An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)

Summary

This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II.

Timeline

Start

2022-10-24

Primary completion

2026-05-27

Completion

2026-05-27

Publications

• Kinaciyan T, Aygoren-Pursun E, Martinez-Saguer I, Soteres DF, Honda D, Manning ME, Wedner HJ, Fukunaga A, Kanarek HJ, Ohmura K, Melamed I, El-Shanawany T, Bouillet L, Lumry WR, Riedl MA, Koleilat M, Geng B, Ohsawa I, Bara N, Rehman S, Bernstein JA, Busse PJ, Cancian M, Cohn DM, Craig TJ, Farkas H, Kiani-Alikhan S, Li HH, Raasch JP, Tachdjian R, Audhya PK, Bajcic P, Chuang YH, Iverson M, Smith MD, Yea CM, Zanichelli A. Sebetralstat for breakthrough attacks in patients with hereditary angioedema receiving long-term prophylaxis in KONFIDENT-S. J Allergy Clin Immunol Glob. 2026 Jun 12;5(5):100750. doi: 10.1016/j.jacig.2026.100750. eCollection 2026 Sep.
• Bernstein JA, Aygoren-Pursun E, Cancian M, Cohn DM, Craig T, Grivcheva-Panovska V, Jordan A, Lumry WR, Martinez-Saguer I, Melamed I, Ohmura K, Peter J, Riedl MA, Soteres DF, Staubach P, Stobiecki M, Chuang YH, Smith MD, Yea CM, Audhya PK, Zanichelli A, Farkas H. Sebetralstat for On-Demand Treatment of Mucosal Hereditary Angioedema Attacks in KONFIDENT-S. Clin Transl Allergy. 2025 Nov;15(11):e70118. doi: 10.1002/clt2.70118.
• Farkas H, Anderson J, Bouillet L, Caballero T, Cancian M, Craig T, Fukunaga A, Grivcheva-Panovska V, Guilarte M, Honda D, Kanarek H, Kiani-Alikhan S, Kinaciyan T, Leguevaques D, Longhurst HJ, Magerl M, Manning ME, Martinez-Saguer I, Melamed I, O'Connor ME, Peter J, Savic S, Soteres DF, Staevska M, Staubach P, Stobiecki M, Tachdjian R, Valerieva A, Yong PFK, Hao J, Iverson M, Smith MD, Yea CM, Audhya PK, Aygoren-Pursun E, Bernstein JA, Cohn DM, Lumry WR, Riedl MA, Zanichelli A, Maurer M. Long-Term Safety and Effectiveness of Sebetralstat: Interim Analysis of KONFIDENT-S Open-label Extension. J Allergy Clin Immunol Pract. 2025 Nov;13(11):3094-3103.e5. doi: 10.1016/j.jaip.2025.08.020. Epub 2025 Aug 29.

Drugs

Indications