NCT06779136 Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis
| NCT ID | NCT06779136 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shanghai Mabgeek Biotech.Co.Ltd |
| Condition | Prurigo Nodularis |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-02-26 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 160 participants in total. It began in 2025-02-26 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Jianzhong Zhang, Medical Ph.D
STUDY DIRECTOR
Feking University People's Hospital
Frequently Asked Questions
Who can join the NCT06779136 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Prurigo Nodularis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06779136 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 160 participants.
Is NCT06779136 currently recruiting?
Yes, NCT06779136 is actively recruiting participants. Contact the research team at xiaofeng.cai@mabgeek.com for enrollment information.
Where is the NCT06779136 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06779136 clinical trial?
NCT06779136 is sponsored by Shanghai Mabgeek Biotech.Co.Ltd. The principal investigator is Jianzhong Zhang, Medical Ph.D at Feking University People's Hospital. The trial plans to enroll 160 participants.