A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II

Summary

This study is a randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adult subjects.

Timeline

Start

2019-07-02

Primary completion

2020-12-08

Completion

2020-12-08

Outcome

Met primary endpoint

paper significantly longer with sebetralstat versus placebo (at quartile 1: >12 h [95% CI 9·6 to >12] vs 8·0 h [3·8 to >12]; p=0·0010). PMID 36774155 ↗

Publications

• Aygoren-Pursun E, Cohn DM, Agmon-Levin N, Banerji A, Bernstein JA, Busse P, Cancian M, de Castro ED, Farkas H, Grivcheva-Panovska V, Hagin D, Hakl R, Honda D, Kessel A, Kinaciyan T, Ifaad, Kurowski M, Li HH, Lleonart R, Longhurst HJ, Lumry WR, Magerl M, Martinez-Saguer I, Melamed I, Psarros F, Savic S, Soteres DF, Staevska M, Stobiecki M, Wedner HJ, Zanichelli A, Hao J, Patil K, Iverson M, Owiredu-Yeboa S, Smith MD, Yea CM, Audhya PK, Riedl MA, Kiani-Alikhan S, Maurer M. Sebetralstat for on-demand treatment of hereditary angioedema: A pooled analysis of placebo-controlled clinical trials. World Allergy Organ J. 2026 Jun 9;19(7):101401. doi: 10.1016/j.waojou.2026.101401. eCollection 2026 Jul.
• Aygoren-Pursun E, Zanichelli A, Cohn DM, Cancian M, Hakl R, Kinaciyan T, Magerl M, Martinez-Saguer I, Stobiecki M, Farkas H, Kiani-Alikhan S, Grivcheva-Panovska V, Bernstein JA, Li HH, Longhurst HJ, Audhya PK, Smith MD, Yea CM, Maetzel A, Lee DK, Feener EP, Gower R, Lumry WR, Banerji A, Riedl MA, Maurer M. An investigational oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema: a two-part, randomised, double-blind, placebo-controlled, crossover phase 2 trial. Lancet. 2023 Feb 11;401(10375):458-469. doi: 10.1016/S0140-6736(22)02406-0.

Drugs

Indications