Trial · NCT06424470
Study on the Treatment of Prurigo Nodularis With Stapokibart Injection
NCT06424470, Phase 3, Completed, Keymed Biosciences Co.Ltd
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study on the Treatment of Prurigo Nodularis With Stapokibart Injection. Trials, record NCT06424470. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06424470
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study on the Treatment of Prurigo Nodularis With Stapokibart Injection
- NCT number
- NCT06424470
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 200 participants, actual
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Conditions
- Prurigo Nodularis
- Interventions
- Stapokibart, Placebo
- First posted
- 2024-05-22
- Last updated
- 2026-06-02
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of subjects with ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at week 24 | 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. |
| Secondary | Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN stage (IGA-CNPG S) at week 24 | Up to 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. |
| Secondary | Change from the baseline in the WI-NRS at each other visit | Up to week 24 | |
| Secondary | Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN Activity (IGA-CNPG A) at each visit | Up to week 24 | A clinician-assessed scale to evaluate the overall appearance of lesions in chronic nodular prurigo |
| Secondary | Change from baseline in Dermatology Life Quality Index (DLQI) score at each visit | Up to week 24 | A patient-reported questionnaire measuring the impact of skin disorders on daily life and quality of life. |
| Secondary | Change from baseline in Skin Pain NRS at each visit | Up to week 24 | A numerical rating scale for patients to self-assess the intensity of skin pain. |
| Secondary | Change from baseline in Sleep NRS at each visit | Up to week 24 | A numeric scale used to quantify sleep disturbance caused by disease symptoms. |
| Secondary | Change from baseline in Hospital Anxiety and Depression Scale (HADS) at each visit | Up to week 24 | A validated scale for screening anxiety and depression symptoms in clinical populations. |
| Secondary | Change from baseline in the European Health Questionnaire 5 Dimensions (EQ-5D-5L) at each visit | Up to week 24 | A standard five-dimension tool to evaluate general health status and health-related quality of life. |
| Secondary | Safety parameters | Up to week 32 | Incidence of treatment-emergent adverse events (TEAEs). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06424470
GET https://conductscience.org/api/trials/v1/NCT06424470/registered