Prurigo NodularisPhase 3NCT06424470
Study on the Treatment of Prurigo Nodularis With Stapokibart Injection
A Phase 3 study testing Stapokibart in people with Prurigo Nodularis, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of Stapokibart Injection in the treatment of subjects with prurigo nodularis, and observe pharmacokinetic characteristics, pharmacological effects, and immunogenicity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prurigo Nodularis
- What is being tested?
- Stapokibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2024to 11 Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and agree to comply with the experimental process of this study and voluntarily sign the informed consent form.
- 18 ≤ Age ≤ 75 years old.
- Received at least 2 weeks of moderate or more potent topical corticosteroid therapy with insufficient efficacy.
Who cannot join
- With drug-induced prurigo nodularis.
- With clinically significant diseases.
- With severe liver and kidney function damage at the screening.
- With malignant tumors within the first 5 years before the screening.
- Plan to undergo major surgical procedures during this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Subjects With Prurigo Nodularis
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of Stapokibart Injection in the treatment of subjects with prurigo nodularis, and observe pharmacokinetic characteristics, pharmacological effects, and immunogenicity.
Read the detailed description
Chronic prurigo (CPG) is an independent chronic inflammatory skin disease characterized by chronic itching and multiple local or systemic prurigo lesions. Prurigo nodularis (PN) is the main subtype of CPG.
- Conditions
- Prurigo Nodularis
- Being tested
- Stapokibart, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StapokibartBiological
Stapokibart Injection
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Stapokibart | Experimental | Stapokibart Injection, subcutaneous injection (SC) Receives: Biological: Stapokibart |
| Placebo | Placebo comparator | subcutaneous injection (SC) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at week 24
The Worst Itch Numerical Rating Scale (WI-NR) is a patient-reported outcome (PRO) consisting of individual items with scores ranging from 0 ("no itching") to 10 ("the most severe itching imaginable"). Subjects are required to use this scale to rate the severity of their most severe itching in the past 24 hours.
Measured: Up to week 24
Secondary outcomes (13)
Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN stage (IGA-CNPG S) at week 24
IGA-CNPG-S stands for Investigator Global Assessment of Chronic Nodular Prurigo - Severity scale, a clinical tool used to rate the overall severity of chronic nodular prurigo (CNPG) by evaluating lesion number, size, and inflammation.
Measured: Up to week 24
Change from the baseline in the WI-NRS at each other visit
Measured: Up to week 24
Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN Activity (IGA-CNPG A) at each visit
A clinician-assessed scale to evaluate the overall appearance of lesions in chronic nodular prurigo
Measured: Up to week 24
Change from baseline in Dermatology Life Quality Index (DLQI) score at each visit
A patient-reported questionnaire measuring the impact of skin disorders on daily life and quality of life.
Measured: Up to week 24
Change from baseline in Skin Pain NRS at each visit
A numerical rating scale for patients to self-assess the intensity of skin pain.
Measured: Up to week 24
Change from baseline in Sleep NRS at each visit
A numeric scale used to quantify sleep disturbance caused by disease symptoms.
Measured: Up to week 24
Change from baseline in Hospital Anxiety and Depression Scale (HADS) at each visit
A validated scale for screening anxiety and depression symptoms in clinical populations.
Measured: Up to week 24
Change from baseline in the European Health Questionnaire 5 Dimensions (EQ-5D-5L) at each visit
A standard five-dimension tool to evaluate general health status and health-related quality of life.
Measured: Up to week 24
Safety parameters
Incidence of treatment-emergent adverse events (TEAEs).
Measured: Up to week 32
Pharmacokinetics (PK)
Concentration of CM310 in serum
Measured: Up to week 32
Pharmacodynamics (PD)
Change from baseline in serum thymus activation-regulated chemokine (TARC) concentration.
Measured: Up to week 32
Anti-drug antibodies (ADA)
Incidence of ADA.
Measured: Up to week 32
Pharmacodynamics (PD)
Change from baseline in serum total immunoglobulin E (IgE) concentration.
Measured: Up to week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start25 Jun 2024
- Primary completion11 Feb 2026
- Study completion11 Feb 2026
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 Keymed Biosciences 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xinghua Gao, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424470
- Sponsor's protocol ID
- CM310-110201
- Status last verified
- May 2026
- First submitted
- 16 May 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Subjects With Prurigo Nodularis
- ClinicalTrials.gov ID
- NCT06424470
- Acronym / sponsor ID
- CM310-110201
- Conditions
- Prurigo Nodularis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 22 May 2024 (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.
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of Stapokibart Injection in the treatment of subjects with prurigo nodularis, and observe pharmacokinetic characteristics, pharmacological effects, and immunogenicity.
Detailed description
Chronic prurigo (CPG) is an independent chronic inflammatory skin disease characterized by chronic itching and multiple local or systemic prurigo lesions. Prurigo nodularis (PN) is the main subtype of CPG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stapokibart | Experimental | Biological: StapokibartStapokibart Injection, subcutaneous injection (SC) |
| Placebo | Placebo comparator | Other: Placebosubcutaneous injection (SC) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to understand and agree to comply with the experimental process of this study and voluntarily sign the informed consent form.
- 18 ≤ Age ≤ 75 years old.
- Received at least 2 weeks of moderate or more potent topical corticosteroid therapy with insufficient efficacy.
Key exclusion criteria (5 listed)
- With drug-induced prurigo nodularis.
- With clinically significant diseases.
- With severe liver and kidney function damage at the screening.
- With malignant tumors within the first 5 years before the screening.
- Plan to undergo major surgical procedures during this study.
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 |
|---|---|---|
| StapokibartStapokibart Injection | Biological | Stapokibart |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Proportion of subjects with ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at week 24
Time frame: Up to week 24
The Worst Itch Numerical Rating Scale (WI-NR) is a patient-reported outcome (PRO) consisting of individual items with scores ranging from 0 ("no itching") to 10 ("the most severe itching imaginable"). Subjects are required to use this scale to rate the severity of their most severe itching in the past 24 hours.
13 secondary outcomes
Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN stage (IGA-CNPG S) at week 24
Time frame: Up to week 24
Change from the baseline in the WI-NRS at each other visit
Time frame: Up to week 24
Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN Activity (IGA-CNPG A) at each visit
Time frame: Up to week 24
Change from baseline in Dermatology Life Quality Index (DLQI) score at each visit
Time frame: Up to week 24
Change from baseline in Skin Pain NRS at each visit
Time frame: Up to week 24
Change from baseline in Sleep NRS at each visit
Time frame: Up to week 24
Change from baseline in Hospital Anxiety and Depression Scale (HADS) at each visit
Time frame: Up to week 24
Change from baseline in the European Health Questionnaire 5 Dimensions (EQ-5D-5L) at each visit
Time frame: Up to week 24
Safety parameters
Time frame: Up to week 32
Pharmacokinetics (PK)
Time frame: Up to week 32
Pharmacodynamics (PD)
Time frame: Up to week 32
Anti-drug antibodies (ADA)
Time frame: Up to week 32
Pharmacodynamics (PD)
Time frame: Up to week 32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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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. This study is not recruiting at the moment.
Xinghua Gao principal investigator
First Hospital of China Medical University
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 testing Stapokibart in people with Prurigo Nodularis, run by Keymed Biosciences 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at week 24 (time frame: Up to 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 2 Jun 2026.