Chronic Urticaria, IdiopathicPhase 2NCT07838727
A Phase 2 Study of MG-K10 in Chronic Spontaneous Urticaria
A Phase 2 study testing MG-K10 Injection in people with Chronic Urticaria, Idiopathic, run by Shanghai Mabgeek Biotech.Co.Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Urticaria, Idiopathic
- What is being tested?
- MG-K10 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2026to 20 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Subjects With Chronic Spontaneous Urticaria
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
- Being tested
- MG-K10 Injection, Matching Placebo
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MG-K10 InjectionDrug
MG-K10 humanized monoclonal antibody injection targeting interleukin-4 receptor alpha (IL-4Rα), administered by subcutaneous injection.
Matching PlaceboDrug
Matching placebo administered by subcutaneous injection, placebo matches MG-K10 in appearance and administration schedule to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| MG-K10；600 mg SC at Week 0, then 300 mg SC Q4W through Week 12，4 doses total. | Experimental | Not described Receives: Drug: MG-K10 Injection |
| Matching placebo SC；4.0 mL at Week 0, then 2.0 mL Q4W，4 doses total. | Placebo comparator | Not described Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 16
Secondary outcomes (2)
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.
Measured: Baseline to Week 16
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.
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start23 Sep 2026 (estimated)
- Primary completion7 May 2027 (estimated)
- Study completion20 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Urticaria, IdiopathicStudies of the same condition, open and under way.
- More trials run by Shanghai Mabgeek Biotech.Co.LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838727
- Sponsor's protocol ID
- MG-K10-CSU-002
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Subjects With Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT07838727
- Acronym / sponsor ID
- MG-K10-CSU-002
- Conditions
- Chronic Urticaria, Idiopathic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2026 (estimated)
- Primary completion
- 7 May 2027 (estimated)
- Study completion
- 20 Sep 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MG-K10 InjectionMG-K10 humanized monoclonal antibody injection targeting interleukin-4 receptor alpha (IL-4Rα), administered by subcutaneous injection. | Drug | MG-K10；600 mg SC at Week 0, then 300 mg SC Q4W through Week 12，4 doses total. |
| Matching PlaceboMatching placebo administered by subcutaneous injection, placebo matches MG-K10 in appearance and administration schedule to maintain blinding. | Drug | Matching placebo SC；4.0 mL at Week 0, then 2.0 mL Q4W，4 doses total. |
Primary outcome
Change from baseline in Urticaria Activity Score over 7 Days (UAS7) at Week 16
Time frame: Baseline to 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.
2 secondary outcomes
Change from baseline in Itch Severity Score over 7 Days (ISS7) at Week 16
Time frame: Baseline to Week 16
Change from baseline in Hives Severity Score over 7 Days (HSS7) at Week 16
Time frame: Baseline to Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianzhong Zhang, MD principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MG-K10 Injection in people with Chronic Urticaria, Idiopathic, run by Shanghai Mabgeek Biotech.Co.Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Project Manager (+86-021-51371305, xiaofeng.cai@mabgeek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Urticaria Activity Score over 7 Days (UAS7) at Week 16 (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.