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A Study of MG-K10 in Chronic Spontaneous Urticaria

ConditionChronic Spontaneous Urticaria (CSU)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-75
SponsorShanghai Mabgeek Biotech.Co.Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MG-K10 Humanized Monoclonal Antibody Injection

    Biological/Vaccine

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

  • Placebo

    Biological/Vaccine

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

Treatment groups

226 Participants
are divided into 2 treatment groups
Group A: MG-K10 humanized monoclonal antibody injectionExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Outcome Measure

Change from baseline in UAS7 at Week 24

Time frame
24 weeks

Secondary outcomes

1

The changes in ISS7 compared

The changes of ISS7 compared to the baseline for each visit

Time frame
Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56
2

The changes in USA7 compared

The changes in each visit compared to the baseline (except for W24) for USA7

Time frame
Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56
3

Outcome Measure

Change from baseline in AAS7 at scheduled visits

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

Proportion of participants with UAS7 ≤6

Proportion of participants with UAS7 ≤6

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Mabgeek Biotech.Co.Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: