This pilot and dose-ranging study will evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A compared with placebo in participants with chronic spontaneous urticaria (CSU) refractory to antihistamines. This study comprises two parts. In Part 1, participants will be randomized to receive MTPS9579A or placebo. On the basis of positive results from Part 1, a dose-ranging Part 2 may be opened, where participants will be randomized to receive one of four MTPS9579A doses or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Change From Baseline in the UAS7
Change from baseline in the Urticaria Activity Score summed over 7 days (UAS7) at Week 12.
Time frame: Week 12
Proportion of Participants With Well-Controlled Urticaria
Proportion of participants with well-controlled urticaria (UAS7\<=6) at Week 12.
Time frame: Week 12
Proportion of Participants Who Achieve Complete Response
Proportion of participants who achieve complete response (UAS7=0) at Week 12.
Time frame: Week 12
Percentage of Participants With Adverse Events
Percentage of participants with adverse events.
Time frame: Up to approximately 96 weeks
Serum Concentration of MTPS9579A
Time frame: Through Week 20
Prevalence of Anti-Drug Antibodies (ADAs)
Time frame: Through Week 20
Incidence of ADAs
Time frame: Through Week 20
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