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Trial record 2 of 14 for:    crohn's celgene

An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

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ClinicalTrials.gov Identifier: NCT03467958
Recruitment Status : Not yet recruiting
First Posted : March 16, 2018
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
This is a Phase 3, open-label, multicenter extension study to evaluate safety and efficacy of ozanimod in subjects with moderately to severely active Crohn's Disease.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
Estimated Study Start Date : July 31, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Administration of oral Ozanimod
Subjects will receive a single 0.92 mg capsule [equivalent to ozanimod HCl 1 mg] once daily x 48 weeks
Drug: Ozanimod
Ozanimod



Primary Outcome Measures :
  1. Proportion of subjects with a CDAI score of < 150 [ Time Frame: Approximately every 12 weeks ]
    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 endoscopy score (SES-CD) decrease from baseline of ≥ 50% [ Time Frame: Up to approximately 48 weeks ]
    The simple endoscopy score (SES-CD) assesses the degree of endoscopic inflammation.


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. [ Time Frame: Up to approximately 48 weeks ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary.

  2. Proportion of subjects with Crohn's Disease Activity Index (CDAI) reduction from baseline of ≥ 100 points or CDAI score of < 150 [ Time Frame: Up to approximately 48 weeks ]
    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 absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% [ Time Frame: Up to approximately 48 weeks ]
    Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.

  4. Proportion of subjects with Crohn's Disease Activity Index (CDAI) reduction from baseline of ≥ 70 points [ Time Frame: Up to approximately 48 weeks ]
    The CDAI is a composite score that is used to measure the clinical activity of CD.

  5. Change from baseline in CDAI [ Time Frame: Up to approximately 48 weeks ]
    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 CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: Up to approximately 48 weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD. The simple endoscopy score (SES-CD) assesses the degree of endoscopic inflammation.

  7. Proportion of subjects with CDAI score of < 150 and SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points [ Time Frame: Up to approximately 48 weeks ]
    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.

  8. Proportion of subjects with average SES-CD ≤ 4 points [ Time Frame: Up to approximately 48 weeks ]
    The simple endoscopy score (SES-CD) assesses the degree of endoscopic inflammation.

  9. Proportion of subjects with SES-CD decrease ≥ 2 points [ Time Frame: Up to approximately 48 weeks ]
    The simple endoscopy score (SES-CD) assesses the degree of endoscopic inflammation.

  10. Proportion of subjects with a CDAI score < 150 in subjects off corticosteroids [ Time Frame: Up to approximately every 48 weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

  11. Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [ Time Frame: Up to approximately 48 weeks ]
    CDEIS (Crohn's Disease Endoscopic Index of Severity) is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon. CDEIS score considers 4 parameters (deep ulcerations, superficial ulcerations, surface involved by disease, and surface involved by ulcerations), each one evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score can be calculated even in case of incomplete investigations, as the results of the individual segments are divided by the number of segments investigated. The presence of stenosis, as a result of ulcer or not, increases the score at the end of the computation.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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. Subjects who are not in clinical response or clinical remission after completing 12 weeks in the Induction Studies RPC01-3201 or RPC01-3202, subjects who experience relapse or who complete the Maintenance Study RPC01-3203, and subjects who complete a study of ozanimod for Crohn's Disease and meet the criteria for participation in the RPC01-3204 Study will have the opportunity to participate in this study.

Exclusion Criteria:

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

Exclusions Related to General Health:

  1. Subject has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study
  2. Subject is pregnant, lactating, or has a positive urine beta human chorionic gonadotropin (β-hCG)
  3. Subject has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated
  4. Subject has a history of uveitis (within the last year) or clinically confirmed diagnosis of macular edema

    Exclusions Related to Medications:

  5. Subject has received any of the following therapies since the first dose of IP in the prior ozanimod study:

    • treatment with a biologic agent
    • treatment with an investigational agent other than ozanimod
    • treatment with D-penicillamine, leflunomide, thalidomide, natalizumab or fingolimod
    • treatment with lymphocyte-depleting therapies (eg, Campath®, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab)
    • treatment with a live vaccine within 4 weeks prior to Day 1 of this study
  6. Subject is currently receiving or requires initiation of any of the following therapies:

    • treatment with corticosteroids at a dose that exceeds the prednisone equivalent of >40 mg
    • treatment with immunomodulatory agents (eg, azathioprine, 6-MP, or methotrexate)
    • chronic non-steroidal anti-inflammatory drug (NSAID) use (note: occasional use of NSAIDs and acetaminophen [eg, headache, arthritis, myalgias, or menstrual cramps] and aspirin up to 325 mg/day is permitted)
    • treatment with Class Ia or Class III anti-arrhythmic drugs or treatment with 2 or more agents in combination known to prolong PR interval
  7. Subject has ECG results showing any clinically significant abnormality on the last ECG of the previous study
  8. Liver function impairment or persisting elevations of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN)
  9. Subject has a forced expiratory volume (FEV1) at 1 second or forced vital capacity (FVC) < 50% of predicted values.
  10. Subject has confirmed absolute lymphocyte count (ALC) < 200 cells/μL.

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): NCT03467958


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

Sponsors and Collaborators
Celgene
Investigators
Study Director: Jerry Liu, MD Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03467958     History of Changes
Other Study ID Numbers: RPC01-3204
U1111-1203-8203 ( Registry Identifier: WHO )
2017-004295-55 ( EudraCT Number )
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 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
RPC01-3204

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