Chronic Spontaneous Urticaria (CSU)Phase 3NCT07546487
A Study of MG-K10 in Chronic Spontaneous Urticaria
A Phase 3 study testing MG-K10 Humanized Monoclonal Antibody Injection in people with Chronic Spontaneous Urticaria (CSU), run by Shanghai Mabgeek Biotech.Co.Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Chronic Spontaneous Urticaria (CSU)
- What is being tested?
- MG-K10 Humanized Monoclonal Antibody Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2026to 31 Mar 2028
- Phase
- Phase 3
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 3.Willing to maintain stable background antihistamine dose during the study (up to 4 times standard dose allowed).
- 4.Agree to use effective contraception during the study and for 6 months after last dose.
Who cannot join
- 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.
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- 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.
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 III Clinical Study Evaluating the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Chronic Spontaneous Urticaria
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.
Read the detailed description
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. A total of 226 patients with chronic spontaneous urticaria (CSU) are planned to be enrolled in this study and randomly assigned to either the experimental group or the control group at a 1:1 ratio. The study consists of a screening period (1-4 weeks), a double-blind treatment period (24 weeks), a continuous treatment period (24 weeks), and a follow-up period (8 weeks).
- Conditions
- Chronic Spontaneous Urticaria (CSU)
- Being tested
- MG-K10 Humanized Monoclonal Antibody Injection, Placebo
- Keywords
- MG-K10
- 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 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).
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measure
Change from baseline in UAS7 at Week 24
Measured: 24 weeks
Secondary outcomes (7)
The changes in ISS7 compared
The changes of ISS7 compared to the baseline for each visit
Measured: Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56
The changes in USA7 compared
The changes in each visit compared to the baseline (except for W24) for USA7
Measured: Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56
Outcome Measure
Change from baseline in AAS7 at scheduled visits
Measured: Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52,56
Proportion of participants with UAS7 ≤6
Proportion of participants with UAS7 ≤6
Measured: Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52,56
Outcome Measure
Time to and proportion of UAS7 MID response (≥11 decrease)
Measured: Up to 56 weeks
DLQI/CDLQI scores change
Change from baseline in DLQI/CDLQI scores
Measured: each visit
Outcome Measure
Incidence and severity of adverse events
Measured: Up to 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start14 Apr 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous Urticaria (CSU)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546487
- Sponsor's protocol ID
- MG-K10-CSU-001
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT07546487
- Acronym / sponsor ID
- MG-K10-CSU-001
- Conditions
- Chronic Spontaneous Urticaria (CSU)
- Keywords
- MG-K10
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 22 Apr 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 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.
Detailed description
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. A total of 226 patients with chronic spontaneous urticaria (CSU) are planned to be enrolled in this study and randomly assigned to either the experimental group or the control group at a 1:1 ratio. The study consists of a screening period (1-4 weeks), a double-blind treatment period (24 weeks), a continuous treatment period (24 weeks), and a follow-up period (8 weeks).
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 humanized monoclonal antibody injection | Experimental | Biological: MG-K10 Humanized Monoclonal Antibody InjectionUsage and dosage: Administer once every 4 weeks, with an initial dose of 600mg (4.0 ml) and subsequent doses of 300mg (2.0 ml) |
| placebo | Placebo comparator | Biological: PlaceboMedication schedule: placebo received on Day 1 (D1) and Week 24 (W24), MG-K10 300mg Q4W received from Week 24 (W24) to Week 48 (W48) |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 3.Willing to maintain stable background antihistamine dose during the study (up to 4 times standard dose allowed).
- 4.Agree to use effective contraception during the study and for 6 months after last dose.
Key exclusion criteria (12 listed)
- 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.
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 Humanized Monoclonal Antibody InjectionAdminister 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 |
| PlaceboReceived placebo on Day 1 (D1) and Week 24 (W24), started receiving MG-K10 300mg Q4W from Week 24 (W24) to Week 48 (W48) | Biological | placebo |
Primary outcome
Outcome Measure
Time frame: 24 weeks
Change from baseline in UAS7 at Week 24
7 secondary outcomes
The changes in ISS7 compared
Time frame: Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56
The changes in USA7 compared
Time frame: Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56
Outcome Measure
Time frame: Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52,56
Proportion of participants with UAS7 ≤6
Time frame: Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52,56
Outcome Measure
Time frame: Up to 56 weeks
DLQI/CDLQI scores change
Time frame: each visit
Outcome Measure
Time frame: Up to 56 weeks
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 22 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MG-K10 Humanized Monoclonal Antibody Injection in people with Chronic Spontaneous Urticaria (CSU), 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 12 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 22 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Outcome Measure (time frame: 24 weeks). 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 22 Apr 2026.