A Study of Navenibart (STAR-0215) in Participants With Hereditary Angioedema

Summary

The goal of this clinical trial is to test the drug navenibart in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of navenibart, and 2 other groups will get 2 doses of navenibart. Researchers will study the effects of navenibart in participants with HAE as this is the first time that the drug has been given to participants with HAE.

Timeline

Start

2023-02-21

Primary completion

2025-03-13

Completion

2025-03-13

Publications

• Results Banerji A, Craig T, Sitz K, Li HH, Lumry W, Adatia A, Yang W, Jacobs JS, Tachdjian R, Soong W, Manning M, Wedner J, Savic S, Manson A, Valerieva A, Gunsior M, Mugundu G, Cohen T, Bernard K, VanEenwyk C, Joseph K, Best JM, Morabito C, Riedl MA. Open-label phase 1b/2 trial of navenibart, a long-acting plasma kallikrein inhibitor for hereditary angioedema. J Allergy Clin Immunol. 2026 May;157(5):1127-1135.e6. doi: 10.1016/j.jaci.2026.02.034. Epub 2026 Mar 5.

Drugs

Indications