Clinical trials: Chronic Spontaneous Urticaria, active
Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)
THB335-201 is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adults with CSU who remain symptomatic despite standard-of-care treatment.
- Trial name
- NCT07766499
- Testing
- THB335 Lower Dose, THB335 Higher Dose
- Volunteers
- 81 people
- Sponsor
- Calixis Inc.
Urticaria Chronic
Mediterranean and Low-Histamine Diets for Pediatric Chronic Spontaneous Urticaria
Chronic spontaneous urticaria (CSU) is a chronic inflammatory skin disease that can substantially impair quality of life in children and adolescents.
- Trial name
- NCT07765979
- Testing
- Low-Histamine Diet, Mediterranean Diet
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Saglik Bilimleri Universitesi
Chronic Spontaneous Urticaria
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
The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to < 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by…
- Trial name
- NCT05677451
- Testing
- LOU064 (blinded)
- Where
- 49 sites in United States, Argentina and 15 more
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
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-CSU2 (NCT06455202)
- Testing
- barzolvolimab
- Where
- 245 sites in United States, Australia and 20 more
- Volunteers
- 976 people
- Sponsor
- Celldex Therapeutics
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 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
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 Inducible Urticaria, Chronic Spontaneous Urticaria
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults
This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered single and multiple doses of EDP-978 in…
- Trial name
- NCT07540910
- Testing
- EDP-978
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
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 (CSU), Hidradenitis Suppurativa (HS)
SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
The goal of this observational study is to comprehensively profile six immune-mediated inflammatory diseases, including atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), cutaneous T-cell lymphoma…
- Conditions
- Chronic Spontaneous Urticaria (CSU), Hidradenitis Suppurativa (HS), Psoriasis (PsO), Atopic Dermatitis (AD)
- Trial name
- SKINERGY (NCT07021495)
- Where
- 8 sites in Netherlands
- Volunteers
- 840 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
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
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
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.
This is a randomized, double-blind, placebo-controlled phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HS-10561 capsule in healthy Chinese adults and patients with…
- Trial name
- NCT06864507
- Testing
- HS-10561
- Where
- China
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Allergic Diseases, Chronic Spontaneous Urticaria (CSU)
Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
This study aims to evaluate the efficacy and safety of lesigercept in approximately 150 participants with CSU. By enrolling participants with an inadequate response to H1-antihistamines, including those previously treated with…
- Trial name
- CLEAR (NCT07415551)
- Testing
- Lesigercept
- Where
- 30 sites in Bulgaria, China and 2 more
- Volunteers
- 150 people
- Sponsor
- Yuhan Corporation
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
Chronic Spontaneous Urticaria (CSU)
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 Antihistamines
The goal of this clinical trial is to evaluate the rapid onset characteristics of TLL-018 in moderate-to-severe CSU with inadequate response to second-generation H1 antihistamines.
- Trial name
- NCT07665996
- Testing
- TLL-018
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Hangzhou Highlightll Pharmaceutical 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 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
Remibrutinib in Real-world Clinical Practice
Prospective, multi-country, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to…
- Trial name
- REASSERT (NCT07358364)
- Where
- United States
- Volunteers
- 3,280 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Inducible Urticaria, Chronic Spontaneous Urticaria
Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)
This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of BLU-808, a wild type KIT inhibitor, in participants…
- Trial name
- NCT06931405
- Testing
- BLU-808
- Where
- 47 sites in United States, Denmark and 4 more
- Volunteers
- 105 people
- Sponsor
- Blueprint Medicines Corporation