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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06516965




Registration number
NCT06516965
Ethics application status
Date submitted
18/07/2024
Date registered
24/07/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis
Secondary ID [1] 0 0
INCB54707-306
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prurigo Nodularis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Povorcitinib
Treatment: Drugs - Placebo

Experimental: Povorcitinib Dose 1 - Povorcitinib at the protocol-defined dose.

Experimental: Povorcitinib Dose 2 - Povorcitinib at the protocol-defined dose.

Placebo comparator: Placebo - Placebo at the protocol-defined dose.


Treatment: Drugs: Povorcitinib
Oral Tablet

Treatment: Drugs: Placebo
Oral Tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Proportion of participants achieving Itch NRS4 at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Proportion of participants achieving IGA-CPG-S-TS at Week 24
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Proportion of participants achieving Itch NRS4 at Week 4
Timepoint [3] 0 0
Week 4
Secondary outcome [4] 0 0
Time to Itch NRS4
Timepoint [4] 0 0
Up to 52 Weeks
Secondary outcome [5] 0 0
Change from baseline in Itch NRS score at each postbaseline visit
Timepoint [5] 0 0
Up to 52 weeks
Secondary outcome [6] 0 0
Percent change from baseline in NRS score at each postbaseline visit
Timepoint [6] 0 0
Up to 52 weeks
Secondary outcome [7] 0 0
Proportion of participants achieving Itch NRS4 at each postbaseline visit
Timepoint [7] 0 0
Up to 52 weeks
Secondary outcome [8] 0 0
Proportion of participants achieving IGA-CPG-S-TS at each postbaseline visit
Timepoint [8] 0 0
Up to 52 weeks
Secondary outcome [9] 0 0
Proportion of participants achieving Investigator's Global Assessment - Chronic Prurigo Activity (IGA-CPG-A) at each postbaseline visit
Timepoint [9] 0 0
Up to 52 weeks
Secondary outcome [10] 0 0
Proportion of participants achieving = 75% healed lesions in Prurigo Activity Score (PAS) at each postbaseline visit
Timepoint [10] 0 0
Up to 52 weeks
Secondary outcome [11] 0 0
Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at each postbaseline visit
Timepoint [11] 0 0
Up to 52 weeks
Secondary outcome [12] 0 0
Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.
Timepoint [12] 0 0
Up to 52 weeks
Secondary outcome [13] 0 0
Percent change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.
Timepoint [13] 0 0
Up to 52 weeks
Secondary outcome [14] 0 0
Proportion of participants with at least a 4-point decrease in DLQI score from baseline at each postbaseline visit for participants with DLQI score = 4 at baseline
Timepoint [14] 0 0
Up to 52 weeks
Secondary outcome [15] 0 0
Change from baseline in Skin Pain NRS score at each postbaseline visit
Timepoint [15] 0 0
Up to 52 weeks
Secondary outcome [16] 0 0
Percent change from baseline in Skin Pain NRS score at each postbaseline visit
Timepoint [16] 0 0
Up to 52 weeks
Secondary outcome [17] 0 0
Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score at each postbasline visit
Timepoint [17] 0 0
Up to 52 weeks
Secondary outcome [18] 0 0
Percent change from baseline in the HADS score at each postbaseline visit
Timepoint [18] 0 0
Up to 52 weeks
Secondary outcome [19] 0 0
Change from baseline in EQ-5D-5L score at each postbaseline visit
Timepoint [19] 0 0
Up to 52 weeks
Secondary outcome [20] 0 0
Percent change from baseline in EQ-5D-5L score at each postbaseline visit
Timepoint [20] 0 0
Up to 52 weeks
Secondary outcome [21] 0 0
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score at each postbaseline visit
Timepoint [21] 0 0
Up to 52 weeks
Secondary outcome [22] 0 0
Percent change in FACIT-F score at each postbaseline visit
Timepoint [22] 0 0
Up to 52 weeks
Secondary outcome [23] 0 0
Proportion of participants with at least a = 4-point increase in FACIT-F score at each postbaseline visit for participants with FACIT-F score = 48 at baseline
Timepoint [23] 0 0
Up to 52 weeks
Secondary outcome [24] 0 0
Number of Participants with Treatment Emergent Adverse Events (TEAE)
Timepoint [24] 0 0
Up to 52 weeks

