13 active not recruiting. 13 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Active not recruiting 13 |
Follow Urticaria: new trials by email Literature Review of Urticaria trials Research Report on Urticaria
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 |
|---|---|---|---|---|---|---|
| A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines Remibrutinib, Remibrutinib matching placebo, Dupilumab - Chronic Spontaneous Urticaria (CSU) | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 409 | 2025-07-11 | 2026-10-13 |
| A Study of Navenibart in Participants With Hereditary Angioedema navenibart, Placebo - Hereditary Angioedema (HAE) | Phase 3 | Active not recruiting | Astria Therapeutics, Inc. | 157 | 2025-03-20 | 2026-06-30 |
| HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE) NTLA-2002, Normal Saline IV Administration - Hereditary Angioedema | Phase 3 | Active not recruiting | Intellia Therapeutics | 80 | 2025-01-15 | 2026-10-08 |
| Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE Deucrictibant, Placebo - Hereditary Angioedema (HAE) | Phase 3 | Active not recruiting | Pharvaris Netherlands B.V. | 81 | 2024-12-01 | 2026-02-13 |
| A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU) barzolvolimab, Matching placebo - Chronic Spontaneous Urticaria | Phase 3 | Active not recruiting | Celldex Therapeutics | 976 | 2024-07-19 | 2026-03-25 |
| A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria barzolvolimab, Matching placebo - Chronic Spontaneous Urticaria | Phase 3 | Active not recruiting | Celldex Therapeutics | 963 | 2024-07-11 | 2026-03-25 |
| A Study of Efficacy and Safety of TLL-018 in CSU Participants TLL-018 tablets, Placebo tablets - Chronic Spontaneous Urticaria | Phase 3 | Active not recruiting | Hangzhou Highlightll Pharmaceutical Co., Ltd | 440 | 2024-03-27 | 2026-06-03 |
| A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines Remibrutinib, Placebo - Chronic Inducible Urticaria | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 362 | 2023-12-07 | 2026-10-15 |
| Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension. Remibrutinib, Placebo to remibrutinib, Placebo to omalizumab - Chronic Spontaneous Urticaria | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 470 | 2023-11-15 | 2026-10-14 |
| 24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up LOU064 (blinded), placebo - Chronic Spontaneous Urticaria | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 100 | 2023-07-11 | 2026-10-15 |
| An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib LOU064 (blinded), Placebo, LOU064 (open label) - Chronic Spontaneous Urticaria | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 696 | 2022-12-09 | 2026-03-11 |
| Berotralstat Treatment in Children With Hereditary Angioedema Berotralstat - Hereditary Angioedema, Pediatric | Phase 3 | Active not recruiting | BioCryst Pharmaceuticals | 29 | 2022-10-25 | 2026-02-25 |
| A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE) Donidalorsen - Hereditary Angioedema | Phase 3 | Active not recruiting | Ionis Pharmaceuticals, Inc. | 154 | 2022-07-13 | 2025-12-12 |
Chronic Urticaria (7) · Angioedemas, Hereditary (5) · Angioedema (1) · Chronic Inducible Urticaria (1) · Cold Urticaria (1)
Hypersensitivity (13) · Hypersensitivity, Immediate (13) · Immune System Diseases (13) · Skin Diseases (13) · Skin Diseases, Vascular (13) · Skin and Connective Tissue Diseases (13) · Chronic Disease (8) · Disease Attributes (8) · Pathologic Processes (8) · Pathological Conditions, Signs and Symptoms (8) · Cardiovascular Diseases (5) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (5) · Genetic Diseases, Inborn (5) · Hereditary Complement Deficiency Diseases (5)
remibrutinib (5) · IONIS-PKK-LRx (1) · Injections (1) · Omalizumab (1) · berotralstat (1) · donidalorsen (1) · dupilumab (1)
Novartis Pharmaceuticals (5) · Celldex Therapeutics (2) · Astria Therapeutics, Inc. (1) · BioCryst Pharmaceuticals (1) · Hangzhou Highlightll Pharmaceutical Co., Ltd (1) · Intellia Therapeutics (1) · Ionis Pharmaceuticals, Inc. (1) · Pharvaris Netherlands B.V. (1)
Canada (11) · Germany (11) · Italy (10) · Poland (10) · Spain (10) · United Kingdom (10) · United States (10) · France (9) · Bulgaria (7) · Netherlands (7) · Turkey (Türkiye) (7) · Argentina (6) · Brazil (6) · Hungary (6) · South Africa (6)
PMID 40673861, PMID 40716738, PMID 41767175, PMID 41854973, PMID 42294842
2023 (1)