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Topical Ruxolitinib Evaluation in Chronic Hand Eczema

Primary Purpose

Hand Eczema

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ruxolitinib cream
Vehicle
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Eczema focused on measuring eczema, chronic hand eczema (CHE), dermatitis, skin disease, JAK inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of CHE for at least 6 months prior to screening. Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3 months or ≥ 2 flares within the previous 12 months. Screening and baseline IGA-CHE 3 or 4. Baseline CHE-related Itch NRS ≥ 4. Have been treated with at least 1 prescription CHE therapy or if such therapy was not advisable or contraindicated. Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol. Exclusion Criteria: Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of this study. Any serious illness or medical, physical, or psychiatric condition(s). Laboratory values outside of the protocol-defined criteria. Use of protocol-defined treatments within the indicated washout period before baseline. Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks before baseline. Pregnant or lactating participants, or those considering pregnancy during the period of their study participation. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Sites / Locations

  • Southwest Skin Specialists Phoenix BiltmoreRecruiting
  • First Oc DermatologyRecruiting
  • Marvel Clinical Research LlcRecruiting
  • Dermatology Research AssociatesRecruiting
  • Skin Research of South Florida, Llc
  • Well Pharma Medical Research CorporationRecruiting
  • Forcare Clinical Research
  • Midwest Allergy Sinus Asthma, Sc
  • The Indiana Clinical Trials Center IctcRecruiting
  • Delricht ResearchRecruiting
  • Delricht ResearchRecruiting
  • Henry Ford Medical Center
  • Jubilee Clinical Research IncRecruiting
  • Forest Hills Dermatology GroupRecruiting
  • Juva Skin and Laser Center
  • Onsite Clinical Solutions, Llc Charlotte Central OfficeRecruiting
  • Bexley DermatologyRecruiting
  • Central Sooner ResearchRecruiting
  • Oregon Dermatology and Research CenterRecruiting
  • Oregon Medical Research CenterRecruiting
  • International Clinical Research Tennessee LlcRecruiting
  • Austin Institute For Clinical Research Aicr Pflugerville
  • Dermatology Clinical Research Center of San AntonioRecruiting
  • Dermatology Research Institute Inc.
  • Care Clinic
  • Simcomed Health LtdRecruiting
  • Fachklinik Bad Bentheim Dermatologie
  • Derma-Study-Center Fn Gmbh
  • Gemeinschaftspraxis Dr. Scholz, Dr. Sebastian
  • Beldio Research Gmbh
  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
  • Centrum Badan Klinicznych Pi-House Sp. Z O.O.
  • Laser Clinic S.C.
  • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Klinika Ambroziak Estederm
  • Dermmedica Sp. Z O.O.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ruxolitinib

Vehicle

Arm Description

Ruxolitinib cream 1.5% twice daily (BID) for 16 weeks followed by ruxolitinib cream 1.5% BID for an additional 16-week treatment extension period.

Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.

Outcomes

Primary Outcome Measures

Proportion of participants achieving IGA-CHE-TS
The Investigator's Global Assessment-Chronic Hand Eczema (IGA-CHE) is an instrument used to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.

