Chronic Spontaneous Urticaria (CSU)
Conditions
Keywords
MG-K10
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.
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).
Interventions
Administer once every 4 weeks, with an initial dose of 600mg (4.0 ml) and subsequent doses of 300mg (2.0 ml).
BIOLOGICALPlacebo
Received placebo on Day 1 (D1) and Week 24 (W24), started receiving MG-K10 300mg Q4W from Week 24 (W24) to Week 48 (W48)
Sponsors
Shanghai Mabgeek Biotech.Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged ≥12 and ≤75 years, body weight ≥30 kg, voluntarily sign ICF. 2. Diagnosed with CSU for ≥6 months, with pruritus and wheals for \>6 weeks despite using second-generation H1 antihistamines. 3. 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.
Exclusion criteria
1. Inducible urticaria (e.g., dermographism, cold, heat, cholinergic) or other chronic pruritic skin diseases (e.g., atopic dermatitis) affecting study assessment. 2. Active tuberculosis, or untreated latent TB; serious active infections. 3. Known or suspected immunodeficiency, or history of invasive opportunistic infections. 4. Known allergy to study drug or excipients. 5. Prior use of MG-K10 or other biologics (anti-IL-4Rα, anti-IgE, etc.) within 16 weeks or 5 half-lives. 6. Use of immunosuppressants, systemic corticosteroids, phototherapy, or Chinese herbal medicine within 4 weeks prior to first UAS assessment. 7. 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. 8. Positive for HBsAg, or HBcAb positive with HBV-DNA ≥1×10³ copies/ml; HCV-Ab positive with HCV-RNA positive; HIV antibody positive. 9. QTcF \>500 msec or other clinically significant ECG abnormalities. 10. Pregnant, breastfeeding, or planning pregnancy during the study. 11. History of malignant tumors within 5 years (except adequately treated non-melanoma skin cancer or cervical carcinoma in situ). 12. Participated in another clinical study and used investigational drug within 12 weeks or 5 half-lives prior to first UAS assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outcome Measure | 24 weeks | Change from baseline in UAS7 at Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes in ISS7 compared | Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56 | The changes of ISS7 compared to the baseline for each visit |
| The changes in USA7 compared | Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56 | The changes in each visit compared to the baseline (except for W24) for USA7 |
| Outcome Measure | Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52,56 | Change from baseline in AAS7 at scheduled visits |
| Proportion of participants with UAS7 ≤6 | Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52,56 | Proportion of participants with UAS7 ≤6 |
| DLQI/CDLQI scores change | each visit | Change from baseline in DLQI/CDLQI scores |
Contacts
CONTACTClinical Project Manager
Outcome results
None listed