To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

  • STATUS
    Recruiting
  • End date
    May 20, 2024
  • participants needed
    195
  • sponsor
    Celgene
Updated on 8 October 2020
Investigator
Eijiro Higashi
Primary Contact
Kanke Gastrointestinal Clinic (3.4 mi away) Contact
+54 other location
endoscopy
flexible sigmoidoscopy
hematochezia
sigmoidoscopy or colonoscopy

Summary

Japanese patients with moderate or severe active ulcerative colitis as a subject when ozanimod 0.46 mg or 0.92 mg is orally administered is evaluated about dose response, efficacy and safety with placebo as a control.

Description

Following the 4-week Screening Period, eligible subjects will be randomized to enter the 12 weeks placebo-controlled Induction Period (IP). Subjects who are responders at Week 12 will continue on their assigned treatment in the 52-week Maintenance Period (MP). Non responders at Week 12 have the option to enter the Open-label Extension (OLE). Subjects who complete the MP will be given the option to participate in the OLE. Subjects that enter the MP and experience disease relapse will also have the option to enter the OLE. The OLE will continue until marketing launch (about 4 years of ozanimod for Ulcerative colitis (UC), or until the Sponsor discontinues the development program.

Details
Treatment Placebo, Ozanimod
Clinical Study IdentifierNCT03915769
SponsorCelgene
Last Modified on8 October 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Ulcerative Colitis or Ulcerative Colitis (Pediatric)?
Main Inclusion Criteria for Induction and Maintenance Periods
Subject is a Japanese male or female subjects aged 18 to 75 years at the time of signing the informed consent form (ICF) at Screening
Subject has had Ulcerative Colitis (UC) diagnosed at least 3 months prior to first investigational product administration. The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histopathology report
Subject has evidence of UC extending 15 cm from the anal verge as determined by Baseline endoscopy (flexible sigmoidoscopy or colonoscopy)
Subject has active UC defined as Mayo score of 6 to 12 inclusive, with endoscopic subscore of 2, a rectal bleeding score of 1, and a stool frequency score 1
Main Inclusion Criteria for Open-label Extension Period
Subjects must satisfy the following criteria to be enrolled in the study
Subject must have completed through the Week 12 Visit in the Induction Period (IP) AND
either
Completed participation through the last study treatment visit at Week 64 and maintained clinical response in the Maintenance Period (MP), OR
Experiencing disease relapse eligible for Open-label Extension (OLE)

Exclusion Criteria

Main Exclusion Criteria
Subject has severe extensive colitis
Subject has diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease or microscopic colitis or radiation colitis or ischemic colitis
Subject has positive stool examination for pathogens (ova and parasites, bacteria) or positive test for toxin producing Clostridium difficile (C. difficile) at Screening.4. Subject is pregnant or breastfeeding
Subject has clinically relevant cardiovascular conditions
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