A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05076175
• Collaborator: (none)
• Enrollment: 120
• Locations: 38
• Arms: 2
• Anticipated Duration (Months): 110.5
• Patients Per Site: 3.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

Condition or Disease	Intervention/Treatment	Phase
Colitis, Ulcerative	Drug: Ozanimod	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 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 Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy
• Actual Study Start Date: May 30, 2022
• Anticipated Primary Completion Date: May 22, 2026
• Anticipated Study Completion Date: Aug 14, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ozanimod High Dose	Drug: Ozanimod; Specified dose on specified days
Experimental: Ozanimod Low Dose	Drug: Ozanimod; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Proportion of participants who achieve clinical remission [At Week 52]

Secondary Outcome Measures

1. Proportion of participants who achieve clinical remission [At Week 10]

2. Proportion of participants who achieve clinical response [At Week 52]

3. Proportion of participants who achieve clinical response [At Week 10]

4. Proportion of participants who achieve symptomatic remission [At Week 10 and Week 52]

5. Time to achievement of symptomatic remission [Up to 6 years]

6. Proportion of participants who achieve endoscopic improvement [At Week 10 and Week 52]

7. Proportion of participants who achieve corticosteroid free remission [At Week 52]

8. Incidence of Adverse Events (AEs) [Up to 6 years]

9. Incidence of Serious Adverse Events [Up to 6 years]

10. Incidence of AEs leading to discontinuation from treatment [Up to 6 years]

11. Incidence of AEs of special interest (AESIs) [Up to 6 years]

12. Steady state systemic exposure of ozanimod and CC112273 [At Week 18 and throughout the study, up to 70 weeks]

13. Absolute change from baseline in Absolute Lymphocyte Count (ALC) [Up to 6 years]

14. Percent change from baseline in ALC [Up to 6 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit

• Evidence of UC extending beyond the rectum, as determined by baseline endoscopy

• Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy

Exclusion Criteria:

• Diagnosis of Crohn's disease or indeterminate colitis

• Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool

• Apheresis within 2 weeks of randomization

• History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Phoenix	Arizona	United States	85016
2	Local Institution	Los Angeles	California	United States	90048
3	Local Institution	Hartford	Connecticut	United States	06106
4	Local Institution	Atlanta	Georgia	United States	30342
5	Local Institution	Boston	Massachusetts	United States	02115
6	Local Institution	Springfield	Massachusetts	United States	01107
7	Washington University	Saint Louis	Missouri	United States	63110
8	Local Institution	New York	New York	United States	10021
9	Local Institution	New York	New York	United States	10029
10	Local Institution	New York	New York	United States	10032
11	Local Institution	Cleveland	Ohio	United States	44195
12	Local Institution	Philadelphia	Pennsylvania	United States	19134
13	Texas Children's Hospital	Houston	Texas	United States	77030
14	Local Institution	Wauwatosa	Wisconsin	United States	53226
15	Local Institution - 0059	Leuven	Vlaams-Brabant	Belgium	3000
16	Local Institution	Bron		France	69500
17	Local Institution - 0030	Caen		France	14033
18	Local Institution - 0017	Paris		France	75015
19	Local Institution	Haifa		Israel	3109601
20	Local Institution	Jerusalem		Israel	9103102
21	Local Institution	Petah Tikva		Israel	4920235
22	Local Institution	Obu-shi	Aichi	Japan
23	Local Institution	Kurume-shi	Fukuoka	Japan	830-0011
24	Local Institution - 0068	Komatsu	Ishikawa	Japan	923-8560
25	Local Institution	Yokohama	Kanagawa	Japan	230-0304
26	Local Institution	Takatsuki	Osaka	Japan	569-8686
27	Local Institution	Bunkyo-ku	Tokyo	Japan	1138431
28	Local Institution	Setagaya-ku	Tokyo	Japan	1570074
29	Local Institution	Shinjuku-ku	Tokyo	Japan	1600023
30	Local Institution - 0069	Hiroshima		Japan	734-8551
31	Local Institution	Tokyo		Japan	113-8519
32	Local Institution	Gdansk		Poland	80-803
33	Local Institution	Rzeszow		Poland	35-302
34	Local Institution	Warszawa		Poland	04-745
35	Local Institution	Wroclaw		Poland	50-369
36	Local Institution	Moscow		Russian Federation	119991
37	Local Institution	Moskva		Russian Federation	119571
38	Local Institution - 0066	London		United Kingdom	E1 1RD

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT05076175
• Other Study ID Numbers: IM047-001; 2021-002308-11
• First Posted: Oct 13, 2021
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Ulcerative Colitis; Ozanimod; Pediatric
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer; Ozanimod

Study Results

No Results Posted as of Aug 15, 2022