Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Jonathan Terdiman
Photo of Jonathan Terdiman
Jonathan Terdiman

Description

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

Official Title

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Details

The trial is an open label extension study. Eligible patients from the RPC01-3101 and RPC01-202 trials were able to roll-over in this trial to receive study medication until the end of 2021 or until marketing approval of RPC1063 for UC is obtained in their country, or until the Sponsor discontinues the development program, whichever comes first.

Keywords

Ulcerative Colitis Colitis Colitis, Ulcerative Ulcer RPC1063 RPC0163 (Ozanimod)

Eligibility

You can join if…

Open to people ages 18-75

  • 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

You CAN'T join if...

  • 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:
  2. Treatment with a biologic agent
  3. Treatment with an investigational agent other than RPC1063
  4. Treatment with D-penicillamine, leflunomide, thalidomide, natalizumab, fingolimod, etrasimod, or tofacitinib
  5. Treatment with lymphocyte-depleting therapies (eg, Campath, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab)
  6. Treatment with a live vaccine or live attenuated vaccine within 4 weeks prior to Visit 1 of this trial
  7. Are currently receiving or require initiation of any of the following therapies:
  8. Treatment with corticosteroids at a dose that exceeds the prednisone equivalent of 40 mg
  9. Treatment with immunosuppressive agents (eg, azathioprine, 6-MP, or methotrexate)
  10. 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)
  11. Treatment with Class Ia or Class III anti-arrhythmic drugs or treatment with two or more agents in combination known to prolong PR interval
  12. Are receiving treatment with any of the following drugs or interventions within the corresponding timeframe:
  13. At Day 1
  14. CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin) rifampicin)
  15. Two weeks prior to Day 1
  16. Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
  17. Are receiving treatment with breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine, eltrombopag)

Exclusions Related to General Health:

  1. Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (hCG)
  2. 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
  3. 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:

  1. 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
  2. FEV1 or FVC < 50% of predicted values

Locations

  • University of California at San Francisco (PARENT)
    San Francisco California 94115 United States
  • OM Research
    Lancaster California 93534 United States

Lead Scientist at UCSF

  • Jonathan Terdiman
    Dr. Jonathan P. Terdiman is a Professor of Clinical Medicine and Surgery and the Chief of the Gastroenterology Division at UCSF. He earned his undergraduate degree from Princeton University in 1985 and his medical degree from the Columbia University College of Physicians and Surgeons in 1989.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
Related Info
ID
NCT02531126
Phase
Phase 3
Study Type
Interventional
Last Updated