Eligibility
Key inclusion criteria
* Male and female participants 18 to 75 years of age.
* Clinical diagnosis of PN for at least 3 months prior to Screening visit.
* Pruritus, defined as an average Itch NRS score = 7 during the 7 days prior to Day 1/Baseline.
* Total of = 20 pruriginous lesions on = 2 different body regions (both legs, and/or both arms, and/or trunk) at Screening and Day 1/Baseline.
* Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment.
* Willingness to avoid pregnancy or fathering children.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus.
* Diagnosis of PN secondary to medications.
* Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit.
* Women who are pregnant (or are considering pregnancy) or breastfeeding.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
* Evidence of infection with TB, HBV, HCV or HIV.
* History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment of PN or any inflammatory disease.
* Laboratory values outside of the protocol-defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
10/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/06/2027
Actual
Sample size
Target
330
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Premier Specialists Pty Ltd - Kogarah
Recruitment hospital [2] 0 0
Novatrials - Newcastle
Recruitment hospital [3] 0 0
Skin & Cancer Foundation Australia - Sydney
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Veracity Clinical Research Pty Ltd - Wolloongabba
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Fremantle Dermatology - Fremantle
Recruitment postcode(s) [1] 0 0
02217 - Kogarah
Recruitment postcode(s) [2] 0 0
02289 - Newcastle
Recruitment postcode(s) [3] 0 0
02010 - Sydney
Recruitment postcode(s) [4] 0 0
02145 - Westmead
Recruitment postcode(s) [5] 0 0
04102 - Wolloongabba
Recruitment postcode(s) [6] 0 0
03004 - Melbourne
Recruitment postcode(s) [7] 0 0
06160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Hampshire
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
United States of America
State/province [22] 0 0
West Virginia
Country [23] 0 0
Belgium
State/province [23] 0 0
Gent
Country [24] 0 0
Belgium
State/province [24] 0 0
Liege
Country [25] 0 0
Belgium
State/province [25] 0 0
Loverval
Country [26] 0 0
Belgium
State/province [26] 0 0
Woluwe-saint-lambert
Country [27] 0 0
Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Canada
State/province [30] 0 0
Saskatchewan
Country [31] 0 0
Chile
State/province [31] 0 0
LAS Condes Santiago
Country [32] 0 0
Chile
State/province [32] 0 0
Santiago
Country [33] 0 0
Chile
State/province [33] 0 0
Valdivia
Country [34] 0 0
Czechia
State/province [34] 0 0
Prague
Country [35] 0 0
Germany
State/province [35] 0 0
Aachen
Country [36] 0 0
Germany
State/province [36] 0 0
Buxtehude
Country [37] 0 0
Germany
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Chemnitz
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Germany
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Darmstadt
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Germany
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Dresden
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Germany
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Frankfurt Am Main
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Germany
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Gottingen
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Germany
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Magdeburg
Country [43] 0 0
Germany
State/province [43] 0 0
Mainz
Country [44] 0 0
Germany
State/province [44] 0 0
Muenchen
Country [45] 0 0
Germany
State/province [45] 0 0
Muenster
Country [46] 0 0
Germany
State/province [46] 0 0
Oldenburg
Country [47] 0 0
Germany
State/province [47] 0 0
Witten
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Japan
State/province [48] 0 0
Bunkyo-ku
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Japan
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Kobe
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Japan
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Sendai
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Japan
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Shinjuku-ku
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Poland
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Gdansk
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Katowice
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Lodz
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Lublin
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Ostrowiec Swietokrzyski
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Poznan
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Poland
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Rzeszow
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Poland
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Tarnow
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Torun
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Poland
State/province [61] 0 0
Warszawa
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Poland
State/province [62] 0 0
Wroclaw
Country [63] 0 0
Spain
State/province [63] 0 0
Alicante
Country [64] 0 0
Spain
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Badalona
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Spain
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Barcelona
Country [66] 0 0
Spain
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Cordoba
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Spain
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Granada
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Spain
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Madrid
Country [69] 0 0
Spain
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Majadahonda
Country [70] 0 0
Spain
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Manises
Country [71] 0 0
Spain
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Santiago de Compostela
Country [72] 0 0
Spain
State/province [72] 0 0
Seville
Country [73] 0 0
Spain
State/province [73] 0 0
Valencia
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Colchester
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Dudley
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Liverpool
Country [77] 0 0
United Kingdom
State/province [77] 0 0
London
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Poole
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Redhill

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Incyte Medical Monitor
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Incyte Corporation Call Center (US)
Address 0 0
Country 0 0
Phone 0 0
1.855.463.3463
Fax 0 0
Email 0 0
medinfo@incyte.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Available to whom?
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.incyte.com/our-company/compliance-and-transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06516965