To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03915769 |
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Recruitment Status :
Active, not recruiting
First Posted : April 16, 2019
Last Update Posted : April 27, 2023
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Sponsor:
Celgene
Information provided by (Responsible Party):
Celgene
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colitis, Ulcerative | Drug: Ozanimod Other: Placebo | Phase 3 |
Following the up to 5-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 40-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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 195 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis |
| Actual Study Start Date : | June 3, 2019 |
| Estimated Primary Completion Date : | February 28, 2025 |
| Estimated Study Completion Date : | February 28, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
| Arm | Intervention/treatment |
|---|---|
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Experimental: 0.46 mg ozanimod oral capsule once daily (QD)
It will be a 7-day dose escalation regimen in the IP consisting of 4 days of treatment with 0.23 mg ozanimod, followed by 3 days of treatment with 0.46 mg ozanimod, followed by 0.46 mg ozanimod.
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Drug: Ozanimod
Ozanimod is an orally bioavailable, small molecule compound that activates the sphingosine 1-phosphate 1 receptor (S1P1) and the S1P 5 receptor (S1P5), although it is more selective towards S1P1 over S1P5 |
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Experimental: 0.92 mg ozanimod oral capsule QD
It will be a 7-day dose escalation regimen in the IP consisting of 4 days of treatment with 0.23 mg ozanimod, followed by 3 days of treatment with 0.46 mg ozanimod, followed by 0.92 mg ozanimod.
|
Drug: Ozanimod
Ozanimod is an orally bioavailable, small molecule compound that activates the sphingosine 1-phosphate 1 receptor (S1P1) and the S1P 5 receptor (S1P5), although it is more selective towards S1P1 over S1P5 |
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Placebo Comparator: Placebo oral capsule QD
It will be a 7-day dose escalation regimen in the IP consisting of 4 days of treatment with a placebo capsule, followed by 3 days of treatment with two placebo capsules, followed by two placebo capsules.
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Other: Placebo
The placebo is a capsule that contains no study medication but looks exactly like the study medication capsule. |
Primary Outcome Measures :
- Proportion of subjects with clinical response [ Time Frame: At Week 12 ]Defined as a reduction from Baseline in the complete Mayo score of ≥ 3 points and ≥ 30%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
Secondary Outcome Measures :
- Proportion of subjects with clinical remission [ Time Frame: At Week 12 and Week 52 ]Defined as: Definition 1. Complete Mayo score of ≤ 2 points with no individual subscore of > 1 point, Definition 2. Rectal bleeding subscore = 0 and stool frequency subscore ≤ 1 (and a decrease of ≥ 1 point from the Baseline stool frequency subscore) and endoscopy subscore ≤ 1
- Proportion of subjects with a clinical response [ Time Frame: At Week 12 and Week 52 ]Defined as a reduction from Baseline in the 9-point Mayo score of ≥ 2 points and ≥ 35%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
- Proportion of subjects with endoscopic improvement [ Time Frame: At Week 12 and Week 52 ]Defined as an endoscopy subscore of ≤ 1 point
- Proportion of subjects with mucosal healing [ Time Frame: At Week 12 and Week 52 ]Defined as an endoscopy subscore of ≤ 1 point and a Geboes index score < 2.0
- Proportion of subjects with a clinical response [ Time Frame: At Week 9 ]Defined as a reduction from Baseline in the partial Mayo score of ≥ 2 points and ≥ 30%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
- Change in the EuroQol-5 Dimension (EQ-5D) from baseline [ Time Frame: At Week 12 ]Is a quality of life questionnaires and will be collected from all subjects at visits
- Proportion of subject with clinical response [ Time Frame: At week 52 ]Defined as a reduction from Baseline in the complete Mayo score of ≥ 3 points and ≥ 30%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
- Proportion of subjects in remission while off corticosteroids for any length of time [ Time Frame: Up to week 52 ]Proportion of subjects in remission while off corticosteroids for any length of time
- Adverse Event (AE) [ Time Frame: From enrollment until at least 75 days after completion of study treatment ]Number of participants with adverse event.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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:
- Must have completed the Week 12 Visit and is non-responder at Week 12
- Who completes the IP and enters the MP, completes participation through the last study treatment visit at Week 52 with maintaining clinical response, OR experiences disease relapse during the MP
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
5. Subject has clinically relevant cardiovascular conditions
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915769
Locations
Show 62 study locations
Sponsors and Collaborators
Celgene
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Celgene |
| ClinicalTrials.gov Identifier: | NCT03915769 |
| Other Study ID Numbers: |
RPC01-3103 U1111-1230-3228 ( Registry Identifier: WHO ) |
| First Posted: | April 16, 2019 Key Record Dates |
| Last Update Posted: | April 27, 2023 |
| Last Verified: | April 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/ |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | See Plan Description |
| Access Criteria: | See Plan Description |
| URL: | https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Keywords provided by Celgene:
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Ulcerative colitis Ozanimod colitis Ulcerative |
Additional relevant MeSH terms:
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Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases |
Pathologic Processes Inflammatory Bowel Diseases Ozanimod Sphingosine 1 Phosphate Receptor Modulators Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |