Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Sponsors
Celgene International II Sàrl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age = 2 and =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: -Clinically relevant cardiovascular, hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study -Diagnosis of Crohn’s disease, indeterminate colitis or the presence or history of a fistula consistent with Crohn’s disease or microscopic colitis, radiation colitis or ischemic colitis. -Has documentation of positive test for toxin producing Clostridium difficile (C. difficile), or polymerase chain reaction (PCR) examination of the stool. If positive, subjects may be rescreened after appropriate treatment and retested no earlier than 7 days after completion of treatment. -History of treatment with topical rectal 5-aminosalicylic acid or topical rectal steroids within 2 weeks of Screening endoscopy or anti-motility medications (such as diphenoxylate/atropine) during Screening. -Apheresis within 2 weeks of randomization. -Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (ß-hCG) measured during Screening. -History or presence of the following clinically relevant cardiovascular conditions: •Structural cardiac disease •Cardiac events or diseases that predispose to cardiac complications •Prolonged QT interval corrected for heart rate or is at additional risk for QT interval prolongation During either Screening or Baseline Day 1 pre-dose assessmsnt, resting HR 1.4 mg/dL for females, or > 1.6 mg/dL for males. -Liver function impairment; or, persisting elevations of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x upper limit of normal (ULN); or, direct bilirubin > 1.5x ULN. -Platelet count < 100,000/µL. -Hemoglobin < 8.0 g/dL.. -Neutrophil count < 1500/µL. -Absolute white blood count < 3500/µL. -ALC < 800/µL. -Stool positive for pathogens. -In subjects with recent pulmonary function test measurements: (FEV1) or (FVC) at < 70% of predicted values. Exclusions related to medications -Hypersensitivity to active ingredients or excipients of ozanimod. -Treated with a biologic agent or 5 elimination half-lives (whichever is shorter) prior to the first dose of IP. -Treated with an investigational agent -Received a live or live attenuated vaccine -Received any previous treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of ozanimod in pediatric subjects with moderately to severely active UC (3-component Mayo Score: clinical remission, Week 52);Secondary Objective: To evaluate the efficacy of ozanimod in pediatric subjects with moderately to severely active UC (3-component Mayo Score: clinical remission, Week 10);Primary end point(s): Proportion of subjects who achieve clinical remission, defined as all the following: • Mayo Endoscopy Subscore (MES) = 1 • Rectal Bleeding Subscore (RBS) = 0 • Stool Frequency Subscore (SFS) = 1, with a decrease of = 1 point from Baseline SFS;Timepoint(s) of evaluation of this end point: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1/Week 10 and week 52 2/Week 10 3/Week 10 and week 52 4/Week 10 and week 52 5/Week 52 6/throughout the study 7/Week 18 and throughout the study 8/Week 10 and week 52;Secondary end point(s): 1/Proportion of subjects who achieve clinical response defined as all the following: • Decrease from Baseline in the 3-component Mayo score of at least 2 points and at least 35% • Decrease in RBS of at least 1 point OR absolute RBS = 1 2/Proportion of subjects who achieve clinical remission defined as all the following: • MES = 1 • RBS = 0 • SFS = 1, with a decrease of =1 point from Baseline SFS 3/Proportion of subjects who achieve symptomatic improvement of UC, defined as all the following: • RBS = 0 • SFS = 1 • Decrease in SFS of = 1 from Baseline 4/Proportion of subjects who achieve endoscopic improvement, defined as MES = 1 5/Proportion of subjects who achieve corticosteroid-free remission at Week 52, defined as all the following: • Did not receive steroids for = 12 weeks prior to Week 52 • Achieved clinical remission defined by the 3-component Mayo score 6/Secondary – Safety and Tolerability Number and proportion of subjects experiencing AEs, SAEs, AEs leading to discontinuation from treatment, and AEs of interest (AEIs) 7/Secondary - Pharmacokinetics Steady state systemic exposure of ozanimod and CC112273 8/Secondary – Pharmacodynamics Absolute and percent change from baseline in ALC | — |
Countries
Belgium, Canada, France, Germany, Israel, Japan, Netherlands, Poland, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactGSM-CT
Bristol-Myers-Squibb International Corporation
Outcome results
None listed