Prurigo Nodularis
Conditions
Keywords
Prurigo nodularis
Brief summary
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.
Detailed description
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).
Interventions
DRUGPlacebo
Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration
Sponsors
Shanghai Mabgeek Biotech.Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A phase III clinical study to evaluate the efficacy and safety of a humanized MG-K10 mab injection in subjects with prurigo nodularis.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
eligibility criteria: 1. voluntarily sign the ICF and comply with all the visits and research-related procedures required by the protocol; 2. Both men and women were required to be ≥ 18 and ≤ 80 years old at the time of signing the informed consent; 3. the duration of PN diagnosed by a dermatologist at the time of screening was ≥ 3 months; 4. In the range of 1-10, WI-NRS≥7 in the past 24 h at screening; WI-NRS in the week before the baseline visit The average weekly score was ≥ 7 points.
Exclusion criteria
： 1. There are skin diseases other than PN and mild atopic dermatitis (AD) that may interfere with the assessment of research outcomes. 2. Patients who had a history of moderate to severe AD during the 6 months prior to the screening visit or screening visit. 3. Receiving potent or super-potent TCS/TCI treatment within 2 weeks before or during screening. 4\) Evidence of active tuberculosis. 5) Participation in any other clinical study within 12 weeks or 5 half-lives prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportions of subjects achieving WI-NRS | week 24 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportions of subjects achieving IGA PN-S score of 0/1 point | week 24 | Proportion of subjects with overall disease score of 0/1 |
| The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit | From baseline to week 56 | The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 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 | The absolute value and percentage change of weekly mean WI-NRS from baseline at each evaluation visit; |
| Duration of onset of response to pruritus | From baseline to week 56 | 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). |
| the first response to pruritus occurred. | from baseline to the week 24 | 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) |
| Proportion of subjects with an IGA PN-S score of 0/1 | From baseline to week 56 | Proportion of subjects with IGA PN-S score of 0/1 at each evaluation visit |
| The time when the first intergroup response difference in pruritus occurred | From baseline to week 24 | 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) |
| The duration of the difference in persistent response to pruritus between groups | From baseline to week 24 | 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) |
| Changes in IGA PN-S scores | From baseline to week 56 | Changes in IGA PN-S scores from baseline at each evaluation site |
| Changes in IGA PN-A scores from baseline | From baseline to week 56 | Changes in IGA PN-A scores from baseline at each evaluation visit |
| Proportion of subjects wit weekly WI-NRS improvement (decrease) of ≥ 4 points and IGA PN-S of 0/1 | From baseline to week 56 | 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 |
| Changes in DLQI scores from baseline | From baseline to week 56 | Change in Dermatology Life Quality Index (DLQI) from baseline at each evaluation visit |
| Changes in HADS from baseline | From baseline to week 56 | Changes in Hospital Anxiety and Depression Scale(HADS) from baseline at each evaluation site |
| safety | From baseline to week 56 | 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; |
| pharmacokinetics | From baseline to week 56 | Ctrough (valley concentration) change over time; |
| pharmacodynamics | From baseline to week 56 | Changes of biomarkers before and after administration |
| immunogenicity | From baseline to week 56 | Occurrence of Anit-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) |
| Proportion of subjects with an IGA PN-A score of 0/1 | From baseline to week 56 | Proportion of subjects with an IGA PN-A score of 0/1 from baseline to each visit point |
Countries
China
Contacts
Primary Contactxiaofeng xiao Cai, bachelor
Outcome results
None listed