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A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

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ClinicalTrials.gov Identifier: NCT03464097
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief Summary:
This is a Phase 3, randomized, double-blind, placebo-controlled study to demonstrate the effect of oral ozanimod as maintenance therapy in 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 : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : June 26, 2024
Estimated Study Completion Date : September 24, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: Administration of oral Ozanimod 0.92mg
Subjects will receive a single 0.92 mg capsule [equivalent to ozanimod HCl 1 mg] once daily x 52 weeks
 Drug: Ozanimod
Ozanimod
Placebo Comparator: Administration of Placebo
Subjects will receive placebo capsule orally once daily x 52 weeks
 Other: Placebo
Placebo
Experimental: Administration of oral Ozanimod 0.46mg
Subjects will receive a single 0.46 mg capsule [equivalent to ozanimod HCl .5 mg] once daily x 52 weeks
 Drug: Ozanimod
Ozanimod


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects with a CDAI score of < 150 [ Time Frame: Up to approximately week 52 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

  2. Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SESCD) score decrease from baseline of ≥ 50% [ Time Frame: Up to approximately week 52 ]
    The SES-CD assesses the degree of endoscopic inflammation.


Secondary Outcome Measures :
  1. Proportion of subjects with average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline [ Time Frame: Up to approximately week 52 ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary

  2. Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 [ Time Frame: Up to approximately week 52 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

  3. Proportion of subjects with a CDAI score < 150 at Week 52, while remaining corticosteroid-free in the prior 12 weeks [ Time Frame: Up to approximately week 52 ]
    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 a CDAI score of < 150 in subjects with a CDAI score < 150 at pre-randomization [ Time Frame: Up to approximately week 52 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

  5. Proportion of subjects with a CDAI score of < 150 at Week 52 and at ≥ 80% of visits between Week 8 and Week 52, inclusive, in subjects with a CDAI score <150 at pre-randomization [ Time Frame: Up to approximately week 52 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

  6. Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥10% [ Time Frame: Up to approximately week 52 ]
    Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.

  7. Histologic improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score [GHAS] changes (Geboes, 2000)) [ Time Frame: Up to approximately week 52 ]
    Global Histologic Disease Activity score is a measure of histologic inflammation.

  8. 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 and an SES-CD decrease from baseline of ≥ 50% [ Time Frame: Up to approximately week 52 ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of endoscopic inflammation

  9. Proportion of subjects with CDAI score of < 150 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: Up to approximately week 52 ]
    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.

  10. 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 and an SES-CD ≤ 4 points and a SES-CD decrease ≥2 points [ Time Frame: Up to approximately week 52 ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of endoscopic inflammation.

  11. 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: Up to approximately week 52 ]
    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.

  12. Proportion of subjects with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: Up to approximately week 52 ]
    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.

  13. Proportion of subjects with CDAI reduction from baseline of ≥ 70 points [ Time Frame: Up to approximately week 52 ]
    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

  14. Proportion of subjects with mucosal healing (SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points) and histologic improvement by GHAS or Robarts Histologic Index (RHI) [ Time Frame: Up to approximately week 52 ]
    Global Histologic Disease Activity score is a measure of histologic inflammation

  15. Time to relapse and exclusion of other causes of an increase in disease activity unrelated to underlying CD (eg, infections, change in medication) [ Time Frame: Up to approximately week 52 ]
    Time to relapse is defined as an increase in the CDAI score from Maintenance Day 1 of ≥ 100 points and a CDAI score > 220, SES-CD score ≥ 6 [or ≥ 4 if isolated ileal disease.

  16. Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [ Time Frame: Up to approximately week 52 ]
    The CDEIS assesses the degree of endoscopic inflammation.

  17. Proportion of adolescent subjects with Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 points [ Time Frame: Up to approximately week 52 ]
    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.

  18. Proportion of adolescent subjects with decrease from baseline in PCDAI score ≥15 points [ Time Frame: Up to approximately week 52 ]
    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.

  19. Change from baseline (Induction) in Inflammatory Bowel Disease Questionnaire (IBDQ) scores (adult subjects only) [ Time Frame: Up to approximately week 52 ]
    The IBDQ is a self-administered, 32-item questionnaire concerning 4 dimensions of quality of life (Hlavaty, 2006).

  20. Change from baseline (Induction) in 36-Item Short Form-36 Survey (SF-36) scores (adult subjects only) [ Time Frame: Up to approximately week 52 ]
    The medical outcomes SF-36 questionnaire provides a measure of the subject's health status. The SF-36 consists of either scaled scores, which are the weighted sums of the questions in their section.

  21. Change from baseline (Induction) in Work Productivity and Activity Impairment questionnaire for Crohn's disease (WPAI-CD) scores (adult subjects only) [ Time Frame: Up to approximately week 52 ]
    The WPAI-CD (Reilly, 1993) is a validated, reliable and responsive instrument that assesses the impact of CD on work and activity during the past 7 days (Reilly, 2008).

  22. Change from baseline (Induction) in EuroQol 5 dimensions questionnaire (EQ-5D) scores [ Time Frame: Up to approximately week 52 ]
    The EQ-5D (The EuroQol Group, 1990) is a validated, 6-item, self-administered instrument designed to measure generic health status.

  23. Patient Global Impression of Change (PGIC) scores (adult subjects only) [ Time Frame: Up to approximately week 52 ]
    The PGIC scale evaluates all aspects of patient's health and assesses if there has been an improvement or decline in clinical status. The self-report measure PGIC reflects a patient's belief about the efficacy of treatment.

  24. Differences in CD-related hospitalizations, procedures, and surgery [ Time Frame: Up to approximately week 52 ]
    Healthcare resource utilization 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).

  25. Assessment of circulating lymphocyte concentration [ Time Frame: Up to approximately week 52 ]
    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.

  26. Assessment of gene expression [ Time Frame: Up to approximately week 52 ]
    Interferon signature are assessed in the blood and in colon biopsies to evaluate differences based on disease activity.

  27. Assessment of protein biomarker concentration [ Time Frame: Up to approximately week 52 ]
    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.

  28. Assessment of pharmacogenetics [ Time Frame: Up to approximately week 52 ]
    Markers such as Interferon Regulatory Factor 5 are evaluated to better understand genetic variations that could lead to differences in response to Ozanimod.

  29. Assessment of impact of SARS-CoV-2 serologic status on subjects receiving ozanimod and CD [ Time Frame: Up to approximately week 52 ]
    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
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Ages Eligible for Study:   12 Years 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. Subject fulfilled the inclusion criteria at time of entry into the Induction Study (RPC01-3201 or RPC01-3202) and have completed the Week 12 efficacy assessments of the Induction Study.
  2. Subject is in clinical response (a reduction from baseline in Crohn's Disease Activity Index (CDAI) of ≥ 100 points or CDAI score of < 150 points) and/or clinical remission (CDAI score of < 150 points) and/or has an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤ 1 with abdominal pain and stool frequency no worse than baseline at Week 12 of the Induction Study.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

Exclusions Related to General Health:

  1. Subject has undergone a colectomy (partial or total), small bowel resection, or an ostomy (ie, temporary colostomy, permanent colostomy, ileostomy, or other enterostomy) since Day 1 of the Induction Studies or has developed symptomatic fistula (enterocutaneous or entero-enteral).

    Exclusions Related to Medications:

  2. Subject has received any of the following therapies during the Induction Study:

    a. rectal steroid therapy (ie, steroids administered to the rectum or sigmoid via foam or enema) b. post-baseline initiation of, or increase in, corticosteroids to treat worsening CD to a dose greater than the maximum daily dose taken between the screening and baseline visits c. rectal 5-ASA (ie, 5-ASA steroids administered to the rectum) d. parenteral corticosteroids e. total parenteral nutrition therapy f. antibiotics for the treatment of CD g. immunomodulatory agents (6-MP, azathioprine, including but not limited to cyclosporine, mycophenolate mofetil, tacrolimus, and sirolimus) h. immunomodulatory biologic agents as well as other treatments for CD such asetrasimod, filgotinib, and upadacitinib I. investigational agents j. apheresis

Contacts and Locations
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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): NCT03464097


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

Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: Jerry Liu, MD Celgene Corporation
More Information
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Additional Information:

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03464097    
Other Study ID Numbers: RPC01-3203
U1111-1203-8002 ( Registry Identifier: WHO )
2017-004294-14 ( EudraCT Number )
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021

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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
RPC01-3203
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases