DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDirect Biologics, LLC
About this trial
This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing Crohn's Disease.
Eligibility criteria
Qualifiers
Written informed consent from participant
Men and women 18-75 years of age with a diagnosis of Crohn's Disease for at least six months duration prior to Day 1
One or two perianal fistula(s) with 1 or two external openings, that are actively draining
Failed at least one medical therapy within the last year including, but not limited to, antibiotics, immunomodulators (6-MP, methotrexate, azathioprine), monoclonal antibodies (adalimumab, certolizumab, golimumab, guselkumab, infliximab, risankizumab, ustekinumab, vedolizumab), or small molecule inhibitors (tofacitinib, upadacitinib)
Disqualifiers
Lack of informed consent
Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding
A participant who is unwilling to use medically acceptable contraception methods during participation in study
Active perianal abscess or infection at screening or Day 1
Trial design
Treatments tested in this trial
- DB-3Q
- Placebo
Treatment groups
36 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov