Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)
United States60 participantsStarted 2021-09-13
Plain-language summary
A Phase II study to assess the safety and efficacy of AVB-114 in treatment of complex Crohn's perianal fistulas in subjects with quiescent rectal disease and whose fistula has failed to respond to biologic or conventional therapy. Combined remission of treated perianal fistula in the investigational treatment arm will be compared to a standard of care control arm.
The study has 2 parts:
Part 1: All required study visits for subjects who initially receive study treatment and those who receive standard of care therapy (control arm).
Part 2: Subjects who are enrolled in the control arm may receive treatment with AVB-114 following week 36. Those subjects then will be followed as specified in the clinical protocol.
Who can participate
Age range18 Years – 70 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
✓. Provision of signed and dated ICF.
✓. Ability and willingness to comply with study protocol and study requirements for the duration of the study.
✓. Male or female, 18-70 years of age
✓. Subjects with CD diagnosed at least 6 months prior to screening visit.
✓. Subjects with a single fistula tract with one internal opening and one external opening.
✓. Subjects whose perianal fistula(s) were previously treated with either biologic or conventional therapy whose fistula has demonstrated a failed response or who have documented medication intolerance.
✓. Women of childbearing potential (WCBP) must have negative serum pregnancy test at screening (sensitive to 25 IU human chorionic gonadotropin). WCBP participating in this study must agree to use an adequate method of contraception during the entire duration of the study. Males who have sexual partners that are women of childbearing potential must be willing to use a barrier method for contraception for the duration of study.
Exclusion criteria
What they're measuring
1
Change in proportions of subjects with combined remission of treated perianal fistula between the AVB-114 and standard of care groups.
. Clinically significant medical conditions within the six months before screening that would, in the opinion of the investigator, compromise the safety of the subject with study participation and/or the ability of the subject to follow study protocol.
✕. Evidence of hepatitis B, C, or HIV or subjects with congenital or acquired immunodeficiencies.
✕. Participation in an investigational drug study (within 30 days of last administration from screening visit) or investigational medical device study (within 1 year of implant from screening visit) where investigational treatment (drug or device) is placed in rectum, vagina, or near fistula location, or that may potentially interact with study treatment.
✕. History (within previous 5 years of screening visit) of invasive cancer including melanoma (with the exception of localized skin cancers).
✕. Subjects pregnant, trying to become pregnant, or are breast feeding.
✕. Subjects with known allergies or hypersensitivity to aminoglycosides and contraindications to Magnetic Resonance (MR) evaluations and/or to MR contrast.
✕. History of clinically significant fat-directed autoimmunity.
✕. Genito-urinary fistulization, including rectovaginal (i.e., fistulae that transverse the vaginal canal).