Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy

Phase 1/2 Completed 121 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network (ITN) · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This trial will test whether a novel therapeutic approach, cat immunotherapy combined with an investigational new drug called MEDI9929/AMG 157 (an anti-TSLP \[thymic stromal lymphopoietin\] antibody being co-developed by Amgen and MedImmune) can lead to lasting tolerance to cat allergen.The objective of the study is to determine whether one year of immunotherapy combined with MEDI9929/AMG 157 can induce tolerance to cat allergen.

Timeline

Start: 2015-03-03
Primary completion: 2019-03-04
Completion: 2019-03-04

Outcome

Missed primary endpoint

registry analysis (superiority test); AMG 157+Cat Immunotherapy vs AMG 157 Placebo+Cat Immunotherapy; p = 0.314; Mean Difference (Net) -0.51 (95% CI -1.51 to 0.49) NCT02237196 ↗

paper the primary end point TNSS AUC0-1h was not significantly different in the tezepelumab/SCIT group compared to SCIT alone PMID 36223848 ↗

Publications

Corren J, Larson D, Altman MC, Segnitz RM, Avila PC, Greenberger PA, Baroody F, Moss MH, Nelson H, Burbank AJ, Hernandez ML, Peden D, Saini S, Tilles S, Hussain I, Whitehouse D, Qin T, Villarreal M, Sever M, Wheatley LM, Nepom GT, Sanda S; Immune Tolerance Network ITN057AD CATNIP Study Team. Effects of combination treatment with tezepelumab and allergen immunotherapy on nasal responses to allergen: A randomized controlled trial. J Allergy Clin Immunol. 2023 Jan;151(1):192-201. doi: 10.1016/j.jaci.2022.08.029. Epub 2022 Oct 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cat Immunotherapy	Unknown	—	Subcutaneous
Subject	Tezepelumab	Monoclonal antibody	700 mg	Intravenous

Indications

No indication recorded.