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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06238817




Registration number
NCT06238817
Ethics application status
Date submitted
25/01/2024
Date registered
2/02/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis
Scientific title
A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis
Secondary ID [1] 0 0
2023-505433-27-00
Secondary ID [2] 0 0
INCB18424-326
Universal Trial Number (UTN)
Trial acronym
TRuE-AD4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ruxolitinib Cream
Treatment: Drugs - Vehicle Cream

Experimental: VC Period: Ruxolitinib 1.5% Cream BID - Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the Vehicle Control (VC) Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.

Placebo comparator: VC Period: Vehicle Cream BID - Participants received vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.

Experimental: VC Extension Period/Escape Arm: Ruxolitinib 1.5% Cream BID - Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 24 during the Vehicle Control Extension (VCE) Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.

Placebo comparator: VC Extension Period/Escape Arm: Vehicle Cream BID - Participants who applied vehicle cream during the VC Period, continued applying vehicle cream as a thin film twice daily (BID) from Weeks 8 to 24 during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. Participants will be eligible to enter the ruxolitinib 1.5% cream open-label escape arm as defined in the protocol.

Experimental: VC Extension Period: Ruxolitinib 1.5% cream open-label escape arm - Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.


Treatment: Drugs: Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

Treatment: Drugs: Vehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
VC Period: Proportion of participants who achieved Eczema Area and Severity Index 75 (EASI75)
Timepoint [1] 0 0
Baseline to Week 8
Primary outcome [2] 0 0
VC Period: Proportion of participants who achieved Investigator's Global Assessment Treatment Success (IGA-TS)
Timepoint [2] 0 0
Baseline to Week 8
Secondary outcome [1] 0 0
VC Period: Proportion of participants with a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
Timepoint [1] 0 0
Baseline to Week 8
Secondary outcome [2] 0 0
VC Period: Proportion of participants with a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
Timepoint [2] 0 0
Baseline to Day 7
Secondary outcome [3] 0 0
VC Period: Proportion of participants with a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
Timepoint [3] 0 0
Baseline to Day 3
Secondary outcome [4] 0 0
VC Period: Proportion of participants with a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
Timepoint [4] 0 0
Baseline to Day 2
Secondary outcome [5] 0 0
VC Period: Number of Treatment Emergent Adverse Events (TEAEs)
Timepoint [5] 0 0
Up to Week 24, followed by 30 days follow-up
Secondary outcome [6] 0 0
VC Period: Proportion of participants who achieved Eczema Area and Severity Index 75 (EASI75)
Timepoint [6] 0 0
Baseline to Weeks 2 and 4
Secondary outcome [7] 0 0
VC Period: Proportion of participants who achieved Investigator's Global Assessment - Treatment Success (IGA-TS)
Timepoint [7] 0 0
Baseline to Weeks 2 and 4
Secondary outcome [8] 0 0
VC Period: Proportion of participants with a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
Timepoint [8] 0 0
Baseline to Weeks 2 and 4
Secondary outcome [9] 0 0
VC Period: Time to achieve a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
Timepoint [9] 0 0
Baseline to Week 8
Secondary outcome [10] 0 0
VC Period: Time to achieve = 2-point improvement from in Itch Numeric Rating Scale (NRS) score (ITCH2)
Timepoint [10] 0 0
Baseline to Week 8
Secondary outcome [11] 0 0
VC Period: Change from baseline (pre-study cream application) in current Itch NRS score at 5, 15, 30, 45, and 60 minutes and 2, 4, and 6 hours post-initial dose on Day 1.
Timepoint [11] 0 0
Baseline to Day 1
Secondary outcome [12] 0 0
VC Period: Proportion of participants achieving at least a 2-point decrease from baseline in current Itch NRS score at 5, 15, 30, 45, and 60 minutes and 2, 4, and 6 hours post-initial dose on Day 1.
Timepoint [12] 0 0
Baseline to Day 1
Secondary outcome [13] 0 0
VC Period: Proportion of participants achieving at least a 4-point decrease from baseline in current Itch NRS score at 5, 15, 30, 45, and 60 minutes and 2, 4, and 6 hours post-initial dose on Day 1.
Timepoint [13] 0 0
Baseline to Day 1
Secondary outcome [14] 0 0
VC and VCE Periods: Proportion of participants who achieved EASI50
Timepoint [14] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [15] 0 0
VC and VCE Periods: Proportion of participants who achieved EASI90
Timepoint [15] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [16] 0 0
VC and VCE Periods: Proportion of participants achieving both EASI75 and IGA-TS
Timepoint [16] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [17] 0 0
VC and VCE Periods: Change from Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA)
Timepoint [17] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [18] 0 0
VC and VCE Periods: Change from baseline in EASI score
Timepoint [18] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [19] 0 0
VC and VCE Periods: Change from baseline in SCORAD score
Timepoint [19] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [20] 0 0
VC and VCE Periods: Change from baseline in Itch NRS score
Timepoint [20] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [21] 0 0
VC and VCE Periods: Change from baseline in Skin Pain NRS score
Timepoint [21] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [22] 0 0
VCE Period: Time to open-label escape arm
Timepoint [22] 0 0
Baseline to Week 24
Secondary outcome [23] 0 0
VC and VCE Periods: Proportion of participants concurrently meeting all of the following criteria: IGA score = 3, EASI score = 16, Itch NRS score = 4, BSA = 10%, and DLQI score > 10
Timepoint [23] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [24] 0 0
VC and VCE Periods: Time to concurrently meeting all of the following criteria: IGA score = 3, EASI score = 16, Itch NRS score = 4, BSA = 10%, and DLQI score > 10
Timepoint [24] 0 0
Baseline to Week 24
Secondary outcome [25] 0 0
VC Period: Proportion of participants who experience a relapse after study treatment discontinuation
Timepoint [25] 0 0
Week 24 to Follow-up (30 days)
Secondary outcome [26] 0 0
VCE period: Time to first re-treatment
Timepoint [26] 0 0
Week 8 to Week 24
Secondary outcome [27] 0 0
VCE Period: Proportion of time off study treatment due to lesion clearance
Timepoint [27] 0 0
Week 8 to Week 24
Secondary outcome [28] 0 0
VCE period: Proportion of time on study treatment
Timepoint [28] 0 0
Week 8 to Week 24
Secondary outcome [29] 0 0
VC and VCE Periods: Proportion of participants who achieve = 4-point improvement in DLQI from baseline
Timepoint [29] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [30] 0 0
VC and VCE Periods: Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Timepoint [30] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [31] 0 0
VC and VCE Periods: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score
Timepoint [31] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [32] 0 0
VC and VCE Periods: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Timepoint [32] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [33] 0 0
VC and VCE Periods: Change from baseline in the HADS scores
Timepoint [33] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [34] 0 0
VC and VCE Periods: Change from baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score
Timepoint [34] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [35] 0 0
VC and VCE Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score
Timepoint [35] 0 0
Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
Secondary outcome [36] 0 0
VC and VCE Periods: Change from baseline score in Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD)
Timepoint [36] 0 0
Baseline to Week 8 and Week 24

