Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Crohn Disease	Drug: Ozanimod; Other: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	600 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Estimated Study Start Date :	March 31, 2018
Estimated Primary Completion Date :	March 31, 2020
Estimated Study Completion Date :	March 31, 2020

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Administration of oral Ozanimod; Subjects will receive ozanimod 0.92 mg capsule orally starting with a 7-day dose escalation	Drug: Ozanimod; Ozanimod
Placebo Comparator: Administration of Placebo; Subjects will receive placebo capsule orally starting with a 7-day dose escalation	Other: Placebo; Placebo

Outcome Measures

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Primary Outcome Measures :

1. Proportion of subjects with a CDAI score < 150 at Week 12 [ Time Frame: Up to approximately week 12 ]
   The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

Secondary Outcome Measures :

1. Proportion of subjects with average daily abdominal pain score ≤ 1 point, average daily stool frequency score ≤ 3, and stool frequency no worse than baseline at week 12. [ Time Frame: Up to approximately week 12 ]
   Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary.
2. Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SES-CD) decrease from baseline of ≥ 50% at Week 12 [ Time Frame: Up to approximately week 12 ]
   The SES-CD assesses the degree of endoscopic inflammation.
3. Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 at Week 12 [ Time Frame: Up to approximately week 12 ]
   The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
4. Proportion of subjects with CDAI reduction from baseline of ≥ 100 points with SES-CD decrease from baseline of ≥ 50% at Week 12 [ Time Frame: Up to approximately week 12 ]
   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 endoscopic inflammation.
5. Proportion of subjects with CDAI score < 150 with SES-CD decrease from baseline of ≥ 50% at Week 12 [ Time Frame: Up to approximately week 12 ]
   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 endoscopic inflammation.
6. Proportion of subjects with CDAI score <150 at Week 12 and SES-CD decrease from baseline of ≥ 50% at Week 12 [ Time Frame: Up to approximately week 12 ]
   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 endoscopic inflammation.
7. Proportion of subjects with histological improvement (ie. as measured by Global Histologic Disease Activity score changes (Geboes, 2000) at Week 12 [ Time Frame: Up to approximately week 12 ]
   Global Histologic Disease Activity score is a measure of histologic inflammation.
8. Proportion of subjects with CDAI reduction from baseline of ≥ 70 points at Week 12 [ Time Frame: Up to approximately week 12 ]
   The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
9. Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥10% at Week 12 [ Time Frame: Up to approximately week 12 ]
   Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.
10. Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% at Week 12 [ Time Frame: Up to approximately week 12 ]
    The CDEIS assesses the degree of endoscopic inflammation.
11. Improvement in Inflammatory Bowel Disease Questionnaire (IBDQ) scores [ Time Frame: Up to approximately week 12 ]
    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.
12. Improvement in 36-Item Short Form-36 Survey (SF-36) scores [ Time Frame: Up to approximately week 12 ]
    The medical outcomes SF-36 questionnaire provides a measure of the subject's health status.
13. Improvement in Work Productivity and Activity Impairment Questionnaire (WPAI)-CD scores [ Time Frame: Up to approximately week 12 ]
    The WPAI-CD is a validated, reliable and responsive instrument that assesses the impact of CD on work and activity.
14. Improvement in EuroQol 5 dimensions questionnaire (EQ-5D) scores [ Time Frame: Up to approximately week 12 ]
    The EQ-5D is a validated, 6-item, self-administered instrument designed to measure generic health status.
15. Differences in CD-related hospitalizations and surgery [ Time Frame: Up to approximately week 12 ]
    Healthcare Resource Utilization (HRU) will be evaluated in this study to assess the impact of CD on healthcare utilization.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

1. Aged 18-75 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 2 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.

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. Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis or known strictures or stenosis leading to symptoms of obstruction.
2. Current stoma, ileal-anal pouch anastomosis, symptomatic fistula, or need for ileostomy or colostomy

Contacts and Locations

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Contacts

Contact: Associate Director Clinical Trial Disclosure	1-888-260-1599	clinicaltrialdisclosure@celgene.com

Sponsors and Collaborators

Celgene

Investigators

Study Director:	Barrett Levesque, MD	Celgene Corporation

More Information

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Responsible Party:	Celgene
ClinicalTrials.gov Identifier:	NCT03440372 History of Changes
Other Study ID Numbers:	RPC01-3201; U1111-1203-7225 ( Registry Identifier: WHO ); 2017-004292-31 ( EudraCT Number )
First Posted:	February 21, 2018
Last Update Posted:	February 21, 2018
Last Verified:	February 2018

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Celgene:

Crohn's Disease; Crohn Disease; Oral; Ozanimod	Moderately active; Severely active; RPC01; RPC01-3201

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis	Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases