Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
- Conditions
- bowel diseaseimmune-mediated inflammatory disease of the gastrointestinal tract10017969
- Registration Number
- NL-OMON55896
- Lead Sponsor
- Celgene International II Sàrl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
1. Male or female subjects aged 18 to 75 years (at Screening).
2. Subject should not have any constraints under local regulations and, 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 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 (FCPB):Note: For the purposes of
this study, a female patient is considered to be of childbearing potential if
she 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. Periodic abstinence (calendar, symptothermal,
post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and
lactational amenorrhoea method are not acceptable methods of cont
Exclusions Related to General Health:
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. Any other modality used in addition to
the colonoscopy to assess this criterion must be discussed with the Medical
Monitor.
4. Subject has current stoma, ileal-anal pouch anastomosis, symptomatic
fistula, 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 a positive test for toxin producing Clostridium
difficile (C. difficile), or polymerase chain reaction (PCR) examination of the
stool on their most recent test, which must have been done in the past 60 days.
If positive, subjects may be treated and retested no earlier than 7 days after
completion of treatment.
8. Subject has documentation of positive examination for pathogens (ova and
parasites, and bacteria), which must have been done in the past 60 days. If
positive, subjects may be treated and retested.
9. Subject is pregnant, lactating, or has a positive serum β-hCG test measured
during Screening.
10. Subject has clinically relevant cardiovascular conditions, making
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:
- 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
*- Second degree atrioventricular (AV) Block (eg, Mobitz II), third degree
heart block unless subjects have a pacemaker in place
* - Prolonged QTcF interval (QTcF > 450 ms males, > 470 ms females)
* - Resting heart rate (HR) <55 bpm when taking vitals as part of a physical
examination at Screening
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 or 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint:<br /><br>- Proportion of subjects with a CDAI score < 150 at Week 12</p><br>
- Secondary Outcome Measures
Name Time Method