Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease

Phase 2

Completed

Brief Summary: The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.

Detailed Description: This open-label trial is composed of two periods: Induction and Extension. All eligible patients will be enrolled into the 12-Week Induction period and receive study medication. Patients who complete the Induction period may then be eligible to enter the 100-Week Extension period where they will continue to receive study medication.

Recruitment & Eligibility

Inclusion Criteria

Crohn's disease (CD) confirmed by endoscopy and histology
Active disease as evaluated by Crohn's Disease Activity Index Score and Simple Endoscopic Score for CD
Inadequate response to aminosalicylates, corticosteroids, immunomodulators or biologic therapy

Key

Exclusion Criteria

Diagnosis of ulcerative colitis or indeterminate colitis
Known strictures/stenosis leading to symptoms of obstruction
Current stoma or need for ileostomy or colostomy
Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
History of uveitis or known macular edema
History of colonic dysplasia

Arm && Interventions

Group	Intervention	Description
RPC1063 (Ozanimod)	RPC1063	-

Primary Outcome Measures

Name	Time	Method
Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) (Paired Segments) From Baseline at Week 12 as Determined by a Blinded Central Reader.	Baseline to Week 12	The simple endoscopy score (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. Each of these components are scored on a scale of 0 to 3. In the SES-CD, each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right, transverse, left (descending and sigmoid), and rectum. The SES-CD is the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores is 0 - 12 for each segment, and 0 - 56 for the overall SES-CD score, with larger scores indicating greater severity of disease.

Secondary Outcome Measures

Name	Time	Method
The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period	From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years	A TEAE = any event with an onset date on or after the first dose date, or any ongoing event on the first dose date that worsens in severity or after the first dose date and until 90 days following the last dose of study drug treatment. An AE = untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which that does not necessarily have a causal relationship with the investigational treatment. An AE can be any unfavorable or unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not considered related to the investigational medicinal product. A serious AE (experience) or reaction is any untoward medical occurrence that at any dose * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity, or * Is a congenital abnormality/birth defect

Locations (28): Adobe Clinical Research LLC
🇺🇸
Tucson, Arizona, United States
Florida Center for Gastroenterology
🇺🇸
Largo, Florida, United States
IMIC, Inc.
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Palmetto Bay, Florida, United States
Atlanta Gastroenterology Specialists PC
🇺🇸
Suwanee, Georgia, United States
DM Clinical Research
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Oak Lawn, Illinois, United States
Gastroenterology Associates LLC
🇺🇸
Baton Rouge, Louisiana, United States
Chevy Chase Clinical Research
🇺🇸
Chevy Chase, Maryland, United States
Ehrhardt Clinical Research LLC
🇺🇸
Belton, Missouri, United States
UC Health Clinical Trials Office
🇺🇸
Cincinnati, Ohio, United States
Ohio State University Clinical Trials Management Office
🇺🇸
Columbus, Ohio, United States
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Adobe Clinical Research LLC
🇺🇸Tucson, Arizona, United States