DB-3Q for Crohn's Disease
EV
Overseen ByExecutive Vice President, Clinical Affairs, MS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Direct Biologics, LLC
Prior Safety DataThis treatment has passed at least one previous human trial
What You Need to Know Before You Apply
What is the purpose of 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.
Are You a Good Fit for This Trial?
This trial is for individuals with Perianal Fistulizing Crohn's Disease who have tried and failed at least one medical therapy in the past year, including antibiotics or monoclonal antibodies. Participants must have stable medical therapy for Crohn's Disease for two months prior to starting the trial, one or two actively draining perianal fistulas, and either a history of unsuccessful surgery or are not candidates/willing to undergo surgery.Inclusion Criteria
I have signed the consent form.
My Crohn's disease treatment has been stable for at least 2 months.
I have 1 or 2 actively draining perianal fistulas.
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Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a single dose of DB-3Q or placebo for the treatment of Perianal Fistulizing Crohn's Disease
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
What Are the Treatments Tested in This Trial?
Interventions
- DB-3Q
Trial Overview The study tests DB-3Q versus a placebo in treating Perianal Fistulizing Crohn's Disease. It’s double-blind (neither doctors nor patients know who gets what), randomized (assigned by chance), placebo-controlled (compared with inactive substance), and doses increase over time to find both safety and effectiveness.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Single dose DB-3Q 30 mL direct injectionExperimental Treatment1 Intervention
Group II: Single dose DB-3Q 15 ml IV and DB-3Q 30 mL direct injectionExperimental Treatment1 Intervention
Group III: Single dose DB-3Q 15 mL direct injectionExperimental Treatment1 Intervention
Group IV: Single dose Placebo 15 ml IV and Placebo 30 mL direct injectionPlacebo Group1 Intervention
Group V: Single dose Placebo 15 mL direct injectionPlacebo Group1 Intervention
Group VI: Single dose Placebo 30 mL direct injectionPlacebo Group1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Direct Biologics, LLC
Lead Sponsor
Trials
11
Recruited
1,100+
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