NCT07546487

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P25-P50 for phase_3

Timeline
23mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Mar 2028

First Submitted

Initial submission to the registry

March 19, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

April 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

March 19, 2026

Last Update Submit

April 16, 2026

Conditions

Chronic Spontaneous Urticaria (CSU)

Keywords

MG-K10

Outcome Measures

Primary Outcomes (1)

  • Outcome Measure

    Change from baseline in UAS7 at Week 24

    24 weeks

Secondary Outcomes (7)

  • The changes in ISS7 compared

    Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56

  • The changes in USA7 compared

    Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56

  • Outcome Measure

    Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52,56

  • Proportion of participants with UAS7 ≤6

    Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52,56

  • Outcome Measure

    Up to 56 weeks

  • +2 more secondary outcomes

Study Arms (2)

MG-K10 humanized monoclonal antibody injection

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

MG-K10 Humanized Monoclonal Antibody InjectionBIOLOGICAL

Administer once every 4 weeks, with an initial dose of 600mg (4.0 ml) and subsequent doses of 300mg (2.0 ml).

MG-K10 humanized monoclonal antibody injection
PlaceboBIOLOGICAL

Received placebo on Day 1 (D1) and Week 24 (W24), started receiving MG-K10 300mg Q4W from Week 24 (W24) to Week 48 (W48)

placebo

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

UrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Project Manager

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
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

March 19, 2026

First Posted

April 22, 2026

Study Start

April 14, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share