Obefazimod for Moderately to Severely Active Crohn's Disease
This study is looking at a medication called obefazimod for people with moderately to severely active Crohn's disease. You might be able to join if your Crohn's hasn't responded well to other treatments. Researchers want to see if obefazimod is safe and effective compared to a placebo (an inactive substance). They will measure how well the treatment works by looking at your Crohn's Disease Activity Index (CDAI) at 12 weeks and 52 weeks, and also by checking your endoscopy results at 52 weeks. The study is currently unclear on its recruitment status. Participants will be between 18 and 75 years old.
- Study design
- This interventional study plans to enroll 212 participants. It has three treatment phases: a 12-week induction, a 40-week maintenance, and a 48-week extension phase.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures outcomes at Week 12 and Week 52, suggesting follow-up for at least 52 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease
At a glance
Conditions
Where it's being run
149 sites across 29 statesWho to contact
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What this trial measures
- Induction and maintenance Phase Efficacy- Crohn's Disease Activity Index (CDAI)Week 12 and week 52
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.
- Maintenance Phase Efficacy - Simple Endoscopic Score for Crohn's disease (SES-CD)Week 52
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
- Maintenance Phase Efficacy - Endoscopic responseWeek 52
Proportion of subjects with endoscopic response at Week 52
- Maintenance Phase Efficacy - SES-CD ulcer subscore > 1Week 52
Proportion of subjects with no SES-CD ulcer subscore \> 1 in at least one segment at Week 52
- Maintenance Phase Efficacy - CDAI clinical remissionWeek 52
Proportion of subjects with CDAI clinical remission at Week 52 Proportion of subjects with sustained CDAI clinical remission at Week 52
- Maintenance Phase Efficacy - PRO-2 clinical remissionWeek 52
Proportion of subjects with patient reported outcome (PRO)-2 clinical remission at Week 52
- Maintenance Phase Efficacy - CDAI clinical responseWeek 52
Proportion of subjects with CDAI clinical response (CDAI decrease from baseline ≥ 100 points) at Week 52
- Maintenance Phase Efficacy - PRO-2 clinical responseWeek 52
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
- Maintenance Phase Efficacy - CDAI clinical response and endoscopic responseWeek 52
Proportion of subjects with CDAI clinical response and endoscopic response at Week 52
- Maintenance Phase Efficacy - endoscopic remissionWeek 52
Proportion of subjects with endoscopic remission at Week 52
- Extension Phase Safety- Adverse eventsWeeks 64, 76, 88,100 and EOS
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
- Extension Phase Safety - Hematology and coagulationWeeks 64, 76, 88,100 and EOS
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
- Extension Phase Safety - BiochemistryWeeks 64, 76, 88,100 and EOS
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)