{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T03:05:58Z","timestamp":1789182358943,"version":"build-2803163510"},"reference-count":22,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T00:00:00Z","timestamp":1785196800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T00:00:00Z","timestamp":1785196800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Coeliac disease is due to an acquired, lifelong gluten\u2010specific immune response resulting in a gluten\u2010dependent chronic immune\u2010mediated enteropathy associated with gastrointestinal and extraintestinal morbidity. Strictly avoiding dietary gluten is the only available management but has never been subjected to rigorous efficacy assessment now required for a pharmaceutical agent. Gluten\u2010free diet (GFD) is partially and inconsistently effective, but it places a high burden on patients, families, the food industry, and regulators and is defined inconsistently around the world, highlighting the need for effective and convenient adjunctive pharmacological therapies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To summarize key patient, scientific, and regulatory considerations for coeliac disease drug development based on a multi\u2010stakeholder meeting focused on accelerating clinical trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A pre\u2010competitive meeting convened by the Beyond Celiac Coalition (May 2024) included patients with coeliac disease, academic experts, pharmaceutical industry representatives, and participants from the US Food and Drug Administration. Moderated panel addressed patient priorities, symptom and histologic endpoints, biopsy and histology methods, gluten challenge design, clinical trial duration, and regulatory expectations. Themes were synthesized qualitatively with focus on trial design implications and unresolved questions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Participants described high symptom burden and psychosocial impact despite gluten\u2010free diet adherence underscoring unmet therapeutic need in coeliac disease. Regulatory perspectives emphasized the need for clinically meaningful improvement and evidence of intestinal benefit, framed as symptom and histology co\u2010primary endpoints in clinical trials. These expectations were discussed as most applicable to trial populations with both clinically meaningful symptoms and active histologic injury at baseline; for other phenotypes, it was emphasized that endpoint strategy, the role of gluten exposure, and trial duration should be tailored case by case to the population and mechanism of action. Practical challenges identified included endpoint selection and definition, discordance between symptoms and histology, selecting fit\u2010for\u2010purpose symptom measures; standardizing biopsy acquisition and central histology reads to address patchiness and variability, pre\u2010specifying definitions of meaningful histologic change given ongoing uncertainty about healing, and trial feasibility. Controlled gluten exposure was discussed as a tool to improve interpretability of efficacy outcomes, with careful consideration of dose, duration, patient burden and safety. Discussion addressed the ideal length of the double\u2010blind period, including a shorter 24\u2010week double\u2010blind study with an open\u2010label extension versus a 52\u2010week double\u2010blind design. Trial duration should balance scientific rigour, patient retention, and the need for longer\u2010term safety and durability data, with flexibility to tailor the approach to context.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Progress in coeliac disease drug development will require patient\u2010centred, scientifically robust but feasible trial designs with appropriate endpoints, justified use of gluten exposure, consideration of improved biomarkers to reduce patient burden and early regulatory engagement. Continued multi\u2010stakeholder collaboration, including dedicated consideration of paediatric drug development, is essential to advance effective therapies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.70873","type":"journal-article","created":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T04:15:12Z","timestamp":1785298512000},"page":"890-896","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Review Article: Accelerating Coeliac Disease Clinical Trials\u2014Beyond Celiac Meeting With Industry, Academics, Patients and the\n                    <scp>FDA<\/scp>"],"prefix":"10.1111","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-5823-425X","authenticated-orcid":false,"given":"Lisa M.","family":"Fahey","sequence":"first","affiliation":[{"name":"Children's Hospital of Philadelphia  Philadelphia Pennsylvania USA"},{"name":"University of Pennsylvania  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Anderson","sequence":"additional","affiliation":[{"name":"International Society for the Study of Celiac Disease  Groningen the Netherlands"},{"name":"Mackay Base Hospital  Mackay Queensland Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edwin","family":"Liu","sequence":"additional","affiliation":[{"name":"Children's Hospital Colorado University of Colorado School of Medicine  Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1941-9090","authenticated-orcid":false,"given":"Joseph A.","family":"Murray","sequence":"additional","affiliation":[{"name":"Mayo Clinic College of Medicine and Science  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6385-4578","authenticated-orcid":false,"given":"Marie 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