A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

Celgene

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: RPC1063

Study type: Interventional

Funder types: Industry

Identifiers

NCT02576717

RPC01-3001

Details and patient eligibility

About

The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.

Full description

The trial is an open label extension study. Eligible patients from the RPC01-201, RPC01-301, and RPC01-1001 trials diagnosed with relapsing Multiple Sclerosis (RMS) will be enrolled to receive study drug until the end of the trial or until the Sponsor discontinues the development program.

Enrollment: 2,494 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria:

To be eligible to participate in this trial, patients must meet all of the following criteria:

1. Completed one of the parent trials

2. Does not have a condition that would require withdrawal from one of the parent trials

3. Has no conditions requiring treatment with a prohibited concomitant medication

4. Is not receiving treatment with any of the following drugs or interventions within the corresponding timeframe:

   At Baseline (Day 1)

   • CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin) Two weeks prior to Baseline (Day 1)
   • Monoamine oxidase inhibitors (eg, selegiline, phenelzine)

5. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments

6. Female patients of childbearing potential:

Must agree to practice a highly effective method of contraception throughout the study until completion of the 90-day Safety Follow-up Visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.

Acceptable methods of birth control in this study are the following:

• Combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
• Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable
• Placement of an intrauterine device (IUD)
• Placement of an intrauterine hormone-releasing system (IUS)
• Bilateral tubal occlusion
• Vasectomised partner
• Sexual abstinence.

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,494 participants in 1 patient group

1 mg RPC1063 (Ozanimod) oral capsule

Experimental group

Description:

1 mg RPC1063 (Ozanimod) oral capsule daily

Treatment:

Drug: RPC1063