A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn*s Disease
- Conditions
- bowel diseaseimmune-mediated inflammatory disease of the gastrointestinal tract10017969
- Registration Number
- NL-OMON54627
- Lead Sponsor
- Celgene International II Sàrl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
1. Subject fulfilled the inclusion criteria at time of entry into the Induction
Study (RPC01-3201 or RPC01-3202) and have completed the Week 12 efficacy
assessments of the Induction Study.
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 is in clinical response (a reduction from baseline in CDAI of >= 100
points or CDAI score of < 150 points) and/or in clinical remission based on an
average daily stool frequency score <= 3 with abdominal pain and stool frequency
no worse than baseline and an average abdominal
pain score <= 1 and/or CDAI score of < 150 points at Week 12 of the Induction
Study.
4. Female subjects of childbearing potential (FCBP):
Note: For the purposes of this study, a female subject 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. 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
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
• complete sexual abstinence
Periodic abstinence (calendar, symptothermal, post-ovulation methods),
withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea
method are not acceptable methods of contraception. Counseling about pregnancy
precautions and the potential risks of fetal exposure must be conducted for
FCBP. The Investigator will educate all FCBP about the different options of
contraceptive methods or abstinence at Day 1, as appropriate. The subject will
be re-educated every time her contraceptive measures/methods or ability to
become pregnant changes. The female subject's chosen form of contraception must
be effective by the time the female subject is randomized into the study (for
example, hormonal contraception should be initiated at least 28 days before
randomization).
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 pregnant, lactating, or has a positive urine beta human
chorionic gonadotropin (ß-hCG) test measured prior to randomization.
3. Subject has suspected or diagnosed intra-abdominal or perianal
abscess that has not been appropriately treated.
4. Subject has undergone a colectomy (partial or total), small bowel
resection, or an ostomy (ie, temporary colostomy, permanent colostomy,
ileostomy, or other enterostomy) since Day 1 of the Induction Studies or
has developed symptomatic fistula (enterocutaneous or entero enteral).
5. Subject has had cancer within 5 years including solid tumors and
hematological malignancies (except basal cell and in situ squamous cell
carcinomas of the skin or cervical dysplasia/cancer that have been
excised and resolved); or colonic dysplasia that has not been completely
removed.
Exclusions Related to Medications:
6. Hypersensitivity to active ingredients or excipients of ozanimod or
placebo
7. Subject has received any of the following therapies during the
Induction Study:
a. rectal steroid therapy (ie, steroids administered to the rectum or
sigmoid via foam or enema)
b. post-baseline (of induction) initiation of, or increase in,
corticosteroids to treat worsening CD to a dose greater than the
maximum daily dose taken between the screening and baseline visits
c. rectal 5- aminosalicylates (ASA) (ie, 5-ASA administered to the
rectum)
d. parenteral corticosteroids > 14 days
e. total parenteral nutrition therapy
f. antibiotics for the treatment of CD
g. immunomodulatory agents (6-MP, AZA, including but not limited to
cyclosporine, mycophenolate mofetil, tacrolimus, and sirolimus)
h. immunomodulatory biologic agents as well as other treatments for CD
such as etrasimod, filgotinib, and upadacitinib
i. investigational agents
j. apheresis
8. Subject has current or planned treatment with immunomodulatory
agents (eg, AZA, 6-MP, or MTX) during the Maintenance Study.
9. Subject has chronic nonsteroidal anti-inflammatory drug (NSAID) use
(note: occasional use of NSAIDs and acetaminophen [eg, headache,
arthritis, myalgias, or menstrual cramps] and aspirin up to 325 mg/day
is permitted).
10. Subject has received treatment with Class Ia or Class III
antiarrhythmic
drugs, treatment with 2 or more agents in combination
known to prolong PR interval or treatment with additional prohibited
systemic cardiac medication provided in Table 7.
11. Subject has received a live or live attenuated vaccine within 4 weeks
prior to first dose of IP.
12. Subject has received previous treatment with lymphocyte-depleting
therapies (eg, Campath*, anti-CD4, cladribine, rituximab, ocrelizumab,
cyclophosphamide, mitoxantrone, total body irradiation, bone marrow
transplantation, alemtuzumab, or daclizumab).
13. Subject has received previous treatment with D-penicillamine,
leflunomide or thalidomide.
14. Subject has received previo
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoints:<br /><br>- Proportion of subjects with a CDAI score of < 150 at Week 52<br /><br>- Proportion of subjects with a SES-CD decrease from baseline of >= 50% at Week<br /><br>52</p><br>
- Secondary Outcome Measures
Name Time Method