer within the last 5 years(with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix). - Drug or alcohol addiction within the last 6 months. Subjects in a supervised methadone treatment program may be enrolled in the study. - Received any experimental agent within 28 days prior to Day 0. ; PRIMARY OUTCOME: Sustained virologic response (SVR); SECONDARY OUTCOME 1: Rapid virologic 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 - SAVE-ONCO; BRIEF: The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism [VTE] in cancer patients at high risk for VTE and who were undergoing chemotherapy. The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population. ; DRUG USED: Visamerin/Mulsevo; DRUG CLASS: Non-NME; INDICATION: Venous Thromboembolism (VTE); TARGET: Coagulation Factor X, Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion Criteria: Cancer patient with metastatic or locally advanced solid tumor of lung, pancreas, stomach, colon/rectum, bladder or ovary initiating a (new) course of chemotherapy with a minimum intent of 3 months therapy Exclusion Criteria: - Required systematic venous thromboprophylaxis or curative treatment with anti-coagulant or thrombolytic; - High risk of bleeding; - Severe renal impairment (estimated creatinine clearance <30 mL/min); - ECOG (Eastern Cooperative Oncology Group) performance status 3 & 4; - Major surgery within 4 weeks before randomization; - Known hypersensitivity to unfractionated heparin [UFH] or low molecular weight heparin [LMWH]. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial ; PRIMARY OUTCOME: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death; SECONDARY OUTCOME 1: Percentage of Participants who required the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment[/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 - TRILOGY 2; BRIEF: The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared to placebo, in lowering fasting TG levels in subjects with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L) after 12 weeks of treatment. Approximately 615 subjects will be screened to obtain 245 randomized subjects following a treatment allocation ratio of 2.5:1 (CaPre:placebo). ; DRUG USED: CaPre; DRUG CLASS: Non-NME; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Diglycerol Acyltransferase (DGAT), Lipoprotein lipase, PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: Acasti Pharma Inc.; CRITERIA: Inclusion Criteria: 1. Subjects ≥18 years of age. 2. Isolated hypertriglyceridemia, with triglycerides ≥500 mg/dL and <1500 mg/dL (≥5.7 mmol/L and <17.0 mmol/L) OR Mixed hyperlipidemia, with serum triglycerides ≥500 and <1500 mg/dL treated with a statin, CAI or PCSK9I inhibitor, alone or in combination, that has been stable for 6 weeks prior to randomization. If the subject is not being treated and not contraindicated, a statin and/or CAI treatment may be initiated at the discretion of the Investigator at time of screening. 3. Willingness to maintain current physical activity level and follow the NCEP-TLC diet throughout the study. 4. Be informed of the nature of the study and give written consent prior to any study procedure. Exclusion Criteria: 1. Allergy or intolerance to OM3 fatty acids, OM3-acid ethyl esters, OM3 phospholipids, fish, shell fish, or any component of the study medication. 2. Known lipoprotein lipase impairment or deficiency, or apo CII deficiency. 3. Subjects with lysosomal acid lipase deficiency. 4. Body mass index greater than 45 kg/m2. 5. Subjects who are pregnant, lactating, and subjects of childbearing potential who are either planning to become pregnant or who are not using acceptable birth control methods during study participation. Subjects of childbearing potential are subjects who have experienced menarche and do not otherwise meet the criteria for subjects not of childbearing potential, defined as: - Subjects who have had surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation); or - Subjects who are postmenopausal, i.e., who have had a cessation of menses for at least 12 months without an alternative medical cause. A follicle stimulating hormone (FSH) test ≥40 mIU/mL may be used to confirm the post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. Subjects of childbearing potential must test negative for pregnancy at the time of enrollment and agree to use an acceptable contraceptive method or remain abstinent during the study or for at least 8 weeks following the last dose of study medication, whichever is longer. 6. Subjects taking tamoxifen, estrogens, or progestins, or other medications or nutritional supplements with mechanisms modifying estrogen or progestogen pathways, who have had dosage changes within 4 weeks prior to Visit 1. 7. Use of oral or injected corticosteroids or anabolic steroids within 6 weeks prior to randomization. 8. History of pancreatitis within the last 6 months prior to Visit 1. 9. History of symptomatic gallstone disease within the last 5 years, unless treated with cholecystectomy. 10. Diabetics requiring changes in medical therapy (other than short acting insulin dosage adjustments) within 6 weeks prior to Visit 1 or who have HbA1c greater than 9.5% at Visit 1. 11. Clinical or biochemical evidence of hyperthyroidism not stable with medication for at least 6 weeks prior to Visit 1 12. Uncontrolled hypothyroidism or thyroid stimulating hormone (TSH) level more than 1.5 × upper limit of normal (ULN). 13. Thyroid hormone replacement therapy that has not been stable for more than 6 weeks prior to Visit 1. 14. History of cancer (other than basal cell carcinoma) within 2 years prior to Visit 1. 15. Cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, exacerbation of congestive heart failure requiring hospitalization or a change in treatment), life threatening arrhythmia, or revascularization procedure within 6 months prior to Visit 1. 16. Use of other prohibited drugs: weight loss prescription medications (including over-the-counter or supplemental agents); human immunodeficiency virus (HIV) protease inhibitors; cyclophosphamide; isotretinoin; routine or anticipated use of systemic corticosteroids (local, topical, inhalation, or nasal corticosteroids are permitted); or anabolic steroids. 17. Use of any lipid-altering drug therapy, other than statins, CAI (such as ezetimibe) or PCSK9I inhibitors, alone or in combination, including niacin at a dose greater than 200 mg/day, fibrates, bile acid sequestrants, OM3 drugs (e.g., Lovaza or its generics,Vascepa, Epanova, Omtryg), OM3 supplements (e.g., fish oil, krill oil products), or any other herbal products or dietary supplements with potential lipid-altering effects. These products must be discontinued at least 6 weeks prior to randomization 18. Resection of an aortic aneurysm or endovascular aortic repair within 6 months prior to Visit 1. 19. Recent history (within 6 months prior to Visit 1) or current significant nephrotic syndrome or ≥3 gram proteinuria daily, pulmonary, gastrointestinal, or immunologic disease. 20. Poorly controlled hypertension (systolic blood pressure ≥170 mmHg and/or diastolic blood pressure ≥100 mmHg). Subjects with hypertension adequately controlled with medication are eligible provided that their antihypertensive therapy has been stable for at least 4 weeks prior to Visit 1. 21. Recent history (past 12 months) of drug abuse or alcohol abuse, or alcohol use greater than 2 units per day (a unit of alcohol is defined as a 12-ounce (350 mL) beer, 5 ounce (150 mL) wine, or 1.5-ounce (45 mL) of 80-proof alcohol for drinks). 22. Hepatobiliary disease or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5× ULN; if ALT/AST is >3× ULN, the levels must have been stable for 3 months prior to Visit 1. 23. Severe renal disease as defined by less than 30 mL/min serum creatinine clearance calculated using the Cockcroft-Gault formula. 24. Significant coagulopathy as defined by a known hereditary deficiency of coagulation factors or platelet function or an unexplained elevation of the prothrombin time (PT) international normalized ratio (INR) of ≥1.5. Subjects using warfarin [Coumadin®] or heparin are allowed. Subjects receiving other anticoagulants dabigatran, rivaroxaban, or apixaban are allowed. Subjects receiving acetylsalicylic acid (ASA) alone or in combination with other anti platelet agents (e.g., clopidogrel, prasugrel, ticagrelor) are also allowed. 25. Unexplained creatine kinase concentration 3 × ULN. 26. Creatine kinase elevation owing to known hereditary or acquired muscle disease. 27. Exposure to any investigational product, within 4 weeks prior to Visit 1. 28. Presence of any other condition the Investigator believes would interfere with the subjects ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk. 29. Any life-threatening disease expected to result in death within 2 years, require frequent hospitalizations, extensive surgery or changes in medications or diet. ; PRIMARY OUTCOME: Percent change in fasting TG levels from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and 12) in patients with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L).; SECONDARY OUTCOME 1: Percent change from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and 12) in non-HDL-C.[/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 - PsOsim; BRIEF: This is a 3-period study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis. ; DRUG USED: Biosimilar Adalimumab (Coherus); DRUG CLASS: Biosimilar; INDICATION: Psoriasis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Coherus Biosciences, Inc.; CRITERIA: Inclusion Criteria: - Male or female adults - PsO diagnosis for 6 months - Active disease: PASI greater than or equal to 12, Physicians Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale of 0-5), - Body Surface Area (BSA) involved with PsO greater than or equal to 10% Exclusion Criteria: - Forms of psoriasis other than PsO - Drug induced psoriasis - Positive QuantiFERON-tuberculosis (TB) Gold Test - Presence of significant comorbid conditions - Chemistry and hematology values outside protocol specified range - Major systemic infections ; PRIMARY OUTCOME: Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12; 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 - KEYNOTE-641; BRIEF: The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Prostate 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: The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: - Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology - Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to randomization - Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI) - Has met one of the following criteria with regard to abiraterone acetate exposure: (1) is abiraterone-naïve; (2) received prior abiraterone acetate for the treatment of mHSPC or mCRPC, for a minimum of 4 weeks and not progressed while on treatment; or (3) received prior abiraterone acetate for the treatment of mHSPC or mCRPC and progressed on treatment after a minimum of 8 weeks treatment (minimum 14 weeks for those with bone progression) - Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM) - Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization - Participants must agree to the following during the study treatment period and for at least 90 days after the last dose of enzalutamide: Refrain from donating sperm, plus EITHER be abstinent OR must agree to use male condom - Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization Exclusion Criteria: - Has a known additional malignancy that is progressing or has required active treatment in the last 3 years - Has an active autoimmune disease that has required systemic treatment in past 2 years - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy - Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications - Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules - Has an active infection (including tuberculosis) requiring systemic therapy - Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease - Has known active human immunodeficiency virus (HIV), concurrent active hepatitis B virus (HBV) or known active hepatitis C virus (HCV) infection - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Has hypersensitivity to pembrolizumab and/or enzalutamide and/or any of their excipients - Has a history of seizure or any condition that may predispose to seizure - Has a history of loss of consciousness within 12 months of screening - Has hypotension (systolic blood pressure <86 millimeters of mercury [mmHg]) or uncontrolled hypertension (systolic blood pressure >170 mmHg or diastolic blood pressure >105 mmHg) at the screening visit - Has bradycardia (heart rate of <50 beats per minute) on the screening electrocardiogram (ECG) - Has history of prostate cancer progression on ketoconazole - Has had prior treatment with enzalutamide, apalutamide, darolutamide or cytochrome P450 (CYP) 17 inhibitor other than abiraterone acetate - Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 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 treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer - Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC - Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization - Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (eg, saw palmetto) prior to randomization - Has received a live or live attenuated vaccine within 30 days prior to randomization - 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 the first dose of study treatment - Has a superscan bone scan - Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of enzalutamide - Has had an allogenic tissue/solid organ transplant ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Time to Initiation of the First Subsequent Anti-cancer Therapy or Death (TFST)[/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 - ESSENCE (Study 4045-301; Exon 45 & 53) ; BRIEF: The main objective of this study is to evaluate the efficacy of SRP-4045 (casimersen) and SRP-4053 (golodirsen) compared to placebo in participants with DMD with out-of-frame deletion mutations amenable to skipping exon 45 and exon 53, respectively. ; DRUG USED: Amondys 45; DRUG CLASS: New Molecular Entity (NME); INDICATION: Duchenne Muscular Dystrophy (DMD); TARGET: Dystrophin gene (DMD); THERAPY: Monotherapy; LEAD SPONSOR: Sarepta Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Genotypically confirmed DMD, with genetic deletion amenable to exon 45 or exon 53 skipping - Stable dose of oral corticosteroids for at least 24 weeks prior to Week 1, and the dose is expected to remain constant throughout the study (except for modifications to accommodate changes in weight). - Intact right and left biceps or 2 alternative upper muscle groups - Mean 6MWT ≥300 meters and ≤450 meters - Stable pulmonary function: forced vital capacity (FVC) ≥50% predicted Exclusion Criteria: - Treatment with gene therapy at any time - Previous treatment with SMT C1100 within 1 week prior to Week 1 and previous treatment with PRO045 (BMN 045), PRO053 (BMN 053), or PRO051 (BMN 051) within 24 weeks prior to Week 1 - Current or previous treatment with any other experimental treatment within 12 weeks prior to Week 1 - Major surgery within 3 months prior to Week 1 - Presence of other clinically significant illness Other inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Change From Baseline in the Total Distance Walked During 6MWT at Week 96; SECONDARY OUTCOME 1: Change from Baseline in the Total Distance Walked During 6MWT at Week 144 (Week 48 of the Open-Label Extension 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 III - Gonadotropin-Dependent Precocious Puberty; BRIEF: This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty. ; DRUG USED: Fensolvi; DRUG CLASS: Non-NME; INDICATION: Endocrine Disorder; TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Tolmar Inc.; CRITERIA: Inclusion Criteria: - Females age 2 to 8 years (inclusive) or males age 2 to 9 years (inclusive) - Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP - Pubertal-type LH response following an abbreviated GnRHa stimulation test before treatment initiation - Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males - Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year Exclusion Criteria: - Gonadotropin-independent (peripheral) precocious puberty - Prior or current GnRH treatment for CPP - Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1) - Diagnosis of short stature (ie, 2.25 standard deviations (SD) below the mean height for age) - Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions - Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study ; PRIMARY OUTCOME: Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.; SECONDARY OUTCOME 1: Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - PRONOUNCE; BRIEF: The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in subjects with prostate cancer and cardiovascular disease. ; DRUG USED: Firmagon; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ferring Pharmaceuticals; CRITERIA: Inclusion Criteria: - Advanced prostate cancer - Indication to initiate androgen deprivation therapy (ADT) - Predefined cardiovascular disease Exclusion Criteria: - Previous or current hormonal management of prostate cancer (unless terminated at least 12 months prior to trial) - Acute cardiovascular disease in the previous 30 days ; PRIMARY OUTCOME: Time From Randomization to the First Confirmed (Adjudicated) Occurrence of the Composite Major Adverse Cardiovascular Event (MACE) Endpoint; Percentage of Observed Subjects With Outcome Measure Events During the Trial; SECONDARY OUTCOME 1: Time From Randomization to the First Confirmed (Adjudicated) Occurrence of Cardiovascular (CV)-Related Death, Non-fatal Myocardial Infarction or Non-fatal Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial[/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 - BEL112234; BRIEF: This is a long-term continuation study to provide continuing treatment to subjects with SLE. ; DRUG USED: Benlysta; DRUG CLASS: Biologic; INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: B-cell activating factor (BAFF); THERAPY: Monotherapy; LEAD SPONSOR: Human Genome Sciences Inc., a GSK Company; CRITERIA: Inclusion Criteria: - Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or Week 48 visits, respectively. Exclusion Criteria: - Have developed any other medical disease or condition that has made the patient unsuitable for this study in the opinion of their physician. ; PRIMARY OUTCOME: Number of Participants With Adverse Events (AE); 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 - PHOTON 2 (w/RBV, GT 1 - 4) (EU); BRIEF: This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1. ; DRUG USED: Sovaldi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Age ≥ 18 years with HIV-1 and chronic HCV genotype 1, 2, 3, or 4 co-infection - HCV RNA > 10,000 IU/mL at screening - HCV treatment history: - Treatment-naive for HCV genotypes 1, 2, 3, or 4, or - Treatment-experienced for HCV genotypes 2 or 3 - HIV antiretroviral (ARV) criteria: - On a stable, protocol-approved, HIV ARV regimen with undetectable HIV RNA for > 8 weeks prior to screening, or - ARV untreated for ≥ 8 weeks prior to screening, with a CD4 T-cell count > 500 cells/mm^3 - Presence or absence of cirrhosis; a liver biopsy may be required - Healthy according to medical history and physical examination with the exception of HCV and HIV diagnosis - Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication Exclusion Criteria: - HCV genotype 1 or 4 with previous HCV treatment - Poor control with HIV ARV regimen requiring a possible dose modification of therapy within 4 weeks of study medication dosing - A new AIDS-defining condition diagnosed within 30 days prior to screening - Prior use of any other inhibitor of the HCV NS5B polymerase - History of any other clinically significant chronic liver disease - Evidence of or history of decompensated liver disease - Chronic hepatitis B virus (HBV) infection - Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers) - Chronic use of immunosuppressive agents or immunomodulatory agents - Clinically relevant drug or alcohol abuse within 12 months of screening - History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participants participation for the full duration of the study or not be in the best interest of the participant in the opinion of the investigator ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)[/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 - VENICE - w/Docetaxel/Prednisone; BRIEF: Primary objective was to demonstrate overall survival improvement with aflibercept compared to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent prostate cancer (MAIPC). The secondary objectives were: - To assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen (PSA) level, cancer related pain, progression free survival (PFS), tumor-based and skeletal events and health-related quality of life (HRQL); - To assess the overall safety in both treatment arms; - To determine the pharmacokinetics of intravenous (IV) aflibercept in this population; - to determine immunogenicity of IV aflibercept. ; DRUG USED: Zaltrap; DRUG CLASS: Biologic; INDICATION: Prostate Cancer; TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion Criteria: - Histologically- or cytologically-confirmed prostate adenocarcinoma; - Metastatic disease; - Progressive disease while receiving hormonal therapy or after surgical castration; - Effective castration. Exclusion Criteria: - Prior cytotoxic chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed >3 years ago; - Prior treatment with Vascular Endothelial Growth Factor (VEGF) inhibitors or VEGF receptor inhibitors; - Eastern Cooperative Oncology Group (ECOG) performance status >2. