DB-3Q for Crohn's Disease

Overseen By Executive Vice President, Clinical Affairs, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Direct Biologics, LLC

Must not be taking: Investigational therapy

Disqualifiers: Pregnancy, HIV, Hepatitis, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

36 Participants Needed

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.

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?

Group I: Single dose DB-3Q 30 mL direct injection Experimental Treatment 1 Intervention

Group II: Single dose DB-3Q 15 ml IV and DB-3Q 30 mL direct injection Experimental Treatment 1 Intervention

Group III: Single dose DB-3Q 15 mL direct injection Experimental Treatment 1 Intervention

Group IV: Single dose Placebo 15 ml IV and Placebo 30 mL direct injection Placebo Group 1 Intervention

Group V: Single dose Placebo 15 mL direct injection Placebo Group 1 Intervention

Group VI: Single dose Placebo 30 mL direct injection Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Direct Biologics, LLC

Lead Sponsor

Trials

11

Recruited

1,100+