Chronic Spontaneous Urticaria Clinical Trial
Official title:
Efficacy and Safety of Levocetirizine Alone or in Combination With Tranexamic Acid in the Treatment of Spontaneous Chronic Urticaria. Multicentric Controlled Randomized Study in Cross-over, Double-blind
Spontaneous chronic urticaria (UCS) is a disease that affects 1% of the general population with a potentially severe impact on quality of life. Most patients respond favorably to long-term antihistamine treatment, but sometimes it is necessary to give a high dose (4 times the formal dose, Berlin consensus 2016). These high doses are often accompanied by side effects requiring cessation of treatment. The therapeutic alternative is then omalizumab, an expensive biotherapy. UCS is secondary to non-specific mast cell activation. It has been shown to be associated with activation of fibrinolysis that correlates with the severity of symptoms. Patients with UCS resistant to levocetirizine were shown to have higher D-dimer levels than patients who responded to antihistamines. Tranexamic acid is a molecule with antifibrinolytic propertiesSeveral cases of severe chronic urticaria responding favorably to treatment with tranexamic acid have been reported. In our department, Investigators also noticed the improvement of some of their patients on tranexamic acid. The combination of these two treatments appears to be synergistic: action on histamine receptors and control of fibrinolysis. The investigators propose to evaluate the association of tranexamic acid and levocetirizine for the treatment of chronic spontaneous urticaria.
Multicentric controlled randomized crossover study, double-blind To evaluate the efficacy and safety of levocetirizine 10mg / day + tranexamic acid (AT) 2g / day versus levocetirizine 20mg / day alone in the chronic treatment of chronic urticaria evaluated at 4 weeks. A hierarchical analysis will be implemented in the following order: 1. Non-inferiority of the combination levocetirizine 10 mg / day + tranexamic acid (TA) 2 g / day versus levocetirizine alone 20 mg / day in terms of effectiveness 2. Superiority of the combination levocetirizine 10 mg / day + tranexamic acid (AT) 2 g / day versus levocetirizine alone 20 mg / day in terms of tolerance 3. Superiority of levocetirizine 10mg / day + tranexamic acid (AT) 2g / day versus levocetirizine alone 20mg / day in terms of effectiveness Each objective will be tested sequentially if and only if the previous objective is validated. ;
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 |