Obefazimod for Crohn's Disease
(ENHANCE-CD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, obefazimod, for individuals with Crohn's disease who have not found success with other therapies. The study compares different doses of obefazimod to a placebo to evaluate the drug's effectiveness and safety over several months. It seeks volunteers with moderately to severely active Crohn's who have tried but did not respond well to treatments like steroids or biologics. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important findings.
Will I have to stop taking my current medications?
The trial protocol mentions a 'washout period' (time without taking certain medications) that must be met before the screening endoscopy, but it does not specify which medications are affected. It's best to discuss your current medications with the study team to understand if any changes are needed.
Is there any evidence suggesting that obefazimod is likely to be safe for humans?
Research has shown that obefazimod was safe in previous studies. In trials involving people with ulcerative colitis (UC), the treatment was well-tolerated and did not cause major side effects. Two studies comparing obefazimod to a placebo, along with other long-term research, found it safe over time. This is encouraging for those considering joining clinical trials for Crohn's disease, as it suggests the treatment is generally safe and does not lead to serious side effects.12345
Why do researchers think this study treatment might be promising for Crohn's disease?
Most treatments for Crohn's disease, like biologics and immunosuppressants, aim to reduce inflammation by targeting the immune system. However, Obefazimod stands out because it uses a different approach by selectively modulating the immune response. This novel mechanism may lead to fewer side effects compared to traditional therapies and provides a promising alternative for those who haven't responded well to existing treatments. Researchers are particularly excited about Obefazimod because it's being tested at different dosages, which could offer flexibility in tailoring treatment to individual patient needs.
What evidence suggests that obefazimod might be an effective treatment for Crohn's disease?
Research shows that obefazimod has promising results for treating Crohn's disease. One study found that 81.6% of patients saw an improvement in their symptoms by week 48, and 72.8% continued to feel better by week 96. Additionally, 54.8% of patients experienced a significant reduction or disappearance of symptoms by week 48, with 52.5% maintaining this improvement by week 96. These results suggest that obefazimod can help improve symptoms over a long time. Furthermore, studies report that patients felt better overall during treatment.14678
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with moderately to severely active Crohn's Disease who haven't responded well to conventional or advanced therapies. Participants must understand the study, agree to use contraception if necessary, and be willing to follow sun protection advice and study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive obefazimod or placebo to evaluate efficacy and safety in moderately to severely active Crohn's Disease
Maintenance
Continued treatment with obefazimod or placebo to assess long-term efficacy and safety
Extension
Evaluation of safety and tolerability of obefazimod compared with placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Obefazimod
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abivax S.A.
Lead Sponsor