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 trial examines a new treatment called DB-3Q for individuals with Perianal Fistulizing Crohn's Disease. The main goal is to determine if DB-3Q is safe and effective for treating this condition, which involves painful and draining fistulas (abnormal connections) near the anus. Participants will receive different doses of DB-3Q or a placebo to compare results. This trial suits those who have had Crohn's Disease for at least six months, experience actively draining perianal fistulas, and have tried other treatments without success.

As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial requires that your current Crohn's Disease medication be stable for at least 2 months before starting. This means you should not change the dose or how often you take it during that time.

Is there any evidence suggesting that DB-3Q is likely to be safe for humans?

A previous study tested DB-3Q for safety in people with perianal fistulizing Crohn's disease who did not respond well to other treatments. The goal was to determine if different doses were safe and effective. As this study is in an early phase, it focuses heavily on safety and side effects. Researchers carefully monitor how well participants tolerate DB-3Q.

While specific safety data is not available, the study's phase indicates that the treatment's safety is still being understood. Participants receive close monitoring for any unwanted side effects, which is standard in early-phase studies to ensure safety.

Overall, while DB-3Q is being tested for safety, the absence of detailed safety data means participants should discuss any concerns with trial coordinators or their healthcare providers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's Disease?

Unlike the standard treatments for Crohn's disease, which often involve oral medications like corticosteroids or immunosuppressants, DB-3Q is an innovative treatment delivered directly through injections or IV. Researchers are excited about DB-3Q because it utilizes a new delivery method, potentially offering more targeted action with fewer systemic side effects. Additionally, this direct delivery approach might lead to faster relief of symptoms, which is a big win for patients seeking quicker improvements in their condition.

What evidence suggests that DB-3Q might be an effective treatment for Perianal Fistulizing Crohn's Disease?

Research has shown that new treatments like DB-3Q, which participants in this trial may receive, could benefit people with Crohn's disease. One study found that more than half of the patients with Crohn's disease responded positively to this treatment. For those with complicated anal fistulas, combining this treatment with surgery proved effective in about 78.5% of cases. DB-3Q specifically targets anal fistulas, which are common and challenging to treat in Crohn’s patients. These early results suggest that DB-3Q might be a promising option for treating anal fistulas in Crohn's disease. ^{1 3 6 7 8}

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 30 mL direct injection Placebo Group 1 Intervention

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

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

Who Is Running the Clinical Trial?

Direct Biologics, LLC

Lead Sponsor

Trials

11

Recruited

1,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06918808

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing ... This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ...

2. columbiasurgery.org columbiasurgery.org/news/columbia-enrolls-nations-first-patient-direct-biologics-phase-2-clinical-trial-fistulizing

Columbia Enrolls Nation's First Patient in Direct Biologics' ... "This study aims to determine if this approach is a viable option to treat anal fistula in patients with Crohn's disease specifically." Crohn's disease is an ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8268494/

Effectiveness of Third-Class Biologic Treatment in Crohn's ... Conclusion: Third-class biological therapy was effective in more than half of the patients with CD. No differences in effectiveness were ...

4. sgo-iasgo.com sgo-iasgo.com/article/predictors-of-long-term-clinical-response-in-complex-perianal-fistulizing-crohn-s-disease-a-retrospective-study

Predictors of Long-Term Clinical Response in Complex ... Conclusion: Complete or partial response to combined biologic and surgical treatment was achieved in 78.5% of patients. Suprasphincteric fistula was a risk ...

5. directbiologics.com directbiologics.com/patients

Patients Perianal Fistulizing Crohn's Disease. A study of DB-3Q for patients with medically refractory perianal fistulizing Crohn's disease. Medically Refractory ...

6. clinconnect.io clinconnect.io/trials/NCT06918808

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing The goal is to see if different doses of DB-3Q are safe and effective for treating these fistulas in patients who have not had success with other treatments. To ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9775949/

Effectiveness and Safety Profiles of Biological Therapies in ... A total of 675 IBD patients were enrolled. A higher persistence rate was noted for UST and ADA in the first year (83.8% and 83.1%, respectively) ...

8. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.30.11.1276

Dose escalation of biologics in biologic-naive patients with ... Dose escalation of biologics may restore response in patients with Crohn's disease (CD) who experience inadequate response or loss of ...