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-GB
• Lead Sponsor: Celgene International II Sàrl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-06
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1350

Inclusion Criteria

1. 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
2. Females patients of childbearing potential(FCBP)*:
Must agree to practice a highly effective method of contraception** throughout the trial until completion of the 90-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
vasectomized partner
complete sexual abstinence
*For the purposes of this study, a female patient is considered to be of
childbearing potential if she has reached menarche, and 1) has not
undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive months (that is, has had menses at any time during the preceding 24 consecutive months)
**Contraception Education: Counselling about pregnancy precautions
and the potential risks of fetal exposure must be conducted for FCBP.
The Investigator will educate all FCBP about the different options of
contraceptive methods or abstinence, as appropriate, at the Screening
and Baseline Visits. The patient will be re-educated every time her
contraceptive measures/methods or ability to become pregnant
changes. The female patient's chosen form of contraception must be
effective by the time the female patient is randomized into the study (for
example, hormonal contraception should be initiated at least 28 days
before baseline).
Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception.
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 trial-related procedures. The parent/legal guardian
of the adolescent must sign an informed consent form. In addition,
adolescent patients must also agree to participate in the study by signing an assent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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, fingolimod, etrasimod, or tofacitinib
• 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 or live attenuated 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 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 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