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Overall Survival Time; SECONDARY OUTCOME 1: Prostate Specific Antigen Response Rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TRACE; BRIEF: The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation. ; DRUG USED: Tirapazamine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Head and Neck Cancer; TARGET: Hypoxia/Tumor Hypoxic Environment; THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion Criteria: - Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. - Stage III or IV disease (excluding T1N1, and T2N1 and metastatic disease). - Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. - Absolute neutrophil count at least 1.5 X 10^9/L, platelet count at least 100 X 10^9/L, and hemoglobin > 9g/dL. - Serum bilirubin < 1.25 times upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine transaminase (ALT) < 2.5 times ULN. - Calculated creatinine clearance (Cockcroft-Gault) > 55 mL/min. Exclusion Criteria: - Metastatic Disease - Primary cancers of the nasal and paranasal cavities and of the nasopharynx - Significant intercurrent illness that will interfere with the Chemotherapy or Radiation Therapy during the trial - Symptomatic peripheral neuropathy > grade 2 - Clinically significant hearing impairment - Significant cardiac disease ; PRIMARY OUTCOME: Overall survival; SECONDARY OUTCOME 1: Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure[/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 - LEAP 1; BRIEF: This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate to severe community-acquired bacterial pneumonia. ; DRUG USED: Xenleta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Community Acquired Pneumonia (CAP) (Antibacterial); TARGET: Bacterial ribosome, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Nabriva Therapeutics AG; CRITERIA: Inclusion Criteria: 1. Be male or female at least 18 years of age. 2. Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions. 3. Have an acute illness (7 days duration) with at least 3 of the following symptoms consistent with a lower respiratory tract infection (new or worsening): - Dyspnea - New or increased cough - Purulent sputum production - Chest pain due to pneumonia 4. Have at least 2 of the following vital sign abnormalities: - Fever (body temperature >38.0°C (100.4°F) measured orally or equivalent temperature from an alternate body site) or hypothermia (body temperature <35.0°C (95.0°F) measured orally or equivalent temperature from an alternate body site) - Hypotension (systolic blood pressure <90 mmHg) - Tachycardia (heart rate >100 beats/min) - Tachypnea (respiratory rate >20 breaths/min) 5. Have at least 1 other clinical sign or laboratory finding of CABP: - Hypoxemia (i.e., O2 saturation <90% on room air or while receiving supplemental oxygen at subjects baseline requirement or PaO2 <60 mmHg) - Auscultatory and/or percussion findings consistent with pneumonia (e.g., crackles, egophony, dullness) - White blood cell (WBC) count >10,000 cells/mm3 or <4500 cells/mm3 or >15% immature neutrophils (bands) regardless of total WBC count 6. Have radiographically-documented pneumonia within 48 hours before enrollment (i.e., infiltrates in a lobar or multilobar distribution or diffuse opacities on chest x-ray or chest computed tomography scan consistent with acute bacterial pneumonia). 7. Have a Pneumonia Outcomes Research Team (PORT) Risk Class ≥III. Exclusion Criteria: 1. Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 72 hours before randomization 2. Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens 3. Have been hospitalized for 2 or more days within 90 days prior to the onset of symptoms or have resided in a nursing home or long-term healthcare facility within 30 days prior to the onset of symptoms. NOTE: Residence in an independent living facility is permitted. 4. Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of the study drugs (e.g., Pseudomonas aeruginosa, any pathogen of the Enterobacteriaceae Family) or attributable to etiologies other than community acquired bacterial pathogens (e.g., ventilator associated pneumonia, hospital acquired bacterial pneumonia, bacterial aspiration pneumonia, Pneumocystis jiroveci pneumonia or other fungal pneumonia, viral or mycobacterial infection of the lung). 5. Have a noninfectious cause of pulmonary infiltrates (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure, bronchial obstruction, lung cancer, cystic fibrosis). 6. Have confirmed or suspected pleural empyema (does not include sterile parapneumonic effusions). 7. Require mechanical ventilation. ; PRIMARY OUTCOME: Early Clinical Response (ECR); SECONDARY OUTCOME 1: Investigators Assessment of Clinical Response (IACR)[/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 - BORA (Long-term Safety); BRIEF: The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020. ; DRUG USED: Fasenra; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion criteria 1. Informed consent (and/or assent as applicable locally) for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent(s)/guardian(s)) and according to international guidelines and/or applicable European Union guidelines. 2. Female and male patients who completed the double-blind treatment period in a predecessor study on benralizumab or matching placebo. 3. Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after last dose of Investigational Product (IP). 4. For WOCBP only: Have a negative urine pregnancy test prior to administration of Investigational Product (IP) at Visit 1. 5. All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose. Exclusion criteria 1. 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 2. A helminth parasitic infection diagnosed during a predecessor study that has either not been treated, has been incompletely treated or has failed to respond to standard of care therapy 3. Any clinically significant change in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during a predecessor study 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 interfere with the patients ability to complete the entire duration of the study 4. Current malignancy or malignancy that developed during a predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded). 5. Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last dose of the investigational product 6. Receipt of immunoglobulin or blood products within 30 days prior to Visit 1 7. Planned major surgical procedures during the conduct of the study 8. Previous participation in the present study 9. Concurrent enrolment in another clinical trial 10. AstraZeneca staff involved in the planning and/or conduct of the study 11. Employees of the study centre or any other individuals involved with the conduct of the study or immediate family members of such individuals 12. Patients with major protocol deviations in any of the predecessor studies at the discretion of the Sponsor ; PRIMARY OUTCOME: Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients; SECONDARY OUTCOME 1: Number of Overall Patients With Asthma Exacerbations During Study 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 - w/Velcade and Dexamethasone; BRIEF: The purpose of this study is to determine if there is an improvement in progression-free survival (length of time during and after treatment in which a patient is living with a disease that does not get worse) when siltuximab is added to VELCADE and dexamethasone in subjects with relapsed or refractory multiple myeloma. ; DRUG USED: Sylvant; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: IL-6 (Interleukin-6); THERAPY: Combination; LEAD SPONSOR: Centocor, Inc.; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of multiple myeloma requiring treatment - Measurable secretory disease, defined as either serum M-protein >=1 g/dL or urine M-protein (light chain) >=¿200 mg/24 hours - Must have received 1 to 3 lines of prior treatment for multiple myeloma - Must have achieved a response (Minimal Response or better) to at least 1 prior line of treatment - Must have progressed on or been refractory (defined as < Minimal Response or disease progression within 60 days of last dose) to the most recent line of treatment - Must not be refractory to any previous line of treatment that included a proteasome inhibitor - Qualifying hematology and chemistry laboratory results. Exclusion Criteria: - Diagnosis of primary amyloidosis, plasma cell leukemia, or other conditions in which a paraprotein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions - Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy - Allogeneic bone marrow transplantation within 28 days - Bone marrow transplant planned within 12 months after study start - Chemotherapy or radiation therapy within 21 days - Clinically significant infection, including known HIV or hepatitis C infection, or known hepatitis B surface antigen positivity - Major surgery within 21 days before or planned during the study - Subjects who the investigator believes would not tolerate starting doses of VELCADE or dexamethasone - Significant cardiac disease or myocardial infarction within 6 months - Vaccination with live attenuated vaccines within 4 weeks - Prior exposure to agents targeting IL-6 or the IL-6 receptor - Received any investigational agent within 30 days¿ ; PRIMARY OUTCOME: Progression-free survival (PFS); SECONDARY OUTCOME 1: Overall survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Bendamustine; BRIEF: This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation. ; DRUG USED: Brukinsa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Mantle Cell Lymphoma - NHL; TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Combination; LEAD SPONSOR: BeiGene; CRITERIA: Key Inclusion Criteria: 1. ≥70 years of age at the time of informed consent, OR ≥60 and <70 years of age with comorbidities precluding autologous stem cell transplantation 2. Histologically confirmed diagnosis of MCL 3. No prior systemic treatments for MCL 4. Measurable disease by CT/MRI 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 6. Adequate marrow and organ function Key Exclusion Criteria: 1. Known central nervous system involvement by lymphoma 2. Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant 3. Clinically significant cardiovascular disease 4. History of severe bleeding disorder 5. Unable to swallow capsules or disease significantly affecting gastrointestinal function 6. Active fungal, bacterial and/or viral infection requiring systemic therapy 7. Requires ongoing treatment with a strong CYP3A inhibitor or inducer NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Progression-free survival (PFS) determined by independent central review; SECONDARY OUTCOME 1: PFS by investigator[/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 - EVOLUTION RMS1 (vs. Avonex); BRIEF: The study was to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Interferon-beta-1a (Avonex®), once a week intramuscularly in participants with RMS. ; DRUG USED: Evobrutinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Monotherapy; LEAD SPONSOR: EMD Serono Research & Development Institute, Inc.; 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 Baseline. Participants with an EDSS score <= 2 at Screening 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 - Female participants must be neither pregnant nor breast-feeding and 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 - 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. - 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: Annualized Relapse Rate (ARR); SECONDARY OUTCOME 1: Time to First Occurrence of 12-Week Confirmed 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 III - w/L19TNF (Stage IIIB/C); BRIEF: Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment in Stage III B/C melanoma patients. ; DRUG USED: Darleukin; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: IL-2 (Interleukin-2); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Philogen S.p.A.; CRITERIA: Inclusion criteria: 1. Diagnosis of malignant melanoma of the skin with locally advanced disease as defined by clinical stage III B and III C according to AJCC 7th Ed., eligible for complete surgical resection. 2. Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (≥ 10 mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm. 3. Prior anti-tumor treatment for the primary melanoma lesion, including surgery and approved adjuvant treatments (e.g., radiotherapy, immune checkpoint inhibitors, BRAF/MEK inhibitors, etc.) is allowed. 4. Males or females, age ≥ 18 years. 5. ECOG Performance Status/WHO Performance Status ≤ 1. 6. Life expectancy of at least 24 months (see paragraph 6.3.1). 7. Absolute neutrophil count > 1.5 x 109/L. 8. Hemoglobin > 9.0 g/dL. 9. Platelets > 100 x 109/L. 10. Total bilirubin ≤ 30 µmol/L (or ≤ 2.0 mg/dl). 11. ALT and AST ≤ 2.5 x the upper limit of normal (ULN). 12. Serum creatinine < 1.5 x ULN. 13. LDH serum level ≤ 1.5 x ULN. 14. Documented negative test for HIV, HBV and HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV (e.g., anti-HBsAg and/or anti-HBc Ab) negative serum HBV-DNA is also required. 15. All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.03) Grade ≤ 1 unless otherwise specified above. 16. Negative pregnancy test at screening for Women Of Childbearing Potential (WOCBP*). Pregnant women are not allowed to participate to this study. WOCBP must be using, from the screening to three months following the last study drug administration, highly effective contraception methods, as defined by the Recommendations for contraception and pregnancy testing in clinical trials issued by the Head of Medicine Agencies Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence. Pregnancy test will be repeated at the Safety Visit (only WOCBP and only for patients in Arm 1). 17. Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e., spermicidal gel plus condom) from the screening to three months following the last study drug administration. 18. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 19. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures. - Women of childbearing potential are defined as females who have experienced menarche, are not postmenopausal (12 months with no menses without an alternative medical cause) and are not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy). Exclusion Criteria: 1. Uveal melanoma, mucosal melanoma or melanoma with unknown primary. 2. Evidence of distant metastases at screening. 3. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1), second primary melanoma in situ or any cancer curatively treated ≥ 5 years prior to study entry. 4. Presence of active infections (e.g., requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study. 5. History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris. 6. Inadequately controlled cardiac arrhythmias including atrial fibrillation. 7. Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria). 8. LVEF ≤ 50% and/or abnormalities observed during baseline ECG and Echocardiogram investigations that are considered as clinically significant by the investigator. 9. Uncontrolled hypertension. 10. Ischemic peripheral vascular disease (Grade IIb-IV). 11. Severe diabetic retinopathy. 12. Active autoimmune disease. 13. History of organ allograft or stem cell transplantation. 14. Recovery from major trauma including surgery within 4 weeks prior to enrollment. 15. Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies or any other constituent of the product. 16. Breast feeding female. 17. Anti-tumor therapy (except allowed treatments listed at point 3 of Inclusion criteria) within 4 weeks before enrollment. 18. Previous in vivo exposure to monoclonal antibodies for biological therapy (except allowed treatments listed at point 3 of Inclusion criteria) in the 6 weeks before enrollment. 19. Planned administration of growth factors or immunomodulatory agents (except allowed treatments listed at point 3 of Inclusion criteria) within 7 days before enrollment. 20. Patient requiring or taking corticosteroids or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion. 21. Any conditions that in the opinion of the investigator could hamper compliance with the study protocol. 22. Previous enrolment and randomization in this same study. ; PRIMARY OUTCOME: Recurrence-free survival (RFS) rate; SECONDARY OUTCOME 1: Local recurrence-free survival (LRFS)[/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 -3004 (Japan); BRIEF: A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present. The main aim of this study is to learn if complex perianal fistulas in children and teenagers close after treatment with darvadstrocel. 2 to 3 weeks before treatment with darvadstrocel, each participant will have surgery to clean the fistula and to drain any abscesses. On the day of treatment, each participant will have the fistula cleaned and will receive an injection of darvadstrocel near the fistula, under anesthetic. For up to 1 year after treatment, participants will regularly visit the clinic for follow-up. The fistula will be examined and any side effects from the treatment will be recorded. Participants will have an MRI at one clinic visit (about 24 weeks after treatment). ; DRUG USED: Cx601; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Has a CD diagnosis based on accepted clinical, endoscopic, histological and/or radiologic criteria at least 6 months before the screening visit. 2. Has complex perianal fistula refractory to at least one of the following treatments: immunosuppressants or biologics (anti-TNFs, anti-integrin, anti-interleukin [IL] 12/23). Fistula(s) refractory to therapy is defined in this study as follows: Immunosuppressants: Inadequate response after 3 months, based on clinical assessment, or more treatment with azathioprine, 6-mercaptopurine or methotrexate. Biologics: Inadequate response after 14 weeks (16 weeks for anti-IL 12/23), based on clinical assessment, or more standard treatment for induction and maintenance. 3. A complex perianal fistula(s) that meets one or more of the following criteria, modified from the American Gastroenterological Association (AGA) technical review: High intersphincteric, transsphincteric, extrasphincteric, or suprasphincteric as assessed by MRI. Presence of 2 or 3 external openings (tracts) as assessed by clinical examination. Associated fluid (abscess) collections as determined by MRI. This study requires that the participant has complex perianal fistulas with a maximum of 2 internal openings and a maximum of 3 external openings, based on clinical assessment. Darvadstrocel treatment is targeted for fistulas that connect between internal and external openings. A central reading of a locally performed pelvic MRI will be performed to confirm the location of the fistula and potential associated perianal abscess(es). Fistulas must have been draining for at least 6 weeks before the screening visit. Participants with actively draining simple subcutaneous fistulas, at the time of the screening visit, are not allowed in this study. 4. Has inactive or mildly active luminal CD defined by meeting all of the following criteria: 1. Colonoscopy, flexible sigmoidoscopy or rectoscopy performed either at screening or within the 6 months before screening, demonstrating no rectal ulcers larger than 0.5 cm. A participant who has documented rectal ulcers larger than 0.5 cm within the 6 months before screening but has undergone subsequent treatment may be eligible if there are no rectal ulcers larger than 0.5 cm on a sigmoidoscopy or rectoscopy performed after treatment or at the time of screening. 2. The improvement of, or no worsening in stool frequency, sustained for 1 week or more, in the interval between the colonoscopy, flexible sigmoidoscopy or rectoscopy in inclusion criteria 4(a) and the screening visit. 3. No initiation or intensification of treatment with corticosteroids, immunosuppressants, or monoclonal antibody dose regimen between the colonoscopy, flexible sigmoidoscopy or rectoscopy in inclusion criteria 4(a) and the screening visit. Exclusion Criteria: 1. Has received any investigational compound within 12 weeks/84 days before screening. 2. Has received darvadstrocel/eASC in a previous clinical study or as a therapeutic agent. 3. The participant weighs <10 kg at screening. 4. Has concomitant perianal fistula(s) with only internal or external opening(s). 5. Has concomitant internal fistula(s) such as ileo-vesical, rectovaginal or ileo-colonic fistula(s). 6. Has an abscess >2 cm, unless resolved in the preparation procedure. 7. Has rectal and/or anal stenosis, and/or active proctitis, which would restrict the surgical procedure. 8. The participant underwent surgery for the fistula other than drainage or seton placement. 9. Has diverting stomas. 10. Has ongoing systemic corticosteroid treatment or has been treated with systemic corticosteroids within 4 weeks before screening. 11. The participant requires new treatment with immunosuppressants/anti-TNF agents during the screening period. 12. The participant has known or suspected COVID-19 by the investigator within the past 2 months (additional testing may be performed at the discretion of the investigator). Positive antibody testing for COVID without other evidence of current or recent active infection does not exclude participation. Participants who were in screening at the time that COVID-19-related factors resulted in discontinuation may also be rescreened with approval of the sponsor or designee. 13. The participant requires surgery in the perianal region for reasons other than fistulas at the time of screening or foreseen either during the study and/or during the 24 weeks after treatment administration. 14. Has malignant tumor or a prior history of any malignant tumor, including any type of fistula carcinoma. 15. Has current or recent (within 3 months before the screening) history of abnormal, severe, progressive, uncontrolled hepatic, hematologic, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease. 16. Has either congenital or acquired immunodeficiencies, including participants known to be HIV carriers or participants with, in the judgment of the investigator, are suspected to have monogenic inflammatory bowel disease. 17. Has previously received a bone marrow transplant. 18. Has a contraindication to MRI scan or other planned study procedures. 19. Has a contraindication to the anesthetic procedure. 20. Had major surgery or severe trauma within 6 months before the screening visit. ; PRIMARY OUTCOME: Percentage of Participants who Achieve Combined Remission; SECONDARY OUTCOME 1: Percentage of Participants who Achieve Clinical Remission[/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 - FLAURA; BRIEF: To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer ; DRUG USED: Tagrisso; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Male or female, aged at least 18 years. 2. Pathologically confirmed adenocarcinoma of the lung. 3. Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy. 4. The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R). 5. Mandatory provision of an unstained, archived tumour tissue sample in a quantity sufficient to allow for central analysis of EGFR mutation status. 6. Patients must be treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with gefitinib or erlotinib as selected by the participating centre. Prior adjuvant and neo-adjuvant therapy is permitted(chemotherapy, radiotherapy, investigational agents). 7. Provision of informed consent prior to any study specific procedures, sampling, and analysis. 8. World Health Organization Performance Status of 0 to 1 with no clinically significant deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks Exclusion Criteria: 1. Treatment with any of the following: - Prior treatment with any systemic anti-cancer therapy for locally advanced/metastatic NSCLC. - Prior treatment with an EGFR-TKI. - Major surgery within 4 weeks of the first dose of study drug. - Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. - Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4. - Alternative anti-cancer treatment - Treatment with an investigational drug within five half-lives of the compound or any of its related material. 2. Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of study drug. 3. Spinal cord compression, symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids. 4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). 5. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291. 6. Any of the following cardiac criteria: - Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTcF value. - Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG. - Any patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval. 7. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. 8. Involvement in the planning and/or conduct of the study ; PRIMARY OUTCOME: Median Progression Free Survival (PFS) (Months); 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 - CAHtalyst; BRIEF: This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 6-month randomized, double-blind, placebo-controlled period, followed by 1 year of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per subject for the OLE (estimated to be approximately 3 years). ; DRUG USED: NBI-74788; DRUG CLASS: New Molecular Entity (NME); INDICATION: Congenital Adrenal Hyperplasia (CAH); TARGET: Corticotropin Releasing Factor -Receptor1 (CRF-R1), Corticotropin Releasing Factor -Receptor2 (CRF-R2); THERAPY: Monotherapy; LEAD SPONSOR: Neurocrine Biosciences; CRITERIA: Inclusion Criteria: 1. Be willing and able to adhere to the study procedures, including all requirements at the study center and return for the follow-up visit. 2. Have a medically confirmed diagnosis of classic 21-hydroxylase deficiency CAH. 3. Be on a stable regimen of steroidal treatment for CAH. 4. Participants of childbearing potential must agree to use an acceptable method of contraception during the study. Exclusion Criteria: 1. Have a diagnosis of any of the other known forms of classic CAH. 2. Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy. 3. Have a clinically significant unstable medical condition or chronic disease other than CAH. 4. Have a history of cancer unless considered cured. 5. Are pregnant. 6. Have a known history of clinically significant arrhythmia or abnormalities on ECG. 7. Have a known hypersensitivity to any corticotropin releasing hormone antagonists. 8. Have received any other investigational drug within 30 days before initial screening or plan to use an investigational drug (other than the study drug) during the study. 9. Have current substance dependence, or current substance (drug) or alcohol abuse. 10. Have had a blood loss ≥550 mL or donated blood or blood products within 8 weeks prior to the study. ; PRIMARY OUTCOME: Percent change from baseline in glucocorticoid daily dose at Week 24; SECONDARY OUTCOME 1: Change from baseline in serum androstenedione at Week 4[/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 - COMFORT-II - PMF/PPV-MF/PET-MF (EU); BRIEF: This was an open label, randomized study comparing the efficacy and safety of randomized 2:1 Ruxolitinib tablets versus best-available therapy, as selected by the investigator. The purpose was to compare the efficacy, safety and tolerability of Ruxolitinib (INC424/INCB018424) given twice daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis (PET-MF). ; DRUG USED: Jakafi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelofibrosis (MF); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Subjects must be diagnosed with PMF, PPV-MF or PET-MF according to the 2008 World Health Organization criteria - Subjects with MF requiring therapy must be classified as high risk OR intermediate risk level 2 according to the prognostic factors defined by the International Working Group - Subjects with an ECOG performance status of 0, 1, 2 or 3 - Subjects with peripheral blood blast count of < 10%. - Subjects who have not previously received treatment with a JAK inhibitor Exclusion Criteria: - Subjects with a life expectancy of less than 6 months - Subjects with inadequate bone marrow reserve as demonstrated by specific clinical laboratory counts - Subjects with any history of platelet counts < 50,000/µL or ANC < 500/µL except during treatment for a myeloproliferative disorder or treatment with cytotoxic therapy for any other reason - Subjects with inadequate liver or renal function - Subjects with clinically significant bacterial, fungal, parasitic or viral infection which require therapy - Subjects with an active malignancy over the previous 5 years except specific skin cancers - Subjects with severe cardiac conditions - Subjects who have had splenic irradiation within 12 months ; PRIMARY OUTCOME: Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48; SECONDARY OUTCOME 1: Duration of Maintenance of Spleen Volume Reduction (Median)[/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 - PEARL 1; BRIEF: The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment. ; DRUG USED: Omontys; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Independent; TARGET: Erythropoietin Receptor (EPOR); THERAPY: Monotherapy; LEAD SPONSOR: Affymax; CRITERIA: Inclusion Criteria: 1. Chronic renal failure with an estimated glomerular filtration rate < 60 milliliter per minute per 1.73m^2 and not expected to begin dialysis for at least 12 weeks. 2. Two consecutive hemoglobin values ≥ 8.0 g/dL and < 11.0 g/dL within 4 weeks prior to randomization. Exclusion Criteria: 1. Females who are pregnant or breast-feeding. 2. Treatment with an ESA in the 12 weeks prior to randomization. 3. Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule. 4. Prior chronic hemodialysis or chronic peritoneal dialysis treatment. 5. Known bleeding or coagulation disorder. 6. Known hematologic disease or cause of anemia other than renal disease 7. Poorly controlled hypertension 8. Evidence of active malignancy within one year prior to randomization. 9. A scheduled kidney transplant ; PRIMARY OUTCOME: Mean Change in Hemoglobin Between Baseline and the Evaluation Period; SECONDARY OUTCOME 1: Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods[/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 - 1311.4 (IMMhance); BRIEF: This was a multinational, multicenter, randomized, double-blind, placebo controlled study with randomized withdrawal and retreatment, evaluating the safety and efficacy of risankizumab 150 mg subcutaneous (SC) in participants with moderate to severe chronic plaque psoriasis. ; DRUG USED: Skyrizi; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion criteria: - Male or female participants. Woman of childbearing potential must be ready and willing to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1 percent per year when used consistently and correctly. - Age ≥18 years at screening - Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the participant. - Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization); Have an involved body surface area (BSA) ≥ 10% and Have a Psoriasis Area and Severity Index (PASI) ≥ 12 and Have a static Physician Global Assessment (sPGA) score of ≥ 3. - Must be a candidate for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator - Signed and dated written informed consent prior to admission to the study and performance of any study procedures in accordance with Good Clinical Practice (GCP) and local legislation Exclusion criteria: - Participants with nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular); current drug-induced psoriasis (including a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium); active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to the investigators judgment. - Previous exposure to ABBV-066 - Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study - Use of any restricted medication as noted or any drug considered likely to interfere with the safe conduct of the study. - Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g., hip replacement, removal aneurysm, stomach ligation). - Known chronic or relevant acute infections such as active tuberculosis, human immunodeficiency virus (HIV), or viral hepatitis - Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix - Evidence of a current or previous disease (including chronic alcohol or drug abuse), medical condition other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram [ECG]), or laboratory value at the screening visit outside the reference range that in the opinion of the Investigator, is clinically significant and would make the study participant unable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data. - History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients - Women who are pregnant, nursing, or who plan to become pregnant while in the trial - Previous enrolment in this trial ; PRIMARY OUTCOME: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16; SECONDARY OUTCOME 1: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/Bevacizumab + TACE (1st Line); BRIEF: This study will evaluate the efficacy and safety of atezolizumab plus bevacizumab combined with on-demand TACE compared to on-demand TACE alone in participants with hepatocellular carcinoma who are at high risk of poorer outcome following TACE treatment. ; DRUG USED: Tecentriq; DRUG CLASS: Biologic; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of HCC by histology/ cytology or clinical criteria - Eligible for TACE treatment - No prior systemic therapy for HCC, especially immunotherapy - No prior locoregional therapy to the target lesion(s) - At least one measurable untreated lesion - ECOG Performance Status of 0-1 - Child-Pugh class A Exclusion Criteria: - Evidence of Vp3/4 and hepatic vein tumor thrombus (HVTT) - Evidence of extrahepatic spread (EHS) - Being a candidate for curative treatments - Any condition representing a contraindication to TACE as determined by the investigators - Active or history of autoimmune disease or immune deficiency - Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding - A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment - Evidence of bleeding diathesis or significant coagulopathy ; PRIMARY OUTCOME: TACE Progression-Free Survival (TACE PFS) as Determined by Investigator; SECONDARY OUTCOME 1: Time to Untreatable (unTACEable) Progression (TTUP) as Determined by Investigator[/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 - P08160 - Russia; BRIEF: The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) [PEG+RBV=PR] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group. ; DRUG USED: Victrelis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion criteria: - body weight ≥40 kg and ≤125 kg - previously documented CHC genotype 1 infection; - must have a liver biopsy with histology consistent with CHC and no other etiology - if cirrhosis present, must have an ultrasound within 6 months of the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC) - agree to use acceptable methods of contraception with partner - previously untreated with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV or failing prior treatment with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV Exclusion criteria: - co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] positive). - required discontinuation of previous interferon or ribavirin regimen for an adverse event (possibly or probably related) - treatment with ribavirin within 90 days and any interferon-alpha, based on the amendment, should be within 1 month prior to screening - treatment with any investigational drug within 30 days of the screening visit in this trial - evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy - diabetic and/or hypertensive with clinically significant ocular examination findings - clinical diagnosis of substance abuse of specified drugs within specified timeframes - any known pre-existing medical condition that could interfere with the participants participation in and completion of the trial ; PRIMARY