Clinical trials: Chronic Spontaneous Urticaria, active
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Characteristics and Management of Patients With Severe Chronic Spontaneous and/or Inducible Urticaria Refractory to Optimized Omalizumab Treatment: A French Multicenter Observational Study.
The study is sponsored by the University Hospital of Besancon under the coordination of Dr. Julie Castagna from the Department of Dermatology and Allergology.
- Trial name
- OMADROP (NCT07833696)
- Testing
- drug effect
- Where
- France
- Volunteers
- 73 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Chronic Urticaria, Idiopathic
A Phase 2 Study of MG-K10 in Chronic Spontaneous Urticaria
This Phase 2 study evaluates the efficacy and safety of MG-K10 in participants with chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines.
- Trial name
- NCT07838727
- Testing
- MG-K10 Injection
- Volunteers
- 60 people
- Sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
Chronic Spontaneous Urticaria
Trial of JYB1904 in Chronic Spontaneous Urticaria.
This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
- Trial name
- NCT06509334
- Testing
- JYB1904, Omalizumab
- Where
- China
- Volunteers
- 135 people
- Sponsor
- Jemincare
Chronic Spontaneous Urticaria
Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
- Trial name
- NCT07402213
- Testing
- JYB1904
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Jemincare
Chronic Idiopathic Urticaria
Autologous Whole Blood Therapy in Chronic Idiopathic Urticaria Patients.
To evaluate the efficacy of Autologous Whole Blood Therapy versus conventional treatment using fourfold dose of antihistamines in Autologus serum skin test (ASST) positive and negative Chronic Idiopathic Urticaria (CIU) patients…
- Trial name
- NCT07486583
- Testing
- Autologous whole blood therapy, Desloratadine
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Cairo University
Chronic Spontaneous Urticaria (CSU)
Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria
The purpose of this study is to compare the efficacy and safety of ICP-332 in moderate to severe chronic spontaneous urticaria subjects inadequately controlled by second generation H1-antihistamines
- Trial name
- NCT07378527
- Testing
- ICP-332 Tablets
- Where
- 30 sites in China
- Volunteers
- 344 people
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
Chronic Urticaria, Chronic Spontaneous Urticaria
Apremilast Added to Antihistamines in Chronic Urticaria
This study evaluates whether adding oral apremilast, a phosphodiesterase-4 inhibitor, to second-generation H1 antihistamines improves disease activity and quality of life in adults with chronic urticaria that is not controlled by…
- Conditions
- Chronic Urticaria, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria
- Trial name
- APREM-CU (NCT07850843)
- Testing
- Apremilast, Second-generation H1 antihistamine
- Where
- Pakistan
- Volunteers
- 86 people
- Sponsor
- Rashid Latif Medical College
Chronic Spontaneous Urticaria
A Study of Efficacy and Safety of TLL-018 in CSU Participants
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TLL-018 in Participants With Moderate-to-Severe Chronic Spontaneous Urticaria (CSU) With Inadequate Controll to…
- Trial name
- NCT06396026
- Testing
- TLL-018 tablets
- Where
- China
- Volunteers
- 440 people
- Sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
Chronic Spontaneous Urticaria
Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
Prospective, non-interventional study in patients with chronic spontaneous urticaria (CSU) where the treatment decision prior enrollment has been made to escalate/switch current treatment to remibrutinib.
- Trial name
- REASSERT (NCT07920315)
- Volunteers
- 578 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria (CSU)
Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with CSU.
- Trial name
- NCT07166211
- Testing
- CM512 injection
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Keymed Biosciences Co.Ltd
Chronic Spontaneous Urticaria (CSU)
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
This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily [b.i.d.] by mouth [p.o.]) compared to dupilumab (600 mg loading dose administered…
- Trial name
- RECLAIM (NCT06868212)
- Testing
- Remibrutinib, Dupilumab
- Where
- 121 sites in United States
- Volunteers
- 409 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
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.
The purpose of the core phase of the trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every…
- Trial name
- NCT06042478
- Testing
- Remibrutinib, Omalizumab
- Where
- 110 sites in Argentina, Brazil and 21 more
- Volunteers
- 470 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
A Study of Single Dose of LP-003 in Healthy Adult Subjects
The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy subjects.
- Trial name
- NCT06604949
- Testing
- LP-003 200mg
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Longbio Pharma
Chronic Spontaneous Urticaria
Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks
The purpose of this open-label study is to assess the efficacy and safety of a novel treatment algorithm for sequencing remibrutinib and omalizumab in the treatment of adult participants with chronic spontaneous urticaria (CSU)…
- Trial name
- NCT07816328
- Testing
- Remibrutinib, Omalizumab
- Where
- 5 sites in Hong Kong, Japan and 1 more
- Volunteers
- 382 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria (CSU)
Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous Urticaria
Chronic spontaneous urticaria (CSU) is an immune-mediated skin disorder characterized by pruritic wheals and/or angioedema. This study aims to evaluate the relationship between diet-derived antioxidant capacity and oxidative…
- Trial name
- NCT07431658
- Where
- Turkey (Türkiye)
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Istanbul Training and Research Hospital
Chronic Spontaneous Urticaria
A Clinical Trial of HRS-3095 in Patients With Chronic Spontaneous Urticaria
The study is being conducted to evaluate the efficacy, and safety of HRS-3095 with Chronic Spontaneous in adults, and to explore the reasonable dosage of HRS-3095 for Chronic Spontaneous Urticaria.
- Trial name
- NCT07613866
- Testing
- HRS-3095 Tablet
- Where
- 2 sites in China
- Volunteers
- 190 people
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Chronic Spontaneous Urticaria (CSU), Healthy Volunteers
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).
This is a randomized, double-blind, placebo-controlled phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Alpha-0261 Tablets in healthy Chinese adults and in patients with…
- Trial name
- NCT07684560
- Testing
- Alpha-0261
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AlphaMol Science Ltd. (Shanghai)
Chronic Spontaneous Urticaria
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation…
- Trial name
- EMBARQ-CSU1 (NCT06445023)
- Testing
- barzolvolimab
- Where
- 235 sites in United States, Argentina and 19 more
- Volunteers
- 963 people
- Sponsor
- Celldex Therapeutics
Chronic Spontaneous Urticaria
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)
This is a Phase IIa, randomized, blinded, placebo controlled,Multiple-Ascending Dose study of BBT001 in adult patients with Chronic Spontaneous Urticaria.
- Trial name
- NCT07717905
- Testing
- BBT001
- Where
- 10 sites in China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Bambusa Therapeutics
Chronic Spontaneous Urticaria
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
This is a Phase 1b study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of multiple-ascending doses of tacabrutideg in adults with chronic spontaneous urticaria (CSU) and in healthy participants.
- Trial name
- NCT07005713
- Testing
- Tacabrutideg
- Where
- 9 sites in China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- BeOne Medicines