Trial · NCT06424470
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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). |
| Secondary | Pharmacokinetics (PK) | Up to week 32 | Concentration of CM310 in serum |
| Secondary | Pharmacodynamics (PD) | Up to week 32 | Change from baseline in serum thymus activation-regulated chemokine (TARC) concentration. |
| Secondary | Anti-drug antibodies (ADA) | Up to week 32 | Incidence of ADA. |
| Secondary | Pharmacodynamics (PD) | Up to week 32 | Change from baseline in serum total immunoglobulin E (IgE) concentration. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06424470/registered