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

Phase 2

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: RPC1063

• Registration Number: NCT02531113
• Lead Sponsor: Celgene

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.

Study Timeline

• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-21
• Study First Posted: 2015-08-24
• Study Start: 2015-10-09
• Primary Completion: 2019-09-12
• Study Completion: 2019-11-28
• Results First Submitted: 2020-09-13
• Results First Submitted QC: 2020-09-13
• Results First Posted: 2020-10-08
• Status Verified: 2020-12
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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

Trial Locations

Locations (28)

LHSC Victoria Hospital; 🇨🇦 London, Ontario, Canada

IMIC, Inc.; 🇺🇸 Palmetto Bay, Florida, United States

DM Clinical Research; 🇺🇸 Oak Lawn, Illinois, United States

GASTROMED Sp.zo.o.; 🇵🇱 Lublin, Poland

Lviv Regional Clinical Hospital; 🇺🇦 Lviv, Ukraine

CI City Hospital #1; 🇺🇦 Zaporizhia, Ukraine

Tolna Megyei Balassa Janos Korhaz; 🇭🇺 Szekszárd, Hungary

Gastroenterology Associates of Orangeburg; 🇺🇸 Orangeburg, South Carolina, United States

Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases; 🇺🇦 Dnipropetrovsk, Ukraine

UC Health Clinical Trials Office; 🇺🇸 Cincinnati, Ohio, United States

Ohio State University Clinical Trials Management Office; 🇺🇸 Columbus, Ohio, United States

Centralny Szpital Kliniczny MSWIA; 🇵🇱 Warsaw, Poland

Santa Familia Centrum Badan, Profilaktyki i Leczenia; 🇵🇱 Lodz, Poland

Nzoz Vivamed; 🇵🇱 Warsaw, Poland

Florida Center for Gastroenterology; 🇺🇸 Largo, Florida, United States

Adobe Clinical Research LLC; 🇺🇸 Tucson, Arizona, 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

Gastro One; 🇺🇸 Germantown, Tennessee, United States

Szent Margit Korhaz; 🇭🇺 Budapest, Hungary

Centrum Zdrowia Matki, Dziecka i Mlodziezy; 🇵🇱 Warsaw, Poland

Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital; 🇺🇦 Kyiv, Ukraine

Atlanta Gastroenterology Specialists PC; 🇺🇸 Suwanee, Georgia, United States

San Antonio Gastroenterology; 🇺🇸 San Antonio, Texas, United States

Vinnytsia Regional Clinical; 🇺🇦 Vinnytsia, Ukraine

Kharkiv City Clinical Hospital 2; 🇺🇦 Kharkiv, Ukraine

Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU; 🇺🇦 Kyiv, Ukraine