Actively Recruiting
Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis
Led by Shanghai Mabgeek Biotech.Co.Ltd · Updated on 2025-04-18
160
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase III clinical study to evaluate the efficacy and safety of a humanized MG-K10 mab injection in subjects with prurigo nodularis.administered every 4 weeks for 56 weeks.
CONDITIONS
Official Title
Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and agree to follow all study visits and procedures
- Men and women aged 18 to 80 years at the time of informed consent
- Diagnosed with prurigo nodularis by a dermatologist at screening for at least 3 months
- Itch severity score (WI-NRS) of 7 or higher in the past 24 hours at screening and an average weekly score of 7 or higher before baseline visit
You will not qualify if you...
- Having skin diseases other than prurigo nodularis or mild atopic dermatitis that might affect study results
- History of moderate to severe atopic dermatitis within 6 months before screening
- Use of potent or super-potent topical corticosteroids or immunomodulators within 2 weeks before or during screening
- Evidence of active tuberculosis
- Participation in another clinical study within 12 weeks or 5 half-lives before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital, Beijing,
Beijing, Bejing, China, 100009
Actively Recruiting
Research Team
X
xiaofeng xiao Cai, bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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