Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

• Status: Active, not recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multicenter, extension trial to evaluate the long-term safety and efficacy of RPC1063 in patients with moderately to severely active ulcerative colitis (UC).

The purpose of this extension trial is to evaluate the long-term safety and efficacy of RPC1063 in patients with moderately to severely active ulcerative colitis (UC).

Only those patients who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene
• Treatments: Ozanimod

Criteria

Inclusion Criteria:

• Aged 18 to 75 years (at screening of parent study RPC01-3102 / RPC01-202)

• Previously participated in a trial of RPC1063 (eg, RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202) and meet the criteria for participation in the open-label extension as outlined in the prior trial

Exclusion Criteria:

• Patients are not eligible for this trial if they fulfill any of the following:

Exclusions Related to Medications:

1. Have received any of the following therapies since the first dose of investigational drug in the prior RPC1063 trial:

• Treatment with a biologic agent

• Treatment with an investigational agent other than RPC1063

• Treatment with D-penicillamine, leflunomide, thalidomide, natalizumab, fingolimod, etrasimod, or tofacitinib

• Treatment with lymphocyte-depleting therapies (eg, Campath, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab)

• Treatment with a live vaccine or live attenuated vaccine within 4 weeks prior to Visit 1 of this trial

2. Are currently receiving or require initiation of any of the following therapies:

• Treatment with corticosteroids at a dose that exceeds the prednisone equivalent of 40 mg

• Treatment with immunosuppressive agents (eg, azathioprine, 6-MP, or methotrexate)

• Chronic non-steroidal anti-inflammatory drug (NSAID) use (Note: occasional use of NSAIDs and acetaminophen [eg, headache, arthritis, myalgias, or menstrual cramps] and aspirin up to 325 mg/day is permitted)

• Treatment with Class Ia or Class III anti-arrhythmic drugs or treatment with two or more agents in combination known to prolong PR interval

3. Are receiving treatment with any of the following drugs or interventions within the corresponding timeframe:

• At Day 1

• CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin) rifampicin)

• Two weeks prior to Day 1

• Monoamine oxidase inhibitors (eg, selegiline, phenelzine)

4. Are receiving treatment with breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine, eltrombopag)

Exclusions Related to General Health:

5. Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (hCG)

6. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric or other major systemic disease making implementation of the protocol or interpretation of the trial difficult or that would put the patient at risk by participating in the trial or that would have required a patient to discontinue treatment in previous RPC1063 trial

7. Clinically relevant cardiovascular conditions, including history or presence of recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, Class III/IV heart failure, sick sinus syndrome, or severe untreated sleep apnea

Exclusions Related to Laboratory Results:

8. Liver function impairment or persisting elevations of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times the upper limit of normal (ULN), or direct bilirubin > 3 times the ULN

9. FEV1 or FVC < 50% of predicted values