A Phase 2 Study of MG-K10 in Chronic Spontaneous Urticaria
ConditionChronic Urticaria, Idiopathic
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Mabgeek Biotech.Co.Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
MG-K10 Injection
DrugMG-K10 humanized monoclonal antibody injection targeting interleukin-4 receptor alpha (IL-4Rα), administered by subcutaneous injection.
Matching Placebo
DrugMatching placebo administered by subcutaneous injection, placebo matches MG-K10 in appearance and administration schedule to maintain blinding.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: MG-K10；600 mg SC at Week 0, then 300 mg SC Q4W through Week 12，4 doses total.Experimental treatment 1 intervention
Group B: Matching placebo SC；4.0 mL at Week 0, then 2.0 mL Q4W，4 doses total.Placebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline to Week 16Secondary outcomes
1
Change from baseline in Itch Severity Score over 7 Days (ISS7) at Week 16
The Itch Severity Score over 7 Days (ISS7) is the sum of the daily itch severity scores over 7 consecutive days. Each daily itch severity score ranges from 0 to 3, where 0 indicates no itch and 3 indicates intense itch. The total ISS7 ranges from 0 to 21, where 0 indicates no itch and 21 indicates the most severe itch. Higher ISS7 scores indicate worse itch severity. Change from baseline is calculated as the ISS7 at Week 16 minus the baseline ISS7; a negative change indicates improvement.
Time frame
Baseline to Week 162
Change from baseline in Hives Severity Score over 7 Days (HSS7) at Week 16
The Hives Severity Score over 7 Days (HSS7) is the sum of the daily hives severity scores over 7 consecutive days. Each daily hives severity score ranges from 0 to 3, where 0 indicates no hives, 1 indicates fewer than 20 hives per 24 hours, 2 indicates 20 to 50 hives per 24 hours, and 3 indicates more than 50 hives per 24 hours or large confluent areas of hives. The total HSS7 ranges from 0 to 21. Higher HSS7 scores indicate greater hives severity and worse outcome. Change from baseline is calculated as the HSS7 at Week 16 minus the baseline HSS7; a negative change indicates improvement.
Time frame
Baseline to Week 16Other outcomes
1
adverse events
Adverse events will be assessed from the first administration of study intervention through the protocol-specified follow-up period. The number of participants experiencing at least one adverse event will be summarized by treatment group.
Time frame
Baseline to Week 24Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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