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

  • Interventional
  • Not Recruiting
  • NCT02531126
Eligibility Details Visit Clinicaltrials.gov

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

The purpose of the trial is to determine the long-term safety and efficacy of RPC1063 in patients diagnosed with moderate to severe ulcerative colitis.

The trial is an open label extension study. Eligible patients from the RPC01-3101 and RPC01-202 trials will have the option to enroll in this trial to receive study medication for up to 5 years or until marketed approval

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         1. Previously participated in a trial of RPC1063 for UC and meet the criteria for participation in the open label extension as outlined in the prior trial

         2. Female patients of childbearing potential:

             Must agree to practice a highly effective method of contraception throughout the trial until completion of the 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 the trial are the following:

             - combined hormonal (oestrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal

             - progestogen-only hormonal contraception associated with inhibition of ovula-tion, 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

             Male patients:

             Must agree to use a latex condom during sexual contact with women of childbearing po-tential while participating in the trial until completion of the safety follow-up visit.

             All patients:

             Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not ac-ceptable methods of contraception. Female condom and male condom should not be used together.

         3. Must provide written informed consent and have the ability to be compliant with the schedule of protocol assessments, which must be obtained prior to any trial-related procedures.

        Exclusion Criteria:

         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 or fingolimod

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

             - Treatment with a live 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 menstru-al 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. Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (hCG)

         4. 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

         5. 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

         6. 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

         7. FEV1 or FVC < 50% of predicted values

At a Glance

National Government IDNCT02531126

IRB#IRB18-1015 (IRB15-1430)

Lead SponsorCelgene

Lead PhysicianRussell D. Cohen

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting