Prurigo NodularisPhase 3NCT06779136
Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis
A Phase 3 study of Prurigo Nodularis, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prurigo Nodularis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 26 Feb 2025to Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
- 4) Evidence of active tuberculosis. 5) Participation in any other clinical study within 12 weeks or 5 half-lives prior to screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital, Beijing,
Beijing, Bejing, 100009
Jianzhong Zhang, Medical Ph.D, 010-88326666, rmzjz@126.com
About this study
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.
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.
Read the 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).
- Conditions
- Prurigo Nodularis
- Being tested
- Placebo
- Keywords
- Prurigo nodularis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration
| Study group | Role | What they receive |
|---|---|---|
| MG-K10 Humanized Monoclonal Antibody Injection | Experimental | Every four weeks, subcutaneous injection ，total of 56W Receives: Drug: Placebo |
| placebo | Placebo comparator | Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of subjects achieving WI-NRS
In the experimental group, the weekly mean value of WI-NRS at week 24 was compared with baseline.Proportion of subjects who improved (decreased) by ≥ 4 points
Measured: week 24
Secondary outcomes (18)
Proportions of subjects achieving IGA PN-S score of 0/1 point
Proportion of subjects with overall disease score of 0/1
Measured: week 24
The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit
The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit
Measured: From baseline to week 56
The absolute value and percentage change of weekly mean WI-NRS from baseline at each evaluation visit;
The absolute value and percentage change of weekly mean WI-NRS from baseline at each evaluation visit;
Measured: From baseline to week 56
Duration of onset of response to pruritus
The proportion of subjects with a weekly mean decrease of ≥4 points from baseline in the WI-NRS was compared, and the difference from the placebo group was first presented p < 0.05).
Measured: From baseline to week 56
the first response to pruritus occurred.
The time from baseline to the 24th week when the first response to pruritus occurred (the average weekly WI-NRS score decreased by ≥ 4 points compared with the baseline)
Measured: from baseline to the week 24
The time when the first intergroup response difference in pruritus occurred
The time of the first intergroup response difference for pruritus (the time when the difference in the proportion of subjects with a weekly average WI-NRS score reduction of ≥ 4 points compared to the baseline first reached p < 0.05 compared with the placebo group)
Measured: From baseline to week 24
The duration of the difference in persistent response to pruritus between groups
The duration of the difference in persistent response between the prurity-onset groups (comparing the change in weekly WI-NRS from baseline between the MG-K10 and placebo groups, the time when the difference between the MG-K10 and placebo groups first appeared to be p < 0.05 and remained significant on subsequent measures)
Measured: From baseline to week 24
Proportion of subjects with an IGA PN-S score of 0/1
Proportion of subjects with IGA PN-S score of 0/1 at each evaluation visit
Measured: From baseline to week 56
Changes in IGA PN-S scores
Changes in IGA PN-S scores from baseline at each evaluation site
Measured: From baseline to week 56
Proportion of subjects with an IGA PN-A score of 0/1
Proportion of subjects with an IGA PN-A score of 0/1 from baseline to each visit point
Measured: From baseline to week 56
Changes in IGA PN-A scores from baseline
Changes in IGA PN-A scores from baseline at each evaluation visit
Measured: From baseline to week 56
Proportion of subjects wit weekly WI-NRS improvement (decrease) of ≥ 4 points and IGA PN-S of 0/1
Proportion of subjects with weekly WI-NRS improvement (decrease) of ≥ 4 points from baseline and IGA PN-S of 0/1 at each evaluation visit
Measured: From baseline to week 56
Changes in DLQI scores from baseline
Change in Dermatology Life Quality Index (DLQI) from baseline at each evaluation visit
Measured: From baseline to week 56
Changes in HADS from baseline
Changes in Hospital Anxiety and Depression Scale(HADS) from baseline at each evaluation site
Measured: From baseline to week 56
safety
These include Treatment Emergent Adverse Events (TEAE) and Serious Adverse events Events (SAE), adverse events of special interest (AESI), clinical laboratory tests, vital signs, physical examination, and abnormalities in 12-lead electrocardiograms;
Measured: From baseline to week 56
pharmacokinetics
Ctrough (valley concentration) change over time;
Measured: From baseline to week 56
pharmacodynamics
Changes of biomarkers before and after administration
Measured: From baseline to week 56
immunogenicity
Occurrence of Anit-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb)
Measured: From baseline to week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start26 Feb 2025
- Primary completionAug 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prurigo NodularisStudies of the same condition, open and under way.
- More trials run by Shanghai Mabgeek Biotech.Co.LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, Medical Ph.D, Study director, Feking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779136
- Sponsor's protocol ID
- MG-K10-PN-001
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06779136
- Acronym / sponsor ID
- MG-K10-PN-001
- Conditions
- Prurigo Nodularis
- Keywords
- Prurigo nodularis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MG-K10 Humanized Monoclonal Antibody Injection | Experimental | Drug: PlaceboEvery four weeks, subcutaneous injection ，total of 56W |
| placebo | Placebo comparator | Drug: PlaceboEvery four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
- 4) Evidence of active tuberculosis. 5) Participation in any other clinical study within 12 weeks or 5 half-lives prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboEvery four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration | Drug | MG-K10 Humanized Monoclonal Antibody Injection, placebo |
Primary outcome
Proportions of subjects achieving WI-NRS
Time frame: week 24
In the experimental group, the weekly mean value of WI-NRS at week 24 was compared with baseline.Proportion of subjects who improved (decreased) by ≥ 4 points
18 secondary outcomes
Proportions of subjects achieving IGA PN-S score of 0/1 point
Time frame: week 24
The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit
Time frame: From baseline to week 56
The absolute value and percentage change of weekly mean WI-NRS from baseline at each evaluation visit;
Time frame: From baseline to week 56
Duration of onset of response to pruritus
Time frame: From baseline to week 56
the first response to pruritus occurred.
Time frame: from baseline to the week 24
The time when the first intergroup response difference in pruritus occurred
Time frame: From baseline to week 24
The duration of the difference in persistent response to pruritus between groups
Time frame: From baseline to week 24
Proportion of subjects with an IGA PN-S score of 0/1
Time frame: From baseline to week 56
Changes in IGA PN-S scores
Time frame: From baseline to week 56
Proportion of subjects with an IGA PN-A score of 0/1
Time frame: From baseline to week 56
Changes in IGA PN-A scores from baseline
Time frame: From baseline to week 56
Proportion of subjects wit weekly WI-NRS improvement (decrease) of ≥ 4 points and IGA PN-S of 0/1
Time frame: From baseline to week 56
Changes in DLQI scores from baseline
Time frame: From baseline to week 56
Changes in HADS from baseline
Time frame: From baseline to week 56
safety
Time frame: From baseline to week 56
pharmacokinetics
Time frame: From baseline to week 56
pharmacodynamics
Time frame: From baseline to week 56
immunogenicity
Time frame: From baseline to week 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Prurigo Nodularis
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Prurigo Nodularis.
Prurigo Nodularis (PN)
RecruitingPhase 3
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
Prurigo Nodularis
RecruitingPhase 2
Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis
Prurigo Nodularis (PN)
RecruitingObservational study
Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults
Prurigo Nodularis
Not yet recruitingPhase 2
Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients
Prurigo Nodularis (PN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianzhong Zhang, Medical Ph.D study director
Feking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Prurigo Nodularis, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiaofeng xiao Cai, bachelor (02151371305, xiaofeng.cai@mabgeek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions of subjects achieving WI-NRS (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.