Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of a Humanized MG-K10 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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a humanized MG-K10 monoclonal antibody injection in adults with prurigo nodularis, a chronic skin condition. This Phase III study is randomized, double-blind, and placebo-controlled, aiming to compare the treatment against placebo over a long period. The study involves about 160 participants aged 18 to 80 years with a diagnosis of prurigo nodularis for at least 3 months and significant itch severity. Participants receive subcutaneous injections every four weeks for a total of 56 weeks. The study includes a screening period of 1 to 4 weeks, followed by a 24-week double-blind treatment phase, then a 24-week maintenance treatment phase, and finally an 8-week follow-up period. Some participants initially receiving placebo will switch to MG-K10 treatment after 24 weeks. During the study, participants will have regular assessments including itch severity scores, skin condition evaluations, quality of life, and mental health questionnaires. Researchers will monitor safety, drug levels, immune response, and treatment effects throughout the 56 weeks. The primary outcome is the proportion of subjects achieving a reduction in itch intensity by week 24, with secondary measures tracking skin scores and other symptoms through week 56.
CONDITIONS
Brief 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 informed consent and comply with all study visits and procedures
- Men and women aged 18 to 80 years at the time of consent
- Diagnosed with prurigo nodularis by a dermatologist for at least 3 months
- Worst Itch Numeric Rating Scale (WI-NRS) score 7 or higher on average in the week before baseline visit
You will not qualify if you...
- Presence of skin diseases other than prurigo nodularis or mild atopic dermatitis that could affect study assessments
- History of moderate to severe atopic dermatitis in the 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 drug half-lives before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 1 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants receive subcutaneous injections every 4 weeks as part of a double-blind treatment period followed by a maintenance treatment period.
Every 4 weeks for 12 visits
Duration - 8 weeks
Participants are monitored for safety and other outcomes following the treatment period.
1 to 2 visits
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
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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