NCT06456593Phase 2Recruiting

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-12Estimated

Enrollment · participants212Estimated

Source updated2026-04-27Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Moderately to Severely Active Crohn Disease

Treatments or interventions studied

ObefazimodDrug

Primary outcomes · main study measures

Read the study measures

measure: Induction and maintenance Phase Efficacy- Crohn's Disease Activity Index (CDAI); description: 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.; timeFrame: Week 12 and week 52; measure: Maintenance Phase Efficacy - Simple Endoscopic Score for Crohn's disease (SES-CD); description: 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; timeFrame: Week 52; measure: Maintenance Phase Efficacy - Endoscopic response; description: Proportion of subjects with endoscopic response at Week 52; timeFrame: Week 52; measure: Maintenance Phase Efficacy - SES-CD ulcer subscore > 1; description: Proportion of subjects with no SES-CD ulcer subscore \> 1 in at least one segment at Week 52; timeFrame: Week 52; measure: Maintenance Phase Efficacy - CDAI clinical remission; description: Proportion of subjects with CDAI clinical remission at Week 52 Proportion of subjects with sustained CDAI clinical remission at Week 52; timeFrame: Week 52; measure: Maintenance Phase Efficacy - PRO-2 clinical remission; description: Proportion of subjects with patient reported outcome (PRO)-2 clinical remission at Week 52; timeFrame: Week 52; measure: Maintenance Phase Efficacy - CDAI clinical response; description: Proportion of subjects with CDAI clinical response (CDAI decrease from baseline ≥ 100 points) at Week 52; timeFrame: Week 52; measure: Maintenance Phase Efficacy - PRO-2 clinical response; description: Proportion of subjects with PRO-2 clinical response (≥ 30% decrease in average daily PRO-2 score (AP + SF) and both no higher than baseline) at Week 52; timeFrame: Week 52; measure: Maintenance Phase Efficacy - CDAI clinical response and endoscopic response; description: Proportion of subjects with CDAI clinical response and endoscopic response at Week 52; timeFrame: Week 52; measure: Maintenance Phase Efficacy - endoscopic remission; description: Proportion of subjects with endoscopic remission at Week 52; timeFrame: Week 52; measure: Extension Phase Safety- Adverse events; description: Incidence of all treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and causally related TEAEs/SAEs Incidence of adverse events (AEs) leading to discontinuation; timeFrame: Weeks 64, 76, 88,100 and EOS; measure: Extension Phase Safety - Hematology and coagulation; description: Number of patients with clinically-significant abnormal laboratory parameters. Hematology: Hematocrit, hemoglobin, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, mean corpuscular volume, platelet count, red blood cells; white blood cells Coagulation: International normalized ratio, activated partial thromboplastin time, fibrinogen, prothrombin time; timeFrame: Weeks 64, 76, 88,100 and EOS; measure: Extension Phase Safety - Biochemistry; description: Number of patients with clinically-significant abnormal laboratory parameters. Albumin, total protein, aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), total bilirubin, gamma glutamyl transferase (GGT), lactate dehydrogenase (LDH), lipase, amylase, creatinine, creatinine clearance, urea, chloride, bicarbonate, sodium, potassium, calcium, phosphate, uric acid, glucose, total cholesterol, LDL cholesterol (direct), HDL cholesterol, triglycerides, creatine phosphokinase (CPK), high sensitivity troponin I and T, N-terminal prohormone of brain natriuretic peptide (NT-proBNP); timeFrame: Weeks 64, 76, 88,100 and EOS

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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