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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03440385




Registration number
NCT03440385
Ethics application status
Date submitted
14/02/2018
Date registered
22/02/2018
Date last updated
12/12/2023

Titles & IDs
Public title
Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Scientific title
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
Secondary ID [1] 0 0
U1111-1203-7949
Secondary ID [2] 0 0
RPC01-3202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ozanimod
Other interventions - Placebo

Experimental: Administration of oral Ozanimod -

Placebo Comparator: Administration of Placebo -


Treatment: Drugs: Ozanimod
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with a Crohn's Disease Activity Index (CDAI) score < 150
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Proportion of participants with average daily abdominal pain score = 1 point, and average daily stool frequency score = 3 points with abdominal pain and stool frequency no worse than baseline
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of = 50%
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score < 150
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score < 150 with SES-CD decrease from baseline of = 50%
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Proportion of participants with CDAI score < 150 with SES-CD decrease from baseline of = 50%
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Proportion of participants with an average daily abdominal pain score = 1 point, and average daily stool frequency score = 3 points and both no worse than baseline AND an SES-CD = 4 points and decrease =2 points
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Proportion of participants with an average daily abdominal pain score = 1 point, and average daily stool frequency score = 3 points and both no worse than baseline AND an SES-CD decrease from baseline of = 50%
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Histologic improvement based on differences between ozanimod and placebo in histologic disease activity scores using the Global Histologic Disease Activity Score
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Proportion of participants with CDAI reduction from baseline of = 70 points
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Proportion of participants with absence of ulcers = 0.5 cm with no segment with any ulcerated surface = 10%
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of = 50%
Timepoint [11] 0 0
Week 12

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit: www.BMSStudyConnect.com



- Crohn's disease for = 3 months on endoscopy and on histological exam

- Inadequate response or loss of response to corticosteroids, immunomodulators, and/or
biologic therapy

- Crohn's Disease Activity Index (CDAI) score = 220 and = 450

- Average daily stool frequency = 4 points and/or an abdominal pain of = 2 points

- Simple Endoscopic Score for Crohn's Disease (SES-CD) score of = 6 (or SES-CD = 4 in
participants with isolated ileal disease)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic
colitis, or has strictures with prestenotic dilatation requiring procedural
intervention

- Extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome,
or requires total parenteral nutrition

- Current stoma, ileal-anal pouch anastomosis, or fistula

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/11/2023
Sample size
Target
Accrual to date
Final
606
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 309 - Liverpool
Recruitment hospital [2] 0 0
Local Institution - 318 - New Lambton Heights
Recruitment hospital [3] 0 0
Local Institution - 328 - Herston
Recruitment hospital [4] 0 0
Local Institution - 313 - Maroorchydore
Recruitment hospital [5] 0 0
Local Institution - 321 - North Mackay
Recruitment hospital [6] 0 0
Local Institution - 312 - South Brisbane
Recruitment hospital [7] 0 0
Local Institution - 307 - Bedford Park
Recruitment hospital [8] 0 0
Local Institution - 326 - Elizabeth Vale
Recruitment hospital [9] 0 0
Local Institution - 317 - Clayton
Recruitment hospital [10] 0 0
Local Institution - 305 - Fitzroy
Recruitment hospital [11] 0 0
Local Institution - 329 - Geelong
Recruitment hospital [12] 0 0
Local Institution - 327 - Melbourne
Recruitment hospital [13] 0 0
Local Institution - 315 - Subiaco
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4558 - Maroorchydore
Recruitment postcode(s) [5] 0 0
4740 - North Mackay
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
05112 - Elizabeth Vale
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3065 - Fitzroy
Recruitment postcode(s) [11] 0 0
3220 - Geelong
Recruitment postcode(s) [12] 0 0
3004 - Melbourne
Recruitment postcode(s) [13] 0 0
6008 - Subiaco
Recruitment outside Australia
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Country [208] 0 0
Turkey
State/province [208] 0 0
Ankara
Country [209] 0 0
Turkey
State/province [209] 0 0
Elazig
Country [210] 0 0
Turkey
State/province [210] 0 0
Istanbul
Country [211] 0 0
Turkey
State/province [211] 0 0
Kadiköy/Istanbul
Country [212] 0 0
Ukraine
State/province [212] 0 0
Chernivtsi
Country [213] 0 0
Ukraine
State/province [213] 0 0
Ivano-Frankivsk
Country [214] 0 0
Ukraine
State/province [214] 0 0
Kharkiv
Country [215] 0 0
Ukraine
State/province [215] 0 0
Khmelnytskyi
Country [216] 0 0
Ukraine
State/province [216] 0 0
Kropyvnytskyi
Country [217] 0 0
Ukraine
State/province [217] 0 0
Kyiv
Country [218] 0 0
Ukraine
State/province [218] 0 0
Lutsk
Country [219] 0 0
Ukraine
State/province [219] 0 0
Lviv
Country [220] 0 0
Ukraine
State/province [220] 0 0
Odesa
Country [221] 0 0
Ukraine
State/province [221] 0 0
Vinnytsia
Country [222] 0 0
Ukraine
State/province [222] 0 0
Vinnytsya
Country [223] 0 0
Ukraine
State/province [223] 0 0
Zaporizhia
Country [224] 0 0
Ukraine
State/province [224] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a study to explore the effect of oral ozanimod as an induction treatment for
participants with moderately to severely active Crohn's Disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03440385
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03440385