Overview

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

Status:
Active, not recruiting
Trial end date:
2022-11-04
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Celgene
Treatments:
Ozanimod
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: