A Study of MG-K10 in Chronic Spontaneous Urticaria

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Биопрепарат 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).
• Биопрепарат 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)

Первичные конечные точки

• Outcome Measure [Срок оценки: 24 weeks]

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07546487 · MG-K10-CSU-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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