A Study of MG-K10 in Chronic Spontaneous Urticaria

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Spontaneous Urticaria (CSU)
• Intervention / Treatment: Biological: MG-K10 Humanized Monoclonal Antibody Injection; Biological: Placebo

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).

• Study Type: Interventional
• Enrollment (Estimated): 226
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Project Manager; Phone Number: +86-021-51371305; Email: xiaofeng.cai@mabgeek.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged ≥12 and ≤75 years, body weight ≥30 kg, voluntarily sign ICF.
2. Diagnosed with CSU for ≥6 months, with pruritus and wheals for >6 weeks despite using second-generation H1 antihistamines.
3. 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:

1. Inducible urticaria (e.g., dermographism, cold, heat, cholinergic) or other chronic pruritic skin diseases (e.g., atopic dermatitis) affecting study assessment.
2. Active tuberculosis, or untreated latent TB; serious active infections.
3. Known or suspected immunodeficiency, or history of invasive opportunistic infections.
4. Known allergy to study drug or excipients.
5. Prior use of MG-K10 or other biologics (anti-IL-4Rα, anti-IgE, etc.) within 16 weeks or 5 half-lives.
6. Use of immunosuppressants, systemic corticosteroids, phototherapy, or Chinese herbal medicine within 4 weeks prior to first UAS assessment.
7. 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.
8. Positive for HBsAg, or HBcAb positive with HBV-DNA ≥1×10³ copies/ml; HCV-Ab positive with HCV-RNA positive; HIV antibody positive.
9. QTcF >500 msec or other clinically significant ECG abnormalities.
10. Pregnant, breastfeeding, or planning pregnancy during the study.
11. History of malignant tumors within 5 years (except adequately treated non-melanoma skin cancer or cervical carcinoma in situ).
12. Participated in another clinical study and used investigational drug within 12 weeks or 5 half-lives prior to first UAS assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MG-K10 humanized monoclonal antibody injection; Usage and dosage: Administer once every 4 weeks, with an initial dose of 600mg (4.0 ml) and subsequent doses of 300mg (2.0 ml)	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).
Placebo Comparator: placebo; Medication schedule: placebo received on Day 1 (D1) and Week 24 (W24), MG-K10 300mg Q4W received from Week 24 (W24) to Week 48 (W48)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcome Measure	Change from baseline in UAS7 at Week 24	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes in ISS7 compared	The changes of ISS7 compared to the baseline for each visit	Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56
The changes in USA7 compared	The changes in each visit compared to the baseline (except for W24) for USA7	Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56
Outcome Measure	Change from baseline in AAS7 at scheduled visits	Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52,56
Proportion of participants with UAS7 ≤6	Proportion of participants with UAS7 ≤6	Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52,56
Outcome Measure	Time to and proportion of UAS7 MID response (≥11 decrease)	Up to 56 weeks
DLQI/CDLQI scores change	Change from baseline in DLQI/CDLQI scores	each visit
Outcome Measure	Incidence and severity of adverse events	Up to 56 weeks

Collaborators and Investigators

• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): April 14, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: MG-K10
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Urticaria; Skin Diseases, Vascular; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Chronic Urticaria
• Other Study ID Numbers: MG-K10-CSU-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No