A Phase 3 interventional study of Placebo in Prurigo Nodularis, sponsored by Shanghai Mabgeek Biotech.Co.Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by Shanghai Mabgeek Biotech.Co.Ltd · Phase 3, Interventional, and Treatment
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.
The study was a multicenter, randomized, double-blind, placebo-controlled Phase III study. Approximately 160 adults with prurigo nodularis were scheduled to receive multiple subcutaneous injections (every 4 weeks for 56 weeks). The study was divided into a screening period (1-4 weeks), a double-blind treatment period (24 weeks), a maintenance treatment period (24 weeks), and a follow-up period (8 weeks).
eligibility criteria:
Exclusion criteria：
Every four weeks, subcutaneous injection ，total of 56W
Drug: Placebo
Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration
Drug: Placebo
Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration
Proportions of subjects achieving WI-NRS
In the experimental group, the weekly mean value of WI-NRS at week 24 was compared with baseline.Proportion of subjects who improved (decreased) by ≥ 4 points
Time frame: week 24
Proportions of subjects achieving IGA PN-S score of 0/1 point
Proportion of subjects with overall disease score of 0/1
Time frame: week 24
The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit
The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit
Time frame: From baseline to week 56
The absolute value and percentage change of weekly mean WI-NRS from baseline at each evaluation visit;
The absolute value and percentage change of weekly mean WI-NRS from baseline at each evaluation visit;
Time frame: From baseline to week 56
Duration of onset of response to pruritus
The proportion of subjects with a weekly mean decrease of ≥4 points from baseline in the WI-NRS was compared, and the difference from the placebo group was first presented p \< 0.05).
Time frame: From baseline to week 56
the first response to pruritus occurred.
The time from baseline to the 24th week when the first response to pruritus occurred (the average weekly WI-NRS score decreased by ≥ 4 points compared with the baseline)
Time frame: from baseline to the week 24
The time when the first intergroup response difference in pruritus occurred
The time of the first intergroup response difference for pruritus (the time when the difference in the proportion of subjects with a weekly average WI-NRS score reduction of ≥ 4 points compared to the baseline first reached p \< 0.05 compared with the placebo group)
Time frame: From baseline to week 24
The duration of the difference in persistent response to pruritus between groups
The duration of the difference in persistent response between the prurity-onset groups (comparing the change in weekly WI-NRS from baseline between the MG-K10 and placebo groups, the time when the difference between the MG-K10 and placebo groups first appeared to be p \< 0.05 and remained significant on subsequent measures)
Time frame: From baseline to week 24
Proportion of subjects with an IGA PN-S score of 0/1
Proportion of subjects with IGA PN-S score of 0/1 at each evaluation visit
Time frame: From baseline to week 56
Changes in IGA PN-S scores
Changes in IGA PN-S scores from baseline at each evaluation site
Time frame: From baseline to week 56
Proportion of subjects with an IGA PN-A score of 0/1
Proportion of subjects with an IGA PN-A score of 0/1 from baseline to each visit point
Time frame: From baseline to week 56
Changes in IGA PN-A scores from baseline
Changes in IGA PN-A scores from baseline at each evaluation visit
Time frame: From baseline to week 56
Proportion of subjects wit weekly WI-NRS improvement (decrease) of ≥ 4 points and IGA PN-S of 0/1
Proportion of subjects with weekly WI-NRS improvement (decrease) of ≥ 4 points from baseline and IGA PN-S of 0/1 at each evaluation visit
Time frame: From baseline to week 56
Changes in DLQI scores from baseline
Change in Dermatology Life Quality Index (DLQI) from baseline at each evaluation visit
Time frame: From baseline to week 56
Changes in HADS from baseline
Changes in Hospital Anxiety and Depression Scale(HADS) from baseline at each evaluation site
Time frame: From baseline to week 56
safety
These include Treatment Emergent Adverse Events (TEAE) and Serious Adverse events Events (SAE), adverse events of special interest (AESI), clinical laboratory tests, vital signs, physical examination, and abnormalities in 12-lead electrocardiograms;
Time frame: From baseline to week 56
pharmacokinetics
Ctrough (valley concentration) change over time;
Time frame: From baseline to week 56
pharmacodynamics
Changes of biomarkers before and after administration
Time frame: From baseline to week 56
immunogenicity
Occurrence of Anit-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb)
Time frame: From baseline to week 56
Plan to share: No
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Shanghai Mabgeek Biotech.Co.Ltd