Ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Product Name: 0.25 mg RPC1063
Product Code: RPC1063
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Current Sponsor code: RPC1063
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)
Sponsors
Celgene International II Sàrl (CIS II)
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 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. For adolescent patients, the parent/legal guardian of the adolescent must give written informed consent, while the adolescent patient must sign the assent form, or as required by local regulations. Are the trial subjects under 18? yes Number of subjects for this age range: 150 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
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 per day • 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 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. Forced expiratory volume at 1 second (FEV1) or (forced vital capacity) FVC < 50% of predicted values.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main Objectives: - To evaluate the long-term safety of RPC1063 for the treatment of all patients with moderate to severe ulcerative colitits. - To evaluate the long-term efficacy of RPC1063 for the treatment of adult patients with moderate to severe ulcerative colitits. Exploratory Objective: - To explore the long-term efficacy of RPC1063 for the treatment of adolescent patients with moderate to severe ulcerative colitits. ;Secondary Objective: Not applicable;Primary end point(s): Due to the open-label nature of the trial and the lack of a control group, all data will be summarized and no hypothesis testing will be performed. Each efficacy endpoint will be summarized and 95% confidence intervals around the estimates may also be presented. Efficacy Endpoints (Adults): • Proportion of patients in clinical remission • Proportion of patients with a clinical response • Proportion of patients with endoscopic improvement • Proportion of patients with mucosal healing • Proportion of patients with corticosteroid-free remission • Change from Baseline in complete Mayo score, partial Mayo score, and 9-point Mayo score • Proportion of patients with histologic remission • Proportion of patients with clinical response, clinical remission, or endoscopic improvement in patients who had previously received anti-TNF therapy Exploratory Efficacy Endpoints (Adolescents): • Proportion of patients in clinical remission • Proportion of patients with a clinical response • Proportion of patients with endoscopic improvement • Proportion of patients with mucosal healing • Proportion of patients with corticosteroid-free remission • Change from Baseline in complete Mayo score, partial Mayo score, and 9-point Mayo score • Proportion of patients with histologic remission • Proportion of patients with clinical response, clinical remission, or endoscopic improvement in patients who had previously received anti-TNF therapy • Proportion of patients with clinical remission based | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Latvia, Moldova, Republic of, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactKeith Usiskin
Celgene International II Sàrl
Outcome results
None listed