43 completed, 13 recruiting, 10 active not recruiting, 9 unknown. 34 Phase 2, 28 Phase 3, 16 Phase 1, 4 Phase 4, 2 Early Phase 1.
Follow Chronic Spontaneous Urticaria: new trials by email Literature Review of Chronic Spontaneous Urticaria trials Research Report on Chronic Spontaneous 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 Trial to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Spontaneous Urticaria AK139, Placebo - Chronic Spontaneous Urticaria | Phase 2 | Not yet recruiting | Akeso | 201 | 2026-10-21 | 2026-10-15 |
| Apremilast Added to Antihistamines in Chronic Urticaria Apremilast, Second-generation H1 antihistamine - Chronic Urticaria, Chronic Spontaneous Urticaria | Phase 2 | Enrolling by invitation | Rashid Latif Medical College | 86 | 2026-09-23 | 2026-09-30 |
| Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks Remibrutinib, Omalizumab - Chronic Spontaneous Urticaria | Phase 3 | Recruiting | Novartis Pharmaceuticals | 382 | 2026-09-21 | 2026-10-13 |
| Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT) Chronic Spontaneous Urticaria | Recruiting | Novartis Pharmaceuticals | 470 | 2026-08-04 | 2026-08-07 | |
| A Trial of HRS-3095 in Healthy Volunteers HRS-3095 - Chronic Spontaneous Urticaria | Early Phase 1 | Recruiting | Atridia Pty Ltd. | 36 | 2026-07-27 | 2026-08-07 |
| A Clinical Trial of HRS-3095 in Patients With Chronic Spontaneous Urticaria HRS-3095 Tablet, HRS-3095 Tablet Placebo - Chronic Spontaneous Urticaria | Phase 2 | Not yet recruiting | Chengdu Suncadia Medicine Co., Ltd. | 190 | 2026-07-01 | 2026-05-29 |
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 Following Intravenous Administration in Participants With Chronic Spontaneous Urticaria (CSU) BBT001, Placebo - Chronic Spontaneous Urticaria | Phase 1 / Phase 2 | Recruiting | Bambusa Therapeutics | 48 | 2026-06-29 | 2026-07-22 |
| A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults EDP-978, Placebo - Chronic Inducible Urticaria, Chronic Spontaneous Urticaria | Phase 1 | Recruiting | Enanta Pharmaceuticals, Inc | 98 | 2026-04-01 | 2026-04-21 |
| A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous Urticaria Dupilumab - Chronic Spontaneous Urticaria | Terminated | Sanofi | 1 | 2026-03-18 | 2026-07-31 | |
| Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria. JYB1904, Placebo+JYB1904 - Chronic Spontaneous Urticaria | Phase 3 | Recruiting | Jemincare | 240 | 2026-03-09 | 2026-08-03 |
| Remibrutinib in Real-world Clinical Practice Chronic Spontaneous Urticaria | Recruiting | Novartis Pharmaceuticals | 3280 | 2026-02-02 | 2026-04-16 | |
| Remibrutinib in Real-world Clinical Practice - a US Sub-study Chronic Spontaneous Urticaria | Recruiting | Novartis Pharmaceuticals | 505 | 2026-02-02 | 2026-02-13 | |
| A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients Chronic Spontaneous Urticaria | Recruiting | Novartis Pharmaceuticals | 350 | 2026-01-17 | 2026-05-11 | |
| Ritlecitinib (PF-06651600) in Participants With Chronic Spontaneous Urticaria Ritlecitinib - Chronic Spontaneous Urticaria, CSU | Phase 2 | Withdrawn | Ahuva D Cices | 2025-12-31 | 2025-12-09 | |
| Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria barzolvolimab, Standard of Care - Chronic Spontaneous Urticaria | Phase 3 | Enrolling by invitation | Celldex Therapeutics | 1370 | 2025-11-25 | 2026-10-07 |
