An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohns Disease.
- Conditions
- Crohns disease, unspecified,
- Registration Number
- CTRI/2023/07/054672
- Lead Sponsor
- PSI CRO Pharma India Pvt Ltd
- Brief Summary
This is a Phase 3, open-label, multicenter extension study to evaluate safety and explore the long-term efficacy of ozanimod in subjects with moderately to severely active CD. It is anticipated that approximately 1200 subjects who have participated in a prior study of ozanimod for CD will be eligible to participate in this study if they meet the eligibility criteria and have not met the discontinuation criteria as outlined in the prior studies (RPC01-3201, RPC01-3203).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 1200
- 1.Subjects who are not in clinical response and/or clinical remission after completing 12 weeks in the Induction Study RPC01-3201, 2.
- Subjects who experience relapse in the Maintenance Study RPC01-3203, subjects who complete the Maintenance Study RPC01-3203.
- Female subjects of child bearing potential.
- Must agree to practice a highly effective method of contraception throughout the study until completion.
- Has any clinically relevant 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 2.
- Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated 3.
- Is receiving treatment with any of the following drugs or interventions within the CYP2C8 inhibitors, inducers and Monoamine oxidase inhibitors Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of Subjects with a CDAI score of less than 150 Subjects will be evaluated Annually for Up to 234 Weeks.
- Secondary Outcome Measures
Name Time Method Proportion of participants with a simple endoscopy score (SES-CD) decrease from baseline of ≥ 50% Subjects will be evaluated Annually for Up to 234 Weeks. Proportion of participants with average daily abdominal pain score ≤ 1 point, & average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline Subjects will be evaluated Annually for Up to 234 Weeks. Change from baseline in CDAI Subjects will be evaluated Annually for Up to 234 Weeks. Proportion of participants with SES-CD ≤ 4 points & a SES-CD decrease ≥ 2 points Subjects will be evaluated Annually for Up to 234 Weeks. Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score of 150 Subjects will be evaluated Annually for Up to 234 Weeks. Proportion of participants with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% Subjects will be evaluated Annually for Up to 234 Weeks. Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score of 150 & SES-CD decrease from baseline of ≥ 50% Subjects will be evaluated Annually for Up to 234 Weeks. Proportion of participants with CDAI score of 150 & SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points Subjects will be evaluated Annually for Up to 234 Weeks. Proportion of participants with CDAI reduction from baseline of ≥ 70 points Subjects will be evaluated Annually for Up to 234 Weeks. Proportion of participants with a Crohns Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% Subjects will be evaluated Annually for Up to 234 Weeks. Proportion of participants with average daily abdominal pain score ≤ 1 point & average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline and SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points Subjects will be evaluated Annually for Up to 234 Weeks. Proportion of participants with a CDAI score 150 in participants off corticosteroids Subjects will be evaluated Annually for Up to 234 Weeks.
Trial Locations
- Locations (13)
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
All India Institute of Medical Sciences, New Delhi
🇮🇳Delhi, DELHI, India
Amrita Institute of Medical Sciences
🇮🇳Ernakulam, KERALA, India
Asian Institute of Gastroenterology
🇮🇳Hyderabad, TELANGANA, India
Dayanand Medical College & Hospital
🇮🇳Ludhiana, PUNJAB, India
Fortis Memorial Research Institute
🇮🇳Gurgaon, HARYANA, India
G.B Pant Institute of Post Graduate Medical Education and Research
🇮🇳Delhi, DELHI, India
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
🇮🇳Belgaum, KARNATAKA, India
SMS Medical College and Attached Hospitals
🇮🇳Jaipur, RAJASTHAN, India
SR Kalla Memorial Gastro & General Hospital
🇮🇳Jaipur, RAJASTHAN, India
Scroll for more (3 remaining)All India Institute of Medical Sciences🇮🇳Delhi, DELHI, IndiaDr Vineet AhujaPrincipal investigator9810707170vineet.aiims@gmail.com