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

Summary

Protocol CELIM-RCD-002 is designed to evaluate the efficacy and safety of AMG 714 for the treatment of adult patients with type II refractory celiac disease (RCD-II), an in-situ small bowel T-cell lymphoma.

Timeline

Start

2016-04-13

Primary completion

2017-04-11

Completion

2017-05-02

Outcome

Missed primary endpoint

registry analysis (superiority test); AMG 714 vs Placebo; p = 0.7451; LS Mean Difference -4.85 (90% CI -30.26 to 20.56); ANCOVA NCT02633020 ↗

paper there was no difference between the groups in terms of the primary endpoint of aberrant intraepithelial lymphocyte reduction from baseline. PMID 31494097 ↗

Publications

• Cellier C, Bouma G, van Gils T, Khater S, Malamut G, Crespo L, Collin P, Green PHR, Crowe SE, Tsuji W, Butz E, Cerf-Bensussan N, Macintyre E, Parnes JR, Leon F, Hermine O, Mulder CJ; RCD-II Study Group Investigators. Safety and efficacy of AMG 714 in patients with type 2 refractory coeliac disease: a phase 2a, randomised, double-blind, placebo-controlled, parallel-group study. Lancet Gastroenterol Hepatol. 2019 Dec;4(12):960-970. doi: 10.1016/S2468-1253(19)30265-1. Epub 2019 Sep 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ORDESEKIMAB	Monoclonal antibody	8 mg/kg	Intravenous

Indications