Ulcerative colitis
Conditions
Interventions
Induction Period
On Day 1, patients will be randomly assigned 1:1:1 to 1 of 3 treatment regimens
through Week 8:
• 0.5 mg RPC1063 oral capsule daily
• 1.0 mg RPC1063 oral capsule daily
• Matching pla
Sponsors
Celgene International II Sarl (CIS II)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Males or female patients aged 18 to 75 years, inclusive 2. Have had UC diagnosed at least 2 months prior to screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence 3. Have active UC confirmed on endoscopy with >= 15 cm involvement 4. Have active UC defined as Mayo score of 6-12 inclusive with endoscopic subscore of >= 2 5. Have undergone colonoscopy or sigmoidoscopy within the past 2 years for extent of disease, and if the UC has been present for > 10 years, have had a colonoscopy with biopsy to rule out dysplasia 6. Female patients of childbearing potential: 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 - Sexual abstinence - Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception. 7. Must be currently receiving treatment with at least 1 of the following therapies: a. Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, balsalazide) for at least 6 weeks with the dose stable for at least 3 weeks prior to screening endoscopy b. Prednisone (doses
Exclusion criteria
Exclusion criteria: 1. Have severe extensive colitis evidenced by: - Physician judgment that patient is likely to require colectomy or ileostomy within 12 weeks of baseline - Current evidence of fulminant colitis, toxic megacolon or bowel perforation - Previous total colectomy - Have 4 or more of the following: Temp > 38°C, Heart rate (HR) > 110 (bpm); Focal severe or rebound abdominal tenderness; Anemia (hemoglobin 5cm on plain X-ray 2. Diagnosis of Crohn*s disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn*s disease 3. Have positive stool culture for pathogens (O+P, bacteria) or positive test for C. difficile at screening. If C. difficile is positive, the patient may be treated and retested 4. Have had treatment with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 16 weeks of screening 5. Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (hCG) measured during screening 6. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric or other major systemic disease making implementation or interpretation of the study difficult or that would put the patient at risk 7. Clinically relevant cardiovascular conditions, including history or presence of i. Recent (within the last 6 months) occurrence of myocardial infarction, unstable angina, stroke, transient ischemic attack, sick sinus syndrome, decompensated heart failure requiring hospitalization, , Class III/IV heart failure or severe untreated sleep apnea ii. Prolonged a QTcF interval (QTcF > 450 msec males, > 470 msec females), or at additional risk for QT prolongation (e.g. hypokalemia, hypomagnesemia, congenital long-QT syndrome) iii. Patients with other pre-existing stable cardiac conditions who have not been cleared for the study by an appropriate cardiac evaluation by a cardiologist. 8. Resting HR less than 55 beats per minute (bpm) when taking vitals as part of a physical exam at screening. 9. History of diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with hemoglobin A1c > 7%, or diabetic patients with significant co-morbid conditions such as retinopathy or nephropathy. 10. History of uveitis 11. Known active bacterial, viral, fungal, mycobacterial infection or other infection (including TB or atypical mycobacterial disease [excluding fungal infection of nail beds]) or any major episode of infection that required hospitalization/treatment with intravenous (IV) antibiotics within 30 days or oral antibiotics within 14 days prior to screening 12. History or known presence of recurrent or chronic infection (e.g., hepatitis A, B, C or E, human immunodeficiency virus, syphilis, TB); recurring urinary tract infections are allowed 13. History of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved) 14. History of alcohol or drug abuse within 1 year prior to randomization 15. History of or currently active primary or secondary immunodeficiency 16. History of treatment with a biologic agent within 5 half-lives of that agent prior to randomization 17. History of treatment with an investigational agent within 5 half-liv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the proportion of patients in clinical remission at Week 8, defined as a Mayo score of 1 point. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoints: • Proportion of patients with a clinical response at Week 8, defined as a reduction from baseline in Mayo score of >= 3 points and >= 30%, and a decrease from baseline in the rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 1 point • Proportion of patients with a clinical response at Week 32, defined as a reduction from baseline in Mayo score of >= 3 points and >= 30%, and a decrease from baseline in the rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of | — |
Countries
Netherlands
Outcome results
None listed