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of HRS-3095 Oral Administration in Healthy Subjects, as Well as the Effect of HRS-3095 on CYP3A4 Metabolic Enzymes HRS-3095 Tablet, HRS-3095 Placebo Tablet - Chronic Spontaneous Urticaria | Phase 1 | Completed | Chengdu Suncadia Medicine Co., Ltd. | 82 | 2025-11-10 | 2026-06-12 |
| A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults. Ritlecitinib 50 mg, Ritlecitinib 100 mg, Placebo - 50 mg - Chronic Spontaneous Urticaria | Phase 2 | Recruiting | Pfizer | 200 | 2025-10-30 | 2026-06-17 |
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of Tacabrutideg (BGB-16673) in Adults With Chronic Spontaneous Urticaria and in Healthy Participants Tacabrutideg, Placebo - Chronic Spontaneous Urticaria | Phase 1 | Recruiting | BeOne Medicines | 58 | 2025-07-19 | 2026-09-09 |
| Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU) BLU-808, Placebo - Chronic Inducible Urticaria, Chronic Spontaneous Urticaria | Phase 2 | Active not recruiting | Blueprint Medicines Corporation | 105 | 2025-05-28 | 2026-07-22 |
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HS-10561 Capsule in Healthy Chinese Adults and Patients With Chronic Spontaneous Urticaria. HS-10561, Placebo - Chronic Spontaneous Urticaria | Phase 1 / Phase 2 | Not yet recruiting | Jiangsu Hansoh Pharmaceutical Co., Ltd. | 150 | 2025-03-31 | 2025-03-07 |
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Chronic Urticaria (94) · Urticaria (16) · Pruritus (6) · Chronic Inducible Urticaria (5) · Angioedema (4) · Cold Urticaria (3) · Skin Diseases (3) · Bronchiolitis Obliterans Syndrome (2) · Alopecia Areata (1) · Chronic Disease (1) · Dermatitis, Atopic (1) · Familial dermographism (1) · Hidradenitis Suppurativa (1) · Immune System Diseases (1) · Parasitic Diseases (1)
Disease Attributes (94) · Hypersensitivity (94) · Hypersensitivity, Immediate (94) · Pathological Conditions, Signs and Symptoms (94) · Skin and Connective Tissue Diseases (94) · Chronic Disease (93) · Immune System Diseases (93) · Pathologic Processes (93) · Skin Diseases, Vascular (93) · Skin Diseases (91) · Urticaria (78) · Signs and Symptoms (6) · Skin Manifestations (6) · Cardiovascular Diseases (4) · Vascular Diseases (4)
Omalizumab (19) · remibrutinib (10) · ligelizumab (9) · dupilumab (4) · Injections (2) · PF-06651600 (2) · AK002 (1) · Control Groups (1) · Histamine H1 Antagonists, Non-Sedating (1) · Loratadine (1) · Saline Solution (1) · Single Person (1) · Standard of Care (1) · Tranexamic Acid (1) · aldesleukin (1)
Novartis Pharmaceuticals (30) · Celldex Therapeutics (5) · Sanofi (4) · Allakos Inc. (3) · Longbio Pharma (3) · Chengdu Suncadia Medicine Co., Ltd. (2) · Hangzhou Highlightll Pharmaceutical Co., Ltd (2) · Jemincare (2) · Ahuva D Cices (1) · Akeso (1) · Amgen (1) · AstraZeneca (1) · Atridia Pty Ltd. (1) · Bambusa Therapeutics (1) · BeOne Medicines (1)
United States (39) · Germany (34) · Canada (26) · Spain (25) · China (22) · Poland (22) · Japan (20) · Argentina (16) · France (15) · Taiwan (15) · South Korea (14) · Russia (13) · United Kingdom (13) · Bulgaria (12) · Hungary (12)
Ahuva Cices, MD (1) · Cheng Zhou (1) · Chia Yu Chu, MD (1) · Chin Lee, MD, MPH (1)
PMID 34773261, PMID 36440464, PMID 38008109, PMID 40043237, PMID 42297099, PMID 27010957, PMID 31577874, PMID 32272284, PMID 33247014, PMID 33865434, PMID 37492920, PMID 37866460, PMID 39066978, PMID 39762098, PMID 40266575, PMID 41272364, PMID 41326897, PMID 41706458, PMID 41712058, PMID 41747871
2019 (7), 2018 (3), 2017 (2), 2014 (1), 2015 (1), 2023 (1), 2025 (1)