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

NCT02531113 | Completed Phase 2 Results DMC

• 1 other identifier: RPC01-2201
• Study Type: interventional
• Target: 69
• Locations: 5 countries
• Sites: 28

Brief Summary

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

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline to Week 12

Secondary Outcomes (1)

• 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

Other Outcomes (29)

• Change in the Crohn's Disease Activity Index (CDAI) Score From Baseline at Week 12

  Baseline to Week 12

• Percentage of Participants With Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12

  Week 12

• Percentage of Participants Who Achieved a Clinical Response Based on Crohn's Disease Activity Index (CDAI) at Week 12

  Week 12

Study Arms (1)

RPC1063 (Ozanimod)

EXPERIMENTAL

Drug: RPC1063

Interventions

RPC1063 DRUG

Also known as: Ozanimod

RPC1063 (Ozanimod)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (28)

Adobe Clinical Research LLC

Tucson, Arizona, 85712, United States

Location

Florida Center for Gastroenterology

Largo, Florida, 33777, United States

Location

IMIC, Inc.

Palmetto Bay, Florida, 33157, United States

Location

Atlanta Gastroenterology Specialists PC

Suwanee, Georgia, 30024, United States

Location

DM Clinical Research

Oak Lawn, Illinois, 60453-3767, United States

Location

Gastroenterology Associates LLC

Baton Rouge, Louisiana, 70809, United States

Location

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Ehrhardt Clinical Research LLC

Belton, Missouri, 64012, United States

Location

UC Health Clinical Trials Office

Cincinnati, Ohio, 45267, United States

Location

Ohio State University Clinical Trials Management Office

Columbus, Ohio, 43210, United States

Location

Gastroenterology Associates of Orangeburg

Orangeburg, South Carolina, 29118, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

San Antonio Gastroenterology

San Antonio, Texas, 78229, United States

Location

LHSC Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Szent Margit Korhaz

Budapest, H-1032, Hungary

Location

Tolna Megyei Balassa Janos Korhaz

Szekszárd, 7100, Hungary

Location

Santa Familia Centrum Badan, Profilaktyki i Leczenia

Lodz, 90-302, Poland

Location

GASTROMED Sp.zo.o.

Lublin, 20-582, Poland

Location

Centrum Zdrowia Matki, Dziecka i Mlodziezy

Warsaw, 00-632, Poland

Location

Centralny Szpital Kliniczny MSWIA

Warsaw, 02-507, Poland

Location

Nzoz Vivamed

Warsaw, 03-580, Poland

Location

Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases

Dnipropetrovsk, 49074, Ukraine

Location

Kharkiv City Clinical Hospital 2

Kharkiv, 61037, Ukraine

Location

Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

Kyiv, 04107, Ukraine

Location

Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU

Kyiv, 1030, Ukraine

Location

Lviv Regional Clinical Hospital

Lviv, 79010, Ukraine

Location

Vinnytsia Regional Clinical

Vinnytsia, 21018, Ukraine

Location

CI City Hospital #1

Zaporizhia, 69104, Ukraine

Location

Related Publications (2)

• Harris S, Feagan BG, Hanauer S, Vermeire S, Ghosh S, Yan J, Wu C, Hu Y, Maddux R, Wolf DC, D'Haens G. Ozanimod Differentially Impacts Circulating Lymphocyte Subsets in Patients with Moderately to Severely Active Crohn's Disease. Dig Dis Sci. 2024 Jun;69(6):2044-2054. doi: 10.1007/s10620-024-08391-z. Epub 2024 Apr 3.

  PMID: 38568396 DERIVED

• Feagan BG, Sandborn WJ, Danese S, Wolf DC, Liu WJ, Hua SY, Minton N, Olson A, D'Haens G. Ozanimod induction therapy for patients with moderate to severe Crohn's disease: a single-arm, phase 2, prospective observer-blinded endpoint study. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):819-828. doi: 10.1016/S2468-1253(20)30188-6. Epub 2020 Jun 15.

  PMID: 32553149 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

please email:

Study Officials

• Kanthi Kollengode, MD

  Celgene Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 24, 2015
• Study Start: October 9, 2015
• Primary Completion: September 12, 2019
• Study Completion: November 28, 2019
• Last Updated: January 22, 2021
• Results First Posted: October 8, 2020

Record last verified: 2020-12

Locations

HU (2); PL (5); US (13); UA (7); CA (1)