3 completed, 2 recruiting, 1 enrolling by invitation, 1 terminated. 7 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 3, Recruiting 2, Enrolling by invitation 1, Terminated 1 |
| Phase 2 | 2 | Completed 2 |
Follow HAE: new trials by email Literature Review of HAE trials Research Report on HAE
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE) ADX-324 Dose Level 1, ADX-324 Dose Level 2 - Hereditary Angioedema (HAE), Hereditary Angioedema - Type 1 | Phase 3 | Recruiting | ADARx Pharmaceuticals, Inc. | 90 | 2026-04-02 | 2026-09-04 |
| STOP-HAE: A Phase 3 Study of ADX-324 in HAE ADX-324, Placebo - Hereditary Angioedema, HAE | Phase 3 | Recruiting | ADARx Pharmaceuticals, Inc. | 90 | 2025-08-28 | 2026-09-10 |
| Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies berotralstat - Hereditary Angioedema, HAE | Phase 3 | Enrolling by invitation | BioCryst Pharmaceuticals | 139 | 2021-07-23 | 2025-12-23 |
| A Long Term Safety Study of BCX7353 in Hereditary Angioedema BCX7353 - Hereditary Angioedema, HAE | Phase 2 / Phase 3 | Completed | BioCryst Pharmaceuticals | 387 | 2018-02-16 | 2023-06-18 |
| Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE BCX7353 capsules, Placebo oral capsule - Hereditary Angioedema, HAE | Phase 3 | Completed | BioCryst Pharmaceuticals | 121 | 2018-02-06 | 2023-06-26 |
| Open-label, Long-term Safety Study of Avoralstat in Subjects With Hereditary Angioedema avoralstat - Hereditary Angioedema, HAE | Phase 3 | Terminated | BioCryst Pharmaceuticals | 6 | 2015-12-01 | 2016-02-17 |
| 12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks BCX4161, Placebo - Hereditary Angioedema, HAE | Phase 2 / Phase 3 | Completed | BioCryst Pharmaceuticals | 110 | 2014-12-17 | 2025-11-17 |
Angioedema (7) · Cardiovascular Diseases (7) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (7) · Genetic Diseases, Inborn (7) · Hereditary Complement Deficiency Diseases (7) · Hypersensitivity (7) · Hypersensitivity, Immediate (7) · Immune System Diseases (7) · Immunologic Deficiency Syndromes (7) · Primary Immunodeficiency Diseases (7) · Skin Diseases (7) · Skin Diseases, Vascular (7) · Skin and Connective Tissue Diseases (7) · Urticaria (7) · Vascular Diseases (7)
berotralstat (3) · avoralstat (2) · RNA, Small Interfering (1) · Sodium Chloride (1)
BioCryst Pharmaceuticals (5) · ADARx Pharmaceuticals, Inc. (2)
France (7) · Germany (6) · United Kingdom (6) · Canada (5) · Hungary (5) · Spain (5) · United States (5) · Austria (4) · Belgium (4) · Czechia (4) · Poland (4) · Australia (3) · Hong Kong (3) · Israel (3) · Italy (3)
Lauge Farnaes, MD (2) · Bruce Zuraw, MD (1) · Henriette Farkas, MD (1) · Henriette Farkas, MD, PhD, DSc (1) · Marc Riedl, MD MS (1) · Vesna Grivcheva-Panoska, MD, PhD (1)
PMID 36326435, PMID 36408587, PMID 33098856, PMID 33866032, PMID 34161665, PMID 35820771, PMID 38006972, PMID 38020288, PMID 40490218