OUTCOME: Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population); SECONDARY OUTCOME 1: Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CLEAR Harmony (1002-040); BRIEF: The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy. ; DRUG USED: Nexletol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: ATP citrate lyase (ACL); THERAPY: Monotherapy; LEAD SPONSOR: Esperion Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Fasting LDL-C ≥ 70 mg/dL - High cardiovascular risk (diagnosis of HeFH or ASCVD) - Be on maximally tolerated lipid-modifying therapy Exclusion Criteria: - Total fasting triglyceride ≥500 mg/dL - Renal dysfunction or nephrotic syndrome or history of nephritis - Body Mass Index (BMI) ≥50kg/m2 - Significant cardiovascular disease or cardiovascular event in the past 3 months ; PRIMARY OUTCOME: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)[/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 - GeparDouze (NSABP Foundation); BRIEF: The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better than the usual chemotherapy plus a placebo. (A placebo is a drug that looks like the study drug but contains no medication.) The usual chemotherapy in this study is paclitaxel (WP) and carboplatin followed by doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC). Usually, after neoadjuvant therapy and surgery for triple negative breast cancer, no additional treatment is given unless the cancer returns. This study will also look at continuing treatment after surgery with atezolizumab or the placebo. To be better, atezolizumab given with the neoadjuvant therapy should be better at: 1) decreasing the amount of tumor in the breast than the placebo given with the usual chemotherapy and 2) decreasing the chance of the cancer from returning after surgery. Another purpose of this study is to test the good and bad effects of atezolizumab when added to the usual chemotherapy. Atezolizumab may keep your cancer from growing but it can also cause side effects. ; DRUG USED: Tecentriq; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: NSABP Foundation Inc; CRITERIA: Inclusion Criteria: - The patient must have consented to participate and, prior to beginning specific study procedures, must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for study treatment and for submission of tumor samples from a research biospy as required by NSABP B-59/GBG 96-GeparDouze for baseline correlative science studies. - The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy. - Local testing on the diagnostic core must have determined the tumor to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP guidelines. (If local testing has determined a tumor to be HER2 equivocal or to have a borderline ER/PgR status (% IHC staining < 10% for both) and other eligibility criteria are met, material may be submitted for central testing to determine eligibility.) - Central testing for ER, PgR, and HER2 will be performed, and the tumor must be determined to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP Guidelines Recommendations. - The tumor specimen used for central ER, PgR, and HER2 testing must also be used for central testing of PD-L1 status using the Ventana PD-L1 testing result including PD-L1 indeterminate Patients will be classifies as positive, negative, or indeterminate for stratification purposes. - Patients must be ≥ 18 years old. - Patient may be female or male. - The ECOG performance status must be 0-1. - The primary tumor can be clinical stage T2 or T3, if clinically node negative according to AJCC 7th Edition. If the regional lymph nodes are cN1 and cytologically or histologically positive or cN2-N3 with or without a biopsy, the primary breast tumor can be clinically T1c, T2, or T3. - Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or MRI) within 84 days prior to study entry. If suspicious or abnormal, FNA or core biopsy is recommended. Findings of these evaluations will be used to define the nodal status prior to study entry according to the following criteria: - Nodal status - negative (Imaging of the axilla is negative; Imaging is suspicious or abnormal but the FNA or core biopsy of the questionable node[s] on imaging is negative) - Nodal status - positive (FNA or core biopsy of the node[s] is cytologically or histologically suspicious or positive; Imaging is suspicious or abnormal but FNA or core biopsy was not performed.) - Patients with synchronous bilateral or multicentric HER2-negative breast cancer are eligible as long as the highest risk tumor is ER-negative and PgR-negative and meets stage eligibility criteria. All of the other invasive tumors must also be HER2-negative by ASCO/CAP Guidelines based on local testing. Central testing to confirm TNBC status is only required for the highest risk tumor. - Blood counts performed within 28 days prior to randomization must meet the following criteria: - ANC must be ≥ 1500/mm3; - platelet count must be ≥ 100,000/mm3; and - hemoglobin must be ≥10 g/dL. - The following criteria for evidence of adequate hepatic function performed within 28 days prior to randomization must be met: - total bilirubin must be ≤ ULN for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilberts disease or similar syndrome involving slow conjugation of bilirubin; and - alkaline phosphatase must be ≤ 2.5 x ULN for the lab; and - AST and ALT must be ≤ 1.5 x ULN for the lab. - Patients with AST or ALT or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (CT, MRI, abdominal ultrasound, PET-CT, or PET scan) performed within 28 days prior to randomization does not demonstrate metastatic disease and the requirements in criterion (just above) are met. - Patients with alkaline phosphatase that is > ULN but less than or equal to 2.5 x ULN or with unexplained bone pain are eligible for inclusion in the study if bone imaging (bone scan, PET-CT scan, or PET scan) supported by additional studies when indicated (CT, x-ray, MRI) performed within 28 days prior to randomization does not demonstrate metastatic disease. - Patients with N2 or N3 nodal disease or T3 primary disease must undergo liver and bone imaging (as described in 4.1.13 and 4.1.14) within 28 days prior to randomization, irrespective of baseline lab results, and studies must not demonstrate metastatic disease. Chest imaging with chest x-ray PA and Lateral, CT of the chest, or PET-CT must also be performed. - Creatinine clearance ≥ 50 mL/min (see Section 7.2.1 for instructions regarding calculation of creatinine clearance) performed within 28 days prior to randomization. - PT/INR ≤ ULN within 28 days of randomization. Patients receiving therapeutic anti-coagulants are not eligible. - A serum TSH and AM (morning) cortisol performed within 28 days prior to randomization to obtain a baseline value. Patients with abnormal TSH or AM cortisol baseline levels should be further evaluated and managed per institutional standards. Asymptomatic patients who require initiation or adjustment of medication or are followed without initiating treatment based on endocrinologists recommendations are eligible. - LVEF assessment must be performed within 42 days prior to randomization. (LVEF assessment performed by echocardiogram is preferred; however, MUGA scan may be substituted based on institutional preferences.) The LVEF must be ≥ 55% regardless of the cardiac imaging facilitys lower limit of normal. - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab/placebo or 12 months after the last dose of chemotherapy. - A woman is considered to be of childbearing potential if she is not postmenopausal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). - Examples of contraceptive methods with a failure rate of < 1% per year include: bilateral tubal ligation; male partner sterilization; hormonal contraceptives that inhibit ovulation; hormone-releasing intrauterine devices; copper intrauterine devices. - The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. - Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: - Excisional biopsy or lumpectomy performed prior to study entry. - FNA alone to diagnose the breast cancer. - Surgical axillary staging procedure prior to randomization. Exception: FNA or core biopsy of an axillary node is permitted for any patient. A pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is prohibited. - Definitive clinical or radiologic evidence of metastatic disease. - Previous history of contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.) - Previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.) - History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry. - Treatment including radiation therapy, chemotherapy, or targeted therapy, for the currently diagnosed breast cancer prior to randomization. - Previous therapy with anthracyclines or taxanes for any malignancy. - Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to: - Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; or symptomatic pericarditis. - History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular function within 6 months prior to randomization; history of documented CHF; or documented cardiomyopathy. - Uncontrolled hypertension defined as sustained systolic BP > 150 mmHg or diastolic BP > 90 mmHg. (Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.) Patients requiring ≥ 3 BP medications are not eligible. - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. - Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells. - Known allergy or hypersensitivity to the components of the atezolizumab formulation. - Known allergy or hypersensitivity to the components of the doxorubicin, epirubicin, cyclophosphamide, carboplatin, or paclitaxel formulations. - Known allergy or hypersensitivity to liposomal or pegylated G-CSF formulations. - Active or history of autoimmune disease or immune deficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis for a more comprehensive list of autoimmune diseases and immune deficiencies) with the following exceptions: - Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. - Patients with controlled Type 1 diabetes mellitus on a stable dose of insulin regimen may be eligible for this study. - Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are permitted provided all of following conditions are met: Rash must cover < 10% of body surface area; Disease is well controlled at baseline and requires only low-potency topical corticosteroids; No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months. - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. - Patients known to be HIV positive. - Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study if active HBV infection is ruled out on the basis of HBV DNA viral load per local guidelines. - Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV RNA. - Patients with clinically active tuberculosis. - Severe infection within 28 days prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. - Prior allogeneic stem cell or solid organ transplantation. - Administration of a live, attenuated vaccine within 28 days prior to randomization or anticipation that such vaccine will be required during the study. Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist) within 28 days prior to randomization, during treatment or within 5 months following the last dose of atezolizumab/placebo. - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications. - Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies. - Treatment with systemic immunosuppressive medications (including but not limited to interferons, IL-2) within 28 days or 5 half-lives of the drug, whichever is longer, prior to randomization. - Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis [anti-TNF] factor agents) within 14 days prior to randomization or anticipation of need for systemic immunosuppressive medications during the study. - Nervous system disorder (paresthesias, peripheral motor neuropathy, or peripheral sensory neuropathy) ≥ Grade 2, per the CTCAE v4.0. - Symptomatic peripheral ischemia. - Pregnancy or lactation at the time of randomization or intention to become pregnant during the study. (Note: Negative serum pregnancy test must be obtained within 14 days prior to randomization). - Use of any investigational agent within 28 days prior to randomization. ; PRIMARY OUTCOME: Event-free survival (EFS); SECONDARY OUTCOME 1: Overall survival (OS)[/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 - Crimson-1; BRIEF: The purpose of the trial is to evaluate the safety and efficacy of MarzAA for on-demand treatment and control of bleeding episodes in hemophilia A or B patients with inhibitors compared with their standard of care (SOC). ; DRUG USED: Marzeptacog alfa; DRUG CLASS: Biologic; INDICATION: Hemophilia A and B - General Clotting Products; TARGET: Coagulation Factor IX, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Catalyst Biosciences; CRITERIA: Inclusion Criteria: - Diagnosis of congenital hemophilia A or B with inhibitors - Male or Female, age 12 or older - History of frequent bleeding episodes - Affirmation of informed consent with signature confirmation and assent for children between ages 12 to 17 before any study related activities Exclusion Criteria: - Previous participation in a clinical trial evaluating a modified rFVIIa agent - Received an investigational drug within 30 days or 5 half-lives or absence of clinical effect - Known hypersensitivity to trial or related product - Known positive antibody to FVII or FVIIa detected by central lab at screening - Have a coagulation disorder other than hemophilia A or B - Be immunosuppressed - Significant contraindication to participate ; PRIMARY OUTCOME: Bleeding episode treatment success; 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 - RAISE-XT (OLE); BRIEF: The RAISE-XT study is an open-label extension study to evaluate the long-term efficacy, safety, and tolerability of zilucoplan in subjects with gMG who have previously participated in a qualifying Ra Pharmaceuticals sponsored zilucoplan study. ; DRUG USED: Zilucoplan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myasthenia Gravis (MG); TARGET: Complement component 5 (C5), Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Ra Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Completion of a qualifying zilucoplan study Exclusion Criteria: - With the exception of a prior zilucoplan trial, participation in another concurrent clinical trial involving an experimental therapeutic intervention (participation in observational studies and/or registry studies is permitted) ; PRIMARY OUTCOME: Incidence of treatment-emergent adverse events (TEAEs); SECONDARY OUTCOME 1: Change from Baseline to Week 12 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) 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 - UNITI-1 (Fail/Intol to TNF Antag; IV); BRIEF: This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohns disease who have either failed or could not tolerate at least one TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab pegol). ; DRUG USED: Stelara; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: IL-12 (Interleukin-12) and IL-12 receptor, IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Have Crohns disease of at least 3 months duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy - Have active Crohns disease, defined as a baseline Crohns Disease Activity Index (CDAI) score of >= 220 and <= 450 - Have received infliximab, adalimumab, or certolizumab pegol at a dose approved for the treatment of Crohn disease and did not respond initially (ie, primary nonresponse) - Or responded initially but then lost response with continued therapy (ie, secondary nonresponse) - Or were intolerant to the medication - Have screening laboratory test results within protocol-specified parameters. Exclusion Criteria: - Patients who have had any kind of bowel resection within 6 months - Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent - Patients who have received infliximab, adalimumab or certolizumab pegol < = 8 weeks before the first administration of study drug - Patients with certain complications of Crohns disease that would make it hard to assess response to study drug - Patients with a history of or ongoing chronic or recurrent infectious disease - Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874) ; PRIMARY OUTCOME: Number of Participants With Clinical Response at Week 6; SECONDARY OUTCOME 1: Number of Participants in Clinical Remission at Week 8[/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 - ATLAS; BRIEF: The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult subjects who are stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible subjects will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52, subjects who were randomized to continue their current ART regimen will be given an option to switch to CAB LA + RPV LA injections. Those subjects would transition to LA dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at Week 56. ; DRUG USED: Cabenuva; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: HIV Integrase; THERAPY: Monotherapy; LEAD SPONSOR: ViiV Healthcare; CRITERIA: Inclusion Criteria: - Aged 18 years or older (or ≥19 where required by local regulatory agencies), at the time of signing the informed consent. - Must be on uninterrupted current regimen (either the initial or second ARV regimen) for at least 6 months prior to Screening. Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for treatment failure (HIV-1 RNA ≥400 c/mL). - Acceptable stable (initial or second) ARV regimens prior to Screening include 2 NRTIs plus: INI with the exception of ABC/DTG/3TC (either the initial or second cART regimen);NNRTI (either the initial or second cART regimen);Boosted PI (or atazanavir [ATV] unboosted) (must be either the initial cART regimen or one historical within class switch is permitted due to safety/tolerability) The addition, removal, or switch of a drug(s) that has been used to treat HIV based on antiretroviral properties of the drug constitutes a change in ART with the following limited exceptions: Historical changes in formulations of ART drugs or booster drugs will not constitute a change in ART regimen if the data support similar exposures and efficacy, and the change must have been at least 3 months prior to Screening; Historical perinatal use of an NRTI when given in addition to an ongoing HAART will not be considered a change in ART regimen; A change in dosing scheme of the same drug from twice daily to once daily will not be considered a change in ART regimen if data support similar exposures and efficacy. - Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: one within the 6 to 12 month window, and one within 6 months prior to Screening; - Plasma HIV-1 RNA <50 c/mL at Screening; - A female subjects is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screen and a negative urine hCG test at Randomization), not lactating, and at least one of the following conditions applies: 1. Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up; confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy; Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. 