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Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

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ClinicalTrials.gov Identifier: NCT03440385
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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 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 # 2, A PHASE 3, MULTI CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS INDUCTION THERAPY FOR MODERATELY TO SEVERLY ACTIVE CROHN's DISEASE
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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




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

  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. It is applicable to a wide range of health conditions and treatments.

  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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440385


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

  Show 246 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Jerry Liu, MD Celgene Corporation

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03440385     History of Changes
Other Study ID Numbers: RPC01-3202
U1111-1203-7949 ( Registry Identifier: WHO )
2017-004293-33 ( EudraCT Number )
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 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
RPC01-3202

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases