DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Phase 2

Recruiting

• Conditions: Perianal Fistula Due to Crohn's Disease
• Interventions: Biological: DB-3Q; Biological: Placebo

• Registration Number: NCT06918808
• Lead Sponsor: Direct Biologics, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Study First Posted: 2025-04-09
• Status Verified: 2025-05
• Study Start: 2025-05-19
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-15
• Primary Completion: 2026-04-30
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Written informed consent from participant
2. 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
3. Single and/or multi-tract perianal fistula(s) with 2 or fewer openings, that are actively draining
4. 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)
5. Previous failed surgical intervention, including seton placement at least two weeks prior to screening, or are not candidates for surgical intervention or are not willing to undergo surgical intervention for the management of their fistula
6. Medical therapy for CD stable for at least 2 months prior to Day 1 (Changes in dosing or dosing intervals related to serum drug levels are not permitted)

Exclusion Criteria

1. Lack of informed consent
2. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding
3. A participant who is unwilling to use medically acceptable contraception methods during participation in study
4. Active perianal abscess or infection at screening or Day 1
5. Clinically significant medical conditions within six months before Day 1 that would, in the opinion of the Investigator, compromise the safety of the participant
6. Confirmed HIV, Hepatitis B, or Hepatitis C infections
7. History of cancer including melanoma (with the exception of localized non-melanoma skin cancers) within one year of screening
8. History of colorectal cancer within 2 years of screening
9. Use of investigational therapy or treatment within 30 days prior to Day 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single dose DB-3Q 15 mL direct injection	DB-3Q	-
Single dose Placebo 15 mL direct injection	Placebo	-
Single dose DB-3Q 30 mL direct injection	DB-3Q	-
Single dose Placebo 15 ml IV and Placebo 30 mL direct injection	Placebo	-
Single dose Placebo 30 mL direct injection	Placebo	-
Single dose DB-3Q 15 ml IV and DB-3Q 30 mL direct injection	DB-3Q	-

Primary Outcome Measures

Name	Time	Method
Combined Remission	24 Weeks	Clinically confirmed 100% closure of all treated external openings, without development of new fistulas or abscesses and drainage \> 1 cm by the external openings, occurring spontaneously or after gentle finger compression; and on blinded central review of the MRI results, combined imaging endpoint of \>50% reduction in MAGNIFI-CD score and \>20% increase in perianal fistula fibrosis-to-fluid ratio.

Secondary Outcome Measures

Name	Time	Method
Combined Remission	12 Weeks	Clinically confirmed 100% closure of all treated external openings, without development of new fistulas or abscesses and drainage \> 1 cm by the external openings, occurring spontaneously or after gentle finger compression; and on blinded central review of the MRI results, combined imaging endpoint of \>50% reduction in MAGNIFI-CD score and \>20% increase in perianal fistula fibrosis-to-fluid ratio.

Trial Locations

Locations (1)

Columbia University Irving Medical Center/NYPH; 🇺🇸 New York, New York, United States