A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
- Conditions
- Ulcerative colitis10017969
- Registration Number
- NL-OMON47857
- Lead Sponsor
- Celgene International II Sarl (CIS II)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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 <= 30 mg) or equivalent for at least 4 weeks and receiving
a stable dose for at least 2 weeks
8. 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
9. All patients aged 45 years or over must have had a colonoscopy to screen for
adenomatous polyps within 5 years of their first dose of investigational drug
or must have had a colonoscopy at screening to assess for polyps. The
adenomatous polyps must be removed prior to their first dose of investigational
drug.
10. Ability to provide written informed consent and to be compliant with the
schedule of protocol assessments
11. patients must have documentation of positive varicella zoster virus (VZV)
IgG antibody status or complete vaccination at least 30 days prior to
randomization.
12. Documentation of no evidence of chronic lung disease or tuberculosis (TB)
on a chest X-ray completed within the 6 months prior to screening. If a chest
x-ray was not done in the 6 months precreding the screening visit, it may be
performed during the screening visit.
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 < 8.5 g/dL); Transverse colon diameter > 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the proportion of patients in clinical remission at<br /><br>Week 8, defined as a Mayo score of <= 2 points and with no individual subscore<br /><br>of > 1 point.</p><br>
- Secondary Outcome Measures
Name Time Method