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

Colitis, Ulcerative Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03915769
• Other study ID #: RPC01-3103
• Secondary ID: U1111-1230-3228
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 3, 2019
• Est. completion date: March 13, 2025

Study information

• Verified date: January 2024
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 195
• Est. completion date: March 13, 2025
• Est. primary completion date: March 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Main Inclusion Criteria for Induction and Maintenance Periods

1. 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.

2. 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.

3. Subject has evidence of UC extending = 15 cm from the anal verge as determined by Baseline endoscopy (flexible sigmoidoscopy or colonoscopy).

4. 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:

1. Must have completed the Week 12 Visit and is non-responder at Week 12

2. 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

1. Subject has severe extensive colitis

2. 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.

3. 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

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

Other:
• Placebo
The placebo is a capsule that contains no study medication but looks exactly like the study medication capsule.

Locations

Country	Name	City	State
Japan	Local Institution - 139	Abiko
Japan	Local Institution - 152	Aki-gun
Japan	Local Institution - 138	Bunkyo-ku	Tokyo
Japan	Local Institution - 122	Chikushino
Japan	Local Institution - 150	Fujiidera
Japan	Local Institution - 114	Fukui
Japan	Local Institution - 124	Fukui
Japan	Local Institution - 155	Fukuoka
Japan	Local Institution - 161	Fukuoka
Japan	Local Institution - 164	Fukuoka
Japan	Local Institution - 140	Gifu
Japan	Local Institution - 151	Hakodate
Japan	Local Institution - 133	Hirosaki
Japan	Local Institution - 106	Hiroshima
Japan	Local Institution - 160	Hiroshima
Japan	Local Institution - 126	Hitachi, Ibaraki
Japan	Local Institution - 162	Iizuka
Japan	Local Institution - 131	Iruma-gun	Saitama
Japan	Local Institution - 134	Isehara City, Kanagawa
Japan	Local Institution - 120	Kahoku-gun
Japan	Local Institution - 135	Kannonji
Japan	Local Institution - 101	Kashihara
Japan	Local Institution - 158	Kashiwa
Japan	Local Institution - 157	Kawagoe
Japan	Local Institution - 130	Kobe
Japan	Local Institution - 163	Kobe
Japan	Local Institution - 121	Komatsu
Japan	Local Institution - 144	Koriyama
Japan	Local Institution - 142	Kurume
Japan	Local Institution - 165	Kurume
Japan	Local Institution - 111	Kurume, Fukuoka
Japan	Local Institution - 141	Kyoto-city
Japan	Local Institution - 118	Matsuyama
Japan	Local Institution - 107	Minato-ku
Japan	Local Institution - 108	Minato-ku
Japan	Local Institution - 109	Mitaka
Japan	Local Institution - 110	Morioka
Japan	Local Institution - 125	Nagaoka
Japan	Local Institution - 167	Nagoya-shi
Japan	Local Institution - 105	Nishinomiya	Hyogo
Japan	Local Institution - 119	Ogaki
Japan	Local Institution - 159	Oita
Japan	Local Institution - 136	Okayama
Japan	Local Institution - 156	Okayama-shi	Okayama
Japan	Local Institution - 132	Osaka	Osaka-shi
Japan	Local Institution - 153	Osaka-shi	Osaka
Japan	Local Institution - 127	Osaki-shi
Japan	Local Institution - 113	Otsu
Japan	Local Institution - 154	Saga
Japan	Local Institution - 116	Saitama
Japan	Local Institution - 145	Sakai
Japan	Local Institution - 102	Sakura
Japan	Local Institution - 103	Sapporo
Japan	Local Institution - 104	Sapporo	Hokkaido
Japan	Local Institution - 147	Sapporo
Japan	Local Institution - 146	Sendai
Japan	Local Institution - 128	Shinagawa-ku, Tokyo
Japan	Local Institution - 117	Shinju-ku
Japan	Local Institution - 137	Shizuoka-shi
Japan	Local Institution - 149	Sunto-gun
Japan	Local Institution - 112	Takamatsu
Japan	Local Institution - 115	Takatsuki
Japan	Local Institution - 143	Takatsuki
Japan	Local Institution - 166	Toshima-ku
Japan	Local Institution - 129	Toyama
Japan	Local Institution - 123	Tsu
Japan	Local Institution - 148	Utsunomiya

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with clinical response	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	At Week 12
Secondary	Proportion of subjects with clinical remission	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	At Week 12 and Week 52
Secondary	Proportion of subjects with a clinical response	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	At Week 12 and Week 52
Secondary	Proportion of subjects with endoscopic improvement	Defined as an endoscopy subscore of = 1 point	At Week 12 and Week 52
Secondary	Proportion of subjects with mucosal healing	Defined as an endoscopy subscore of = 1 point and a Geboes index score < 2.0	At Week 12 and Week 52
Secondary	Proportion of subjects with a clinical response	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	At Week 9
Secondary	Change in the EuroQol-5 Dimension (EQ-5D) from baseline	Is a quality of life questionnaires and will be collected from all subjects at visits	At Week 12
Secondary	Proportion of subject with clinical response	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	At week 52
Secondary	Proportion of subjects in remission while off corticosteroids for any length of time	Proportion of subjects in remission while off corticosteroids for any length of time	Up to week 52
Secondary	Adverse Event (AE)	Number of participants with adverse event.	From enrollment until at least 75 days after completion of study treatment

External Links

•   BMS Clinical Trial Information