A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)

Summary

A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).

Timeline

Start

2018-08-06

Primary completion

2019-09

Completion

2019-09

Outcome

Missed primary endpoint

paper non-homozygous Nexvax2 group was 2·86 (SD 2·28) compared with 2·63 (2·07) for the non-homozygous placebo group (p=0·43). PMID 36898393 ↗

Publications

• Tye-Din JA, Daveson AJM, Goel G, Goldstein KE, Hand HL, Neff KM, Popp A, Taavela J, Maki M, Isola J, Williams LJ, Truitt KE, Anderson RP; RESET CeD Study Group. Efficacy and safety of gluten peptide-based antigen-specific immunotherapy (Nexvax2) in adults with coeliac disease after bolus exposure to gluten (RESET CeD): an interim analysis of a terminated randomised, double-blind, placebo-controlled phase 2 study. Lancet Gastroenterol Hepatol. 2023 May;8(5):446-457. doi: 10.1016/S2468-1253(22)00428-9. Epub 2023 Mar 7.
• Tye-Din JA, Daveson AJM, Goldstein KE, Hand HL, Neff KM, Goel G, Williams LJ, Truitt KE, Anderson RP; RESET CeD Study Group. Patient factors influencing acute gluten reactions and cytokine release in treated coeliac disease. BMC Med. 2020 Nov 26;18(1):362. doi: 10.1186/s12916-020-01828-y.

Drugs

Indications