Matches in SemOpenAlex for { <https://semopenalex.org/work/W4289444310> ?p ?o ?g. }
- W4289444310 endingPage "1521.e6" @default.
- W4289444310 startingPage "1510" @default.
- W4289444310 abstract "Background & AimsGluten ingestion in patients with celiac disease can lead to gastrointestinal symptoms and small intestinal mucosal injury.MethodsThis gluten challenge phase 2 trial was double blind and placebo controlled, and it assessed the efficacy and safety of a 1200-mg dose of IMGX003 in patients with celiac disease exposed to 2 g of gluten per day for 6 weeks. The change in the ratio of villus height to crypt depth was the primary endpoint. Secondary endpoints included density of intraepithelial lymphocytes and symptom severity. These endpoints were evaluated by analysis of covariance. Additional endpoints included serology and gluten-immunogenic peptides in urine.ResultsFifty patients were randomized, and 43 patients completed the study (IMGX003, n = 21; placebo, n = 22). The mean change in the ratio of villus height to crypt depth (primary endpoint) for IMGX003 vs placebo was –0.04 vs –0.35 (P = .057). The mean change in the density of intraepithelial lymphocytes (secondary endpoint) for IMGX003 vs placebo was 9.8 vs 24.8 cells/mm epithelium (P = .018). The mean change (worsening) in symptom severity in relative units (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 × 2-week trend line significance values for these symptoms, respectively, were P = .014, .030, and .002.ConclusionsIMGX003 reduced gluten-induced intestinal mucosal damage and symptom severity. (ClinicalTrials.gov, Number: NCT03585478) Gluten ingestion in patients with celiac disease can lead to gastrointestinal symptoms and small intestinal mucosal injury. This gluten challenge phase 2 trial was double blind and placebo controlled, and it assessed the efficacy and safety of a 1200-mg dose of IMGX003 in patients with celiac disease exposed to 2 g of gluten per day for 6 weeks. The change in the ratio of villus height to crypt depth was the primary endpoint. Secondary endpoints included density of intraepithelial lymphocytes and symptom severity. These endpoints were evaluated by analysis of covariance. Additional endpoints included serology and gluten-immunogenic peptides in urine. Fifty patients were randomized, and 43 patients completed the study (IMGX003, n = 21; placebo, n = 22). The mean change in the ratio of villus height to crypt depth (primary endpoint) for IMGX003 vs placebo was –0.04 vs –0.35 (P = .057). The mean change in the density of intraepithelial lymphocytes (secondary endpoint) for IMGX003 vs placebo was 9.8 vs 24.8 cells/mm epithelium (P = .018). The mean change (worsening) in symptom severity in relative units (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 × 2-week trend line significance values for these symptoms, respectively, were P = .014, .030, and .002. IMGX003 reduced gluten-induced intestinal mucosal damage and symptom severity. (ClinicalTrials.gov, Number: NCT03585478)" @default.
- W4289444310 created "2022-08-02" @default.
- W4289444310 creator A5004920167 @default.
- W4289444310 creator A5015158610 @default.
- W4289444310 creator A5028074536 @default.
- W4289444310 creator A5038399044 @default.
- W4289444310 creator A5047373886 @default.
- W4289444310 creator A5050982279 @default.
- W4289444310 creator A5054931107 @default.
- W4289444310 creator A5057084111 @default.
- W4289444310 creator A5076040523 @default.
- W4289444310 creator A5076659587 @default.
- W4289444310 creator A5078060473 @default.
- W4289444310 creator A5078984714 @default.
- W4289444310 creator A5079910350 @default.
- W4289444310 creator A5082265798 @default.
- W4289444310 date "2022-12-01" @default.
- W4289444310 modified "2023-10-10" @default.
- W4289444310 title "Latiglutenase Protects the Mucosa and Attenuates Symptom Severity in Patients With Celiac Disease Exposed to a Gluten Challenge" @default.
- W4289444310 cites W1531267945 @default.
- W4289444310 cites W1544004437 @default.
- W4289444310 cites W1992198528 @default.
- W4289444310 cites W2015753971 @default.
- W4289444310 cites W2034141008 @default.
- W4289444310 cites W2034235107 @default.
