Obefazimod for Crohn's Disease

(ENHANCE-CD Trial)

Recruiting at140 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Abivax S.A.

Must not be taking: Natalizumab, α4β1 integrin agonists

Disqualifiers: Ulcerative colitis, Malignancy, Hepatitis, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study has 3 treatment phases, a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase. The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies. The primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared with placebo in subjects who are enrolled in the Extension Phase.

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.

Research Team

Eligibility Criteria

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 am not pregnant, breastfeeding, nor planning to become pregnant; my partner is also not planning to become pregnant.

Trial Timeline

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

Treatment Details

Interventions

• Obefazimod (Sphingosine-1-phosphate receptor modulator)

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.

Participant Groups

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+