2. Reproductive potential and agrees to the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, and until from 30 days prior to the first dose of study medication throughout the study, and for at least 30 days after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of CAB LA and RPV LA. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form. Eligible subjects or their legal guardians (and next of kin when locally required), must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrolment of subjects who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures. - Subjects enrolled in France must be affiliated to, or a beneficiary of, a social security category. - All subjects participating in the study should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner. Exclusion Criteria: - Within 6 months prior to Screening and after confirmed suppression to <50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement ≥50 c/mL - Within the 6 to 12 month window prior to Screening and after confirmed suppression to <50 c/mL, any plasma HIV-1 RNA measurement >200 c/mL, or 2 or more plasma HIV-1 RNA measurements ≥50 c/mL - Any drug holiday during the window between initiating first HIV ART and 6 months prior to Screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns - Any switch to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV-1 RNA measurement ≥400 c/mL after initial suppression to <50 c/mL while on first line HIV therapy regimen) - Abacavir/dolutegravir/lamivudine, (ABC/DTG/3TC) as current ART regimen - A history of use of any regimen consisting of only single NNRTI therapy (even if only for peri-partum treatment), or only single or dual NRTI therapy prior to starting cART - Subjects who are currently participating in or anticipate to be selected for any other interventional study - Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study - Any evidence of an active Center for Disease Control and Prevention (CDC) Stage 3 disease [CDC, 2014], except cutaneous Kaposis sarcoma not requiring systemic therapy and historical or current CD4 cell counts less than 200 cells/mm^3 - Subjects with moderate to severe hepatic impairment - Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the subjects ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the subject. - Subjects determined by the Investigator to have a high risk of seizures, including subjects with an unstable or poorly controlled seizure disorder. A subject with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrolment - All subjects will be screened for syphilis (rapid plasma reagin [RPR]). Subjects with untreated syphilis infection, defined as a positive RPR without clear documentation of treatment, are excluded. Subjects with a serofast RPR result (persistence of a reactive nontreponemal syphilis test) despite history of adequate therapy and no evidence of re-exposure may enrol after consultation with the Medical Monitor. Subjects with a positive RPR test who have not been treated may be rescreened at least 30 days after completion of antibiotic treatment for syphilis - Subjects who, in the investigators judgment, pose a significant suicide risk. Subjects recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk - The subject has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions - Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:•Subjects positive for HBsAg are excluded; - Subjects negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded - Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; subjects who are anticipated to require HCV treatment within 12 months must be excluded. (HCV treatment on study may be permitted post Week 48, following consultation with the medical monitor) Subjects with HCV co-infection will be allowed entry into phase 3 studies if: Liver enzymes meet entry criteria; HCV Disease has undergone appropriate work-up, and is not advanced, and will not require treatment prior to the Week 48 visit. Additional information (where available) on subjects with HCV co-infection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment. In the event that recent biopsy or imaging data is not available or inconclusive, the Fib-4 score will be used to verify eligibility: Fib-4 score > 3.25 is exclusionary; Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation Fibrosis 4 Score Formula:( Age x AST ) / ( Platelets x ( sqr [ ALT ]) - Unstable liver disease (as defined by any of the following: presence of ascites,encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices,or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment) - History of liver cirrhosis with or without hepatitis viral co-infection. - Ongoing or clinically relevant pancreatitis - Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease - Ongoing malignancy other than cutaneous Kaposis sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject prior to randomization - Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the subject unable to receive study medication - History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled - Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (≤325mg). - Any evidence of primary resistance based on the presence of any major known INI or NNRTI resistance-associated mutation, except for K103N, (International AIDS Society [IAS]-USA, 2015) by any historical resistance test result. - Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result - Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the subjects participation in the study of an investigational compound - Subject has estimated creatine clearance <50mL/min per 1.73m^2 via CKDEPI Method - Alanine aminotransferase (ALT) ≥3 × ULN Exposure to an experimental drug or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study; - Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid,INH); anti-coagulation agents; Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. Note: Subjects using short term (e.g. ≤21 days) systemic corticosteroid treatment; topical, inhaled and intranasal corticosteroids are eligible for enrolment. - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening - Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 within 28 days of study Day 1 - Use of medications which are associated with Torsade de Pointes. - Current or prior history of etravirine (ETR) - Current use of tipranavir/ritonavir or fosamprenavir/ritonavir - Subjects receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication. ; PRIMARY OUTCOME: Number of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48; SECONDARY OUTCOME 1: Number of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48[/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 - OASIS (CM); BRIEF: This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine. The study hypothesis is that in pediatric participants with chronic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP). ; DRUG USED: Aimovig; DRUG CLASS: Biologic; INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Children (6 to less than 12 years of age) or adolescent (12 to less than 18 years of age) at the time of signing, if developmentally appropriate, the formal assent to participate to the study. - Participants parent or legal representative has provided written informed consent before initiation of any study-specific activities/procedures. - History of migraine (with or without aura) for ≥ 12 months before screening according to the IHS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013) ICHD-3 specifications for pediatric migraine (participants aged less than 18 years), should be considered for the diagnosis of migraine. - History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the participant as migraine days per month in each of the 3 months prior to screening. - Migraine frequency: greater than or equal to 8 migraine days based on the eDiary data during the last 28 days of the baseline phase if more than 28 days in duration. - Headache frequency of greater than or equal to 15 headache days based on the eDiary data during the last 28 days of the baseline phase if more than 28 days in duration. - Demonstrated at least 80% compliance with the eDiary based on the last 28 days of the baseline period, if more than 28 days in duration (eg, completing eDiary items for at least 23 out of the last 28 days of the baseline phase). Key Exclusion Criteria: - History of cluster headache or hemiplegic migraine headache. - Chronic migraine with continuous pain, in which the participant does not have any pain free periods (of any duration) during the 1 month prior to screening. - No therapeutic response with greater than 3 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. No therapeutic response is defined as no reduction in headache frequency, duration, or severity after administration of the medication for at least 6 weeks at the generally-accepted therapeutic dose(s) based on the investigators assessment. - History of suicidal behavior or the participant is at risk of self-harm or harm to others. - History of major psychiatric disorder. Participants with anxiety disorder and/or mild major depressive disorder (Patient Health Questionnaire Modified for Adolescents [PHQ-A] score 9 for adolescents or based on medical judgement of the investigator for children) are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication for each disorder. Participants must have been on a stable dose within the 3 months before the start of the baseline phase. ; PRIMARY OUTCOME: Change from baseline in MMDs; SECONDARY OUTCOME 1: Change in monthly headache days from 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 - MACRO; BRIEF: The purpose of this study is to compare the free time to disease progression of combination therapy with capecitabine, oxaliplatin and bevacizumab until disease progression versus capecitabine, oxaliplatin and bevacizumab for 6 cycles followed by bevacizumab until disease progression or a premature drop out of the study. ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD); CRITERIA: Inclusion Criteria: - Written informed consent given. - Patients who are able to understand the study request. - Men and women > or = 18 years, not hospitalized. - Outpatients with ECOG performance status ≤ 2. - Histologically confirmed diagnosis of colorectal cancer (CRC) patients with metastasis. - Presence of at least one detectable lesion in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) criteria. - Life expectancy of greater than 3 months. - Men and women potentially fertile using an effective contraceptive method Exclusion Criteria: - Patients who have been treated with bevacizumab previously. - Received any systemic treatment previously to treat an advanced or metastatic disease - Adjuvant or neoadjuvant treatment to non-metastatic disease is allowed, provided that it has been finished at least 6 months before the initial study treatment. - If the patient has been treated with adjuvant therapy previously, it is not allowed to be included in the study in case of disease progression during treatment or for 6 months after the end of treatment. - If radiotherapy has not been administered in the lesion selected for the study, previous radiotherapy is allowed, unless progression of those injuries can be documented in the radiated field, as long as the end of the treatment has been finished at least 4 weeks before study initiation. - Previous surgical procedure of stage IV disease is allowed. - Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or this study indication, unless there has been a disease-free interval of at least 2 years. - History or evidence upon physical examination of central nervous system - History of psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake. - Clinically significant cardiovascular disease (active). - Patients who have undergone myocardial infarction or cerebrovascular accident 6 months prior to randomisation will be excluded. - Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medications. - Patients subjected to allogeneic transplant and request immunotherapy. - Bone fracture not healed, wounds or severe ulcers. - Known hemorrhagic diathesis or coagulopathy. - Uncontrolled and severe intercurrent infections or other severe and uncontrolled concomitant diseases. - Moderate or severe renal impairment (creatinine clearance < 30 ml/min [calculated according to Cockroft-Gault formula] or serum creatinine ≥ 2 mg/dl or 177 μmol/l). - Any of the following laboratory values: - Absolute neutrophil count (ANC) ≤ 1.5 x 10^9/l. - Platelet count ≤ 100 x 10^9/l. - Hemoglobin ≤ 9 g/dl. - International Normalized Ratio (INR) ≥ 1.5. - Total bilirubin ≥ 1.5 x upper limit of normal (ULN). - ALT and/or AST ≥ 2.5 x ULN or ≥ 5 x ULN (in case of hepatic metastasis). - Alkaline phosphatase > 2.5 x ULN or 5 x ULN (in case of hepatic metastasis), or > 10 x ULN (in case of bone metastasis). - History of unexpected serious adverse events to fluoropyrimidine treatments or known dihydropyrimidine dehydrogenase (DPD) deficiency. - Patients subjected to major surgical procedure or open biopsy; or patients have had significant traumatic injuries 28 days before the initial study treatment; or patients with a major surgical procedure planned during the study period. - Fine needle aspiration biopsy 7 days before study initiation. - Use of full dose of oral or parenteral anticoagulants (at least 10 days before the initial study treatment) or thrombolytic agents. Low dose of warfarin is allowed, with an INR ≤ 1.5. - Subjects requiring chronic use of high dose aspirin (> 325 mg/day) or non-steroidal anti-inflammatory treatment (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases). - Pregnant or lactating women. - Patients with known allergy to Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies; or to any excipients of bevacizumab formulation; or to any other study drugs. - Received any investigational drug or agent/procedure, i.e. participation in another treatment trial within 30 days of randomisation. - Evidence of another disease, metabolic malfunction, discovery in a physical examination or in a clinical laboratory test to result in reasonable suspicion of a condition or disease that contraindicates investigational medicine use or exposes the patient to high risk treatment complications. ; PRIMARY OUTCOME: Determine the free time to disease progression; 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 - MATrX-1; BRIEF: Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or Primary Open-Angle Glaucoma. All subjects who meet the studys enrollment criteria following Screening will undergo washout of all prohibited medications, including their routine glaucoma medications. During the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled. The purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for 12 weeks. Timolol is being included in the trial in order to have an active control to ensure the integrity of the trial from an efficacy perspective; the primary comparator for all statistical purposes is the placebo arm. ; DRUG USED: INO-8875; DRUG CLASS: New Molecular Entity (NME); INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Adenosine A1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Inotek Pharmaceuticals Corporation; CRITERIA: Inclusion Criteria: - Diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) - Mean Intraocular pressure (IOP) of ≥24 and ≤34 Exclusion Criteria: - Significant visual field loss or any new field loss within the past year - Cup-to-disc ratio >0.8 - Central corneal thickness <490 µm or >610 µm - A recent (acute) or chronic medical condition that might obfuscate the Subjects study data ; PRIMARY OUTCOME: Mean Intraocular Pressure (IOP); 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 - 3725 - BEGIN: BB T1 Extension; BRIEF: ; DRUG USED: Tresiba; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Combination; 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 III - TRINOVA-3 (w/Paclitaxel/Carboplatin); BRIEF: The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer. ; DRUG USED: Trebananib; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: Angiopoietins; THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded - Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization - Subjects with FIGO Stage IIIC or IV disease must either: - Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or - Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer - ECOG performance status of 0 or 1 - Adequate bone marrow, renal and hepatic function Exclusion Criteria: - Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer - Previous abdominal and/or pelvic external beam radiotherapy - History of central nervous metastasis - History of arterial or venous thromboembolism within 12 months prior to randomization - Clinically significant cardiovascular disease within 12 months prior to randomization ; PRIMARY OUTCOME: Progression free survival; SECONDARY OUTCOME 1: Overall survival (OS)[/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 - DREAMM 8 (w/ Pd); BRIEF: This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM). ; DRUG USED: Blenrep; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: Antibody-drug Conjugate (ADC), B-cell maturation antigen (BCMA), Immune System, Tumor Cells; THERAPY: Combination; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Capable of giving signed informed consent. - Male or female, 18 years or older. - Have a confirmed diagnosis of multiple myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. - Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy. (Participants treated with lenalidomide ≥10 mg daily for at least 2 consecutive cycles are eligible). - Must have at least 1 aspect of measurable disease defined as one of the following; 1. Urine M-protein excretion greater than or equal to (≥)200 milligrams (mg) per 24-hour, or 2. Serum M-protein concentration ≥0.5 grams/deciliters (g/dL) (≥5.0 g/liter [L]), or 3. Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (less than [<]0.26 or greater than [>]1.65) only if participant has no measurable urine or serum M spike. - Have undergone autologous stem cell transplant (ASCT) or are considered transplant ineligible. Participants with a history of ASCT are eligible for study participation provided the following eligibility criteria are met: a. ASCT was >100 days prior to the first dose of study medication. b. No active bacterial, viral, or fungal infection(s) present - All prior treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be less than or equal to (≤)Grade 1 at the time of enrolment, except for alopecia. - Adequate organ system functions as mentioned in the protocol. - Male and female participants agree to abide by protocol-defined contraceptive requirements. Exclusion Criteria: - Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening. - Prior allogeneic SCT. - Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs. - Plasmapheresis within 7 days prior to the first dose of study drug. - Received prior treatment with or intolerant to pomalidomide. - Received prior Beta cell maturation antigen (BCMA) targeted therapy. - Intolerant to bortezomib or refractory to bortezomib (for example; participant experienced progressive disease during treatment, or within 60 days of completing treatment, with a bortezomib-containing regimen of 1.3 mg/meter square [m^2] twice weekly). - Evidence of cardiovascular risk including any of the following; 1. Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second degree (Mobitz type II) or third degree atrioventricular (AV) block. 2. Recent history within (3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting . 3. Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system 4. Uncontrolled hypertension. - Any major surgery within the last 4 weeks. - Previous or concurrent invasive malignancy other than multiple myeloma, except: 1. The disease must be considered medically stable for at least 2 years; or 2. The participant must not be receiving active therapy, other than hormonal therapy for this disease. - Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment. - Evidence of active mucosal or internal bleeding. - Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice. - Active infection requiring treatment. - Known or active human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C will be excluded unless the protocol-defined criteria are met. - Presence of active renal conditions (such as infection, severe renal impairment requiring dialysis or any other condition that could affect participants safety). - Ongoing Grade 2 peripheral neuropathy with pain within 14 days prior to randomization or ≥Grade 3 peripheral neuropathy. - Active or history of venous and arterial thromboembolism within the past 3 months. - Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis. - Current corneal disease except for mild punctate keratopathy. - Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including laboratory abnormalities) that could interfere with participants safety, obtaining informed consent or compliance to the study procedures. - Pregnant or lactating female. ; PRIMARY OUTCOME: Progression-free survival (PFS); SECONDARY OUTCOME 1: Duration of response (DoR)[/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 - INFUS-ON; BRIEF: This is a Phase 3, multicenter, open-label, safety and tolerability study of continuous apomorphine infusion in subjects with advanced Parkinsons Disease (PD) whose motor fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one other class of drugs or mode of therapy for PD. ; DRUG USED: Apokyn; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Alpha 1 Adrenergic Receptor , Alpha 2 Adrenergic Receptor, Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Dopamine 4 (D4) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals; CRITERIA: Inclusion Criteria: - Advanced idiopathic PD consistent with UK Parkinsons Disease Society Brain Bank Clinical Diagnostic Criteria - Overall motor control is unsatisfactory in the opinion of the Investigator and subject despite optimized treatment with available therapies, which must include a stable regimen of daily maintenance levodopa (or levodopa/carbidopa), and at least one of the following other classes of therapies: - Dopamine agonists (note: APOKYN intermittent injection is not to be considered here) - Monoamine oxidase B [MAO B] inhibitors - Catechol-O-methyltransferase (COMT) inhibitors - Deep brain stimulation (DBS) - Levodopa/carbidopa intestinal gel surgery (Duopa, Duodopa) - Other - amantadine at doses of up to 400 mg per day) - Experiences off periods averaging ≥3.0 hours per waking day - Other criteria will be discussed in detail with potential subjects by site Investigator Exclusion Criteria: - Planned surgical intervention for the treatment of Parkinsons disease during participation in the study - History of hypersensitivity to apomorphine hydrochloride or any of the ingredients of APOKYN PFS, including sodium metabisulfite - Known, suspected, or planned pregnancy or lactation. - Recent history (within the previous 12 months) of alcohol or substance abuse - History of impulsive/compulsive behaviors primarily associated with the use of dopamine agonists - History of previously treated or current diagnosis of malignant melanoma - Exhibits certain signs and symptoms of cardiovascular disease - Other criteria will be discussed in detail with potential subjects by site Investigator ; PRIMARY OUTCOME: Percent of daily off time during the waking day; SECONDARY OUTCOME 1: Percent daily on time without troublesome dyskinesias during waking day[/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 - 301 - Secondary AML; BRIEF: To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival. ; DRUG USED: Vyxeos; DRUG CLASS: Non-NME; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: DNA polymerase, DNA synthesis, Topoisomerase II (DNA gyrase); THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria: - Ability to understand and voluntarily give informed consent - Age 60-75 years at the time of diagnosis of AML - Pathological diagnosis of AML according to WHO criteria (with at least 20% blasts in the peripheral blood or bone marrow) - Confirmation of: - Therapy related AML: t-AML must have a documented history of prior cytotoxic therapy or ionizing radiotherapy for an unrelated disease - AML with a history of myelodysplasia: MDSAML must have bone marrow documentation of prior MDS - AML with a history of CMMoL: CMMoLAML must have bone marrow documentation of prior CMMoL - De novo AML with karyotypic abnormalities characteristic of MDS: de novoAML must have cytogenetics with abnormalities per WHO. - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Able to adhere to the study visit schedule and other protocol requirements - Laboratory values fulfilling the following: - Serum creatinine < 2.0 mg/dL - Serum total bilirubin < 2.0 mg/dL, patients with Gilberts Syndrome should contact the medical monitor - Serum alanine aminotransferase or aspartate aminotransferase < 3 times the ULN Note: If elevated liver enzymes, above the ULN, are related to disease; contact medical monitor to discuss. - Cardiac ejection fraction ≥ 50% by echocardiography or MUGA - Patients with second malignancies in remission may be eligible if there is clinical evidence of disease stability for a period of greater than 6 months off cytotoxic chemotherapy, documented by imaging, tumor marker studies, etc., at screening. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible. Exclusion Criteria: - Except for CMMoL, patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible. - Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization. - Clinical evidence of active CNS leukemia - Patients with active (uncontrolled, metastatic) second malignancies are excluded. - Prior treatment intended for induction therapy of AML; only hydroxyurea is permitted for control of blood counts. For example, a patient with MDS that changes HMA dose and schedule after the diagnosis of AML is excluded. AML-type therapy, such as cytarabine alone (>1g/m2/day) or cytarabine plus an anthracycline as well as prior HSCT are also excluded. - Administration of any therapy for MDS (conventional or investigational) must be completed by 2 weeks prior to of the first dose of study drug; in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment. Toxicities associated with prior MDS therapy must have recovered to grade 1 or less prior to start of treatment. - Any major surgery or radiation therapy within four weeks. - Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent). - Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent - Patients with myocardial impairment of any cause (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV staging) - Active or uncontrolled infection. Patients with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ≥72 hrs. - Current evidence of invasive fungal infection (blood or tissue culture); patients with recent fungal infection must have a subsequent negative cultures to be eligible; known HIV (new testing not required) or evidence of active hepatitis B or C infection (with rising transaminase values) - Hypersensitivity to cytarabine, daunorubicin or liposomal products - History of Wilsons disease or other copper-metabolism disorder ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Proportion of Subjects With a 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 - Extension Study (Familial Chylomicronemia); BRIEF: This study was to determine long-term safety and tolerability, and continued efficacy in lowering triglycerides of LCQ908 in subjects with Familial Chylomicronemia Syndrome (FCS) (HLP type I). ; DRUG USED: LCQ908; DRUG CLASS: New Molecular Entity (NME); INDICATION: Familial Chylomicronemia Syndrome (FCS)/Lipoprotein Lipase Deficiency (LPLD); TARGET: Diglycerol Acyltransferase (DGAT); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Subjects that either discontinue prematurely or complete the CLCQ908B2302 study after 52 weeks or FCS subjects who have previously completed study CLCQ908A2212. Exclusion Criteria: 1. Subjects discontinued from the CLCQ908B2302 study for serious, potentially study drug related adverse events. 2. Subjects from the CLCQ908B2302 study who have developed any other contraindication to participation (for example, renal failure) 3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 4. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 5. Subjects with type 1 diabetes mellitus or type 2 diabetes mellitus if HbA1C is ≥ 8.5%. 6. Treatment with fish oil preparations within 4 weeks prior to randomization. 7. Treatment with bile acid binding resins (i.e., colesevelam, etc) within 4 weeks prior to randomization. 8. Treatment with fibrates within 8 weeks prior to randomization. Washout may occur following screening if required. 9. Glybera [alipogene tiparvovec (AAV1-LPLS447X )] gene therapy exposure within the two years prior to screening. 10. eGFR <45 ml/min/1.73m2 or history of chronic renal disease. Other protocol defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Number of Patients With Any Adverse Events, Serious Adverse Events and Death; SECONDARY OUTCOME 1: Changes From Baseline in Triglyceride Levels up to 52 Weeks[/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 - vs. Fluticasone/Salmeterol (116974); BRIEF: This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week parallel group study evaluating the effects of once daily in the morning treatment of FF/VI Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on lung function in COPD subjects. Subjects will be screened and will enter a 2-week, single-blind (placebo), Run-In Period to evaluate the subjects adherence with study treatment, study procedures and assessment of disease stability. At the end of the Run-In Period, subjects will return to the Clinic and who meet all of the Randomization Criteria will be randomized to double-blind study medication (12-week treatment period). Subjects will be randomized to receive either FF/VI 100/25 via NDPI or Fluticasone Propionate/Salmeterol 250/50mcg via ACCUHALER/DISKUS. Matching placebos will be available in NDPI and ACCUHALER/DISKUS. Each morning (approximately 6-10 AM) subjects will take 1 inhalation from the NDPI followed by 1 inhalation from the ACCUHALER/DISKUS. Each evening (approximately 6-10 PM), approximately 12 hours after the morning dose with blinded study medication, subjects will take 1 inhalation from the ACCUHALER/DISKUS. Subjects will return to the clinic at the end of the treatment period. A follow-up phone contact will be performed approximately 7 days after the last clinic visit. The overall study duration (Screening to Follow-up) for each subject is approximately 15 weeks. ; DRUG USED: Breo Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Combination; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - A male or female >=40 years of age at Screening (Visit 1). - Capable of giving written informed consent. - Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. - Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society. - Subject with a measured post-albuterol (salbutamol) FEV1/forced vital capacity(FVC) ratio of <=0.70 at Screening. - Subjects with a measured post-albuterol (salbutamol) FEV1 <=70% of predicted normal values. - Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening. Exclusion Criteria: - Current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD). - Other respiratory disorders (alpha1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases). - Lung volume reduction surgery within the 12 months prior to Screening. - Hospitalized due to poorly controlled COPD within 12 weeks of Screening. - Poorly controlled COPD (occurrence of the following in the 6 weeks prior to Screening -Acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician). - Lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Screening. - Moderate/severe COPD exacerbation/lower respiratory tract infection during Run-In Period. - Abnormal and clinically significant 12-lead ECG at Screening - Historical or current evidence of uncontrolled or clinically significant disease like cardiovascular, hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. - History of hypersensitivity to any of the study medications or components of the inhalation powder; or history of severe milk protein allergy. - Known or suspected history of alcohol or drug abuse within the last 2 years. - Subjects who are medically unable to withhold their albuterol (salbutamol) and/or their ipratropium for the 4-hour period required prior to spirometry testing at each study visit. - The subject has taken any other investigational drug within 30 days or 5 half-lives of the investigational product (IP) prior to the first dosing day in the current study. - Use of additional medications prior to Screening (list of medications and time intervals are different for different class of medications and are indicated in the protocol) - Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., <=12 hours per day) is not exclusionary. - Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening - Subjects at risk of non-compliance, or unable to comply with study procedures. - Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study. - Women who are pregnant or lactating or are planning on becoming pregnant during the study. - Previously randomized to either the HZC113109 or HZC112352 clinical studies. ; PRIMARY OUTCOME: Change From Baseline Trough in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) on Treatment Day 84; SECONDARY OUTCOME 1: Time to Onset on Treatment Day 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 - vs. Placebo; BRIEF: A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks. ; DRUG USED: Gelnique; DRUG CLASS: Non-NME; INDICATION: Overactive Bladder (OAB); TARGET: Calcium Channel, Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Watson Pharmaceuticals; CRITERIA: Inclusion Criteria: - Females and males, 18 years of older with overactive bladder symptoms Exclusion Criteria: - Treatable conditions that may cause urinary incontinence - Medical conditions in which it would be unsafe to use an anti-cholinergic agent. - The use of concomitant drugs that would confound the efficacy evaluation. - The use of concomitant drugs that would be unsafe with an anti-cholinergic agent. ; PRIMARY OUTCOME: Baseline Average Number of Daily Incontinence Episodes; SECONDARY OUTCOME 1: Baseline Average Daily Urinary Frequency[/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 (Adenoviral Conjunctivitis); BRIEF: The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with adenoviral conjunctivitis. ; DRUG USED: TAK-640; DRUG CLASS: Non-NME; INDICATION: Other Ophthalmological Indications (Ophthalmology); TARGET: Bacteria-miscellaneous, Glucocorticoid Receptor (GR), Microbial DNA, Viral Envelope; THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: - An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable). - Ability to voluntarily provide written, signed, and dated (personally or via a parent(s), guardian, or legally authorized representative(s) informed consent (and assent, if applicable) to participate in the study. - Participants of any age at Visit 1 (Note: participants lesser than (<) 3 months of age at Visit 1 must have been full-term, i.e. greater than or equal to (>=) 37 weeks gestational age at birth). - Meet at least 1 of the 2 criteria below: a) Have a positive AdenoPlus test at Visit 1 in at least 1 eye. b) Have at least 2 of the following 5 criteria, based upon medical history and examination: i.Symptoms within the past 7 days consistent with acute upper respiratory tract infection (eg. sore throat, cough, rhinorrhea, etc). ii. Contact within the past 7 days with family members or other individuals with recent onset of symptoms consistent with conjunctivitis iii. Acute onset within the past 4 days of one or more of the following ocular symptoms: burning/irritation, foreign body sensation, light sensitivity. iv. Enlarged periauricular lymph node(s). v. Presence of follicles on tarsal conjunctiva. Note:If the participant only meets Inclusion Criterion (a positive AdenoPlus test in at least 1 eye), then the same eye must meet the mentioned below Inclusion Criterion. - Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye: 1. Report presence of signs and/or symptoms of adenoviral conjunctivitis for lesser than or equal to (<=) 4 days prior to Visit 1 2. Bulbar conjunctival injection: a grade of >= 1 (mild) on a 0-4 Bulbar Conjunctival Injection Scale. 3. Watery conjunctival discharge: a grade of >= 1 (mild) on a 0-3 Watery Conjunctival Discharge Scale - Be willing to discontinue contact lens wear for the duration of the study. - Have a Best Corrected Visual Acuity (BCVA) of 0.60 logMAR or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. BCVA will be assessed by an age appropriate method in accordance with the AAP Policy Statement for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians (Donahue and Baker 2016; American Academy of Pediatrics 2016).The policy statement recommends formal vision screening can begin at 3 years of age. VA measurements for children under the age of 3 will be done at the discretion of the investigator. - If not done, child should be able to fixate on and follow a moving object, except participants <2 months of age who have not yet developed this ability. Participants <2 months will be enrolled at the discretion of the investigator. - Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential. Exclusion Criteria: - Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigators discretion. - Current or relevant history of physical or psychiatric illness, any medical disorder that may make the participants unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures. - Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients. - Prior enrollment in a FST-100 or SHP640 clinical study. - Participants who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site. - Have a history of ocular surgical intervention within <= 6 months prior to Visit 1 or planned for the period of the study. - Have a pre-planned overnight hospitalization during the period of the study. - Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis. - Have presence of corneal subepithelial infiltrates at Visit 1. - Have active or history of ocular herpes. - Have at enrollment or within <= 30 days of Visit 1, a clinical presentation more consistent with the diagnosis of non-infectious conjunctivitis (except presumed seasonal/perennial allergic conjunctivitis), or non-adenoviral ocular infection (e.g. bacterial, fungal, acanthamoebal, or other parasitic). Note:history or concomitant presence of presumed seasonal or perennial allergic conjunctivitis signs/symptoms is not exclusionary. - Neonates or infants (i.e. participants less than 12 months of age) who have suspected or confirmed (based on the result of any test conducted prior to screening) conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin. - Neonates or infants (i.e. participants less than 12 months of age) whose birth mothers had any sexually transmitted disease within 1 month of delivery or any history of genital herpes. - Presence of nasolacrimal duct obstruction at Visit 1 (Day 1). - Presence of any significant ophthalmic condition (e.g. Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables. - Be a known intraocular pressure (IOP) steroid responder, have a known history or current diagnosis of glaucoma, or be a glaucoma suspect. - Have any known clinically significant optic nerve defects. - Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1. - Presence of significant, active condition in the posterior segment which requires invasive treatment (e.g. intravitreal treatment with VEGF inhibitors or corticosteroids) and may progress during the study participation period. - Have used any topical ocular or systemic anti-vials or antibiotics within <= 7 days of enrollment. - Have used any topical ocular Non-steroidal Anti-inflammataory Drugs (NSAIDs) within <= 1 day of enrollment. - Have used any topical ophthalmic steroids in the last <= 14 days. - Have used any systemic corticosteroid agents within <= 14 days of Day 1. Stable (initiated >= 30 days prior to enrollment) use of inhaled and nasal corticosteroids is allowed, given no anticipated change in dose for the duration of the study. Topical dermal steroids are allowed except in the peri-ocular area. - Have used non-corticosteroid immunosuppressive agents within <= 14 days of Day 1. - Have used any topical ophthalmic products, including tear substitutes, and over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic products for the duration of the study. Use of hot or cold compresses is also not permitted during the study. - Have any significant ocular disease (eg, Sjogrens syndrome) or any uncontrolled systemic disease or debilitating disease (eg, cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes or cystic fibrosis), that may affect the study parameters, per the investigators discretion. - Any known history of immunodeficiency disorder or known active conditions predisposing to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence of active hepatitis A (antihepatitis A virus immunoglobulin M), or organ or bone marrow transplantation. - Within 30 days prior to the first dose of investigational product: 1. Have used an investigational product or device, or 2. Have been enrolled in a clinical study (including vaccine studies) that, in the investigators opinion, may impact this Shire-sponsored study ; PRIMARY OUTCOME: Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 6; SECONDARY OUTCOME 1: Number of Participants With Clinical Resolution Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EBBINGHAUS (Cognitive Function; FOURIER Substudy); BRIEF: This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo. ; DRUG USED: Repatha; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Randomized into Study 20110118 (FOURIER; NCT01764633) Exclusion Criteria: - Current or known past diagnosis of dementia or mild cognitive impairment (MCI) ; PRIMARY OUTCOME: Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score; SECONDARY OUTCOME 1: Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z 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 - 15352A (OLE Sleep Disturbances); BRIEF: To assess effects of brexpiprazole on sleep patterns of depressed patients with sleep disturbances. ; DRUG USED: Rexulti; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine 2 (D2) Receptor, Norepinephrine (Noradrenaline), Serotonin 5-HT1A receptor, Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria - at Screening: - The patient has a Major Depressive Episode (MDE) associated to Major Depressive Disorder (MDD), diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™). The current MDE should be confirmed using the Mini International Neuropsychiatric Interview (MINI). - The patient has an inadequate response to at least one antidepressant treatment (including the treatment the patient is taking at screening) in the current MDE, as documented by self-report as less than a pre-defined response on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ). - The patient has a pre-defined Montgomery Aasberg Depression Rating Scale (MADRS) total score, and a pre-defined Clinical Global Impression - Severity of Illness (CGI-S) score at screening, and has had the current MDE for ≥10 weeks. - The patient is currently treated for the current MDE with an adequate selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant treatment for ≥6 weeks, at the same dosage for ≥2 weeks. - The patient has sleep disturbances (difficulty falling asleep and/or difficulty staying asleep and/or problem waking up too early) confirmed by a pre-defined Insomnia Severity Index (ISI) score. - The patient agrees to protocol-defined use of effective contraception. Entry Criteria to Treatment Period (Baseline Visit): - The patient still fulfils DSM-IV-TR™ criteria for MDE. - The patient received the same SSRI or SNRI antidepressant treatment at adequate dose during the entire lead-in period. - The patient has a pre-defined MADRS total score. - The patients improvement in the MADRS total score is a pre-defined percentage compared to screening. - The patient has a pre-defined Clinical Global Impression - Global Improvement (CGI-I) score. - The patient has sleep disturbances (difficulty falling asleep and/or difficulty staying asleep and/or problem waking up too early) confirmed by a pre-defined ISI score. - The patient has sleep disturbances confirmed by pre-defined Latency to Persistent Sleep (LPS) and pre-defined Sleep Efficiency (SE). Exclusion Criteria: - The patient is, in the investigators opinion, unlikely to comply with the protocol or is unsuitable for any reason. Other inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Parameters; 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 - faSScinate; BRIEF: This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks. ; DRUG USED: Actemra (Subcutaneous); DRUG CLASS: Biologic; INDICATION: Scleroderma; TARGET: IL-6 Receptor (IL-6R); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Adult patients, >/= 18 years of age - Systemic sclerosis, as defined by American College of Rheumatology (1980) criteria - Disease duration of </= 60 months (defined as time from first non-Raynaud phenomenon manifestation) - >/= 15 and </= 40 mRSS units at screening - Active disease, as defined by protocol - Uninvolved skin at injection sites - Negative pregnancy test for a female subject of childbearing potential Exclusion Criteria: - Major surgery (including joint surgery) within 8 weeks prior to and/or during study enrollment - Rheumatic autoimmune disease other than systemic sclerosis - Skin thickening (scleroderma) limited to areas distal to the elbows or knees at screening - Previous treatment with tocilizumab - History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies - Severe cardiopulmonary disease - Known active current or history of recurrent infections - Use of any investigational, biologic, or immunosuppressive therapies including intra-articular or parenteral corticosteroids prior to study enrollment as specified in the protocol - As specified in the protocol, any current or past medical condition or medical history involving but not limited to the nervous, renal, pulmonary, endocrine, and gastrointestinal organ systems determined by the Principal Investigator to pose a significant safety risk to any subject while participating in the study - Primary or secondary immunodeficiency ; PRIMARY OUTCOME: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24; SECONDARY OUTCOME 1: Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Transpher A Study; BRIEF: The main objective of this study is to evaluate the efficacy and safety of ABO-102 for the treatment of MPS IIIA. ; DRUG USED: ABO-102; DRUG CLASS: Biologic; INDICATION: Mucopolysaccharidosis IIIA (MPS IIIA; Sanfilippo A Syndrome); TARGET: Heparan-N-sulfatase (N-sulphoglucosamine sulphohydrolase, sulfamidase), N-sulfo-D-glucosamine; THERAPY: Monotherapy; LEAD SPONSOR: Ultragenyx Pharmaceutical Inc; CRITERIA: Inclusion Criteria: - Diagnosis of MPS IIIA confirmed by the following methods: - No detectable or significantly reduced SGSH enzyme activity by leukocyte assay, and - Genomic DNA analysis demonstrating homozygous or compound heterozygous mutations in the SGSH gene - Age: From birth to 2 years or children older than 2 years with a minimum cognitive Developmental Quotient (DQ) of 60 or above (calculated by Bayley Scales of lnfant and Toddler Development - Third Edition) Exclusion Criteria: - Inability to participate in the clinical evaluation as determined by Principal Investigator (PI) - Identification of two nonsense or null variants on genetic testing of the SGSH gene - At least one S298P mutation in the SGSH gene - Has evidence of an attenuated phenotype of MPS IIIA - Presence of a concomitant medical condition that precludes lumbar puncture or use of anesthetics - Active viral infection based on clinical observations - Concomitant illness or requirement for chronic drug treatment that in the opinion of the PI creates unnecessary risks for gene transfer or precludes the child from participating in the protocol assessments and follow up - Subjects with total anti-AAV9 antibody titers ≥ 1:100 equivalent to a positive screen as determined by ELISA in serum - Subjects with a positive response for the enzyme-linked immunosorbent spot (ELISpot) for T-cell responses to AAV9 - Serology consistent with exposure to HIV, or serology consistent with active hepatitis B or C infection - Bleeding disorder or any other medical condition or circumstance in which a lumbar puncture (for collection of CSF) is contraindicated according to local institutional policy - Visual or hearing impairment sufficient to preclude cooperation with neurodevelopmental testing - Uncontrolled seizure disorder - Any item (braces, etc.) which would exclude the subject from being able to undergo MRI according to local institutional policy - Any other situation that precludes the subject from undergoing procedures required in this study - Subjects with cardiomyopathy or significant congenital heart abnormalities - The presence of significant non-MPS IlIA related CNS impairment or behavioral disturbances that would confound the scientific rigor or interpretation of results of the study - Abnormal laboratory values Grade 2 or higher as defined in CTCAE v4.03 for GGT, total bilirubin, creatinine, hemoglobin, WBC count, platelet count, PT and aPTT - Female participant who is pregnant or demonstrates a positive urine or bhCG result at screening assessment (if applicable) - Any vaccination with viral attenuated vaccines less than 30 days prior to the scheduled date of treatment (and use of prednisolone) - Previous treatment by Hematopoietic Stem Cell transplantation - Previous participation in a gene/cell therapy or enzyme replacement therapy (ERT) clinical trial ; PRIMARY OUTCOME: Change from Baseline in Cognitive Domain Bayley Scales of Infant and Toddler Development Raw Scores-Third edition (BSID-III); SECONDARY OUTCOME 1: Change From Baseline in Vineland Adaptive Behavior Scale II-Survey Interview Form[/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 - SIRROUND-H; BRIEF: The primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate responders to methotrexate. ; DRUG USED: Sirukumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 (Interleukin-6); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Have a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening - Have moderately to severely active RA with at least 8 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline - Have previous or current treatment with methotrexate (MTX) and are considered intolerant to MTX, and/or are considered inappropriate for treatment with MTX, (including MTX-naïve subjects for whom it is inappropriate to administer MTX) and/or an inadequate responder to methotrexate - Must not have received MTX or any other non-biologic DMARD including but not limited to sulfasalazine, hydroxychloroquine, chloroquine, and bucillamine for at least 2 weeks prior to the first administration of the study agent - C-reactive protein >= 10.00 mg/L or erythrocyte sedimentation rate >=28 mm/hr at screening Exclusion Criteria: - Has Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis - Has ever received biologic therapy for RA, including but not limited to the following: TNF-alpha inhibitors, tocilizumab, rituximab, anakinra, abatacept - Has ever used tofacitinib therapy or any other JAK inhibitor - Has received intra-articular, intramuscular, or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration - Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable ; PRIMARY OUTCOME: Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24; SECONDARY OUTCOME 1: Percentage of Participants With Disease Activity Index Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Remission 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 - BR vs. R-CHOP (StiL); BRIEF: The study addresses the question if the first line therapy of low malignant and mantle cell lymphomas with bendamustine plus rituximab is comparable (non inferior) with CHOP plus rituximab with regard to progression free survival (PFS). ; DRUG USED: Treanda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Indolent Non-Hodgkins Lymphoma (Including Follicular Lymphoma) - NHL; TARGET: DNA, p53; THERAPY: Combination; LEAD SPONSOR: University of Giessen; CRITERIA: Inclusion Criteria: - Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities: - Follicular lymphoma grade 1 and 2 - Immunocytoma and lymphoplasmocytic lymphoma - Marginal zone lymphoma, nodal and generalised - Mantle cell lymphoma - lymphocytic lymphoma (CLL without leucaemic characteristics) - non-specified/classified lymphomas of low malignancy - No prior therapy with cytotoxics,interferon or monoclonal antibodies - Need for therapy, except mantle cell lymphomas - Stadium III or IV - Written informed consent - Performance status WHO 0-2 - Histology not older than 6 months Exclusion Criteria: - Patients not establishing all above mentioned prerequisites - Option of a primary, potential curative radiation therapy - Pretreatment except a unique local delimited radiation (radiation fiel not expanding two adjacent lymph node regions - Comorbidities excluding a study conform therapy: - heart attack during the last 6 months - severe, medicinal not adjustable hypertonia - severe functional defects of the heart (NYHA III or IV) - lung (WHO grade III or IV), liver or kidney (creatinine > 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma. ; PRIMARY OUTCOME: Progression free survival; SECONDARY OUTCOME 1: Determination and comparison of remission rates, of toxicity, infectious complications, overall survival, EFS, TTNT, capacity of peripheral blood stem cell mobilization[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - Expanded Access Program; BRIEF: The purpose of this study is to provide Decitabine to patients with Myelodysplastic syndrome (MDS) of all FAB (French-American-British) subtypes and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups, including both previously treated and untreated patients. ; DRUG USED: Dacogen; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelodysplastic Syndrome (MDS); TARGET: DNA Methyltransferase (DNMT); THERAPY: Monotherapy; LEAD SPONSOR: Janssen-Cilag Farmaceutica Ltda.; CRITERIA: Inclusion Criteria: - Must have a diagnosis of MDS (de novo / primary or secondary) of all FAB subtypes and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups - Has an Eastern Oncology Cooperative Group (ECOG) performance status of 0-2 - Adequate hepatic and renal function as measured by the following pre-treatment laboratory criteria within 21 days of starting treatment with Decitabine (laboratory measure of liver function no more than 2.5 times the upper limit of normal, laboratory measure of total bilirubin and serum creatinine no more than 1.5 times the upper limit of normal) - Female patients must be postmenopausal, or surgically sterile, or abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study - Have a negative serum or urine pregnancy test at screening - Male subjects should be advised not father a child while on or within 2 months of completion of Decitabine therapy Exclusion Criteria: - Have a diagnosis of AML (>20% bone marrow blasts) or other progressive malignant disease - has previously been treated with Azacitidine or Decitabine - Have uncontrolled heart disease or uncontrolled congestive heart failure - Have uncontrolled restrictive or obstructive pulmonary disease - Have active viral or bacterial infection - Have known positive serology for HIV - Have a mental illness or any other condition that could prevent full cooperation with the treatment and monitoring requirements of the study - Have known hypersensitivity to any of the excipients of decitabine - Are pregnant or breast-feeding ; PRIMARY OUTCOME: ; 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 - G551D-CFTR Mutation (Age 2-5) (KIWI Study); BRIEF: The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD), of ivacaftor in children with cystic fibrosis (CF) who are 2 through 5 years of age and have a CF Transmembrane Conductance Regulator (CFTR) gating mutation in at least 1 allele. Part A is designed to evaluate the safety and PK of multiple-dose administration of ivacaftor in participants 2 through 5 years of age and to confirm the doses for Part B. Part B is designed to evaluate the safety, PK, PD, and efficacy of ivacaftor in participants 2 through 5 years of age. ; DRUG USED: Kalydeco; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Monotherapy; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Inclusion Criteria: - Male or female with confirmed diagnosis of CF - Must have a CFTR gating mutation in at least 1 allele - Aged 2 through 5 years at screening and Day 1 - Weight >= 8 kg at screening and Day 1 - Hematology, serum chemistry, coagulation, and vital signs results at screening with no clinically significant abnormalities that would interfere with the study assessments, as judged by the investigator Exclusion Criteria: - History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant - An acute upper or lower respiratory infection, or pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks before Day 1 - Abnormal liver function, at screening - History of solid organ or hematological transplantation - Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A within 2 weeks before Day 1 - Participation in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 