Eligibility
Key inclusion criteria
* Adults aged = 18 years at screening (Note: Legal adult age for Korea is = 19 years).
* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.
* AD duration of at least 2 years.
* IGA score of 3 at screening and Day 1.
* EASI score > 7 at screening and Day 1.
* Itch NRS score = 4 at Day 1, defined as the average of the 7 days directly before Day 1, with Itch NRS values available for at least 4 of the 7 days.
* %BSA (excluding the scalp) with AD involvement of at least 10% and up to 20% at screening and Day 1.
* DLQI score > 10 at screening and Day 1.
* Documented recent history (within 12 months before the screening visit) of inadequate response, intolerance, or contraindication to TCSs and TCIs.
* Agree to discontinue all agents used to treat AD from screening through the final follow up visit, except as outlined in the protocol.
* Willingness to avoid pregnancy or fathering children based on the criteria as outlined in the protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Day 1.
* Concurrent conditions and history of other diseases as follows:

* Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
* Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Day 1.
* Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox) within 1 week before Day 1.
* Any other concomitant skin disorder (eg, generalized erythroderma, such as Netherton syndrome), pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
* Presence of AD lesions only on the hands or feet without prior history of involvement of other classic areas of involvement such as the face or the flexural folds.
* Other types of eczema within the 6 months prior to screening. Note: Seborrheic dermatitis on the scalp is allowed, as the scalp will not be treated with study cream.
* Current or history of hepatitis B or C virus infection.
* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Any of the following clinical laboratory test results at screening:

* Hemoglobin < 10 g/dL.
* Liver function tests:

* AST or ALT = 2 × ULN.
* Alkaline phosphatase > 1.5 × ULN.
* Bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%) with the exception of Gilbert's disease.
* Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration equation).
* Positive serology test results for HIV antibody.
* Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant.
* Use of any of the following treatments within the indicated washout period before Day 1:

* 5 half-lives or 12 weeks, whichever is longer: biologic agents. For biologic agents with washout periods longer than 12 weeks (eg, rituximab), consult the medical monitor.
* 4 weeks: systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive (eg, JAK inhibitors) or immunomodulating agents (eg, mycophenolate or tacrolimus).
* 2 weeks or 5 half-lives, whichever is longer - strong systemic CYP3A4 inhibitors.
* 2 weeks: immunizations with live-attenuated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted).

Note: COVID-19 vaccination is allowed.

• 1 week: use of other topical treatments for AD, other than bland emollients (eg, Aveeno creams, ointments, sprays, soap substitutes), such as antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), antibiotics, or antibacterial cleansing body wash/soap.

Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.

