Chronic Urticaria clinical trials
The registry lists 194 studies for Chronic Urticaria across more than 10 countries. 46 are recruiting or about to start. 178 of them are mainly about Chronic Urticaria (how this is decided). Per ClinicalTrials.gov, last updated 2026-11-09. Counting its narrower condition Cryopyrin-Associated Periodic Syndromes too: 229 studies, 49 open.
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Status
Who runs them
Novartis Pharmaceuticals (37) · Charite University, Berlin, Germany (7) · Genentech, Inc. (6) · Celldex Therapeutics (5) · Hangzhou Highlightll Pharmaceutical Co., Ltd (4) · Sanofi (4) · Allakos Inc. (4) · Organon and Co (3)
What is being tested here
Drugs under test in Chronic Urticaria studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted
| Drug | Open | Phase 3 | All |
|---|---|---|---|
| Remibrutinib | 2 | 9 | 12 |
| TLL-018 | 2 | 1 | 4 |
| UB-221 | 2 | 0 | 4 |
| Ozureprubart | 2 | 1 | 2 |
| Omalizumab | 1 | 11 | 21 |
| Levocetirizine | 1 | 3 | 8 |
| Barzolvolimab | 1 | 3 | 5 |
| HRS-3095 | 1 | 0 | 3 |
| PF-06651600 | 1 | 0 | 2 |
| Apremilast | 1 | 0 | 1 |
Drug classes tested here Tyrosine kinase inhibitors (TKIs) 4 open · Antihistamines 1 open · JAK inhibitors 1 open
Coming up
Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.
The 10 nearest, phase 3 first
- Nov 202624 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 · Phase 3 · Novartis Pharmaceuticals
- Feb 2027A 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 · Phase 3 · Novartis Pharmaceuticals
- Jun 2027Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria. · Phase 3 · Jemincare
- Nov 2026A Study of Single Dose of LP-003 in Healthy Adult Subjects · Longbio Pharma
- Nov 2026A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults · Enanta Pharmaceuticals, Inc
- Nov 2026Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU) · Keymed Biosciences Co.Ltd
- Nov 2026Pseudoallergen-Free and Low-Histamine Diet in Adolescents With Chronic Spontaneous Urticaria · Istanbul University
- Nov 2026A 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 · BeOne Medicines
- Dec 2026Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous Urticaria · Istanbul Training and Research Hospital
- Dec 2026A Clinical Trial of HRS-3095 in Patients With Chronic Spontaneous Urticaria · Chengdu Suncadia Medicine Co., Ltd.
Who these studies take
Of the 24 Chronic Urticaria studies recruiting now, 11 (46%) set no upper age limit and 9 (38%) stop at 75 or younger. 1 (4%) take children under 18. 0 (0%) are for women only and 0 (0%) for men only; 5 (21%) take healthy volunteers.
| Age | Women | Men |
|---|---|---|
| 10 | 0 (0%) | 0 (0%) |
| 18 | 24 (100%) | 24 (100%) |
| 30 | 23 (96%) | 23 (96%) |
| 40 | 23 (96%) | 23 (96%) |
| 50 | 23 (96%) | 23 (96%) |
| 65 | 23 (96%) | 23 (96%) |
| 75 | 19 (79%) | 19 (79%) |
| 85 | 14 (58%) | 14 (58%) |
Across all 194 studies, recruiting or not: 51% stop at 75 or younger and 24% at 65; 20% take children; 0% are for women only and 1% for men only; 12% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.
How long Chronic Urticaria studies take
Of 31 phase 2 interventional studies under Chronic Urticaria, half reached primary completion within 19 months of starting, counting those still running.
| Start to primary completion | Every sponsor | Industry | Non-industry |
|---|---|---|---|
| Phase 1 | 15 mo8–21 · 15 studies | — | — |
| Phase 2 | 19 mo16–31 · 31 studies | — | — |
| Phase 3 | 24 mo19–32 · 29 studies | 24 mo19–32 · 27 studies | — |
Each figure is the month by which half the studies had reached primary completion, with the range in which the middle half did. Studies still running count until their last registry update; studies that stopped early are left out. Phase 1 includes early phase 1; observational means prospective or not stated, as retrospective and cross-sectional studies date a window of data rather than a study. How these figures are worked out
What changed recently
From the registry's own updates since Oct 13, 2026.
Started recruiting1
Newly registered2
- Remibrutinib in Real-world Clinical Practice - a South Korea Sub-StudyNov 5, 2026NCT07920315
- A Trial to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Spontaneous UrticariaOct 15, 2026NCT07875426
Studies
Recruiting first, then most recently updated. Showing 50 of 194. Browse all 194 → or search them.
- Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 WeeksRecruitingNCT07816328Phase 34 countries
- Remibrutinib in Real-world Clinical Practice - a South Korea Sub-StudyNot yet recruitingNCT07920315
- Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous UrticariaEnrolling by invitationNCT07256392Phase 330 countries
- A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)RecruitingNCT07766499Phase 21 country
- A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.RecruitingNCT07219615Phase 210 countries
- A Trial to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Spontaneous UrticariaNot yet recruitingNCT07875426Phase 2
- Apremilast Added to Antihistamines in Chronic UrticariaEnrolling by invitationNCT07850843Phase 21 country
- Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic UrticariaRecruitingNCT06865651Phase 25 countries
- A Phase 2 Study of MG-K10 in Chronic Spontaneous UrticariaNot yet recruitingNCT07838727Phase 2
- Characteristics and Management of Patients With Severe Chronic Spontaneous and/or Inducible Urticaria Refractory to Optimized Omalizumab Treatment: A French Multicenter Observational Study.RecruitingNCT078336961 country
- An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous UrticariaRecruitingNCT06927999Phase 22 countries
- 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 ParticipantsRecruitingNCT07005713Phase 11 country
- Mediterranean and Low-Histamine Diets for Pediatric Chronic Spontaneous UrticariaRecruitingNCT07765979Not applicable1 country
- Compassionate Use or Expanded Access of DupilumabAvailableNCT04776694
- A Phase Ib/IIa Study Assessing the Rapid Onset Characteristics of TLL-018 for Moderate-to-Severe CSU With Inadequate Response to Second-Generation H1 AntihistaminesNot yet recruitingNCT07665996Phase 1/21 country
- A Study of Efficacy and Safety of TLL-018 in CSU Participants With Inadequate Response to 2nd-generation H1-AHsNot yet recruitingNCT07764003Phase 2
- Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)RecruitingNCT076425571 country
- Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.RecruitingNCT07402213Phase 31 country
- 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)RecruitingNCT07717905Phase 1/21 country
- Phase Ib, Randomized, Double-blind, Placebo-Controlled, Dose-Escalation Study of Alpha-0261 Tablets to Assess Safety and Tolerability in Patients With Chronic Spontaneous Urcaria (Part 1) and Food Effect in Healthy Adults (Part 2).Not yet recruitingNCT07684560Phase 11 country
- Pseudoallergen-Free and Low-Histamine Diet in Adolescents With Chronic Spontaneous UrticariaEnrolling by invitationNCT07632040Not applicable1 country
- A Clinical Trial of HRS-3095 in Patients With Chronic Spontaneous UrticariaNot yet recruitingNCT07613866Phase 21 country
- A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria PatientsRecruitingNCT074082191 country
- A Prospective, Single-centre, Observational Cohort Study on the Efficacy and Safety of Bacterial Lysate (OM-85) in Combination With Antihistamines for the Treatment of Chronic Spontaneous Urticaria (CSU)Not yet recruitingNCT075578881 country
- A Study of MG-K10 in Chronic Spontaneous UrticariaNot yet recruitingNCT07546487Phase 3
- A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy AdultsRecruitingNCT07540910Phase 11 country
- Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous UrticariaRecruitingNCT07378527Phase 2/31 country
- Remibrutinib in Real-world Clinical PracticeRecruitingNCT073583641 country
- Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-AntihistaminesRecruitingNCT07415551Phase 24 countries
- Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)RecruitingNCT07166211Phase 21 country
- Autologous Whole Blood Therapy in Chronic Idiopathic Urticaria Patients.Not yet recruitingNCT07486583Phase 31 country
- Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous UrticariaEnrolling by invitationNCT074316581 country
- ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab BiosimilarRecruitingNCT074256391 country
- Remibrutinib in Real-world Clinical Practice - a US Sub-studyRecruitingNCT073587801 country
- Analysis of the Role of IgE Proteoforms in Health and DiseaseRecruitingNCT073281781 country
- Global Managed Access Program Cohort for Remibrutinib in Adult Patients With Chronic Spontaneous UrticariaAvailableNCT05170724
- Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous UrticariaRecruitingNCT05916937Phase 41 country
- SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)RecruitingNCT070214951 country
- 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.Not yet recruitingNCT06864507Phase 1/21 country
- Treatment Options for Chronic UrticariaNot yet recruitingNCT06816784Phase 21 country
- Trial of JYB1904 in Chronic Spontaneous Urticaria.RecruitingNCT06509334Phase 21 country
- A Study to Explore the Efficacy and Safety of HWH486 in Adults With Chronic Spontaneous UrticariaRecruitingNCT06295302Phase 21 country
- Efficacy and Safety of Histamine Human Immunoglobulin in the Treatment of Chronic Spontaneous Urticaria (CSU)Not yet recruitingNCT06250400Phase 4
- Assessment of Serum Levels of Adenosine Deaminase and Immunoglobulin E in Patients With Chronic Spontaneous UrticariaNot yet recruitingNCT05992987
- Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous UrticariaNot yet recruitingNCT04175704Phase 1
- Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy VolunteersNot yet recruitingNCT04404023Phase 1
- 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-antihistaminesActive, not recruitingNCT06868212Phase 31 country
- A Trial of HRS-3095 in Healthy VolunteersActive, not recruitingNCT07686484Early Phase 11 country
- A Single-Arm Exploratory Study of NatureU Hista Dissolve on Chronic Urticaria SymptomsCompletedNCT07611032Not applicable1 country
- Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) TreatmentCompletedNCT06228560Phase 21 country