Evaluating MG-K10 injection for treating prurigo nodularis

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.

This study is testing a new injection to see if it can help adults with prurigo nodularis feel better by reducing their symptoms.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd (Industry-sponsored)
• Locations: 1 site (Beijing, Bejing)
• Trial ID: NCT06779136 on ClinicalTrials.gov

What this trial studies

This phase III clinical study aims to assess the efficacy and safety of a humanized MG-K10 monoclonal antibody injection in adults suffering from prurigo nodularis. Participants will receive subcutaneous injections every four weeks for a total of 56 weeks, with a structured approach that includes a screening period, a double-blind treatment phase, a maintenance phase, and a follow-up period. Approximately 160 adults will be enrolled, and the study will compare the effects of the MG-K10 injection against a placebo to determine its effectiveness in alleviating symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a diagnosis of prurigo nodularis lasting at least three months and experiencing severe itching.

Not a fit: Patients with other significant skin diseases or those who have had recent treatments that could interfere with the study outcomes may not benefit.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the symptoms and improve the quality of life for patients with prurigo nodularis.

How similar studies have performed: Other studies have shown promise with monoclonal antibody treatments for similar conditions, indicating potential for success with this approach.

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

Where this trial is running

Beijing, Bejing

• Peking University People's Hospital, Beijing, — Beijing, Bejing, China (Recruiting)

Study contacts

• Study coordinator: xiaofeng xiao Cai, bachelor

Conditions Prurigo Nodularis; Prurigo nodularis