Trial · NCT07883213
A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Prurigo Nodularis.
NCT07883213, Phase 2, Not yet recruiting, Akeso
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Prurigo Nodularis. Trials, record NCT07883213. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07883213
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Prurigo Nodularis.
- NCT number
- NCT07883213
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 132 participants, estimated
- Lead sponsor
- Akeso
- Conditions
- Prurigo Nodularis (PN)
- Interventions
- AK139, Placebo, AK139
- First posted
- 2026-10-20
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes10
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 16 | Up to week 16 | The Worst Itch Numerical Rating Scale（WI-NRS) is a patients-reported outcome (PRO) consisting of individual items with scores ranging from 0 ("no itching") to 10 ("the most severe itching imaginable"). It is used for patients to rate the severity of the 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 PN-S) at efficacy Visit | Up to week 20 | It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe PN. |
| Secondary | Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN Activity (IGA PN-A) at efficacy Visit | Up to week 20 | It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe PN activity. |
| Secondary | Change from the baseline in the WI-NRS at each other Visit | Up to week 20 | The Worst Itch Numerical Rating Scale（WI-NRS) is a patients-reported outcome (PRO) consisting of individual items with scores ranging from 0 ("no itching") to 10 ("the most severe itching imaginable"). It is used for patients to rate the severity of the most severe itching in the past 24 hours. |
| Secondary | Change from baseline in Dermatology Life Quality Index (DLQI) score at efficacy Visit | Up to week 20 | A patient-reported questionnaire measuring the impact of skin disorders on daily life and quality of life. It comprises of set of 10 questions. Each item is scored on a 4-point scale ranging from 0 (not at all) to 3 (very much). Higher scores indicated more impact on quality of life. |
| Secondary | Change from baseline in Hospital Anxiety and Depression Scale (HADS) at week 16 | week 16 | A validated scale for screening anxiety and depression symptoms in clinical populations. It comprises a total of 14 items, 7 each for anxiety and depression symptoms. Each item is scored on a 4-point scale ranging from 0 to 3, possible scores range from 0 to 21 for each subscale. |
| Secondary | Safety parameters | Up to week 20 | Incidence of treatment-emergent adverse events (TEAEs). |
| Other | Pharmacokinetics(PK) | Up to week 20 | The concentration of AK139 in plasma will be determined. |
| Other | Pharmacodynamics (PD) | Up to week 20 | Change from baseline in serum biomarker levels |
| Other | Anti-drug antibodies (ADA) and Neutralizing Antibodies(Nab) | Up to week 20 | Incidence of ADA and Nab afterment AK139 injection |
Source ClinicalTrials.gov
Outcomes0
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/NCT07883213
GET https://conductscience.org/api/trials/v1/NCT07883213/registered