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A Study of MG-K10 in Chronic Spontaneous Urticaria

NCT07546487 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2026-04-22

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Spontaneous Urticaria (CSU)

Interventions

BIOLOGICAL

MG-K10 Humanized Monoclonal Antibody Injection

Administer once every 4 weeks, with an initial dose of 600mg (4.0 ml) and subsequent doses of 300mg (2.0 ml).

BIOLOGICAL

Placebo

Received placebo on Day 1 (D1) and Week 24 (W24), started receiving MG-K10 300mg Q4W from Week 24 (W24) to Week 48 (W48)

Sponsors & Collaborators

  • Shanghai Mabgeek Biotech.Co.Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-14
Primary Completion
2028-03-31
Completion
2028-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07546487 on ClinicalTrials.gov