Table 1.

Ongoing clinical trials in chronic spontaneous urticaria (www.clinicaltrials.gov)

Therapy	Mechanism of action	NCT#	Phase	Primary outcomes
Dupilumab	Monoclonal antibody against IL-4/13Rα	NCT05526521 NCT04180488	Phase 3 Phase 3	The concentration of dupilumab in serum over time Change from baseline in weekly itch severity score (ISS7) and weekly urticarial activity score (UAS7)
UB221	Monoclonal antibody against CD23-bound IgE	NCT05298215 NCT04175704 NCT04404023	Phase 2 Phase 1 Phase 1	Change in serum free IgE level from baseline over time To evaluate the safety of UB-221 in CSU patients The adverse event incidence from the baseline to day 15 after infusion
Remibrutinib	Bruton tyrosine kinase inhibitor	NCT05513001 NCT05677451 NCT05048342 NCT05032157 NCT05030311	Phase 3 Phase 3 Phase 3 Phase 3 Phase 3	Time to first composite event (i.e., relapse (UAS7 ≥ 16) Change from baseline in UAS7, ISS7, and weekly hives severity score (HSS7) The number and the proportion of participants with adverse events Change from baseline in UAS7 Change from baseline in UAS7
Rilzabrutinib	Bruton tyrosine kinase inhibitor	NCT05107115	Phase 2	Change from baseline in UAS7 and ISS7 at Week 12
Mepolizumab	Anti-IL5 monoclonal antibodies	NCT03494881	Phase 1	Mean UAS7
Benralizumab	Anti-IL5 monoclonal antibodies	NCT04612725	Phase 2	Change from baseline in ISS7 at Week 12
Tezepelumab	Anti-TSLP monoclonal antibody	NCT04833855	Phase 2	Change from baseline in UAS7
Lirentelimab	Anti-Siglec-8 monoclonal antibody	NCT05528861	Phase 2	Absolute change in UAS7 at Week 12
Barzolvolimab	Anti-KIT monoclonal antibody	NCT05368285	Phase 2	Mean change from baseline to Week 12 of UAS7