Obefazimod for Crohn's Disease

(ENHANCE-CD Trial)

Recruiting at 175 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Abivax S.A.

Must not be taking: Natalizumab, α4β1 integrin agonists

Disqualifiers: Ulcerative colitis, Malignancy, Hepatitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

212 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 4 6 7 8}

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

Able and willing to comply with study visits and procedures as per protocol

My Crohn's disease diagnosis was confirmed through endoscopy and biopsy.

Subject should be affiliated to a health insurance policy whenever required by a participating country or state

Exclusion Criteria

I have a history of torsade de pointes.

I am currently not institutionalized by court or administrative order.

I have been diagnosed with ulcerative colitis or indeterminate colitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive obefazimod or placebo to evaluate efficacy and safety in moderately to severely active Crohn's Disease

12 weeks

Maintenance

Continued treatment with obefazimod or placebo to assess long-term efficacy and safety

40 weeks

Extension

Evaluation of safety and tolerability of obefazimod compared with placebo

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Obefazimod

Trial Overview

The trial tests Obefazimod against a placebo over three phases: a 12-week Induction Phase, a 40-week Maintenance Phase, and a 48-week Extension Phase. It aims to see if Obefazimod is effective and safe as both an induction therapy and maintenance treatment for Crohn's Disease.

How Is the Trial Designed?

Group I: Obefazimod 50mg Experimental Treatment 1 Intervention

Obefazimod 50mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)

Group II: Obefazimod 25mg Experimental Treatment 1 Intervention

Obefazimod 25mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)

Group III: Obefazimod 12.5mg Experimental Treatment 1 Intervention

Obefazimod 12.5mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)

Group IV: Placebo Placebo Group 1 Intervention

Placebo given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)

Who Is Running the Clinical Trial?

Abivax S.A.

Lead Sponsor

Trials

22

Recruited

4,400+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06456593

NCT06456593 | Efficacy and Safety of Obefazimod in ...

Higher scores mean a worse outcome. Week 12 and week 52. Maintenance Phase Efficacy - Simple Endoscopic Score for Crohn's disease (SES-CD). Change from baseline ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40417999/

Obefazimod in patients with moderate-to-severely active ...

Clinical response was achieved at weeks 48 and 96 in 177 (81.6%) and 158 (72.8%) patients and clinical remission in 119 (54.8%) and 114 (52.5%) ...

3.

academic.oup.com

academic.oup.com/ecco-jcc/article/19/5/jjaf074/8149142

Obefazimod in patients with moderate-to-severely active ...

These findings suggest that long-term treatment with obefazimod provides continued improvement of clinical symptoms of the disease. Safety data ...

4.

ir.abivax.com

ir.abivax.com/news-releases/news-release-details/abivax-reports-positive-interim-efficacy-and-safety-analysis

Abivax Reports Positive Interim Efficacy and Safety Analysis of ...

At study baseline, 89% (116/130) of patients were in clinical remission. At weeks 48 and 96 of treatment, 84% (95/113) and 87% (64/74) of ...

5.

biospace.com

biospace.com/press-releases/abivax-announces-patient-reported-outcomes-data-from-the-phase-3-abtect-induction-trials-of-obefazimod-demonstrating-significant-improvements-in-quality-of-life-for-patients-with-moderate-to-severely-active-ulcerative-colitis

Abivax Announces Patient-Reported Outcomes Data ...

Improvements across all patient reported outcomes (PROs) were observed from baseline to Week 8 in all PRO instruments utilized in the ABTECT ...

6.

academic.oup.com

academic.oup.com/ecco-jcc/article/19/Supplement_1/i1554/7967848

P0813 Integrated summary of safety of obefazimod for patients ...

Obefazimod demonstrated efficacy and safety in patients with UC across 4 clinical studies: two placebo-controlled Phase 2 induction trials, and two subsequent ...

7.

ir.abivax.com

ir.abivax.com/news-releases/news-release-details/abivax-reports-two-year-efficacy-and-safety-data-obefazimod

Abivax reports two-year efficacy and safety data of obefazimod ...

Moreover, obefazimod also continues to show excellent safety and is well-tolerated by patients, which is important for its chronic, once-daily ...

8.

clinicaltrials.eu

clinicaltrials.eu/inn/obefazimod/

Obefazimod – Application in Therapy and Current ...

Obefazimod is a new drug being tested for treating moderately to severely active Crohn's disease. It is taken once daily with food, preferably in the morning.