A Phase 2 Study of MG-K10 in Chronic Spontaneous Urticaria

NCT07838727 | Not Yet Recruiting Phase 2

• 1 other identifier: MG-K10-CSU-002
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Phase 2 study evaluates the efficacy and safety of MG-K10 in participants with chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines. Participants are randomized 1:1 to MG-K10 or placebo for 16 weeks, followed by an 8-week follow-up period.

Conditions

Chronic Urticaria, Idiopathic

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Urticaria Activity Score over 7 Days (UAS7) at Week 16

  UAS7 is the sum of daily itch severity and hive severity scores over 7 days, with total scores ranging from 0 to 42. The change from baseline at Week 16 will be compared between MG-K10 and placebo.

  Baseline to Week 16

Secondary Outcomes (2)

• Change from baseline in Itch Severity Score over 7 Days (ISS7) at Week 16

  Baseline to Week 16

• Change from baseline in Hives Severity Score over 7 Days (HSS7) at Week 16

  Baseline to Week 16

Other Outcomes (1)

• adverse events

  Baseline to Week 24

Study Arms (2)

MG-K10；600 mg SC at Week 0, then 300 mg SC Q4W through Week 12，4 doses total.

EXPERIMENTAL

Drug: MG-K10 Injection

Matching placebo SC；4.0 mL at Week 0, then 2.0 mL Q4W，4 doses total.

PLACEBO COMPARATOR

Drug: Matching Placebo

Interventions

MG-K10 Injection DRUG

MG-K10 humanized monoclonal antibody injection targeting interleukin-4 receptor alpha (IL-4Rα), administered by subcutaneous injection.

MG-K10；600 mg SC at Week 0, then 300 mg SC Q4W through Week 12，4 doses total.

Matching Placebo DRUG

Matching placebo administered by subcutaneous injection, placebo matches MG-K10 in appearance and administration schedule to maintain blinding.

Matching placebo SC；4.0 mL at Week 0, then 2.0 mL Q4W，4 doses total.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CSU diagnosed ≥6 months.
• Itch and hives present continuously for \>6 weeks despite second-generation H1-antihistamine treatment.
• Before randomization：UAS7 ≥16，ISS7 ≥8，at least one investigator-assessed UAS ≥4.
• Stable second-generation H1-antihistamine background therapy per protocol.
• Effective contraception requirements during study and for 6 months after last dose.

You may not qualify if:

• Chronic inducible urticaria or other urticaria/angioedema-mimicking diseases.
• Other chronic pruritic skin disease affecting assessment.
• Active or inadequately treated tuberculosis；acute/subacute infection.
• Clinically significant uncontrolled diabetes，cardiac，renal，hepatic，neurologic，autoimmune，or other severe systemic disease.
• Hypersensitivity to study drug/excipients；severe monoclonal-antibody reaction history.
• Prior MG-K10 trial participation.

Sponsors & Collaborators

• Shanghai Mabgeek Biotech.Co.Ltd: lead

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jianzhong Zhang, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Project Manager

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 24, 2026
• Study Start: September 23, 2026
• Primary Completion (Estimated): May 7, 2027
• Study Completion (Estimated): September 20, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09