A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK139 in Subjects With Prurigo Nodularis
Sponsor study identifier
interventional
132
0 countries
N/A
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 8, 2026
Actual (reported)October 20, 2026
Actual (reported)August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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
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
Up to week 20
Change from the baseline in the WI-NRS at each other Visit
Up to week 20
Change from baseline in Dermatology Life Quality Index (DLQI) score at efficacy Visit
Up to week 20
Change from baseline in Hospital Anxiety and Depression Scale (HADS) at week 16
week 16
Pharmacokinetics(PK)
Up to week 20
Pharmacodynamics (PD)
Up to week 20
Anti-drug antibodies (ADA) and Neutralizing Antibodies(Nab)
Up to week 20
Biological: AK139 low dose
Other: Placebo
First Submitted
October 8, 2026
First Posted
October 20, 2026
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
August 2027
Biological: AK139 high dose
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 20, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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