A Study of MG-K10 in Chronic Spontaneous Urticaria
Starting soon · Phase 3 · Has a placebo group
Conditions studied: Chronic Spontaneous Urticaria (CSU)
In brief
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.
Key facts
- Study ID
- NCT07546487
- Run by
- Shanghai Mabgeek Biotech.Co.Ltd
- People needed
- 226
- Starts
- 2026-04-14
- Expected to finish
- 2028-03-31
- Last updated by the study team
- 2026-04-22
Who can join
Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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