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: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-001600-64-LV
• Lead Sponsor: Celgene International II Sàrl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-13
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1200

Inclusion Criteria

1. Previously participated in a trial of RPC1063 (ie, 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
2. Female patients 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. 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 ovulation, 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 potential while participating in the trial until completion of the 75-day safety follow-up visit.
All patients:
Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable 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.
Are the trial subjects under 18? no
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 a live vaccine or live attenuated vaccine within 4 weeks prior to Visit 1 of this trial
• 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)
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 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)
• 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 the 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

Study & Design

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