PRV-015 in Gluten-free Diet Non-responsive Celiac Disease

Summary

This study will evaluate the efficacy and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).

Timeline

Start

2020-08-24

Primary completion

2024-07-30

Completion

2024-07-30

Outcome

Missed primary endpoint

registry analysis (other test); Placebo vs PRV-015 100 mg; p = 0.8543; Least square (LS) mean difference 0.04 (95% CI -0.43 to 0.52); MMRM NCT04424927 ↗

release “patients with nonresponsive celiac disease was completed as planned and did not meet primary or secondary endpoints.” amgen.com ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ORDESEKIMAB	Monoclonal antibody	—	Subcutaneous

Indications