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

Phase 3

Recruiting

• Conditions: 10017969; inflammatory bowel disease; ulcerative colitis

• Registration Number: NL-OMON53026
• Lead Sponsor: Celgene International II Sàrl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

1. Previously participated in a trial of RPC1063 (eg, RPC01-3101 or completed
at least 1 year of the open-label period for 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 (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
-vasectomised 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 amenorrhoea
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.

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, etrasimod, or tofacitinib
• Treatment with lymphocyte-depleting therapies (e.g., Campath, anti-CD4,
cladribine, rituximab, ocrelizumab, cyclophosphamide, 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 immunosupressive 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 indcers (eg, rifampicin)
Two weeks prior to Day 1
- Monamine 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
• Study Design: Not specified