Not Yet RecruitingPhase 3

A Study of MG-K10 in Chronic Spontaneous Urticaria

226 participantsStarted 2026-04-14

Plain-language 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.

Who can participate

Age range12 Years – 75 Years

SexALL

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

What they're measuring

Outcome Measure

Timeframe: 24 weeks

Trial details

NCT IDNCT07546487

SponsorShanghai Mabgeek Biotech.Co.Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-03-31

Contact for this trial

Clinical Project Manager

+86-021-51371305 xiaofeng.cai@mabgeek.com

View on ClinicalTrials.gov More Chronic Spontaneous Urticaria (CSU) trials