Secondary Outcome Measures

Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch Numerical Rating Scale (NRS) score
The Itch NRS is an instrument for measurement of intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score
The Itch NRS is an instrument for measurement of intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score
The Itch NRS is an instrument for measurement of intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Proportion of participants achieving an IGA-CHE-TS from baseline
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.
Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score
The Itch NRS is an instrument for measurement of intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Change from baseline in CHE-related Itch NRS score
The Itch NRS is an instrument for measurement of itch intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Time to ≥ 4-point improvement from baseline in CHE-related Itch NRS score
The Itch NRS is an instrument for measurement of itch intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Change from baseline in CHE-related Skin Pain NRS score
The Pain NRS is an instrument for measurement of pain intensity and participant will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score
The Pain NRS is an instrument for measurement of pain intensity and participant will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time to ≥ 2-point improvement from baseline in CHE-related Pain NRS score
The Pain NRS is an instrument for measurement of pain intensity and participant will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Percentage change from baseline in Hand Eczema Severity Index (HECSI)
The Hand Eczema Severity Index (HECSI) is an instrument used to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales.
Proportion of participants with each score on the PGIC
The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
Change from baseline in DLQI score
The Dermatology Life Quality Index (DLQI) is a 10-question questionnaire to measure how much the skin problem has affected the participant over the previous 7 days and participant will rate each question as 1-very much, 2- a lot, 3-a little, or 4-not at all.
Change from baseline in EQ-5D-5L score
The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: Level 1 = no problems, Level 2 = slight problems, Level 3 = moderate problems, Level 4 = severe problems, and Level 5 = extreme problems.
Change from baseline in QOLHEQ score
The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) is a disease-specific instrument to assess disease-specific health-related quality of life in participants with CHE over the past 7 days. It consists of 30 items covering impairments in 4 domains: 1) symptoms, 2) emotions, 3) limitations in functioning, and 4) treatment and prevention. Each item is scored in a 5-point scale: 0) never, 1) rarely, 2) sometimes, 3) often, and 4) all the time.
Change from baseline in WPAI-ChHD
The Work Productivity and Activity Impairment Questionnaire Specific Health Problem v2.0 in Chronic Hand Eczema (WPAI-ChHD) questionnaire is a 6-item questionnaire used to assess the impact of chronic hand dermatitis on job performance and productivity over the past 7 days.
Number of Participants with Treatment Emergent Adverse Events (TEAE)
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Full Information

