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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Ulcerative Colitis
  • Age: Between 18 Year(s) - 99 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Previously participated in a trial of RPC1063 and meet the criteria for participation in the open-label extension as outlined in the prior trial
    2. Female subjects of childbearing potential must agree to practice a highly effective method of contraception£ throughout the trial until completion of the 75-day Safety Follow-up Visit
    3. Must provide written informed consent/assent and have the ability to be compliant with the schedule of protocol assessments, which must be obtained prior to any trialrelated procedures

You may not be eligible for this study if the following are true:

    1. Subjects who 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. Subjects who 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
      • 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. Subjects who 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)
      • Two weeks prior to Day 1 - Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
    4. Subjects who are receiving treatment with breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine, eltrombopag)

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