Chronic Spontaneous Urticaria Clinical Trial
Official title:
A Multi-center, Single-arm Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Male and Female Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU)
This is a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study is to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of H1-antihistamine treatment. Study details include: Screening: 2 to 4 weeks; The treatment duration will be 24 weeks; Follow-up period: 12 weeks; The study duration will be 38 to 40 weeks (including screening and follow-up); The number of study visits will be 6.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06077773 -
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria
|
Phase 2 | |
| Completed |
NCT04538794 -
A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
|
Phase 1 | |
| Completed |
NCT01803763 -
Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05298215 -
A Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of UB-221 IV Infusion as an add-on Therapy in Patients With Chronic Spontaneous Urticaria
|
Phase 2 | |
| Terminated |
NCT04612725 -
A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)
|
Phase 2 | |
| Terminated |
NCT05528861 -
A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria
|
Phase 2 | |
| Completed |
NCT04109313 -
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU
|
Phase 2 | |
| Completed |
NCT03580356 -
A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
|
Phase 3 | |
| Completed |
NCT03580369 -
A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
|
Phase 3 | |
| Completed |
NCT05030311 -
A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines
|
Phase 3 | |
| Recruiting |
NCT06162728 -
Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)
|
Phase 1/Phase 2 | |
| Completed |
NCT05107115 -
Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine
|
Phase 2 | |
| Recruiting |
NCT06042478 -
A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients.
|
Phase 3 | |
| Terminated |
NCT04159701 -
A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria
|
Phase 2 | |
| Completed |
NCT03749135 -
Dupilumab in Chronic Spontaneous Urticaria
|
Phase 2 | |
| Not yet recruiting |
NCT06396026 -
A Study of Efficacy and Safety of TLL-018 in CSU Participants
|
Phase 3 | |
| Completed |
NCT02649218 -
A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
|
Phase 2 | |
| Active, not recruiting |
NCT05368285 -
A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
|
Phase 2 | |
| Completed |
NCT05373355 -
Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria.
|
Phase 1 | |
| Not yet recruiting |
NCT06365879 -
To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria
|
Phase 3 |