First Posted
June 7, 2023
Last Updated
October 5, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05906628
Brief Title
Topical Ruxolitinib Evaluation in Chronic Hand Eczema
Official Title
A Phase 2, Double-Blind, Randomized, 16-Week, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Open-Label Extension Period in Adults With Chronic Hand Eczema
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
August 26, 2024 (Anticipated)
Study Completion Date
January 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Eczema
Keywords
eczema, chronic hand eczema (CHE), dermatitis, skin disease, JAK inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants will receive ruxolitinib cream (1.5%) or vehicle cream for 16 weeks, after which they will be offered the opportunity to receive ruxilitinib cream (1.5%) in the open-label treatment extension period for another 16 weeks.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ruxolitinib
Arm Type
Experimental
Arm Description
Ruxolitinib cream 1.5% twice daily (BID) for 16 weeks followed by ruxolitinib cream 1.5% BID for an additional 16-week treatment extension period.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib cream
Other Intervention Name(s)
INCB18424 cream
Intervention Description
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle cream is a topical formulation applied as a thin film to affected areas.
Primary Outcome Measure Information:
Title
Proportion of participants achieving IGA-CHE-TS
Description
The Investigator's Global Assessment-Chronic Hand Eczema (IGA-CHE) is an instrument used to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch Numerical Rating Scale (NRS) score
Description
The Itch NRS is an instrument for measurement of intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Time Frame
Week 16
Title
Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score
Description
The Itch NRS is an instrument for measurement of intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Time Frame
Week 4
Title
Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score
Description
The Itch NRS is an instrument for measurement of intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Time Frame
Week 1 (Day 7)
Title
Proportion of participants achieving an IGA-CHE-TS from baseline
Description
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.
Time Frame
Up to Week 32
Title
Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score
Description
The Itch NRS is an instrument for measurement of intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Time Frame
Day 3
Title
Change from baseline in CHE-related Itch NRS score
Description
The Itch NRS is an instrument for measurement of itch intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Time Frame
Up to Week 32
Title
Time to ≥ 4-point improvement from baseline in CHE-related Itch NRS score
Description
The Itch NRS is an instrument for measurement of itch intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Time Frame
Up to Week 32
Title
Change from baseline in CHE-related Skin Pain NRS score
Description
The Pain NRS is an instrument for measurement of pain intensity and participant will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time Frame
Up to Week 32
Title
Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score
Description
The Pain NRS is an instrument for measurement of pain intensity and participant will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time Frame
Week 16
Title
Time to ≥ 2-point improvement from baseline in CHE-related Pain NRS score
Description
The Pain NRS is an instrument for measurement of pain intensity and participant will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time Frame
Up to Week 32
Title
Percentage change from baseline in Hand Eczema Severity Index (HECSI)
Description
The Hand Eczema Severity Index (HECSI) is an instrument used to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales.
Time Frame
Week 16
Title
Proportion of participants with each score on the PGIC
Description
The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
Time Frame
Up to Week 32
Title
Change from baseline in DLQI score
Description
The Dermatology Life Quality Index (DLQI) is a 10-question questionnaire to measure how much the skin problem has affected the participant over the previous 7 days and participant will rate each question as 1-very much, 2- a lot, 3-a little, or 4-not at all.
Time Frame
Up to week 32
Title
Change from baseline in EQ-5D-5L score
Description
The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: Level 1 = no problems, Level 2 = slight problems, Level 3 = moderate problems, Level 4 = severe problems, and Level 5 = extreme problems.
Time Frame
Up to Week 32
Title
Change from baseline in QOLHEQ score
Description
The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) is a disease-specific instrument to assess disease-specific health-related quality of life in participants with CHE over the past 7 days. It consists of 30 items covering impairments in 4 domains: 1) symptoms, 2) emotions, 3) limitations in functioning, and 4) treatment and prevention. Each item is scored in a 5-point scale: 0) never, 1) rarely, 2) sometimes, 3) often, and 4) all the time.
Time Frame
Up to week 32, followed by 30 days follow-up
Title
Change from baseline in WPAI-ChHD
Description
The Work Productivity and Activity Impairment Questionnaire Specific Health Problem v2.0 in Chronic Hand Eczema (WPAI-ChHD) questionnaire is a 6-item questionnaire used to assess the impact of chronic hand dermatitis on job performance and productivity over the past 7 days.
Time Frame
Up to week 32, followed by 30 days follow-up
Title
Number of Participants with Treatment Emergent Adverse Events (TEAE)
Description
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time Frame
Up to week 32, followed by 30 days follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of CHE for at least 6 months prior to screening. Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3 months or ≥ 2 flares within the previous 12 months. Screening and baseline IGA-CHE 3 or 4. Baseline CHE-related Itch NRS ≥ 4. Have been treated with at least 1 prescription CHE therapy or if such therapy was not advisable or contraindicated. Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol. Exclusion Criteria: Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of this study. Any serious illness or medical, physical, or psychiatric condition(s). Laboratory values outside of the protocol-defined criteria. Use of protocol-defined treatments within the indicated washout period before baseline. Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks before baseline. Pregnant or lactating participants, or those considering pregnancy during the period of their study participation. Other protocol-defined Inclusion/Exclusion Criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
eumedinfo@incyte.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Incyte Medical Monitor
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Southwest Skin Specialists Phoenix Biltmore
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Individual Site Status
Recruiting
Facility Name
First Oc Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
Marvel Clinical Research Llc
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Research of South Florida, Llc
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Well Pharma Medical Research Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Forcare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Midwest Allergy Sinus Asthma, Sc
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
The Indiana Clinical Trials Center Ictc
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Individual Site Status
Recruiting
Facility Name
Delricht Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Name
Delricht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Jubilee Clinical Research Inc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Name
Forest Hills Dermatology Group
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Individual Site Status
Recruiting
Facility Name
Juva Skin and Laser Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Onsite Clinical Solutions, Llc Charlotte Central Office
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Recruiting
Facility Name
Bexley Dermatology
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Individual Site Status
Recruiting
Facility Name
Central Sooner Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Individual Site Status
Recruiting
Facility Name
International Clinical Research Tennessee Llc
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin Institute For Clinical Research Aicr Pflugerville
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Research Institute Inc.
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Care Clinic
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4P-1K4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Simcomed Health Ltd
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 1G7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Fachklinik Bad Bentheim Dermatologie
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Derma-Study-Center Fn Gmbh
City
Friedrichshafen
ZIP/Postal Code
88045
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Gemeinschaftspraxis Dr. Scholz, Dr. Sebastian
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Beldio Research Gmbh
City
Memmingen
ZIP/Postal Code
87700
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Badan Klinicznych Pi-House Sp. Z O.O.
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Laser Clinic S.C.
City
Szczecin
ZIP/Postal Code
70-332
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Klinika Ambroziak Estederm
City
Warszawa
ZIP/Postal Code
02-953
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Dermmedica Sp. Z O.O.
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

Topical Ruxolitinib Evaluation in Chronic Hand Eczema

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