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The trial is taking place at:
H

Hightower Clinical | Oklahoma City, OK

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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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Celgene

Status and phase

Active, not recruiting
Phase 3

Conditions

Crohn Disease

Treatments

Other: Placebo
Drug: Ozanimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT03464097
2023-510426-33 (Registry Identifier)
RPC01-3203
U1111-1203-8002 (Registry Identifier)

Details and patient eligibility

About

This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.

Enrollment

550 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Inclusion Criteria:

  • Fulfilled the inclusion criteria at time of entry into the induction study and completed the week 12 efficacy assessments of the induction study
  • In clinical response and/or clinical remission and/or 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:

  • Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula
  • Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

550 participants in 2 patient groups, including a placebo group

Ozanimod
Experimental group
Treatment:
Drug: Ozanimod
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

779

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,

Data sourced from clinicaltrials.gov

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