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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG-K10 Humanized Monoclonal Antibody Injection | Experimental | Every four weeks, subcutaneous injection ，total of 56W |
|
| placebo | Placebo Comparator | Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of subjects achieving IGA PN-S score of 0/1 point | Proportion of subjects with overall disease score of 0/1 | week 24 |
| The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit |
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eligibility criteria:
Exclusion criteria：
4) Evidence of active tuberculosis. 5) Participation in any other clinical study within 12 weeks or 5 half-lives prior to screening
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaofeng xiao Cai, bachelor | Contact | 02151371305 | xiaofeng.cai@mabgeek.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianzhong Zhang, Medical Ph.D | Feking University People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital, Beijing, | Recruiting | Beijing | Bejing | 100009 | China |
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A phase III clinical study to evaluate the efficacy and safety of a humanized MG-K10 mab injection in subjects with prurigo nodularis.
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The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit
| 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; | 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). | 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) | 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) | 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) | 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 | From baseline to week 56 |
| Changes in IGA PN-S scores | Changes in IGA PN-S scores from baseline at each evaluation site | 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 | 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 | 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 | From baseline to week 56 |
| Changes in DLQI scores from baseline | Change in Dermatology Life Quality Index (DLQI) from baseline at each evaluation visit | From baseline to week 56 |
| Changes in HADS from baseline | Changes in Hospital Anxiety and Depression Scale(HADS) from baseline at each evaluation site | 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; | From baseline to week 56 |
| pharmacokinetics | Ctrough (valley concentration) change over time; | From baseline to week 56 |
| pharmacodynamics | Changes of biomarkers before and after administration | From baseline to week 56 |
| immunogenicity | Occurrence of Anit-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) | From baseline to week 56 |