A Phase 2 interventional study of AK139 and Placebo in Prurigo Nodularis (PN), sponsored by Akeso. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Akeso · Phase 2, Interventional, and Treatment
This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of subjects with prurigo nodularis. The total duration of the study (including screening period, treatment period and follow-up period) planned for each subject is approximately 24 weeks.
Akeso is the lead sponsor of 156 studies on the registry; 67 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Biological: AK139
Biological: AK139
Other: Placebo
Proportion of subjects with ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at 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.
Time frame: Up to week 16
Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN stage (IGA PN-S) at efficacy Visit
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.
Time frame: Up to week 20
Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN Activity (IGA PN-A) at efficacy Visit
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.
Time frame: Up to week 20
Change from the baseline in the WI-NRS at each other Visit
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.
Time frame: Up to week 20
Change from baseline in Dermatology Life Quality Index (DLQI) score at efficacy Visit
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.
Time frame: Up to week 20
Change from baseline in Hospital Anxiety and Depression Scale (HADS) at 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.
Time frame: week 16
Safety parameters
Incidence of treatment-emergent adverse events (TEAEs).
Time frame: Up to week 20
Pharmacokinetics(PK)
The concentration of AK139 in plasma will be determined.
Time frame: Up to week 20
Pharmacodynamics (PD)
Change from baseline in serum biomarker levels
Time frame: Up to week 20
Anti-drug antibodies (ADA) and Neutralizing Antibodies(Nab)
Incidence of ADA and Nab afterment AK139 injection
Time frame: Up to week 20
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: AK139