Prurigo Nodularis (PN)Phase 2NCT07883213
A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Prurigo Nodularis.
A Phase 2 study testing AK139 in people with Prurigo Nodularis (PN), run by Akeso.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prurigo Nodularis (PN)
- What is being tested?
- AK139
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand the study and voluntarily sign the ICF.
- Diagnosed PN by a dermatologist for at least 3 months before the Screening visit.
- Participants must have a minimum of 20 PN lesions in total at Screening visit and Day 1.
- Received at least 2 weeks of moderate or more potent topical corticosteroid therapy with insufficient efficacy.
- an average worst itch score of the Worst Itch Numeric Rating Scale (WI-NRS) ≥7 in the 7 days prior to Day1.
Who cannot join
- Presence of skin morbidities other than PN and mild atopic dermatitis that may interfere with the assessment of the study outcomes.
- With drug-induced prurigo nodularis.
- Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the participant's participation in the study.
- With malignant tumors within the first 5 years before the screening.
- Plan to undergo major surgical procedures during this study.
- Known or suspected immunodeficiency
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK139 in Subjects With Prurigo Nodularis
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.
- Conditions
- Prurigo Nodularis (PN)
- Being tested
- AK139, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK139Biological
Biological: AK139 low dose
PlaceboOther
Other: Placebo
AK139Biological
Biological: AK139 high dose
| Study group | Role | What they receive |
|---|---|---|
| cohort 1：AK139 regiment 1 | Experimental | Not described Receives: Biological: AK139 |
| cohort 2：AK139 regiment 2 | Experimental | Not described Receives: Biological: AK139 |
| placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to week 16
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 16
Safety parameters
Incidence of treatment-emergent adverse events (TEAEs).
Measured: Up to week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prurigo Nodularis (PN)Studies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883213
- Sponsor's protocol ID
- AK139-206
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK139 in Subjects With Prurigo Nodularis
- ClinicalTrials.gov ID
- NCT07883213
- Acronym / sponsor ID
- AK139-206
- Conditions
- Prurigo Nodularis (PN)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cohort 1：AK139 regiment 1 | Experimental | Biological: AK139 |
| cohort 2：AK139 regiment 2 | Experimental | Biological: AK139 |
| placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand the study and voluntarily sign the ICF.
- Diagnosed PN by a dermatologist for at least 3 months before the Screening visit.
- Participants must have a minimum of 20 PN lesions in total at Screening visit and Day 1.
- Received at least 2 weeks of moderate or more potent topical corticosteroid therapy with insufficient efficacy.
- an average worst itch score of the Worst Itch Numeric Rating Scale (WI-NRS) ≥7 in the 7 days prior to Day1.
Key exclusion criteria (6 listed)
- Presence of skin morbidities other than PN and mild atopic dermatitis that may interfere with the assessment of the study outcomes.
- With drug-induced prurigo nodularis.
- Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the participant's participation in the study.
- With malignant tumors within the first 5 years before the screening.
- Plan to undergo major surgical procedures during this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK139Biological: AK139 low dose | Biological | cohort 1：AK139 regiment 1 |
| PlaceboOther: Placebo | Other | placebo |
| AK139Biological: AK139 high dose | Biological | cohort 2：AK139 regiment 2 |
Primary outcome
Proportion of subjects with ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at week 16
Time frame: 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.
6 secondary outcomes
Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN stage (IGA PN-S) at efficacy Visit
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
Time frame: Up to week 20
Change from the baseline in the WI-NRS at each other Visit
Time frame: Up to week 20
Change from baseline in Dermatology Life Quality Index (DLQI) score at efficacy Visit
Time frame: Up to week 20
Change from baseline in Hospital Anxiety and Depression Scale (HADS) at week 16
Time frame: week 16
Safety parameters
Time frame: Up to week 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK139 in people with Prurigo Nodularis (PN), run by Akeso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Guoqin (+86 (0760) 8987 3999, global.trials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at week 16 (time frame: Up to week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.