Perianal Fistula Due to Crohn's Disease study: DB-3Q
Official title DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease
ClinicalTrials.gov ID: NCT06918808
What this study is testing
What is DB-3Q?
DB-3Q is an investigational frozen liquid formulation being studied for the treatment of perianal fistulas in Crohn's disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if DB‑3Q is safe and can help close perianal fistulas in people with Crohn’s disease.
- Who it's for
- Adults who have perianal fistulas caused by Crohn’s disease.
- What's involved
- Participants will receive either DB‑3Q or a placebo in a double‑blind, randomized setting, with visits and tests to monitor safety and fistula healing.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Previous failed surgical intervention, including seton placement at least two weeks prior to screening, or are not candidates for surgical...
You likely can't join if
- 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
- Clinically significant medical conditions within six months before Day 1 that would, in the opinion of the Investigator, compromise the safety of the...
- Confirmed HIV, Hepatitis B, or Hepatitis C infections
See the full eligibility criteria
- 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...
- 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...
- 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)
- Antibiotics for the treatment of CD (e.g., ciprofloxacin, metronidazole, or rifaximin) must have been stable for at least 2 weeks prior to Day 1
- Oral corticosteroids ≤ 20 mg/day prednisone or its equivalent and must have been stable for at least 4 weeks prior to Day 1
- 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.
- Fulfillment of radiologic inclusion by a central radiologist. Radiologic inclusion on MRI is presence of 1 or 2 qualifying perianal fistula(s).
- 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
- Clinically significant medical conditions within six months before Day 1 that would, in the opinion of the Investigator, compromise the safety of the participant
- Confirmed HIV, Hepatitis B, or Hepatitis C infections
- History of cancer including melanoma (with the exception of localized non-melanoma skin cancers) within one year of screening
- History of colorectal cancer within 2 years of screening
- History of coagulation disorders and/or are currently on anti- coagulant therapy
- Presence of a recto/ano-vaginal fistula
- Presence of an ileal anal pouch and/or history of proctectomy
- Presence of severe proctitis (SES CD \>6)
- 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...
- The following out of range laboratory results at screening
- WBC \> 13 x 109 /L
- Hemoglobin \< 8 g/dL
- Platelet count \< 100,000/mL
- AST/ALT \> 3 times the upper limit of normal
- Creatinine \> 2 μmol/L
- PT/INR: 2 times the upper limit of normal
- Hemoglobin A1c \> 6.5 mg/dL
- Use of investigational therapy or treatment within 30 days prior to Day 1
- 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 fistula
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States; St Louis, Missouri, United States; New York, New York, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.