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A Phase 2 Study of MG-K10 in Chronic Spontaneous Urticaria
Sponsor: Shanghai Mabgeek Biotech.Co.Ltd
Summary
This Phase 2 study evaluates the efficacy and safety of MG-K10 in participants with chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines. Participants are randomized 1:1 to MG-K10 or placebo for 16 weeks, followed by an 8-week follow-up period.
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Subjects With Chronic Spontaneous Urticaria
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-09-23
Completion Date
2027-09-20
Last Updated
2026-09-24
Healthy Volunteers
No
Conditions
Interventions
MG-K10 Injection
MG-K10 humanized monoclonal antibody injection targeting interleukin-4 receptor alpha (IL-4Rα), administered by subcutaneous injection.
Matching Placebo
Matching placebo administered by subcutaneous injection, placebo matches MG-K10 in appearance and administration schedule to maintain blinding.