Efficacy and Safety Study of Ozanimod in Ulcerative Colitis (Touchstone)

Celgene

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Ozanimod; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01647516

RPC01-202

Details and patient eligibility

About

The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).

Enrollment: 199 patients

Sex: All

Ages: 18 to 73 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ulcerative colitis (UC) confirmed on endoscopy
• Moderately to severely active UC (Mayo score 6-12)

Exclusion criteria

• Current use of anti-TNF agents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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199 participants in 3 patient groups, including a placebo group

Ozanimod 0.5 mg

Experimental group

Description:

Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 0.5 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.

Treatment:

Drug: Ozanimod

Ozanimod 1 mg

Experimental group

Description:

Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 1 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.

Treatment:

Drug: Ozanimod

Placebo

Placebo Comparator group

Description:

Identically matching placebo capsules daily for 32 weeks followed by an optional open label treatment period.

Treatment:

Drug: Placebo