A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2024
• Main ID: NCT03464097
• Date of registration: 26/02/2018
• Prospective Registration: Yes
• Primary sponsor: Celgene
• Public title: A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
• Scientific title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
• Date of first enrolment: June 27, 2018
• Target sample size: 485
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03464097
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Moldova, Republic of, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

• Name: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,

Key inclusion & exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit: www.BMSStudyConnect.com

Inclusion Criteria:

- Fulfilled the inclusion criteria at time of entry into the induction study and
completed the week 12 efficacy assessments of the induction study

- In clinical response and/or clinical remission and/or an average daily stool frequency
score = 3 and an average abdominal pain score = 1 with abdominal pain and stool
frequency no worse than baseline at Week 12 of the Induction Study

Exclusion Criteria:

- Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the
induction studies or has developed a symptomatic fistula

- Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids,
immunomodulatory agents, investigational agents or apheresis

Other protocol-defined inclusion/exclusion criteria apply



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Ozanimod

Other: Placebo

Primary Outcome(s)

Proportion of participants with a Crohn's Disease Activity Index (CDAI) score of < 150 [Time Frame: Weekk 52]

Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of = 50% [Time Frame: Week 52]

Secondary Outcome(s)

Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score of < 150 [Time Frame: Week 52]

Time to relapse and exclusion of other causes of an increase in disease activity unrelated tounderlying CD (eg, infections, change in medication) [Time Frame: Week 52]

Histologic improvement based on differences between ozanimod and placebo in histologic diseaseactivity scores (ie, Global Histologic Disease Activity Score [GHAS] changes) [Time Frame: Week 52]

Proportion of participants with absence of ulcers = 0.5 cm with no segment with any ulcerated surface = 10% at Week 52 [Time Frame: Week 52]

Proportion of participants with average daily abdominal pain score = 1 point, with average daily stool frequency score = 3 points with abdominal pain and stool frequency no worse than baseline and an SES-CD decrease from baseline of = 50% [Time Frame: Week 52]

Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score < 150 with SES-CD decrease from baseline of = 50% [Time Frame: Week 52]

Proportion of participants with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of =50% [Time Frame: Week 52]

Proportion of participants with a CDAI score < 150 at Week 52, while remaining corticosteroid-free in the prior 12 weeks [Time Frame: Week 52]

Proportion of participants with average daily abdominal pain score = 1 point, with average daily stoolfrequency score = 3 points with abdominal pain and stool frequency no worse than baseline and an SES-CD = 4 points and a SES-CD decrease =2 points [Time Frame: Week 52]

Proportion of participants with a CDAI score of < 150 at Week 52 and at = 80% of visits between Week 8 and Week 52, inclusive, in participants with a CDAI score <150 at pre-randomization [Time Frame: Week 52]

Proportion of participants with a CDAI score of < 150 in participants with a CDAI score < 150 at pre-randomization [Time Frame: Week 52]

Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of = 50% [Time Frame: Week 52]

Proportion of participants with average daily abdominal pain score = 1 point and average daily stoolfrequency = 3 points with abdominal pain and stool frequency no worse than baseline [Time Frame: Week 52]

Proportion of participants with mucosal healing (SES-CD = 4 points and a SES-CD decrease = 2 points) with histologic improvement by GHAS or Robarts Histologic Index [Time Frame: Week 52]

Proportion of participants with CDAI reduction from baseline of = 70 points [Time Frame: Week 52]

Proportion of participants with CDAI score of < 150 and SES-CD decrease from baseline of = 50% [Time Frame: Week 52]

Secondary ID(s)

RPC01-3203

2017-004294-14

U1111-1203-8002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors