20 completed, 3 active not recruiting, 1 recruiting, 1 terminated. 25 Phase 1, 6 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 25 | Completed 20, Active not recruiting 3, Recruiting 1, Terminated 1 |
| Phase 2 | 6 | Active not recruiting 3, Completed 2, Recruiting 1 |
Follow Angioedema: new trials by email Literature Review of Angioedema trials Research Report on Angioedema
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 |
|---|---|---|---|---|---|---|
| Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients Deucrictibant XR tablet, Placebo comparator to XR tablet, Deucrictibant 20 mg capsule - Hereditary Angioedema (HAE), Angioedema | Phase 1 / Phase 2 | Recruiting | Institute for Asthma and Allergy | 10 | 2025-03-10 | 2025-07-02 |
| A Study of Navenibart (STAR-0215) in Participants With Hereditary Angioedema Navenibart - Hereditary Angioedema | Phase 1 / Phase 2 | Completed | Astria Therapeutics, Inc. | 29 | 2023-02-21 | 2026-05-08 |
| Safety, Tolerability, PK, PD of ADX-324 in Healthy Volunteers and Hereditary Angioedema Patients ADX-324, Placebo - Hereditary Angioedema | Phase 1 / Phase 2 | Active not recruiting | ADARx Pharmaceuticals, Inc. | 53 | 2022-12-14 | 2026-06-16 |
| A Study of STAR-0215 in Healthy Adult Participants STAR-0215 (SC), Placebo (SC), STAR-0215 (IV) - Hereditary Angioedema | Phase 1 | Completed | Astria Therapeutics, Inc. | 41 | 2022-07-27 | 2024-01-11 |
| A Gene Therapy Study of BMN 331 in Subjects With Hereditary Angioedema Dose 1 of BMN 331, Dose 2 of BMN 331, Dose 3 of BMN 331 - Hereditary Angioedema, HAE | Phase 1 / Phase 2 | Active not recruiting | BioMarin Pharmaceutical | 44 | 2022-02-15 | 2024-05-16 |
| NTLA-2002 in Adults With Hereditary Angioedema (HAE) Biological NTLA-2002, Normal Saline IV Administration - Hereditary Angioedema | Phase 1 / Phase 2 | Active not recruiting | Intellia Therapeutics | 37 | 2021-12-10 | 2026-09-25 |
| Evaluation of Safety, Tolerability and Immune Responses of Ebola-S and Marburg Vaccines in Healthy Adults cAd3-Marburg, cAd3-EBO-S - Ebola Virus Disease, Marburg Virus Disease | Phase 1 | Completed | Albert B. Sabin Vaccine Institute | 32 | 2021-01-06 | 2022-08-03 |
| Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations KVD824 Prototype 1 modified-release tablet, KVD824 Prototype 2 modified-release tablet, KVD824 Immediate-Release Capsule - Hereditary Angioedema | Phase 1 | Completed | KalVista Pharmaceuticals, Ltd. | 37 | 2020-05-19 | 2021-11-12 |
| Safety and Pharmacokinetics of GNR-038 in Healthy Volunteers GNR-038, 25 МЕ/kg, GNR-038, 50 МЕ/kg, GNR-038, 100 МЕ/kg - Hereditary Angioedema | Phase 1 | Completed | AO GENERIUM | 36 | 2020-03-10 | 2020-09-30 |
| A Single and Multiple Doses Safety, Tolerability, Pharmacokinetics and Food Effect Study of KVD824 in Healthy Volunteers KVD824, Placebo to KVD824 - Hereditary Angioedema | Phase 1 | Completed | KalVista Pharmaceuticals, Ltd. | 108 | 2019-02-12 | 2022-02-17 |
| A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers KVD900, Placebo to KVD900 - Hereditary Angioedema | Phase 1 | Completed | KalVista Pharmaceuticals, Ltd. | 84 | 2018-01-04 | 2025-04-29 |
| A Relative Bioavailability Study of Two Formulations of BCX7353 BCX7353 - Hereditary Angioedema | Phase 1 | Completed | BioCryst Pharmaceuticals | 24 | 2017-02-27 | 2020-01-27 |
| A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions BCX7353, Digoxin, BCX7353 + digoxin - Hereditary Angioedema | Phase 1 | Completed | BioCryst Pharmaceuticals | 54 | 2017-02-17 | 2017-10-26 |
