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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 3 October 2023
Main ID:  EUCTR2017-004294-14-HU
Date of registration: 30/01/2018
Prospective Registration: Yes
Primary sponsor: Celgene International II Sàrl
Public title: Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease
Scientific title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease
Date of first enrolment: 06/03/2018
Target sample size: 485
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004294-14
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Argentina Australia Austria Belarus Belgium Bosnia and Herzegovina Brazil Bulgaria
Canada China Croatia Czech Republic Czechia Denmark Finland France
Georgia Germany Greece Hong Kong Hungary Ireland Israel Italy
Japan Korea, Republic of Latvia Lithuania Mexico Moldova, Republic of Netherlands New Zealand
Norway Poland Portugal Puerto Rico Romania Russian Federation Saudi Arabia Serbia
Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan
Turkey Ukraine United Kingdom United States
Contacts
Name: GSM-CT   
Address:  Parc de l'Alliance - Avenue de Finlande, 4 1420 Braine-l'Alleud Belgium
Telephone:
Email: clinical.trials@bms.com
Affiliation:  Bristol-Meyers Squibb International Corporation
Name: GSM-CT   
Address:  Parc de l'Alliance - Avenue de Finlande, 4 1420 Braine-l'Alleud Belgium
Telephone:
Email: clinical.trials@bms.com
Affiliation:  Bristol-Meyers Squibb International Corporation
Key inclusion & exclusion criteria
Inclusion criteria:
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

Exclusion criteria:
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 anti-arrhythmic 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg/h milligram(s)/hour
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)
Secondary Objective: -Demonstrate the efficacy of ozanimod compared to placebo on maintenance of
clinical response
-Demonstrate the efficacy of ozanimod compared to placebo on maintenance of
endoscopic remission and mucosal healing
- Demonstrate the efficacy of ozanimod, compared to placebo, in achieving
corticosteroid-free remission
-Demonstrate the efficacy of ozanimod, compared to placebo, on healthcare-resource utilization, (HRU), subject-reported outcomes, and quality of life
-Demonstrate the safety and tolerability of ozanimod as maintenance therapy
Main Objective: Demonstrate the efficacy of ozanimod compared to placebo on the maintenance of clinical remission and endoscopic response
Timepoint(s) of evaluation of this end point: - The first primary endpoint is CDAI clinical remission at Week 40. Subjects will be deemed responders with respect to this endpoint if they meet the definition, CDAI score of < 150 at Week 52.
- The second primary endpoint is endoscopic response (50%) at Week 52. Subjects will be deemed responders with respect to this endpoint if they meet the definition, SES-CD decrease from baseline of = 50% at Week 52.
Primary end point(s): - Proportion of subjects with a CDAI score of < 150 at Week 52
- Proportion of subjects with a Simple Endoscopic Score for Crohn’s Disease (SESCD) decrease from baseline of = 50% at Week 52
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: at Week 52
Secondary end point(s): Major Secondary Endpoints:
- Proportion of subjects with average daily abdominal pain score = 1 point and average
daily stool frequency = 3 points, and a stool frequency no worse than baseline at Week 52
- Proportion of subjects with average daily abdominal pain score = 1 point and average daily stool frequency = 3 points with abdominal pain and stool frequency no worse than baseline at Week 52
- Proportion of subjects with a CDAI score < 150 at Week 52, while remaining corticosteroid free in the prior 12 weeks
- Proportion of subjects with CDAI reduction from baseline of = 100 points or CDAI score of < 150 at Week 52
- Proportion of subjects with a CDAI score of < 150 at both pre-randomization and Week 52
- Proportion of subjects with a CDAI score of < 150 at Week 52 in subjects with a CDAI score < 150 at pre-randomization
- Proportion of subjects with a CDAI score < 150 at Week 52 and at = 80% of visits between Week 8 and Week 52, inclusive, in subjects with a CDAI score < 150 at pre randomization
- Proportion of subjects with absence of ulcers = 0.5 cm with no segment with any ulcerated surface =10% at Week 52
- Histologic improvement based on the significant differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes (Geboes, 2000) at Week 52
Additional Secondary Endpoints:
- Proportion of subjects with CDAI score of < 150 and SES-CD decrease from baseline of = 50% at Week 52
- Proportion of subjects with CDAI reduction from baseline of = 70 points at Week 52 Mucosal healing (SES-CD = 4 points and a SES-CD decrease = 2 points and histologic improvement) at Week 52
- Time to relapse (an increase in the CDAI score from Maintenance Day 1 of = to 100 points and a CDAI score > 220, SES-CD score = 6 (or = 4 if isolated ileal disease), and exclusion of other causes of an increase in disease activity unrelated to underlying CD (eg, infections, change in medication)
• Proportion of subjects with a Crohn’s Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of = 50% at Week 52
Secondary ID(s)
RPC01-3203
Source(s) of Monetary Support
Celgene Corporation
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 27/02/2018
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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