Back to results

TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ruxolitinib cream

Vehicle cream

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, pruritus, eczema, topical therapy, JAK inhibitor

Eligibility Criteria

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

Inclusion Criteria:

Adolescents aged ≥ 12 to 17 years, inclusive, and men and women aged ≥ 18 years.
Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria.
AD duration of at least 2 years.
Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at Screening and Baseline (VC Period) and 0 to 4 at Week 8 (LTS Period).
Participants with percentage body surface area (%BSA) (excluding scalp) of AD involvement of 3% to 20% at Screening and Baseline (VC Period) and 0% to 20% at Week 8 (LTS Period).
Participants who agree to discontinue all agents used to treat AD from Screening through the final follow-up visit.
Participants who have at least 1 "target lesion" that measures approximately 10 cm^2 or more at Screening and Baseline. Lesion must be representative of the participant's disease state and not be located on the hands, feet, or genitalia.
Willingness to avoid pregnancy or fathering of children.

Exclusion Criteria:

Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Baseline.
Concurrent conditions and history of other diseases:
- Immunocompromised.
- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline.
- Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline.
- Any other concomitant skin disorder, 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 classical areas of involvement such as the face or the folds.
- Other types of eczema.
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 drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Use of any of the following treatments within the indicated washout period before Baseline:
- 5 half-lives or 12 weeks, whichever is longer - biologic agents (e.g. dupilumab).
- 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (e.g. mycophenolate or tacrolimus).
- 2 weeks - immunizations and sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted).
- 1 week - use of other topical treatments for AD (other than bland emollients). 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.
Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical.
Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 2 weeks prior to Baseline and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD.
Positive serology test results at screening for human immunodeficiency virus (HIV) antibody.
Liver function tests: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN); alkaline phosphatase and/or bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
Pregnant or lactating participants, or those considering pregnancy.
History of alcoholism or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the administration schedule and study assessments.
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.

Sites / Locations

University Of Alabama At Birmingham
Center For Dermatology Cosmetic And Laser Surgery
Marvel Clinical Research - Clinedge - PPDS
Allergy And Asthma Associates Of Southern California - CRN
Synexus Clinical Research US Inc. Santa Rosa
Olympian Clinical Research
San Marcus Research Clinic Inc
Well Pharma Medical Research Corporation
Forward Clinical Trials Inc
Clinical Research Atlanta - ERN - PPDS
Northwest Clinical Trials Clinedge
Randall Dermatology
Derm Research LLC
Dermatology Specialists PSC
Michael W Simon MD Office
Delricht Clinical Research - Clinedge - PPDS Baton Rouge
Hamzavi Dermatology
Jubilee Clinical Research - BTC - PPDS
ActivMed Practices & Research Inc
Hassman Research Institute
Skin Laser and Surgery specialists of New York and New Jersey LLC
Derm Research Center Of New York Inc
University of North Carolina at Chapel Hill
Synexus Clinical Research US, Inc. - Cincinnati
Ohio Pediatric Research Association
Synexus Clinical Research US, Inc. - Anderson
International Clinical Research Tennessee LLC
Epiphany Dermatology Fort Worth
Dermatology Clinical Research Center of San Antonio
Center for Clinical Studies
Tanner Clinic
Advanced Research Institute
PI Coor Clinical Research LLC
Clinical Research Partners LLC
Dermatology Specialists of Spokane
Medical Center Unimed EOOD
Medical Center Excelsior OOD - PPDS
Diagnostic Consultative Center XXVIII - Sofia - EOOD
Synexus - Medical Center Synexus Sofia EOOD
Synexus - Medical Centre Synexus Sofia EOOD (branch - Stara Zagora)
Wiseman Dermatology Research Inc.
The Centre For Clinical Trials Inc.
Dermatology Ottawa Research Centre
Dermamedica, s.r.o. - Kozni Ambulance Nachod
CTCenter MaVe s.r.o.
CCR Ostrava, s.r.o.
Synexus Czech s.r.o.
Synexus Affiliate - CLINTRIAL s.r.o.
Charité - Universitätsmedizin Berlin
Hautarztpraxis Mahlow
Universitatsklinikum Schleswig-Holstein
Centrum Medyczne Matusiak
Synexus Affiliate - Bialystok - ClinicMed Daniluk, Nowak Spółka Jawna
Centrum Badan Klinicznych PI-House sp. z o.o.
Synexus - Gdynia
Centrum Medyczne Angelius Provita
Synexus Affiliate - Krakowskie Centrum Medyczne
Twoja Przychodnia - Szczecińskie Centrum Medyczne
Synexus - Warsaw
EMC Instytut Medyczny S.A.
Wro Medica
Hospital de Manises
Hospital General Universitario de Alicante
Hospital de La Santa Creu i Sant Pau
Hospital General Universitario Reina Sofia
Hospital Universitario La Paz - PPDS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Experimental

