Perianal Fistula Due to Crohn's Disease
DB-3Q for Adults With Perianal Fistulizing Crohn’s Disease
This randomized Phase 2 study is investigating the safety and efficacy of ascending DB-3Q doses, compared with placebo, in adults with actively draining perianal fistulas caused by Crohn’s disease.
Registry title: DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease
5 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–75 Years
- Treatment
- DB-3Q or Placebo
- Design
- Randomized · Quadruple
- Central study contact
- Executive Vice President, Clinical Affairs, MS1-800-791-1021clinicalaffairs@directbiologics.com
- Sponsor
- Direct Biologics, LLC
Research question
What are the safety and efficacy of ascending doses of DB-3Q for treating perianal fistulizing Crohn’s disease compared with placebo?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 75 who have had Crohn’s disease for at least six months.
- Participants must have one or two actively draining perianal fistulas, with one or two external openings.
- The study is looking for people who failed at least one listed medical therapy during the previous year.
- Participants must have failed a previous surgical intervention, be unsuitable for surgery, or be unwilling to undergo surgery for the fistula.
- A central radiologist must approve the screening pelvic magnetic resonance imaging (MRI) and confirm the study’s anatomical and imaging requirements.
Participation overview
What participation may involve
Participants receive a single assigned treatment using DB-3Q or saline placebo. Depending on the arm, this is a 15 mL or 30 mL direct injection, or a 15 mL intravenous dose plus a 30 mL direct injection. What participation may involve: - Receive the assigned DB-3Q or placebo treatment by direct injection, with some arms also receiving an intravenous dose. - Complete a screening pelvic magnetic resonance imaging (MRI) examination for central radiologist review. - Undergo clinical assessment of treated fistula openings and MRI assessment for the study outcomes at 12 and 24 weeks.
Study interventions
What participants may receive or do
- DB-3Q: DB-3Q is a frozen, cell-free liquid containing secreted proteins and extracellular vesicles isolated from human bone marrow mesenchymal stem cells. Study arms use a single direct injection, with one arm also using an intravenous dose.
- Placebo: The placebo is 0.9% sodium chloride solution. Placebo arms use a single direct injection, with one arm also using an intravenous dose.
Study design
How the comparison works
This is a randomized, placebo-controlled, sequential-cohort Phase 2 study testing ascending DB-3Q doses. The registry estimates enrollment of 36 participants. Participants are assigned at random to a DB-3Q or placebo arm; the registry does not report the assignment ratio. The participant, care provider, investigator, and outcome assessor are masked to treatment assignment. The comparison group receives placebo, described as 0.9% sodium chloride solution. Placebo may be given by direct injection alone or by intravenous administration plus direct injection, depending on the assigned arm.
Reported activities
Procedures and tests
- A screening pelvic magnetic resonance imaging (MRI) scan must be approved by a central radiologist.
- MRI is used to assess fistula anatomy, the MAGNIFI-CD imaging score, fistula length and composition, and the fibrosis-to-fluid ratio.
- Study treatment is administered by direct injection; one DB-3Q arm and one placebo arm also include intravenous administration.
- Clinical outcome assessment checks treated external fistula openings for closure, drainage, new fistulas, and abscesses.
- Blinded central MRI review evaluates changes in the MAGNIFI-CD score and fistula fibrosis-to-fluid ratio.
- Screening laboratory criteria include white blood cell count, hemoglobin, platelet count, liver enzymes, creatinine, clotting tests, and hemoglobin A1c.
- A documented negative urine or serum pregnancy test is required for women of childbearing potential.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must provide written informed consent.
- Participants must be ages 18 through 75 and have had Crohn’s disease for at least six months before Day 1.
- Participants must have one or two actively draining perianal fistulas, with one or two external openings.
- At least one medical therapy must have failed within the previous year.
- Participants must have failed previous fistula surgery, be unsuitable for surgery, or be unwilling to undergo surgery; qualifying seton placement must have occurred at least two weeks before screening.
- Crohn’s disease medical therapy must be stable for at least two months before Day 1, without dose or interval changes based on serum drug levels.
- Crohn’s disease antibiotics must be stable for at least two weeks, and oral corticosteroids must be no more than 20 mg/day prednisone equivalent and stable for at least four weeks before Day 1.
- Central MRI review must confirm one or two qualifying fistulas that meet the study’s anatomical and imaging thresholds.
Possible reasons someone may not be able to join
- Pregnancy, breastfeeding, or lack of a documented negative pregnancy test when of childbearing potential excludes participation.
- A participant unwilling to use medically acceptable contraception during the study is excluded.
- An active perianal abscess or infection at screening or Day 1 excludes participation.
- Confirmed human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection excludes participation.
- A coagulation disorder or current anticoagulant therapy excludes participation.
- A rectovaginal or anovaginal fistula, an ileal anal pouch, or a history of proctectomy excludes participation.
- Severe proctitis, defined in the registry as a Simple Endoscopic Score for Crohn’s Disease above 6, excludes participation.
- A condition that makes MRI evaluation unsafe or unsuitable, such as a nonremovable MRI-unsafe device or claustrophobia, excludes participation.
- Screening laboratory results outside the registry’s listed limits exclude participation.
- Use of an investigational therapy or treatment within 30 days before Day 1 excludes participation.
- Fistulas that communicate primarily with the rectum, are extrasphincteric, or fall outside the study’s MRI score and fibrosis thresholds are excluded.
Important unknowns
What the record does not make clear
- The registry does not provide the number, timing, or format of study visits.
- The outcomes are assessed at 12 and 24 weeks, but the registry does not state each participant’s total time in the study.
- The study is randomized and includes placebo arms, but the assignment ratio and chance of receiving placebo are not reported.
- The registry requires stable Crohn’s disease therapy before Day 1 but does not fully explain which treatments continue after treatment assignment.
- The registry does not describe treatment available if fistula symptoms worsen or an abscess develops.
- Severe proctitis measured by the Simple Endoscopic Score for Crohn’s Disease is an exclusion, but the registry does not state whether the study requires a new endoscopy.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report reimbursement or support for transportation, lodging, or meals.
- The registry does not describe access to DB-3Q after study participation.
- Five locations are listed as recruiting, but the registry does not identify which sequential dose cohort each site is currently enrolling.
- The registry lists laboratory thresholds, but some units and formatting should be confirmed with the study team before interpretation.
Before contacting the site
Questions for the study team
- Which sequential dose cohort is currently enrolling, and what treatment assignments are possible in that cohort?
- What is the chance of receiving placebo in the currently enrolling cohort?
- What is the complete visit schedule, including screening, treatment, MRI, and follow-up visits?
- Which current Crohn’s disease medicines, antibiotics, or corticosteroids must continue unchanged during the study?
- Is a new colonoscopy or other endoscopic examination needed to assess the severe-proctitis exclusion?
- What care is provided if fistula drainage worsens or a new infection or abscess develops?
- Which study-related costs are covered, and are compensation or travel assistance available?
- Can you confirm the units and cutoffs for all screening laboratory exclusions?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease and fistula disease on my current treatment?
- Would screening or participation require changes to my current biologic, immunomodulator, antibiotic, or corticosteroid treatment?
- What approved medical or surgical alternatives remain reasonable for my fistula, including seton management?
- Are MRI, injection, infection, bleeding, or abscess concerns especially important in my medical situation?
- How should my gastroenterology and colorectal-surgery teams coordinate with the research team if my symptoms or medicines change?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Direct Biologics, LLC
- Organization class
- Industry
- Organization study ID
- 3Q-PFCD-201
- Lead sponsor
- Direct Biologics, LLC
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Sequential
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Single dose DB-3Q 15 mL direct injection
Interventions: Biological: DB-3Q
Placebo Comparator
Single dose Placebo 15 mL direct injection
Interventions: Biological: Placebo
Experimental
Single dose DB-3Q 30 mL direct injection
Interventions: Biological: DB-3Q
Placebo Comparator
Single dose Placebo 30 mL direct injection
Interventions: Biological: Placebo
Experimental
Single dose DB-3Q 15 ml IV and DB-3Q 30 mL direct injection
Interventions: Biological: DB-3Q
Placebo Comparator
Single dose Placebo 15 ml IV and Placebo 30 mL direct injection
Interventions: Biological: Placebo
Interventions
Biological
DB-3Q
DB-3Q (IMP) is the frozen liquid formulation of acellular secretome proteins and extracellular vesicles isolated from human bmMSC and processed under current Good Manufacturing Process standards.
Biological
Placebo
0.9% NaCl
Eligibility
18 Years–75 Years
All
Not accepted
Inclusion criteria (10)
- Written informed consent from participantRegistry-derived · unreviewed
- Men and women 18-75 years of age with a diagnosis of Crohn's Disease for at least six months duration prior to Day 1Registry-derived · unreviewed
- One or two perianal fistula(s) with 1 or two external openings, that are actively drainingRegistry-derived · unreviewed
- 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)Registry-derived · unreviewed
- 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 fistulaRegistry-derived · unreviewed
- 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)Registry-derived · unreviewed
- Antibiotics for the treatment of CD (e.g., ciprofloxacin, metronidazole, or rifaximin) must have been stable for at least 2 weeks prior to Day 1Registry-derived · unreviewed
- Oral corticosteroids ≤ 20 mg/day prednisone or its equivalent and must have been stable for at least 4 weeks prior to Day 1Registry-derived · unreviewed
- Approval of a screening pelvic MRI by review of a central radiologist. The definition of an acceptable screening pelvic MRI is provided in the study imaging manual.Registry-derived · unreviewed
- Fulfillment of radiologic inclusion by a central radiologist. Radiologic inclusion on MRI is presence of 1 or 2 qualifying perianal fistula(s). Radiologic inclusion assesses anatomic criteria of a perianal fistula and study-defined imaging endpoint criteria. a. Anatomically, a qualifying perianal fistula on MRI fulfills the following from central radiologist assessment: i. has a communication with the internal sphincter of the anal canal ii. is classified as a Parks intersphincteric, transsphincteric, or suprasphincteric perianal fistula. b. For study imaging endpoints, a central radiologist confirms that a fistula has a minimum score of 7 (range 0 to 25) on MAGNIFI-CD and a fistula fibrosis -to-fluid ratio of less than 80%.25, 37 Within components of MAGNIFI-CD, the fistula has a length of 2.5 cm or greater and has a composition of either 'predominantly fluid/pus' or 'predominantly granulation tissue'. c. Within components of fistula fibrosis-to-fluid ratio, the ratio of hypointense scarring or fibrosis on MRI T2 weighted sequences to hyperintense fluid on MRI T2 weighted sequences is below 80%.25 The fistula is categorized into one of following ranges of fibrosis-to- fluid ratio: i) 0%, ii) 1-19%, iii) 20-39%, iv) 40-59%, or v) 60-79%Registry-derived · unreviewed
Exclusion criteria (24)
- Lack of informed consentRegistry-derived · unreviewed
- Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feedingRegistry-derived · unreviewed
- A participant who is unwilling to use medically acceptable contraception methods during participation in studyRegistry-derived · unreviewed
- Active perianal abscess or infection at screening or Day 1Registry-derived · unreviewed
- Clinically significant medical conditions within six months before Day 1 that would, in the opinion of the Investigator, compromise the safety of the participantRegistry-derived · unreviewed
- Confirmed HIV, Hepatitis B, or Hepatitis C infectionsRegistry-derived · unreviewed
- History of cancer including melanoma (with the exception of localized non-melanoma skin cancers) within one year of screeningRegistry-derived · unreviewed
- History of colorectal cancer within 2 years of screeningRegistry-derived · unreviewed
- History of coagulation disorders and/or are currently on anti- coagulant therapyRegistry-derived · unreviewed
- Presence of a recto/ano-vaginal fistulaRegistry-derived · unreviewed
- Presence of an ileal anal pouch and/or history of proctectomyRegistry-derived · unreviewed
- Presence of severe proctitis (SES CD \>6)Registry-derived · unreviewed
- Any condition which, in the opinion of the Investigator, would make it unsafe or unsuitable for participant to undergo MRI evaluations (i.e., presence of implantable or external MRI unsafe device that cannot be removed, body weight exceeding limitations, claustrophobia, etc.)Registry-derived · unreviewed
- The following out of range laboratory results at screeningRegistry-derived · unreviewed
- WBC \> 13 x 109 /LRegistry-derived · unreviewed
- Hemoglobin \< 8 g/dLRegistry-derived · unreviewed
- Platelet count \< 100,000/mLRegistry-derived · unreviewed
- AST/ALT \> 3 times the upper limit of normalRegistry-derived · unreviewed
- Creatinine \> 2 μmol/LRegistry-derived · unreviewed
- PT/INR: 2 times the upper limit of normalRegistry-derived · unreviewed
- Hemoglobin A1c \> 6.5 mg/dLRegistry-derived · unreviewed
- Use of investigational therapy or treatment within 30 days prior to Day 1Registry-derived · unreviewed
- Does not meet the radiologic anatomic inclusion criteria: i) has a primary communication with the rectum and not the anal canal; ii) is classified as a Parks extrasphincteric fistulaRegistry-derived · unreviewed
- Does not meet the minimum thresholds for the radiologic imaging endpoint inclusion criteria: i) has a MAGNIFI-CD score of \<7 (range 0-6) on screening pelvic MRI; ii) has a fibrosis-to-fluid ratio of 80% or more (range 80-100%) on screening pelvic MRIRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Combined Remission
Time frame: 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
Combined Remission
Time frame: 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.
Recruiting locations in the United States
Direct Biologics Investigational Site
RecruitingAurora, Colorado, 80045, United States
Direct Biologics Investigational Site
RecruitingSt Louis, Missouri, 63130, United States
Columbia University Irving Medical Center/NYPH
RecruitingNew York, New York, 10032, United States
Claudia Musatcm2065@cumc.columbia.edu
Direct Biologics Investigational Site
RecruitingPhiladelphia, Pennsylvania, 19104, United States
Direct Biologics Investigational Site
RecruitingNashville, Tennessee, 37232, United States
Central study contacts
Executive Vice President, Clinical Affairs, MS
Contact
Registry dates
- First posted
- Apr 9, 2025
- Primary completion
- Jul 30, 2027
- Overall completion
- Dec 31, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.