Phase 3 Study of Cx601 in Participants With Complex Perianal Fistulising Crohn's Disease (NCT03706456) | Clinical Trial Compass
CompletedPhase 3
Phase 3 Study of Cx601 in Participants With Complex Perianal Fistulising Crohn's Disease
Japan22 participantsStarted 2019-03-06
Plain-language summary
The purpose of this study is to evaluate the efficacy of darvadstrocel for the treatment of complex perianal fistulas in adult participants with Crohn's disease over 24 weeks.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. In the opinion of the investigator, the participant is capable of understanding and complying with the protocol requirements.
✓. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
✓. The participant who was diagnosed with Crohn's disease at least 6 months prior to the screening period according to the Diagnostic Criteria for Crohn's Disease issued by Research Group for Intractable Inflammatory Bowel Disease Designated as Specified Disease by the Ministry of Health, Labour and Welfare (MHLW) of Japan (revised January 2017).
✓. The participant is either a male or female outpatient, aged 18 years or older at the time of signing the informed consent form.
✓. The participant who has non-active or mildly active Crohn's disease defined by the Crohn's disease activity index (CDAI) =\<220 evaluated at any time between Visit 1 and Visit 2.
✓. The participant who has complex perianal fistulas with a maximum of 2 internal openings and a maximum of 3 external openings, confirmed by clinical assessment and MRI. All of the external openings must connect to internal openings. Fistula must have been draining for at least 6 weeks prior to the screening. Complex perianal fistula is defined as the one that meets 1 or more of the following criteria:
✓. The participant whose perianal fistulas were previously treated and have shown an inadequate response (absence of closure of part or all fistula tract, or new fistula during induction treatment) or a loss of response (fistula relapse after complete closure of initial fistula, or fistula worsening after partial closure of initial fistula during maintenance treatment) while they were receiving either immunosuppressants or biologics, or having documented intolerance (occurrence, at any time, of an unacceptable level of treatment-related side effects that makes necessary treatment discontinuation) to any of these treatments administered at least approved or recommended doses during the minimum period mentioned;
Exclusion criteria
✕. The participant whose CDAI is \>220 at any time between Visit 1 and Visit 2, or who has active Crohn's disease requiring a new of escalating immediate therapy.
✕. The participant who has concomitant rectovaginal or rectovesical fistulas.
✕. The participant who has \>2 internal openings of \>3 external openings.
✕. The participant who is naïve to protocol required treatment for complex perianal fistulising Crohn's disease (ie, antibiotics, immunosuppressants or biologics).
✕. The participant who has an abscess or collections \>2 cm.
✕. The participant who has rectal and/or anal stenosis and/or active proctitis, which would restrict the surgical procedure.
✕. The participant who underwent surgery other than drainage or seton placement for the to be treated fistula.
✕. The participant who has diverting stomas.
What they're measuring
1
Percentage of Participants With Combined Remission of Perianal Fistulising Crohn's Disease (CD) at Week 24
✓. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent up to Week 52 of the study.