A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease

Summary

This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge.

Timeline

Start

2016-04-13

Primary completion

2017-02-15

Completion

2017-03-14

Outcome

Missed primary endpoint

registry analysis (superiority test); AMG 714 150 mg vs Placebo; p = 0.7271; LS Mean Difference -2.49 (95% CI -16.82 to 11.83); ANCOVA NCT02637141 ↗

paper The primary endpoint, change in VHCD ratio from baseline after 12 weeks of treatment in patients with coeliac disease undergoing gluten challenge, was not significantly different PMID 31494096 ↗

Publications

• Zhang X, Jia L, Lin X, Zhou L. Exhaustion-Resistant CD8 + T Cells in Ankylosing Spondylitis: A Proposed Three-Axis Model. Immunology. 2025 Dec;176(4):409-420. doi: 10.1111/imm.70044. Epub 2025 Oct 2.
• Lahdeaho ML, Scheinin M, Vuotikka P, Taavela J, Popp A, Laukkarinen J, Koffert J, Koivurova OP, Pesu M, Kivela L, Lovro Z, Keisala J, Isola J, Parnes JR, Leon F, Maki M. Safety and efficacy of AMG 714 in adults with coeliac disease exposed to gluten challenge: a phase 2a, randomised, double-blind, placebo-controlled study. Lancet Gastroenterol Hepatol. 2019 Dec;4(12):948-959. doi: 10.1016/S2468-1253(19)30264-X. Epub 2019 Sep 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ORDESEKIMAB	Monoclonal antibody	150 mg	Subcutaneous
Subject	ORDESEKIMAB	Monoclonal antibody	300 mg	Subcutaneous

Indications