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Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease

ConditionModerately to Severely Active Crohn Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAbivax S.A.

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female (at birth) 18 to 75 years old and able to understand, sign, and date the written voluntary informed consent at the visit prior to any protocol-specified procedures

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

Confirmed and documented diagnosis of CD based on endoscopy and histology reports.

Moderately to severely active CD as defined by 220 ≤ CDAI ≤ 450 and SES-CD ≥ 6 for ileo-colonic or colonic disease or SES-CD ≥ 4 for isolated ileal disease (per central reading).

Disqualifiers

WOCBP subject who is pregnant or breast-feeding at screening, or intends to become pregnant during the study; or male subject with WOCBP partner who intends to be pregnant during the study.

Current diagnosis of ulcerative colitis (UC) or indeterminate colitis

CD without ileal and/or colonic involvement

Untreated active external or perianal fistula or abscess. Stable fistula without abscess and with minimal or low drainage may be enrolled. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before screening colonoscopy or 8 weeks before screening colonoscopy for intra-abdominal abscesses, if no additional surgery is anticipated.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Obefazimod

    Drug

    Obefazimod is administered once-daily in fed condition (ideally at the same time in the morning).

  • Placebo

    Other intervention

    Matching placebo will be administered QD in fed condition (ideally at the same time in the morning).

Treatment groups

212 Participants
are divided into 4 treatment groups
Group A: Obefazimod 50mgExperimental treatment 1 intervention
Group B: Obefazimod 25mgExperimental treatment 1 intervention
Group C: Obefazimod 12.5mgExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Induction and maintenance Phase Efficacy- Crohn's Disease Activity Index (CDAI)

Change from baseline in Crohn's Disease Activity Index (CDAI) score at Week 12 and Week 52 The CDAI total score ranges from 0 to over 600. Higher scores mean a worse outcome.

Time frame
Week 12 and week 52
2

Maintenance Phase Efficacy - Simple Endoscopic Score for Crohn's disease (SES-CD)

Change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at Week 52 The SES-CD is an endoscopic grading system that consists of a composite score based on 4 components: the size of mucosal ulcers, the extent of the ulcerated surface, the endoscopic extension, and the presence of stenosis (26). Each of the 4 SES-CD components are assessed in the 5 segments of the ileum and colon: ileum, right, transverse, left, and rectum. The SES-CD is the sum of the individual scores of each of the components across the 5 segments. The total score ranges from 0 to 60. Higher scores mean a worse outcome

Time frame
Week 52
3

Maintenance Phase Efficacy - Endoscopic response

Proportion of subjects with endoscopic response at Week 52

Time frame
Week 52
4

Maintenance Phase Efficacy - SES-CD ulcer subscore > 1

Proportion of subjects with no SES-CD ulcer subscore \> 1 in at least one segment at Week 52

Time frame
Week 52

Secondary outcomes

1

Induction Phase Efficacy - SES-CD

Change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at Week 12

Time frame
Week 12
2

Induction Phase Efficacy - Endoscopic response

Proportion of subjects with endoscopic response at Week 12

Time frame
Week 12
3

Induction Phase Efficacy-SES-CD ulcer subscore > 1

Proportion of subjects with no SES-CD ulcer subscore \> 1 in at least one segment at Week 12

Time frame
Week 12
4

Induction Phase Efficacy-CDAI clinical remission

Proportion of subjects with Crohn's Disease Activity Index (CDAI) clinical remission (CDAI score \< 150) at Week 12 The total CDAI score ranges from 0 to over 600. Higher scores mean a worse outcome

Time frame
Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abivax S.A.

Lead sponsor

Source ClinicalTrials.gov
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