BACKGROUND & AIMS
Gluten ingestion in celiac disease (CeD) patients can lead to gastrointestinal symptoms and small intestinal mucosal injury METHODS: This gluten-challenge (GC) Phase 2 trial was double-blind, placebo-controlled, and assessed the efficacy and safety of a 1,200 mg dose of IMGX003 in CeD patients exposed to 2 g of gluten per day for 6 weeks. The change in the ratio of villus height to crypt depth (Vh:Cd) was the primary endpoint. Secondary endpoints included densities of intraepithelial lymphocytes (IEL) and symptom severity. These endpoints were evaluated by ANCOVA. Additional endpoints included serology and gluten-immunogenic peptides (GIP) in urine RESULTS: Fifty (50) patients were randomized, and 43 patients completed (n=21 IMGX003, n=22 placebo). The mean ΔVh:Cd (primary endpoint) for IMGX003 vs. placebo was -0.04 vs. -0.35 (p = .057). The mean ΔIEL (secondary endpoint) for IMGX003 vs. placebo was 9.8 vs. 24.8 (p = .018). The mean change (worsening) in symptom severity (secondary endpoint) for IMGX003 vs. placebo was 0.22 vs. 1.63 (abdominal pain, p = .231), 0.96 vs. 3.29 (bloating, p = .204), and 0.02 vs. 3.20 (tiredness, p = .113). The 3 x 2-week trend-line significance for these symptoms, respectively, were p = .014, .030 and .002 CONCLUSION: IMGX003 reduced gluten-induced intestinal mucosal damage and symptom severity.
CLINICALTRIALS
gov number NCT03585478.