- W4289444310 cites W2036798664 @default.
- W4289444310 cites W2037244637 @default.
- W4289444310 cites W2039229476 @default.
- W4289444310 cites W2059270897 @default.
- W4289444310 cites W2095360455 @default.
- W4289444310 cites W2097463067 @default.
- W4289444310 cites W2129504431 @default.
- W4289444310 cites W2148551386 @default.
- W4289444310 cites W2162876267 @default.
- W4289444310 cites W2165428460 @default.
- W4289444310 cites W2203036197 @default.
- W4289444310 cites W2464790419 @default.
- W4289444310 cites W2555924858 @default.
- W4289444310 cites W2741991215 @default.
- W4289444310 cites W2756086142 @default.
- W4289444310 cites W2790164824 @default.
- W4289444310 cites W2793797392 @default.
- W4289444310 cites W2934657065 @default.
- W4289444310 cites W2971540436 @default.
- W4289444310 cites W2980268811 @default.
- W4289444310 cites W2989243993 @default.
- W4289444310 cites W2999703451 @default.
- W4289444310 cites W3175190885 @default.
- W4289444310 cites W3184072560 @default.
- W4289444310 cites W4221072522 @default.
- W4289444310 cites W4251897673 @default.
- W4289444310 doi "https://doi.org/10.1053/j.gastro.2022.07.071" @default.
- W4289444310 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/35931103" @default.
- W4289444310 hasPublicationYear "2022" @default.
- W4289444310 type Work @default.
- W4289444310 citedByCount "10" @default.
- W4289444310 countsByYear W42894443102023 @default.
- W4289444310 crossrefType "journal-article" @default.
- W4289444310 hasAuthorship W4289444310A5004920167 @default.
- W4289444310 hasAuthorship W4289444310A5015158610 @default.
- W4289444310 hasAuthorship W4289444310A5028074536 @default.
- W4289444310 hasAuthorship W4289444310A5038399044 @default.
- W4289444310 hasAuthorship W4289444310A5047373886 @default.
- W4289444310 hasAuthorship W4289444310A5050982279 @default.
- W4289444310 hasAuthorship W4289444310A5054931107 @default.
- W4289444310 hasAuthorship W4289444310A5057084111 @default.
- W4289444310 hasAuthorship W4289444310A5076040523 @default.
- W4289444310 hasAuthorship W4289444310A5076659587 @default.
- W4289444310 hasAuthorship W4289444310A5078060473 @default.
- W4289444310 hasAuthorship W4289444310A5078984714 @default.
- W4289444310 hasAuthorship W4289444310A5079910350 @default.
- W4289444310 hasAuthorship W4289444310A5082265798 @default.
- W4289444310 hasBestOaLocation W42894443101 @default.
- W4289444310 hasConcept C126322002 @default.
- W4289444310 hasConcept C142724271 @default.
- W4289444310 hasConcept C152605822 @default.
- W4289444310 hasConcept C168563851 @default.
- W4289444310 hasConcept C193230392 @default.
- W4289444310 hasConcept C203014093 @default.
- W4289444310 hasConcept C203092338 @default.
- W4289444310 hasConcept C204787440 @default.
- W4289444310 hasConcept C27081682 @default.
- W4289444310 hasConcept C2776336767 @default.
- W4289444310 hasConcept C2776956441 @default.
- W4289444310 hasConcept C2778271842 @default.
- W4289444310 hasConcept C2779134260 @default.
- W4289444310 hasConcept C2780955771 @default.
- W4289444310 hasConcept C3019118998 @default.
- W4289444310 hasConcept C71924100 @default.
- W4289444310 hasConcept C8891405 @default.
- W4289444310 hasConcept C90924648 @default.
- W4289444310 hasConceptScore W4289444310C126322002 @default.
- W4289444310 hasConceptScore W4289444310C142724271 @default.
- W4289444310 hasConceptScore W4289444310C152605822 @default.
- W4289444310 hasConceptScore W4289444310C168563851 @default.
- W4289444310 hasConceptScore W4289444310C193230392 @default.
- W4289444310 hasConceptScore W4289444310C203014093 @default.
- W4289444310 hasConceptScore W4289444310C203092338 @default.