Clinical trial NCT06779136: Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prurigo Nodularis
Keywords: Prurigo nodularis
Lead sponsor: Shanghai Mabgeek Biotech.Co.Ltd
Sponsor class: OTHER_GOV
First posted: 2025-01-16
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Proportions of subjects achieving WI-NRS
timeFrame: week 24
Secondary outcomes:
measure: Proportions of subjects achieving IGA PN-S score of 0/1 point
timeFrame: week 24
measure: The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit
timeFrame: From baseline to week 56
measure: The absolute value and percentage change of weekly mean WI-NRS from baseline at each evaluation visit;
timeFrame: From baseline to week 56
measure: Duration of onset of response to pruritus
timeFrame: From baseline to week 56
measure: the first response to pruritus occurred.
timeFrame: from baseline to the week 24
measure: The time when the first intergroup response difference in pruritus occurred
timeFrame: From baseline to week 24
measure: The duration of the difference in persistent response to pruritus between groups
timeFrame: From baseline to week 24
measure: Proportion of subjects with an IGA PN-S score of 0/1
timeFrame: From baseline to week 56
measure: Changes in IGA PN-S scores
timeFrame: From baseline to week 56
measure: Proportion of subjects with an IGA PN-A score of 0/1
timeFrame: From baseline to week 56
measure: Changes in IGA PN-A scores from baseline
timeFrame: From baseline to week 56
measure: Proportion of subjects wit weekly WI-NRS improvement (decrease) of ≥ 4 points and IGA PN-S of 0/1
timeFrame: From baseline to week 56
measure: Changes in DLQI scores from baseline
timeFrame: From baseline to week 56
measure: Changes in HADS from baseline
timeFrame: From baseline to week 56
measure: safety
timeFrame: From baseline to week 56
measure: pharmacokinetics
timeFrame: From baseline to week 56
measure: pharmacodynamics
timeFrame: From baseline to week 56
measure: immunogenicity
timeFrame: From baseline to week 56
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital, Beijing,
state: bejing
Study officials:
affiliation: Feking University People's Hospital
name: Jianzhong Zhang, Medical Ph.D
role: STUDY_DIRECTOR
References: