Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease
NCT ID: NCT02531113
Last Updated: 2021-01-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2015-10-09
2019-11-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RPC1063 (Ozanimod)
RPC1063
Interventions
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RPC1063
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Kanthi Kollengode, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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Adobe Clinical Research LLC
Tucson, Arizona, United States
Florida Center for Gastroenterology
Largo, Florida, United States
IMIC, Inc.
Palmetto Bay, Florida, United States
Atlanta Gastroenterology Specialists PC
Suwanee, Georgia, United States
DM Clinical Research
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
Gastroenterology Associates of Orangeburg
Orangeburg, South Carolina, United States
Gastro One
Germantown, Tennessee, United States
San Antonio Gastroenterology
San Antonio, Texas, United States
LHSC Victoria Hospital
London, Ontario, Canada
Szent Margit Korhaz
Budapest, , Hungary
Tolna Megyei Balassa Janos Korhaz
Szekszárd, , Hungary
Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, , Poland
GASTROMED Sp.zo.o.
Lublin, , Poland
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warsaw, , Poland
Centralny Szpital Kliniczny MSWIA
Warsaw, , Poland
Nzoz Vivamed
Warsaw, , Poland
Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases
Dnipropetrovsk, , Ukraine
Kharkiv City Clinical Hospital 2
Kharkiv, , Ukraine
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, , Ukraine
Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
Kyiv, , Ukraine
Lviv Regional Clinical Hospital
Lviv, , Ukraine
Vinnytsia Regional Clinical
Vinnytsia, , Ukraine
CI City Hospital #1
Zaporizhia, , Ukraine
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RPC01-2201
Identifier Type: -
Identifier Source: org_study_id
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