Multicenter Study of Oral Ozanimod as Maintenance 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
- EUCTR2017-004294-14-NL
- Lead Sponsor
- Celgene International II Sàrl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 485
Subjects must satisfy the following criteria to be enrolled in the study:
1. Subject fulfilled the inclusion criteria at time of entry into the
Induction Study (RPC01 3201 or RPC01-3202) and has 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 clinical remission
(CDAI score of < 150 points) and/or has an average daily stool
frequency score = 3 and an average abdominal pain score = 1 with
abdominal pain and stool frequency no worse than baseline 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 435
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
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 in this study.
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 within 8 weeks of first dose of IP in Induction.
14. Subject has received previous treatment with natalizumab,
fingolimod, or other S1P modulators.
15. Subject has received previous treatment with cyc
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