* History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, upadacitinib) for AD or any other inflammatory condition.
* Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study that is thought by the investigator to potentially impact the participant's AD.
* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with another investigational medication or current enrollment in another investigational drug protocol.
* In the opinion of the investigator, are unable or unlikely to comply with the administration schedule, study evaluations, and procedures (eg, eDiary compliance).

Other protocol-defined Inclusion/Exclusion Criteria may 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
Actual
26/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2025
Actual
Sample size
Target
225
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Premier Specialists Pty Ltd - Kogarah
Recruitment hospital [2] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [3] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [4] 0 0
Clinical Trials Sa - Campbelltown
Recruitment hospital [5] 0 0
Skin Health Institute Inc. - Carlton
Recruitment hospital [6] 0 0
Paratus Clinical Research, Woden - Phillip
Recruitment postcode(s) [1] 0 0
02217 - Kogarah
Recruitment postcode(s) [2] 0 0
02035 - Maroubra
Recruitment postcode(s) [3] 0 0
04102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
05074 - Campbelltown
Recruitment postcode(s) [5] 0 0
03053 - Carlton
Recruitment postcode(s) [6] 0 0
02606 - Phillip
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
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
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Belgium
State/province [13] 0 0
Brussels
Country [14] 0 0
Belgium
State/province [14] 0 0
Bruxelles
Country [15] 0 0
Belgium
State/province [15] 0 0
Edegem
Country [16] 0 0
Belgium
State/province [16] 0 0
Gent
Country [17] 0 0
Belgium
State/province [17] 0 0
Kortrijk
Country [18] 0 0
Belgium
State/province [18] 0 0
Loverval
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Gabrovo
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Haskovo
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Pleven
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Sofia
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
Canada
State/province [25] 0 0
Manitoba
Country [26] 0 0
Canada
State/province [26] 0 0
New Brunswick
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Canada
State/province [28] 0 0
Newfoundland
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
France
State/province [30] 0 0
Le Mans Cedex
Country [31] 0 0
France
State/province [31] 0 0
Lille Cedex
Country [32] 0 0
France
State/province [32] 0 0
Nantes
Country [33] 0 0
France
State/province [33] 0 0
Pierre Bénite Cedex
Country [34] 0 0
France
State/province [34] 0 0
Rouen
Country [35] 0 0
France
State/province [35] 0 0
Saint Etienne Cedex 2
Country [36] 0 0
Germany
State/province [36] 0 0
Augsburg
Country [37] 0 0
Germany
State/province [37] 0 0
Bad Bentheim
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Muenster
Country [40] 0 0
Germany
State/province [40] 0 0
Potsdam
Country [41] 0 0
Hungary
State/province [41] 0 0
Budapest
Country [42] 0 0
Hungary
State/province [42] 0 0
Debrecen
Country [43] 0 0
Hungary
State/province [43] 0 0
Szeged
Country [44] 0 0
Italy
State/province [44] 0 0
Milano
Country [45] 0 0
Italy
State/province [45] 0 0
Naples
Country [46] 0 0
Italy
State/province [46] 0 0
Napoli
Country [47] 0 0
Italy
State/province [47] 0 0
Rome
Country [48] 0 0
Italy
State/province [48] 0 0
Rozzano
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Seoul
Country [50] 0 0
Netherlands
State/province [50] 0 0
Bergen Op Zoom
Country [51] 0 0
Netherlands
State/province [51] 0 0
Breda
Country [52] 0 0
Netherlands
State/province [52] 0 0
Groningen
Country [53] 0 0
Poland
State/province [53] 0 0
Gdansk
Country [54] 0 0
Poland
State/province [54] 0 0
Katowice
Country [55] 0 0
Poland
State/province [55] 0 0
Krakow
Country [56] 0 0
Poland
State/province [56] 0 0
Lodz
Country [57] 0 0
Poland
State/province [57] 0 0
Lublin
Country [58] 0 0
Poland
State/province [58] 0 0
Poznan
Country [59] 0 0
Poland
State/province [59] 0 0
Szczecin
Country [60] 0 0
Poland
State/province [60] 0 0
Warszawa
Country [61] 0 0
Poland
State/province [61] 0 0
Wroclaw
Country [62] 0 0
Spain
State/province [62] 0 0
Badalona
Country [63] 0 0
Spain
State/province [63] 0 0
Barcelona
Country [64] 0 0
Spain
State/province [64] 0 0
Madrid
Country [65] 0 0
Spain
State/province [65] 0 0
Manises
Country [66] 0 0
Spain
State/province [66] 0 0
Villajoyosa
Country [67] 0 0
Switzerland
State/province [67] 0 0
Basel
Country [68] 0 0
Switzerland
State/province [68] 0 0
Bern
Country [69] 0 0
Switzerland
State/province [69] 0 0
Buochs
Country [70] 0 0
Switzerland
State/province [70] 0 0
Zuerich
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Isleworth
Country [72] 0 0
United Kingdom
State/province [72] 0 0
London
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Northampton
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Plymouth
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Walsall

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/NCT06238817