Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease
- Conditions
- Moderately to Severely Active Crohn’s DiseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-004293-33-HU
- Lead Sponsor
- Celgene International II Sàrl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
1Subjects must satisfy the following criteria to be enrolled in the study:
1.Male or female subjects aged 18 to 75 years (at Screening)
2.Subject should not have any constraints under local regulations, must provide written informed consent prior to any study-related procedures, and must have the ability to comply with the Table of Events.
3.Subject has signs and symptoms consistent with a diagnosis of CD for at least 3 months (prior to first IP administration). The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histology report. (Note: endoscopy and local histopathology confirmation may be obtained during Screening if no prior report is readily available).
4.Subject has met each of the following 2 criteria:
•a CDAI score = 220 and = 450
•an average daily stool frequency = 4 points and/or an abdominal pain of = 2 points
5.Subject has a SES-CD score of = 6 (or SES-CD = 4 in subjects with isolated ileal disease).
6.Subject has an inadequate response or loss of response to or is intolerant of at least 1 of the following systemic CD treatments (see Appendix B for additional details):
•corticosteroids
•immunomodulators
•biologic therapies (eg, ustekinumab, TNFa antagonists, or vedolizumab)
7.If the subject is taking the following background therapies for CD, a stable dose must be maintained throughout the study beginning from the screening period as indicated below:
•oral aminosalicylates (eg, mesalamine, sulfasalazine, olsalazine, balsalazide) with a stable dose for at least 3 weeks prior to Screening endoscopy
•prednisone (doses = 20 mg per day) or equivalent with a stable dose for at least 2 weeks prior to Screening endoscopy
•budesonide therapy (doses = 9 mg per day) or beclomethasone (doses = 5 mg per day) at a stable dose for at least 2 weeks prior to the Screening endoscopy
8.Subject at high risk (ie, family history, CD duration) for colonic malignancy has documented evidence of having had a surveillance colonoscopy within the last 2 years or according to local and national medical guidelines to evaluate for polyps, dysplasia, or malignancy. If there is no recent history of surveillance colonoscopy, this can be done as part of the colonoscopy performed during Screening. Any visualized adenomatous polyps must be removed and any suspicious lesion confirmed free of cancer and/or dysplasia prior to randomization.
9.Female subjects of childbearing potential (FCBP):
Note: For the purposes of this study, a female subject is considered to be of childbearing potential if 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive months (that is, has had menses at any time during the preceding 24 consecutive months). Must agree to practice a highly effective method of contraception throughout the study 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. Examples of acceptable methods of birth control in the study are the following:
•combined hormonal (containing oestrogen and progestogen) contraception, which may be oral, intravaginal, or transdermal
•progestogen-only hormonal contraception associated with inhibition of ovulatio
1.Subject has any clinically relevant cardiovascular, hepatic, neurological, pulmonary [severe respiratory disease (pulmonary fibrosis or chronic obstructive pulmonary disease)], ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study.
2.Subject is likely to require, in the physician's judgment, bowel resection within 12 weeks of entry into the study.
3.Subject has a diagnosis of UC, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, subjects with colonic or ileal strictures that are not passable with an age-appropriate colonoscope that the endoscopist normally uses in clinical practice, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded. .
4.Subject has current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the physician’s judgement, surgical or medical intervention within 12 weeks of entry into the study or need for ileostomy or colostomy.
5.Subject has extensive small bowel resection (> 100 cm) or known diagnosis of short bowel syndrome, or subject requires total parenteral nutrition.
6.Subject has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated.
7.Subject has documentation of positive test for toxin producing Clostridium difficile (C. difficile), or polymerase chain reaction (PCR) examination of the stool.
9.Subject is pregnant, lactating, or has a positive serum beta human chorionic gonadotropin (ß-hCG) test measured during Screening.
10.Subject has any condition that would make implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study, including history or presence of the following clinically relevant cardiovascular conditions.
11.Subject has a history of diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with hemoglobin A1c (HbA1c) > 9% or is a diabetic subject with significant comorbid conditions such as retinopathy or nephropathy.
12.Subject has a history of uveitis (within the last year prior to Screening) or a history of macular edema.
13.Subject has a known active bacterial, viral, fungal (excluding fungal infection of nail beds, minor upper respiratory tract infections, and minor skin infections), mycobacterial infection (including tuberculosis [TB] or atypical mycobacterial disease) or any major episode of infection that either required hospitalization, treatment with intravenous (IV) antibiotics within 30 days of Screening, or treatment with oral antibiotics within 14 days of Screening
14.History or known presence of recurrent or chronic infection (eg, hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV); recurrent urinary tract infections are allowed.
15.Subject has a history of cancer within 5 years
16.Subject has a history of alcohol or drug abuse within 1 year prior to initiation of Screening.
Exclusions Related to Medications:
17.Hypersensitivity to active ingredients or excipients of ozanimod or placebo
18.Prior participation in an ozanimod clinical study.
19.Subject has a history of primary nonresponse to 2 or more approved biologic agents or has been
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