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Not yet recruiting NCT07546487

A Study of MG-K10 in Chronic Spontaneous Urticaria

Phase III Interventional Chronic Spontaneous Urticaria (CSU)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MG-K10 Humanized Monoclonal Antibody Injection, Placebo.
Who it may be relevant to
Registry conditions: Chronic Spontaneous Urticaria (CSU). Basic parameters: 12 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Chronic Spontaneous Urticaria

Overview

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.

Detailed description

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. A total of 226 patients with chronic spontaneous urticaria (CSU) are planned to be enrolled in this study and randomly assigned to either the experimental group or the control group at a 1:1 ratio. The study consists of a screening period (1-4 weeks), a double-blind treatment period (24 weeks), a continuous treatment period (24 weeks), and a follow-up period (8 weeks).

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)

Primary outcome measures

  • Outcome Measure [Time frame: 24 weeks]
Secondary outcome measures (7)
  • The changes in ISS7 compared [Time frame: Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56]
  • The changes in USA7 compared [Time frame: Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56]
  • Outcome Measure [Time frame: Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52,56]
  • Proportion of participants with UAS7 ≤6 [Time frame: Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52,56]
  • Outcome Measure [Time frame: Up to 56 weeks]
  • DLQI/CDLQI scores change [Time frame: each visit]
  • Outcome Measure [Time frame: Up to 56 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

3.Willing to maintain stable background antihistamine dose during the study (up to 4 times standard dose allowed).

4.Agree to use effective contraception during the study and for 6 months after last dose.

Exclusion criteria

  • 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.
  • Prior use of MG-K10 or other biologics (anti-IL-4Rα, anti-IgE, etc.) within 16 weeks or 5 half-lives.
  • Use of immunosuppressants, systemic corticosteroids, phototherapy, or Chinese herbal medicine within 4 weeks prior to first UAS assessment.
  • Clinically significant laboratory abnormalities at screening: ANC <1.2×10⁹/L, platelets <90×10⁹/L, ALT/AST/total bilirubin >2×ULN, creatinine >1.5×ULN.
  • Positive for HBsAg, or HBcAb positive with HBV-DNA ≥1×10³ copies/ml; HCV-Ab positive with HCV-RNA positive; HIV antibody positive.
  • QTcF >500 msec or other clinically significant ECG abnormalities.
  • Pregnant, breastfeeding, or planning pregnancy during the study.
  • History of malignant tumors within 5 years (except adequately treated non-melanoma skin cancer or cervical carcinoma in situ).
  • Participated in another clinical study and used investigational drug within 12 weeks or 5 half-lives prior to first UAS assessment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07546487 · MG-K10-CSU-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