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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.
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Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Clinicaltrials.gov identifier NCT03440372

Recruitment Status Recruiting

First Posted February 22, 2018

Last update posted January 22, 2021

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study description
Study Description

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:Crohn Disease
  • Intervention/Treatment: Drug: Ozanimod
    Other: Placebo
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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
  • Actual Study Start Date: February 2018
  • Estimated Primary Completion Date: June 2023
  • Estimated Study Completion Date: September 2023
Arms and interventions
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
  • Primary Outcome Measures: 1. Proportion of subjects with a CDAI score < 150 [ Time Frame: 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, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline [ Time Frame: 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) score decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
    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.
  • 3. Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 [ Time Frame: 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 or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: 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 inflammation.
  • 5. Proportion of subjects with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: 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 inflammation.
  • 6. 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 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. The SES-CD assesses the degree of inflammation.
  • 7. 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% 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. The SES-CD assesses the degree of inflammation.
  • 8. Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes (Geboes, 2000) [ Time Frame: Week 12 ]
    Global Histologic Disease Activity score is a measure of histologic inflammation.
  • 9. Proportion of subjects with CDAI reduction from baseline of ≥ 70 points [ Time Frame: Week 12 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • 10. Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% [ Time Frame: Week 12 ]
    Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.
  • 11. Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
    The CDEIS assesses the degree of endoscopic inflammation.
  • 12. Proportion of adolescent subjects with clinical remission, defined as Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 points at week 12 [ Time Frame: Up to approximately week 12 ]
    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.
  • 13. Proportion of adolescent subjects with clinical response, defined as a decrease in PCDAI ≥ 15 points from baseline [ Time Frame: Up to approximately week 12 ]
    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.
  • 14. Assessment of circulating lymphocyte concentration [ Time Frame: Up to approximately week 12 ]
    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.
  • 15. Assessment of gene expression [ Time Frame: Up to approximately week 12 ]
    Interferon signature are assessed in the blood and in colon biopsies to evaluate differences based on disease activity.
  • 16. Assessment of protein biomarker concentration [ Time Frame: Up to approximately week 12 ]
    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.
  • 17. Assessment of pharmacogenetics [ Time Frame: Up to approximately week 12 ]
    Markers such as Interferon Regulatory Factor 5 are evaluated to better understand genetic variations that could lead to differences in response to Ozanimod.
  • 18. Assessment of impact of SARS-CoV-2 serologic status on subjects receiving ozanimod and CD [ Time Frame: Up to approximately week 12 ]
    SARS-CoV-2 serology (anti-SARS-CoV-2 total or IgG) from serum samples are measured to support advancing the understanding of the impact of SARS-CoV-2 on ozanimod and Crohn's disease. It may also be used to support health authority requests for analysis and advancement of pharmacodiagnostic development to better target drugs to the right patients
Eligibility Criteria
  • Ages Eligible for Study: 12 to 75 Years (Child, 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 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).

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.

Contacts and Locations
Contacts

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

Locations
Show 330 Study Locations
Sponsors and Collaborators

Celgene

Investigators

Study Director: Kanthi Kollengode, MD Celgene Corporation

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03440372 History of Changes
  • Other Study ID Numbers: RPC01-3201, U1111-1203-7225, 2017-004292-31
  • First Posted: February 22, 2018 Key Record Dates
  • Last Update Posted: January 22, 2021
  • Last Verified: January 2021
  • 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
= Our trial