We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03440385
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : December 6, 2022
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE February 14, 2018
First Posted Date  ICMJE February 22, 2018
Last Update Posted Date December 6, 2022
Actual Study Start Date  ICMJE March 7, 2018
Estimated Primary Completion Date March 22, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2021)
Proportion of participants with a Crohn's Disease Activity Index (CDAI) score < 150 [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2021)
  • 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 [ Time Frame: Week 12 ]
  • Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
  • Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 [ Time Frame: Week 12 ]
  • Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 with SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
  • Proportion of participants with CDAI score < 150 with SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
  • 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 [ Time Frame: Week 12 ]
    Both no worse than baseline and an SES-CD ≤ 4 points and decrease ≥2 points
  • 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% [ Time Frame: Week 12 ]
    Both no worse than baseline and an SES-CD decrease from baseline of ≥ 50%
  • Histologic improvement based on differences between ozanimod and placebo in histologic disease activity scores using the Global Histologic Disease Activity Score [ Time Frame: Week 12 ]
  • Proportion of participants with CDAI reduction from baseline of ≥ 70 points [ Time Frame: Week 12 ]
  • Proportion of participants with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% [ Time Frame: Week 12 ]
  • Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn Disease
Intervention  ICMJE
  • Drug: Ozanimod
    Specified dose on specified days
  • Other: Placebo
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Administration of oral Ozanimod
    Intervention: Drug: Ozanimod
  • Placebo Comparator: Administration of Placebo
    Intervention: Other: Placebo
Publications * Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Nov;122:106958. doi: 10.1016/j.cct.2022.106958. Epub 2022 Oct 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 14, 2018)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 28, 2024
Estimated Primary Completion Date March 22, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Inclusion Criteria:

  • 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)

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.
Listed Location Countries  ICMJE Australia,   Austria,   Bulgaria,   Canada,   China,   Colombia,   Finland,   France,   Georgia,   Germany,   Greece,   Hong Kong,   Hungary,   Israel,   Korea, Republic of,   Lithuania,   Netherlands,   Poland,   Portugal,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United States
Removed Location Countries Brazil
 
Administrative Information
NCT Number  ICMJE NCT03440385
Other Study ID Numbers  ICMJE RPC01-3202
U1111-1203-7949 ( Registry Identifier: WHO )
2017-004293-33 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Celgene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Celgene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Celgene
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP