Evaluating MG-K10 injection for treating prurigo nodularis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: xiaofeng xiao Cai, bachelor
• Email: xiaofeng.cai@mabgeek.com
• Phone: 02151371305

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Investigating Dupilumab for Children with Prurigo Nodularis

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  Recruiting at 15 sites Phase 3 Sanofi · Palo Alto, California and 14 other locations · NCT06293053

• Understanding the factors influencing chronic inflammatory skin diseases

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• Improving diagnosis and treatment for type 2 inflammatory skin diseases

  This study is trying to improve how we diagnose and treat type 2 inflammatory skin diseases like atopic dermatitis by creating a specialized center and looking at different treatment methods to see what works best.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.