Chronic Spontaneous Urticaria Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Phase 2 Study of Rilzabrutinib Followed by an Open-label Extension Phase in Patients With Moderate-to-severe Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment
The first phase of this study will be a parallel, 12-week treatment, Phase 2, double-blind, 4 arm study to assess the safety and effectiveness of 3 oral doses of SAR444671 (rilzabrutinib), i.e. dose A, B and C, compared with placebo for decreasing the frequency and severity of itch and urticaria in male and female participants aged 18 years inclusive or older with CSU. After completion of the double-blind phase of the study, participants will be given the option of enrolling in the 40-week open label extension (OLE) phase of the study. Participants will receive open-label rilzabrutinib at dose C (the dose may be modified based on the 12-week safety and efficacy data). Due to the fact that some participants may be receiving rilzabrutinib for the first time, all participants will be monitored at Week 14, Week 16, Week 20, and Week 24. Afterwards, participants will be monitored at Week 36 and Week 52.
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 | |
| Active, not recruiting |
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 | |
| 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 | |
| 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 | |
| Not yet recruiting |
NCT06250400 -
Efficacy and Safety of Histamine Human Immunoglobulin in the Treatment of Chronic Spontaneous Urticaria (CSU)
|
Phase 4 | |
| Completed |
NCT03926611 -
This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines
|
Phase 2 |