A Study of MG-K10 in Chronic Spontaneous Urticaria
ConditionChronic Spontaneous Urticaria (CSU)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-75
SponsorShanghai Mabgeek Biotech.Co.Ltd
About this trial
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial aimed at evaluating the efficacy and safety of MG-K10 humanized monoclonal antibody injection in CSU trial participants with poor control of second-generation H1 antihistamines.
Eligibility criteria
Qualifiers
Aged ≥12 and ≤75 years, body weight ≥30 kg, voluntarily sign ICF.
Diagnosed with CSU for ≥6 months, with pruritus and wheals for >6 weeks despite using second-generation H1 antihistamines.
Within 7 days prior to randomization: UAS7 score ≥16, ISS7 score ≥8, and at least one UAS ≥4.
Disqualifiers
Inducible urticaria (e.g., dermographism, cold, heat, cholinergic) or other chronic pruritic skin diseases (e.g., atopic dermatitis) affecting study assessment.
Active tuberculosis, or untreated latent TB; serious active infections.
Known or suspected immunodeficiency, or history of invasive opportunistic infections.
Known allergy to study drug or excipients.
Trial design
Treatments tested in this trial
- MG-K10 Humanized Monoclonal Antibody Injection
- Placebo
Treatment groups
226 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov