The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).
- Conditions
- ulcerative colitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2015-000319-41-DE
- Lead Sponsor
- Celgene International II Sàrl (CIS II)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1050
1. Must meet one of the following criteria:
- Male or female adult patients aged 18 to 75 years (at screening), inclusive for Cohort 1 or Cohort 2, or
- Male or adolescent patients aged 12 to < 18 years (at Screening) with a body weight = 45kg for Cohort 3.
Note: Countries or sites with local restrictions that prohibit enrollment of adolescents (aged 12 to <18 years) will only enroll patients who are aged 18 to 75 years, inclusive. Enrollment of adolescent patients will only begin after the applicable regulatory requirements for studying patients in that age group have been satisfied and the necessary health authority agreements have been granted.
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 complete 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.
- 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.
7. Females of childbearing potential (FCBP):
Must agree to practice a highly effective method of contraception
throughout the trial until completion of the 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
sexual abstinence
Male patients:
Must agree to use a latex condom during sexual contact with females of
childbearing potential while participating in the study until completion of
the safety follow-up visit.
A
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
• For Adult patients: Prolonged Fridericia’s corrected QT interval (QTcF; QTcF > 450 msec for males, > 470 msec for females), or at additional risk for QT interval prolongation
• For Adolescent patients: Prolonged Fridericia’s corrected QT interval (QTcF; QTcF >450 msec for both males and females), or at additional risk for QT interval prolongation
• 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. Subject has a known active bacterial, viral, or fungal infection [excluding fungal infection of nail beds, minor upper respiratory tract infections, and minor skin infections] a mycobacterial infection (including tuberculosis[TB] or atypical mycobacterial disease),or any major episode of infection that required hospitalization or treatment with intravenous (IV) 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
12. History of treatment with a biologic agent within 8 weeks 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 with
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method