terminal half-lives before screening ; PRIMARY OUTCOME: Part A: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs; SECONDARY OUTCOME 1: Part B: Plasma Concentration of Ivacaftor and Its Metabolites[/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-008 (+/-Pembrolizumab); BRIEF: This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR). ; DRUG USED: Lenvima; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Fibroblast Growth Factor Receptor (FGFR) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), Tyrosine Kinases, VEGF Receptor (VEGFR); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Has a histologically or cytologically confirmed diagnosis of metastatic squamous or nonsquamous NSCLC (Stage IV: M1a, M1b, M1c). - Has PD on treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. - Retreatment with the same anti-PD-L1/PD-L1 mAb is acceptable in the overall course of treatment - Has PD during/after platinum doublet chemotherapy for metastatic disease. - Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R], and absence of ALK and ROS1 gene rearrangements OR presence of a K-ras mutation). - Has submitted pre-study imaging that confirmed evidence of PD following initiation of an anti-PD-1/PD-L1 inhibitor. - Has at least 1 measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1, as determined by the local site assessment. - Has provided tumor tissue for PD-L1 biomarker analysis from an archival sample (defined as: from initial diagnosis of NSCLC and prior to receiving immunotherapy [antiPD-1/PD-L1], from the primary lesion or a metastatic lesion). - Has provided prior to allocation tissue from a newly obtained formalin-fixed sample from a new biopsy (defined as: after completion of immunotherapy [anti-PD-1/PD-L1] and before receiving a randomization number), of a tumor lesion not previously irradiated. - Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention but before randomization. - Has a life expectancy of at least 3 months. - Male participants receiving pembrolizumab ± lenvatinib or lenvatinib must agree to refrain from donating sperm, and either 1) be abstinent from heterosexual intercourse; or 2) follow contraceptive guidance during the treatment period or 7 days after the last dose of lenvatinib. Male participants receiving docetaxel agree to adhere to the same conditions during the treatment period and for ≥90 days after the last dose of study treatment. - Female participants must not be pregnant, not be breastfeeding, and not be a woman of child-bearing potential (WOCBP). If a WOCBP, agrees to not donate eggs and either use contraception, or be abstinent from heterosexual intercourse during the treatment period and for ≥120 days after the last dose of pembrolizumab or 30 days after the last dose of lenvatinib, whichever occurs last. If a WOCBP receiving docetaxel, agrees to adhere to the same conditions during the treatment period and for ≥30 days after the last dose of study treatment. - Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg and no change in antihypertensive medications within 1 week before randomization. - If participant received major surgery or radiation therapy of >30 Gy, they have recovered from the toxicity and/or complications from the intervention. - Has adequate organ function. Exclusion Criteria: - Has received docetaxel as monotherapy or in combination with other therapies. - Has received lenvatinib as monotherapy or in combination with an anti-PD-1/PD-L1 mAb. - Has received: 1) radiotherapy within 2 weeks before the first dose of study treatment; or 2) lung radiation therapy >30 Gy within 6 months before the first dose of study treatment. - Has received a live vaccine within 30 days before the first dose of study treatment. - Has clinically significant hemoptysis or tumor bleeding within 2 weeks before the first dose of study treatment. - Has radiographic evidence of intratumoral cavitation, encasement, or invasion of a major blood vessel. - Has clinically significant cardiovascular impairment within 12 months of the first dose of study treatment. - Has a history of a gastrointestinal condition or procedure that may affect oral absorption of study treatment. - Has a pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula. - Is currently participating in a clinical trial and receiving study therapy or participated in a study of an investigational agent within 4 weeks of the first dose of study treatment. - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment. - Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy. - Has known active central nervous system metastases and/or carcinomatous meningitis. - Has severe hypersensitivity to pembrolizumab and/or any of its excipients. - Has a sensitivity to any of the excipients contained in lenvatinib and/or docetaxel. - Has an active autoimmune disease that has required systemic treatment in the past 2 years. - Has a history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease. - Has an active infection requiring systemic therapy. - Has a known history of human immunodeficiency virus (HIV) infection. - Has a known history of hepatitis B reactive or known active hepatitis C virus infection. - Has active tuberculosis. - Has a known psychiatric or substance abuse disorder that would interfere with the participants ability to cooperate with the requirements of the study. - Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through at least 120 days after the last dose of pembrolizumab or lenvatinib, or 90 days (male participants) or 30 days (for female participants) after the last dose of docetaxel. - Has had an allogeneic tissue/solid organ transplant. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Docetaxel[/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 - MERLIN TIMI-36 ; BRIEF: MERLIN-TIMI 36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of ranolazine during acute and long-term treatment in approximately 5,500 patients with non-ST elevation acute coronary syndromes (ACS) treated with standard therapy. The primary efficacy endpoint in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with ranolazine compared to placebo. ; DRUG USED: Ranexa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Coronary Syndrome (ACS); TARGET: Late Sodium Current; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Hospitalized with non-ST elevation acute coronary syndrome - Ischemic symptoms (more than or equal to 5 minutes) at rest within 48 hours of study entry - At least one additional risk factor (e.g., elevated cardiac enzymes, ST-depression, diabetes) Exclusion Criteria: - Persistent acute ST-segment elevation - Successful revascularization during the qualifying hospitalization, prior to study entry - Acute pulmonary edema, hypotension, or evidence of cardiogenic shock - Clinically significant liver disease - End stage kidney disease requiring dialysis - Concomitant use of drugs known to prolong the QT interval, or any digitalis drugs - Use at study entry of drugs that are strong inhibitors of cytochrome P450 3A4 - Pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control Additional study entry criteria will be evaluated during initial screening. ; PRIMARY OUTCOME: Time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia through the end of the follow-up in non-ST elevation ACS.; SECONDARY OUTCOME 1: Composite of cardiovascular death, myocardial infarction, or severe recurrent ischemia. Safety of long-term treatment with ranolazine compared to placebo; safety endpoints are death from any cause and symptomatic documented arrhythmia.[/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 - SPITFIRE (Ambulatory Boys); BRIEF: This is a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of two different weekly doses of RO7239361 in ambulatory boys with Duchenne Muscular Dystrophy (DMD). ; DRUG USED: RG6206; DRUG CLASS: Biologic; INDICATION: Duchenne Muscular Dystrophy (DMD); TARGET: Myostatin/GDF-8; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Diagnosed with DMD by confirmed medical history and genetic testing - Able to walk without assistance - Minimum North Star Ambulatory Assessment score of 15 at screening - Able to walk up 4 stairs in 8 seconds or less - Weigh at least 15 kg (33 lbs) - Taking corticosteroids for DMD Exclusion Criteria: - Any behavior or mental issue that will affect the ability to complete the required study procedures - Previously or currently taking medications like androgens or human growth hormone - Use of a ventilator during the day - Unable to have blood samples collected or receive an injection under the skin - Concomitant or previous participation at any time in a gene therapy study Other protocol defined Inclusion/Exclusion Criteria could apply. ; PRIMARY OUTCOME: Baseline for the North Star Ambulatory Assessment (NSAA) Total Score; SECONDARY OUTCOME 1: Baseline Time for 4 Stair Climb[/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 - EXPEDITION-8 (Treatment-Naive, GT 1-6); BRIEF: A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir. ; DRUG USED: Mavyret; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6 infection. - Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000 IU/mL at Screening. - Treatment-naive to any approved or investigational anti-HCV medication. - Participant must be documented as cirrhotic, with a Child-Pugh score of less than or equal to 6. Exclusion Criteria: - Female participant who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug. - Any current or historical clinical evidence of decompensated cirrhosis. - Positive test result at Screening for hepatitis B surface antigen (HBsAg), HBV deoxyribonucleic acid > lower limit of quantification (LLOQ) in subjects with isolated positive antibody to hepatitis B core antigen (anti-HBc) (i.e., negative HBsAg and anti-hepatitis B),or anti human immunodeficiency virus antibody (HIV Ab). - HCV genotype performed by the central laboratory during screening indicating co-infection with more than one HCV genotype. - History of suspected or confirmed hepatocellular carcinoma. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Hepatitis C Virus (HCV) Genotype (GT) 1,2,4,5 and 6-infected Participants in the Per Protocol (PP) Population; SECONDARY OUTCOME 1: Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the PP Population[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SUSTAIN; BRIEF: To compare the efficacy of oral brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV seronegative pretransplant and received a kidney from a CMV seropositive donor ; DRUG USED: Tembexa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cytomegalovirus (CMV) Infection (Antiviral); TARGET: DNA polymerase; THERAPY: Monotherapy; LEAD SPONSOR: Chimerix; CRITERIA: Inclusion Criteria Subjects must have met all of the following criteria, as applicable, to be eligible to participate in this study: 1. Were male or female kidney transplant recipients who were ≥18 years of age (subject to local law/practice for clinical trial participation) and ≤14 days following their first or second renal allograft. 2. Were at high risk of cytomegalovirus (CMV) infection defined as CMV-seronegative recipients who have received an allograft from a CMV-seropositive donor. 3. Had an estimated glomerular filtration rate of >10 mL/min (Cockcraft-Gault equation) at screening based on local laboratory results. 4. Were CMV viremia negative (i.e., not detected) as measured by the desginated central virology laboratory using the Roche COBAS® AmpliPrep/COBAS® TaqMan® CMV Test no more than 5 days prior to subject randomization, and at all prior assessments performed since transplant under local standard of care. 5. Were able to ingest, absorb, and tolerate tablets. 6. If male, was willing to use an acceptable contraceptive method(s) throughout the duration of his participation in the study, i.e., through Week 52. 7. If female of childbearing potential, i.e., not post menopausal or surgically sterile, was willing to use 2 acceptable contraceptive methods, 1 of which must have been a barrier method, throughout the duration of her participation in the study, i.e., through Week 52. 8. Were willing and able to provide informed consent. 9. Were willing and able to participate in all required study activities for the entire duration of the study (i.e., through Week 52). Exclusion Criteria Subjects who met any of the following criteria were not eligible to participate in this study: 1. Weighed ≤50 kg (110 lbs) or ≥120 kg (265 lbs). 2. Were pregnant or breastfeeding or intended to conceive during the study period (i.e., through Week 52). 3. Received a stem cell transplant or a solid organ transplant other than a kidney transplant. 4. Had suspected CMV disease (either syndrome or tissue-invasive disease) or detectable CMV viremia by the central virology laboratory prior to the first dose of study drug. 5. Had a history of CMV disease (either syndrome or tissue-invasive disease) within 6 months prior to the first dose of study drug. 6. Had an absolute neutrophil count of <500 cells/μL, platelet count of <25,000/μL, or hemoglobin of <8 g/dL at screening. 7. Had hypersensitivity (not including renal dysfunction or an eye disorder) to valganciclovir (vGCV), ganciclovir (GCV), cidofovir (CDV) or to brincidofovir (BCV) or their excipients. 8. Received (or were anticipated to need treatment with) any of the following: - GCV, vGCV, foscarnet, intravenous CDV, or any other anti-CMV therapy (including CMV immune globulin, cell-based therapies, and investigational anti-CMV drugs, e.g., leflunomide, letermovir [previously AIC246], or maribavir) at any time posttransplant; - Any anti-CMV vaccine at any time; - Any other investigational drug within 14 days prior to the first dose of study drug (unless prior approval had been received from the Chimerix Medical Monitor or designee); or - Prior treatment with BCV at any time. [Note: An investigational drug was defined as any drug that is not approved for any indication by the FDA (or appropriate regulatory authority).] 9. Received acyclovir orally at >2000 mg total daily dose (TDD) or intravenously at >15 mg/kg TDD, valacyclovir at >3000 mg TDD on the first dose of study drug or were anticipated to receive any of these drugs at the doses described after the the first dose of study drug. 10. Were infected with HIV, hepatitis B virus (HBV), and/or hepatitis C virus (HCV), had evidence of active viral replication within 6 months prior to screening, as demonstrated by detectable HIV or HCV RNA, or detectable HBV DNA in blood, plasma or serum. 11. Had severe vomiting, diarrhea, or malabsorption syndrome on or prior to the first dose of study drug. 12. Had gastrointestinal (GI) disease that would have, in the judgement of the investigator, precluded the subject form taking or absorbing oral medication (e.g., gastroparesis, diabetic autonomic neuropathy affecting the GI tract, clinically active Crohns disease, ischemic colitis, moderate or severe ulcerative colitis, small bowel resection, ileus, or any condition that was expected to require abdominal surgery during the course of study participation). 13. Had serum alanine aminotransferase or aspartate aminotransferase concentrations >5 x the upper limit of normal (ULN). 14. Had total serum bilirubin >2 x the ULN and direct bilirubin >1.5x the ULN. 15. Had moderate (Class B) to severe (Class C) hepatic dysfunction according to the Child-Pugh Turcotte scoring system. 16. Were receiving or would require digoxin or ketoconazole therapy (other than topical formulations) during the treatment phase of the study. 17. Had active malignancies (with the exception of basal cell carcinoma). 18. Had a serious psychiatric, medical disorder, including abnormal laboratory values, that would have, in the judgement of the investigator, put the subject at increased risk by participating in the study, or would have interfered with the conduct of the study. ; PRIMARY OUTCOME: The Incidence of CMV Disease; 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 - Lighthouse (vs. Seroquel); BRIEF: To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia. ; DRUG USED: Rexulti; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Dopamine 2 (D2) Receptor, Norepinephrine (Noradrenaline), Serotonin 5-HT1A receptor, Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: - The patient has schizophrenia, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI). - The patient has an acute exacerbation of psychotic symptoms and marked deterioration of usual function. - The patient is willing to be hospitalised from the Screening Visit through Week 6. - The patient will benefit from hospitalisation or continued hospitalisation for treatment of a current acute relapse of schizophrenia at study entry. - The patient has a history of relapse and/or exacerbation of symptoms when not receiving antipsychotic treatment, excluding the current episode. - The patient agrees to protocol-defined use of effective contraception. Exclusion Criteria: - The patient has a current Axis I diagnosis (DSM-IV-TR™ criteria) other than schizophrenia established as primary diagnosis. - The patient suffers from a current Axis II diagnosis (DSM-IV-TR™ criteria). - The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria). - The patient, in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide. - The patient has clinically significant tardive dyskinesia or severe akathisia at enrolment. - The patient has a history of neuroleptic malignant syndrome. - The patient has any relevant medical history or current presence of systemic disease. - The patient has, at the Screening Visit an abnormal ECG or other abnormal ECG tests that are, in the investigators opinion, clinically significant. - The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for >5 years prior to the first dose of brexpiprazole. - The patient is, in the investigators opinion, unlikely to comply with the protocol or is unsuitable for any reason. Other inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Change From Baseline to Week 6 in PANSS Total Score; SECONDARY OUTCOME 1: Change From Baseline to Week 6 in CGI-S 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 - nmCF; BRIEF: This is an open-label extension study for participants who completed a Phase 3, placebo-controlled study of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides. ; DRUG USED: Translarna; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: RNA translation; THERAPY: Monotherapy; LEAD SPONSOR: PTC Therapeutics; CRITERIA: Inclusion Criteria: - Completion of study treatment (placebo or active) in the previous Phase 3, double-blind study protocol (Protocol PTC124-GD-021-CF) - Evidence of signed and dated informed consent/assent document(s) indicating that the participant (and/or the participants parent/legal guardian) has been informed of all pertinent aspects of the trial. Exclusion Criteria: - Known hypersensitivity to any of the ingredients or excipients of the study drug. - Ongoing participation in any other therapeutic clinical trial. ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Change From Baseline in Percent-Predicted Forced Expiratory Volume in 1 Second (FEV1) as Measured by Spirometry at Week 24[/INST]No</s>