Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod in Pediatric Participants with Moderately to Severely Active Crohn's Disease with an Inadequate Response to Conventional Therapy

Phase 1

Recruiting

• Conditions: Moderately to Severely Active Crohn's Disease; MedDRA version: 20.0Level: PTClassification code: 10011401Term: Crohn's disease Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-508777-91-00
• Lead Sponsor: Celgene International II S.a.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Signed Written Informed Consent, Type of Participant and Target Disease Characteristics a) Participant is willing and able to adhere to the study visit schedule and other protocol requirements including is willing and able to swallow a capsule until a sprinkle formulation of ozanimod is available. b) Participant has been diagnosed with CD = 3 months prior to the Screening Visit. The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histopathology report (Note: Local histopathology sample collection and analysis may also be performed during endoscopy at Screening if no prior report is readily available). c) Participant has met each of the following 2 criteria: i) A PCDAI score = 30. ii) Participant has a SES-CD score = 6 (or SES-CD = 4 in participants with isolated ileal disease). d) Participant has an inadequate response, intolerance, or loss of response to at least 1 of the following treatments for CD. i) corticosteroids (eg, oral prednisone, oral budesonide MMX, intravenous [IV] corticosteroids). ii) immunomodulators (eg, AZA, 6-MP, cyclosporine, MTX). iii) biologic therapy (eg, ustekinumab, abatacept, infliximab, etanercept, adalimumab, anakinra, rituximab, vedolizumab). iv) other systemic immunomodulatory therapies for CD. e) If the participant is taking the following background therapies for CD, a stable dose must be maintained as indicated below (dosage regimen can be adjusted to accommodate mg/kg/day dosing as appropriate): i) Oral aminosalicylates (eg, mesalamine, sulfasalazine, olsalazine, balsalazide), the dose must have been stable starting 3 weeks prior to Screening endoscopy. ii) Prednisone (= 0.5 mg/kg/day up to 20 mg/day), the dose must have been stable starting 2 weeks prior to Screening endoscopy and must remain stable through the first 5 weeks of treatment. iii) Oral budesonide therapy (doses = 9 mg per day) or oral beclomethasone (doses = 5 mg per day), the dose must have been stable starting 2 weeks prior to Screening endoscopy and must remain stable through the first 5 weeks of treatment. a) Participant must have documentation of vaccinations per standard immunization schedule including complete varicella vaccination at least 30 days prior to randomization (Day 1) ordocumentation of positive varicella zoster virus (VZV) immunoglobulin G (IgG) antibody prior to randomization (Day 1)., Age of Participant

Exclusion Criteria

a) Participant has 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 participant at risk by participating in the study. i) Clinically relevant pulmonary conditions include, but are not limited to, history of severe or chronic lung disease, bronchopulmonary dysplasia, cystic fibrosis, or severe asthma (ie, that interferes with normal activities of daily living). b) Participant is likely to require, in the physician’s judgment, bowel resection within 12 weeks of entry into the study. c) Participant has a diagnosis of UC, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, participants with colonic or ileal strictures that are not passable with an age-appropriate colonoscope that the endoscopist normally uses in clinical practice, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded. d) Participant has current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the physician’s judgment, surgical or medical intervention within 12 weeks of entry into the study or need for ileostomy or colostomy. e) Participant has extensive small bowel resection (> 100 cm) or known diagnosis of short bowel syndrome or participant requires total parenteral nutrition. f) Participant has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated. g) Participant has documentation of positive test for toxigenic Clostridioides difficile (formerly Clostridium difficile [C difficile]) by polymerase chain reaction examination of the stool during Screening. If positive, participants may be rescreened after appropriate treatment and negative retest no earlier than 7 days after completion of treatment. h) Participant has documentation of positive examination for pathogens (ova, parasites, and bacteria). If positive, participants may be treated and rescreened.i) Participant requires or is expected to undergo apheresis (eg, Adacolumn apheresis) within 2 weeks of randomization (Day 1). j) Participant is pregnant, lactating, has a positive serum ß-subunit human chorionic gonadotropin (ß-hCG) measured during Screening or a positive urine pregnancy test on Day 1. k) Participant has a history or presence of the following clinically relevant cardiovascular conditions: i) Structural cardiac disease (eg, hypertrophic obstructive cardiomyopathy, unrepaired congenital heart defects). Participants with repaired congenital heart defects should be discussed with the Clinical Trial Physician or designee prior to enrollment. ii) Cardiac events (eg, myocardial infarction) or diseases that predispose to cardiac complications. iii) History of stroke, heart failure, or symptomatic bradycardia defined as < 5th percentile of normal sinus rhythm HR for age 29 [...]

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified