The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-001600-64-IT
• Lead Sponsor: CELGENE INTERNATIONAL II SàR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1350

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. Men and women of childbearing potential must agree to use adequate
birth control measures during the trial. Acceptable methods of birth
control in this trial include: surgical sterilization, intrauterine device,
oral contraceptive, contraceptive patch, long acting injectable
contraceptive, partner's vasectomy, double-barrier method (condom
or diaphragm with spermicide or condom and diaphragm) or abstinence
during trial participation and for 30 days after their last dose of
investigational drug. Patients must follow the strictest applicable local
requirement as specified by the Regulatory Agency or Ethics Committee
approving the trial
3. Must be able and willing to adhere to the trial visit schedule and
comply with other protocol requirements
4. Provide written informed consent, which must be obtained prior to
any trial-related procedures
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1164
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

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 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 (e.g., azathioprine, 6-MP, or methotrexate)
•Chronic treatment with therapies that strongly inhibit or induce cytochrome P450 3A4 (CYP3A4) metabolism
•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 medications with a known impact on the cardiac conduction system (e.g., beta blockers, diltiazem, verapamil, and Class Ia or Class III anti-arrhythmic drugs)
Exclusions Related to General Health:
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
Exclusions Related to Laboratory Results:
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified