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: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2015-000319-41-SK
- Lead Sponsor
- Celgene International II Sàrl (CIS II)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1050
1. Must meet one of the following criteria:
- Male or female adult patients aged 18 to 75 years (at Screening),
Cohort 1 or Cohort 2, or
- Male or female adolescent patients aged 12 to < 18 years (at
Screening) with a body weight = 45 kg 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 a 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 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 les
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 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