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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03440385
Ethics application status
Date submitted
14/02/2018
Date registered
22/02/2018
Date last updated
1/09/2020

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 - Subjects will receive ozanimod 0.92 mg capsule orally starting with a 7-day dose escalation

Placebo Comparator: Administration of Placebo - Subjects will receive placebo capsule orally starting with a 7-day dose escalation


Treatment: Drugs: Ozanimod
Ozanimod

Other interventions: Placebo
Placebo

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 subjects with a CDAI score < 150 - The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Proportion of subjects 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 - Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary.
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of = 50% - The SES-CD assesses the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing.
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Proportion of subjects with CDAI reduction from baseline of = 100 points or CDAI score < 150 - The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Proportion of subjects with CDAI reduction from baseline of = 100 points or CDAI score < 150 and SES-CD decrease from baseline of = 50% - The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Proportion of subjects with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of = 50% - The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Proportion of subjects 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 - Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.
Timepoint [6] 0 0
Up to approximately week 12
Secondary outcome [7] 0 0
Proportion of subjects 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% - Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.
Timepoint [7] 0 0
Up to approximately week 12
Secondary outcome [8] 0 0
Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes (Geboes, 2000) - Global Histologic Disease Activity score is a measure of histologic inflammation.
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Proportion of subjects with CDAI reduction from baseline of = 70 points - The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Proportion of subjects with absence of ulcers = 0.5 cm with no segment with any ulcerated surface = 10% - Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of = 50% - The CDEIS assesses the degree of endoscopic inflammation.
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
Proportion of adolescent subjects with clinical remission, defined as Pediatric Crohn's Disease Activity Index (PCDAI) = 10 points - The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.
Timepoint [12] 0 0
Up to approximately week 12
Secondary outcome [13] 0 0
Proportion of adolescent subjects with clinical response, defined as a decrease in PCDAI = 15 points from baseline - The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.
Timepoint [13] 0 0
Up to approximately week 12
Secondary outcome [14] 0 0
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) scores (adult subjects only) - The IBDQ is a frequently used outcome parameter in clinical trials. The IBDQ is a responsive instrument for reflection quick change in the quality of life of patients with CD, within a 2-week period. The IBDQ has evolved into a standard for measuring disease-specific quality of life in patients with CD.
Timepoint [14] 0 0
Up to approximately week 12
Secondary outcome [15] 0 0
Change from baseline in 36-Item Short Form-36 Survey (SF-36) scores (adult subjects only) - The medical outcomes SF-36 questionnaire provides a measure of the subject's health status.
Timepoint [15] 0 0
Up to approximately week 12
Secondary outcome [16] 0 0
Change from baseline in Work Productivity and Activity Impairment questionnaire for Crohn's disease (WPAI-CD) scores (adult subjects only) - The WPAI-CD is a validated, reliable and responsive instrument that assesses the impact of CD on work and activity.
Timepoint [16] 0 0
Up to approximately week 12
Secondary outcome [17] 0 0
Change from baseline in EuroQol 5 dimensions questionnaire (EQ- 5D) scores - The EQ-5D is a validated, 6-item, self-administered instrument designed to measure generic health status.
Timepoint [17] 0 0
Up to approximately week 12
Secondary outcome [18] 0 0
Differences in CD-related hospitalizations, procedures, and surgery - Healthcare Resource Utilization (HRU) will be evaluated in this study to assess the impact of CD and health-related outcomes (hospitalizations, emergency department or urgent care clinic visits, procedures, and physician visits).
Timepoint [18] 0 0
Week 12
Secondary outcome [19] 0 0
Assessment of circulating lymphocyte concentration - T and B cell panels consisting of Treg cells, naïve T and B cells, memory cells and plasmablasts are evaluated for assessment of immune status.
Timepoint [19] 0 0
Up to approximately week 12
Secondary outcome [20] 0 0
Assessment of gene expression - Interferon signature are assessed in the blood and in colon biopsies to evaluate differences based on disease activity.
Timepoint [20] 0 0
Up to approximately week 12
Secondary outcome [21] 0 0
Assessment of protein biomarker concentration - Protein biomarkers such as high-density lipoprotein, C-reactive protein, fecal calprotectin, Immunoglobulin A (IgA) are measured in addition to assessing clinical endpoints to help evaluate disease activity.
Timepoint [21] 0 0
Up to approximately week 12
Secondary outcome [22] 0 0
Assessment of pharmacogenetics - Markers such as Interferon Regulatory Factor 5 are evaluated to better understand genetic variations that could lead to differences in response to Ozanimod.
Timepoint [22] 0 0
Up to approximately week 12

Eligibility
Key inclusion criteria
Subjects must satisfy the following criteria to be enrolled in the study:

1. Aged 12-75 years 2. Crohn's disease for = 3 months on endoscopy and on histological exam
3. Inadequate response or loss of response to corticosteroids, immunomodulators, and/or
biologic therapy 4. Patient has met each of the following clinical and endoscopic criteria:

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

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

3. SES-CD score of = 6 (or SES-CD = 4 in subjects with isolated ileal disease)
Minimum age
12 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The presence of any of the following will exclude a subject from enrollment or at the time
point specified in the following criteria:

1. Subject has a diagnosis of UC, indeterminate colitis, radiation colitis, or ischemic
colitis, or has strictures with prestenotic dilatation, requiring procedural
intervention, or with obstructive symptoms. In addition, subjects with colonic or
ileal strictures that are not passable with an age-appropriate colonoscope that the
endoscopist normally uses in clinical practice, or strictures in the ileum or
ileocecal valve that are fibrotic in nature, will be excluded.

2. Current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the
physician's judgement, surgical or medical intervention within 12 weeks of entry into
the study, or need for ileostomy or colostomy.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
John Hunter Hospital and Hunter Medical Research Institute - New Lambton Heights
Recruitment hospital [3] 0 0
Coastal Digestive Health - Maroorchydore
Recruitment hospital [4] 0 0
University of the Sunshine Coast - North Mackay
Recruitment hospital [5] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [6] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [7] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [8] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [9] 0 0
St John of God Subiaco Hospital - 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
4558 - Maroorchydore
Recruitment postcode(s) [4] 0 0
4740 - North Mackay
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
6008 - Subiaco
Recruitment outside Australia
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Zaporizhzhya

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect
of oral ozanimod as an induction treatment for subjects with moderately to severely active
Crohn's Disease.
Trial website
https://clinicaltrials.gov/show/NCT03440385
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kanthi Kollengode, MD
Address 0 0
Celgene Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Associate Director Clinical Trial Disclosure
Address 0 0
Country 0 0
Phone 0 0
1-888-260-1599
Fax 0 0
Email 0 0
clinicaltrialdisclosure@celgene.com
Contact person for scientific queries

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