Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Mabgeek Biotech.Co.Ltd

About this trial

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.

Eligibility criteria

Qualifiers

voluntarily sign the ICF and comply with all the visits and research-related procedures required by the protocol;

Both men and women were required to be ≥ 18 and ≤ 80 years old at the time of signing the informed consent;

the duration of PN diagnosed by a dermatologist at the time of screening was ≥ 3 months;

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.

Disqualifiers

There are skin diseases other than PN and mild atopic dermatitis (AD) that may interfere with the assessment of research outcomes.

Patients who had a history of moderate to severe AD during the 6 months prior to the screening visit or screening visit.

Receiving potent or super-potent TCS/TCI treatment within 2 weeks before or during screening.

Trial design

Treatments tested in this trial

  • Placebo

Treatment groups

160 Participants
are divided into 2 treatment groups