| An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates BCX7353 and probes - Hereditary Angioedema | Phase 1 | Completed | BioCryst Pharmaceuticals | 20 | 2016-03-01 | 2017-01-31 |
| Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects Recombinant human C1 esterase inhibitor, Placebo, SHP623 - Hereditary Angioedema (HAE) | Phase 1 | Completed | Shire | 48 | 2016-02-19 | 2021-06-03 |
| First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers BCX7353, Placebo to match BCX7353 - Hereditary Angioedema | Phase 1 | Completed | BioCryst Pharmaceuticals | 122 | 2015-05-01 | 2016-01-13 |
| Study to Determine How BCX4161 is Metabolized and Eliminated by the Body BCX4161 - Hereditary Angioedema | Phase 1 | Completed | BioCryst Pharmaceuticals | 7 | 2014-08-01 | 2014-10-29 |
| A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants DX-2930, Placebo - Hereditary Angioedema (HAE) | Phase 1 | Completed | Shire | 38 | 2014-05-14 | 2021-05-27 |
| A Study of the Relative Bioavailability of a New Formulation of BCX4161 and the Effect of Food on BCX4161 BCX4161 - Hereditary Angioedema | Phase 1 | Completed | BioCryst Pharmaceuticals | 28 | 2014-04-01 | 2014-08-15 |
| Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers Icatibant (30 mg) - Hereditary Angioedema (HAE) | Phase 1 | Completed | Shire | 12 | 2014-02-21 | 2021-06-03 |
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Angioedemas, Hereditary (22) · Cardiovascular Diseases (2) · Genetic Diseases, Inborn (2) · Hereditary Angioedema Types I and II (2) · Hypersensitivity (2) · Hypersensitivity, Immediate (2) · Immune System Diseases (2) · Skin Diseases (2) · Skin Diseases, Vascular (2) · Urticaria (2) · Vascular Diseases (2) · Acquired Immunodeficiency Syndrome (1) · Acquired angioedema (1) · Communicable Diseases (1)
Skin and Connective Tissue Diseases (25) · Cardiovascular Diseases (23) · Hypersensitivity (23) · Hypersensitivity, Immediate (23) · Immune System Diseases (23) · Skin Diseases (23) · Skin Diseases, Vascular (23) · Urticaria (23) · Vascular Diseases (23) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (22) · Hereditary Complement Deficiency Diseases (22) · Immunologic Deficiency Syndromes (22) · Primary Immunodeficiency Diseases (22) · Genetic Diseases, Inborn (20)
berotralstat (4) · Complement C1 Inhibitor Protein (2) · avoralstat (2) · icatibant (2) · lanadelumab (2) · Cyclosporine (1) · Digoxin (1) · RNA, Small Interfering (1) · Rosuvastatin Calcium (1) · Sodium Chloride (1) · conestat alfa (1) · sebetralstat (1)
BioCryst Pharmaceuticals (6) · Shire (5) · KalVista Pharmaceuticals, Ltd. (3) · Astria Therapeutics, Inc. (2) · CSL Behring (2) · ADARx Pharmaceuticals, Inc. (1) · AO GENERIUM (1) · Albert B. Sabin Vaccine Institute (1) · BioMarin Pharmaceutical (1) · Institute for Asthma and Allergy (1) · Intellia Therapeutics (1) · Vanderbilt University (1)
United States (12) · United Kingdom (11) · Germany (4) · Australia (3) · Bulgaria (1) · Canada (1) · Czechia (1) · France (1) · Italy (1) · Jordan (1) · Netherlands (1) · New Zealand (1) · Russia (1) · Spain (1)
Joanne Collier, MBChB, FFPM, Dip Stats (OU) (2) · David Hoover, MD (1) · Firas Almazedi, MBChB, Msc, CPI (1) · Joanne Collier (1) · Lauge Farnaes, MD (1) · Litza McKenzie, MBChB (1) · Litza McKenzie, MBChB, BScMedSci (1) · Michael Stevenson, MD (1) · Nancy J. Brown, MD (1) · Oksana A. Markova, MD (1) · Roxana Rustomjee, MBChB (1) · Tuan Le, MD (1)
PMID 1538192, PMID 15577929, PMID 16375711, PMID 24980392, PMID 25426834, PMID 26016741, PMID 28225674, PMID 35086692, PMID 38294975, PMID 39445704, PMID 40158724, PMID 41794053, PMID 8237108
R01HL079184 (1)