Clinical trials: 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
Hereditary Angioedema
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
This Phase 3 study aims to evaluate the efficacy and safety of NTLA-2002 compared to placebo in participants with HAE.
- Trial name
- NCT06634420
- Testing
- NTLA-2002, Normal Saline IV Administration
- Where
- 29 sites in United States, Australia and 7 more
- Volunteers
- 80 people
- Sponsor
- Intellia Therapeutics
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.
Skin Diseases, Angio-Oedema and/or Urticaria
Deep Phenotyping of CIndU
Chronic inducible urticaria (CIndU) is a group of skin disorders defined by recurrent itchy or burning wheals or angioedema that recur for more than six weeks with a specific triggering factor.
- Trial name
- NCT07359430
- Where
- 3 sites in Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Centre for Human Drug Research, Netherlands
Hereditary Angioedema (HAE)
A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema
Hereditary angioedema (HAE) is a rare condition. It causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals.
- Trial name
- AHAE (NCT07293364)
- Testing
- Technochrom C1-INH Kit
- Where
- Algeria
- Volunteers
- 514 people
- Sponsor
- Takeda
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
Hereditary Angioedema
Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL)
This is a Phase 4, prospective, open-label trial to evaluate the safety and effectiveness of sebetralstat when used for STP for a qualifying procedures in patients 12 years of age or older with hereditary angioedema (HAE).
- Trial name
- NCT07654829
- Testing
- KVD900 600 mg
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
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
Hereditary Angioedema, HAE
A Gene Therapy Study of BMN 331 in Subjects With Hereditary Angioedema
This is a Phase 1/2, single-arm, open-label, dose-escalation and dose-expansion study of BMN 331 for the treatment of hereditary angioedema (HAE) due to C1 Esterase Inhibitor (C1-INH) protein deficiency.
- Trial name
- HAErmony-1 (NCT05121376)
- Testing
- Dose 1 of BMN 331, Dose 2 of BMN 331, Dose 3 of BMN 331
- Where
- 16 sites in United States, Australia and 1 more
- Volunteers
- 44 people
- Sponsor
- BioMarin Pharmaceutical
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
NOMID, DIRA
Natural History, Pathogenesis, and Outcome of Autoinflammatory Diseases (NOMID/CAPS, DIRA, CANDLE, SAVI, NLRC4-MAS, Still'S-like Diseases, and Other Undifferentiated Autoinflammatory Diseases)
Background: Some diseases cause chronic inflammation with intermittent flares in the body. These are called autoinflammatory diseases. They can cause fevers, rashes, ulcers, and other problems.
- Conditions
- NOMID, DIRA, NLRC4-MAS, SAVI
- Trial name
- NCT02974595
- Where
- United States
- Volunteers
- 3,200 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chronic Inducible Urticaria, Cold Urticaria
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism…
- Conditions
- Chronic Inducible Urticaria, Cold Urticaria, Cold-Induced Urticaria, Symptomatic Dermographism
- Trial name
- NCT07266402
- Testing
- Barzolvolimab
- Where
- 72 sites in United States, Germany and 5 more
- Volunteers
- 240 people
- Sponsor
- Celldex Therapeutics
Hereditary Angioedema (HAE)
A Survey of Lanadelumab in Participants With Hereditary Angioedema
This study is a survey in Japan of Lanadelumab used to treat people with hereditary angioedema (HAE). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics…
- Trial name
- NCT05397431
- Testing
- Lanadelumab
- Where
- Japan
- Volunteers
- 155 people
- Sponsor
- Takeda
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