Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
NCT07402213 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2026-02-11
Summary
This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
Conditions
Interventions
- DRUG
-
JYB1904
300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from Day 1 to Week 48.
- DRUG
-
Placebo+JYB1904
Placebo administered SC on D1 and W12; 300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from W24 to W48.
Sponsors & Collaborators
-
Jemincare
lead INDUSTRY
Principal Investigators
-
Jianzhong Zhang · Peking University People's Hospital
-
Cheng Zhou · Peking University People's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2027-06-30
- Completion
- 2028-04-28
More Related Trials
-
Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria
NCT04175704 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines
NCT05024058 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria
NCT04159701 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
NCT01292473 ·Status: COMPLETED ·Phase: PHASE3
-
Cholinergic Urticaria - Efficacy of Dupilumab
NCT03749148 ·Status: COMPLETED ·Phase: PHASE2
-
Dupilumab in Chronic Spontaneous Urticaria
NCT03749135 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines
NCT05030311 ·Status: COMPLETED ·Phase: PHASE3
-
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
NCT06868212 ·Status: RECRUITING ·Phase: PHASE3
-
Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
NCT02477332 ·Status: COMPLETED ·Phase: PHASE2
-
Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)
NCT04681729 ·Status: COMPLETED ·Phase: PHASE3
-
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
NCT05677451 ·Status: RECRUITING ·Phase: PHASE3
-
Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients
NCT02329223 ·Status: COMPLETED ·Phase: PHASE3
-
Interleukin-2 for Refractory Chronic Spontaneous Urticaria
NCT06924762 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
NCT03580356 ·Status: COMPLETED ·Phase: PHASE3
-
Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)
NCT04180488 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria
NCT04944602 ·Status: UNKNOWN ·Phase: PHASE3
-
A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
NCT03580369 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment
NCT01287117 ·Status: COMPLETED ·Phase: PHASE3
-
Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)
NCT07166211 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
NCT06865651 ·Status: RECRUITING ·Phase: PHASE2
-
Study to Investigate the Efficacy and Safety of QGE031 in Adolescent Patients With Chronic Spontaneous Urticaria (CSU)
NCT03437278 ·Status: COMPLETED ·Phase: PHASE2
-
Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects
NCT05449535 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous Urticaria
NCT07316114 ·Status: RECRUITING
-
A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria
NCT05129423 ·Status: WITHDRAWN ·Phase: PHASE2
-
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients
NCT03632291 ·Status: COMPLETED ·Phase: PHASE1