Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria

Summary

The primary objective of this study is to evaluate the effect of tezepelumab on improvement in the Urticaria Activity Score over 7 days (UAS7).

Timeline

Start

2021-04-15

Primary completion

2022-12-20

Completion

2023-04-13

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Tezepelumab 210 mg SC Q4W; p = 0.99; LSM difference 0.0 (95% CI -4.3 to 4.4) NCT04833855 ↗

registry analysis (superiority test); Placebo vs Tezepelumab 420 mg SC Q2W; p = 0.60; LSM difference -1.1 (95% CI -5.4 to 3.1) NCT04833855 ↗

release “A Phase 2b study of TEZSPIRE in chronic spontaneous urticaria did not meet the primary endpoint” amgen.com ↗

Publications

• Background McLaren J, Chon Y, Gorski KS, Bernstein JA, Corren J, Hayama K, Jain V, Lima H, Sofen H, Ponnarambil S, Molfino NA, Maurer M. Tezepelumab for the treatment of chronic spontaneous urticaria: Results of the phase 2b INCEPTION study. J Allergy Clin Immunol. 2025 Jun;155(6):1945-1956. doi: 10.1016/j.jaci.2025.01.045. Epub 2025 Feb 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Omalizumab	Monoclonal antibody	—	Subcutaneous
Subject	Tezepelumab	Monoclonal antibody	—	Subcutaneous

Indications