The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Phase 1

• Conditions: ulcerative colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-000319-41-BE
• Lead Sponsor: Celgene International II Sàrl (CIS II)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-24
• Study Completion: 2020-06-17
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1012

Inclusion Criteria

1. Male or female patients aged 18 to 75 years (at screening), inclusive
2. Have had UC diagnosed at least 3 months prior to first investigational drug administration. The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histopathology report (note: endoscopy and histopathology may be performed at Screening if no prior report is readily available)
3. Evidence of UC extending = 15 cm from the anal verge as determined by Baseline endoscopy (flexible sigmoidoscopy or colonoscopy)
4. Have active UC defined as Mayo score of 6 to 12 inclusive, with endoscopic subscore of = 2, a rectal bleeding score of = 1, and a stool frequency score = 1
5. Must be currently receiving treatment with at least 1 of the following therapies and must continue on these therapies during Induction:
- Oral aminosalicylates at a therapeutic dose for their disease (eg, mesalamine, sulfasalazine, olsalazine, balsalazide), with the dose stable for at least 3 weeks, prior to Screening endoscopy
- Prednisone (doses = 20 mg per day) or equivalent receiving a stable dose for at least 2 weeks prior to Screening endoscopy
- Budesonide MMX therapy receiving a stable dose for at least 2 weeks prior to Screening endoscopy
6. Have undergone colonoscopy (or are willing to undergo colonoscopy during Screening):
- within the past 2 years, to screen for dysplasia (unless otherwise recommended by local and national guidelines) if the patient has had left-sided colitis of > 12 years duration or total/extensive colitis of > 8 years duration
- within the past 5 years, to screen for polyps if the patient age is > 45 years
7. If oral aminosalicylates or corticosteroids have been recently discontinued, they must have been stopped for at least 2 weeks prior to the endoscopy used for Baseline Mayo score
8. 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 study 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.
9. Must provide written informed consent and have the ability to be compliant with the schedule of protocol assessments
10. Patients must have documentation of positive Varicella zoster virus IgG antibody status or complete Varicella zoster virus vaccination at least 30 days prior to randomization
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Exclusion Criteria

Exclusions Related to General Health:
1. Have severe extensive colitis as evidenced by:
• Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of Baseline
• Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation
2. Diagnosis of Crohn’s disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn’s disease or microscopic colitis or radiation colitis or ischemic colitis
3. Have positive stool examination for pathogens (ova and parasites, bacteria) or positive test for toxin producing Clostridium difficile (C. difficile) at Screening. PCR
(polymerase chain reaction) examination of the stool for C. difficile may be used to exclude false positives. If positive, patients may be treated and retested. Documentation of a negative test result for pathogens (ova and parasites, bacteria) is required within 60 days of Day 1.
4. Pregnancy, lactation, or a positive serum ß-human chorionic gonadotropin (ß-hCG) measured during Screening
5. 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
6. Clinically relevant cardiovascular conditions, including history or presence of:
• Recent (within the last 6 months) occurrence of 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
• Prolonged Fridericia's corrected QT interval (QTcF; QTcF > 450 msec for males, > 470 msec for females), or at additional risk for QT interval prolongation (eg, hypokalemia, hypomagnesemia, congenital long-QT syndrome)
• Resting HR < 55 bpm when taking vital signs as part of a physical exam at Screening
7. History of diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with glycosylated Hb (HbA1c) > 9% , or diabetic patients with significant comorbid conditions such as retinopathy or nephropathy
8. History of uveitis (within the last year) or macular edema
9. Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis [TB] or atypical mycobacterial disease [but excluding fungal infection of nail beds, minor upper respiratory tract infections and minor skin infections]) or any major episode of infection that required hospitalization or treatment with intravenous antibiotics within 30 days of Screening or oral antibiotics within 14 days of Screening
10. History of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin or uterine cervix that have been excised and resolved) or colonic mucosal dysplasia
11. History of alcohol or drug abuse within 1 year prior to randomization
Exclusions Related to Medications:
12. History of treatment with a biologic agent within 8weeks or 5 elimination half-lives (whichever is less) of that agent prior to randomization
13. History of treatment with an investigational agent within 5 elimination half-lives of that agent prior to randomization
14. History of treatment with topical rectal 5-aminosalicylic acid or topical rectal steroids within 2 weeks of Screening endoscopy or anti-motility medications

Study & Design

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