drugset / Trial / NCT07046806
Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients
RandomizedCrossoverTriple-blindPrevention
Summary
To assess the efficacy of prophylactic treatment with deucrictibant extended release (XR) tablet versus placebo in preventing angioedema attacks, and to also assess the efficacy of deucrictibant soft capsules as on-demand treatment versus placebo in achieving angioedema symptom relief during acute attacks.
Timeline
- Start
- 2025-03-10
- Primary completion
- 2026-04-01
- Completion
- 2026-04-01
Publications
- Background Weller K, Groffik A, Magerl M, Tohme N, Martus P, Krause K, Metz M, Staubach P, Maurer M. Development and construct validation of the angioedema quality of life questionnaire. Allergy. 2012 Oct;67(10):1289-98. doi: 10.1111/all.12007. Epub 2012 Aug 23.
- Background Riedl MA, Danese M, Danese S, Ulloa J, Maetzel A, Audhya PK. Hereditary Angioedema With Normal C1 Inhibitor: US Survey of Prevalence and Provider Practice Patterns. J Allergy Clin Immunol Pract. 2023 Aug;11(8):2450-2456.e6. doi: 10.1016/j.jaip.2023.01.023. Epub 2023 Jan 30.
- Background Lumry WR, Li HH, Levy RJ, Potter PC, Farkas H, Moldovan D, Riedl M, Li H, Craig T, Bloom BJ, Reshef A. Randomized placebo-controlled trial of the bradykinin B(2) receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: the FAST-3 trial. Ann Allergy Asthma Immunol. 2011 Dec;107(6):529-37. doi: 10.1016/j.anai.2011.08.015. Epub 2011 Oct 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CRICTIBANT | Small molecule | 20 mg | Oral |
| Subject | CRICTIBANT | Small molecule | 40 mg | Oral |