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The purpose of this study is to evaluate the combined remission of complex perianal fistulas,
defined as the clinical assessment at Week 24 of closure of all treated external openings
that were draining at baseline despite gentle finger compression, and absence of collections
greater than (>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central
magnetic resonance imaging (MRI) assessment at Week 24.
This study is to assess the efficacy and safety of Cx601, eASC, for the treatment of complex
perianal fistulas in participants with Crohn's disease.
The study will randomize approximately 554 participants.
Study treatments will be allocated, on a 1:1 ratio, by central randomization through
interactive web response system (IWRS). The study will follow an add-on design, participants
receiving any ongoing concomitant medical treatment, at stable doses at the time of
screening, for the CD will be allowed to continue it throughout the study.
The primary efficacy analysis, will be conducted at Week 24 timepoint. The double blind
design will be maintained up to Week 52 (both participant and investigator) by a specific
blinding for study treatment administration and for evaluating its efficacy.
This multicenter trial will be conducted globally across 150 centers. The overall time to
participate in this study is approximately 5 years.
Clinical Study Identifier
Last Modified on
5 August 2020
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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