Arm Label

Vehicle Control (VC) Period: Vehicle Cream BID

VC Period: Ruxolitinib 0.75% Cream BID

VC Period: Ruxolitinib 1.5% Cream BID

Long-Term Safety (LTS) Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID

LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID

LTS Period: Ruxolitinib 0.75% Cream BID

LTS Period: Ruxolitinib 1.5% Cream BID

Arm Description

Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.

Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.

Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.

Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.

Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.

Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.

Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.

Outcomes

Primary Outcome Measures

VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8

The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.

Secondary Outcome Measures

VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Week 8

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.

VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8

The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours.

VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Sleep Disturbance (8b - 24-Hour Recall) Score at Week 8

The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance.

VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a - 24-Hour Recall) Score at Week 8

The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. Each item asks the participant to rate the severity of the participant's sleep impairment.

VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE)

An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.

LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE

VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4

VC Period: Percentage of Participants Achieving an IGA of 0 or 1

LTS Period: Percentage of Participants Achieving an IGA of 0 or 1

VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4

VC Period: Percentage of Participants Who Achieved EASI50

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI50 responder was defined as a participant achieving 50% or greater improvement from Baseline in EASI score.

VC Period: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4

VC Period: Percentage of Participants Who Achieved EASI90

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI90 responder was defined as a participant achieving 90% or greater improvement from Baseline in EASI score.

VC Period: Percent Change From Baseline in EASI Score

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. A negative change from Baseline indicates improvement.

VC Period: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score

The SCORAD is a tool to assess extent and severity of eczema. To determine the extent, the rule of nines or handprint method is used to assess eczema affected area (A). To determine disease severity (B) it evaluates 6 clinical characteristics: 1. redness, 2. swelling, 3. oozing/crusting, 4. scratch marks, 5. lichenification, and 6. dryness on a 4-point scale of 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), added to give B with maximum score of 18. Subjective symptoms (C) of itch and sleeplessness are assessed using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), added to give C with maximum score of 20. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combined using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. A negative change from Baseline indicates improvement.

VC Period: Change From Baseline in Itch NRS Score

VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points

VC Period: Change From Baseline in Skin Pain NRS Score

The Skin Pain NRS is a daily patient-reported measure (24-hour recall), of the worst level of pain intensity from 0 (no pain) to 10 (worst imaginable pain) using a diary. Participants will be asked, "Rate the pain severity from your atopic dermatitis skin changes by selecting a number that best describes your worst level of pain in the past 24 hours." A negative change from Baseline indicates improvement.

VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score at Weeks 2 and 4

VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score at Weeks 2 and 4

VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score

VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score

The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement.

LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score

The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement.

LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score

VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA)

Body surface area affected by AD was assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region was assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage was reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSA head and neck + 0.3*BSA trunk + 0.2* BSA upper limbs + 0.4*BSA lower limbs. A negative change from Baseline indicates improvement.

LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA

VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score

The POEM is a 7-question quality-of-life assessment that asks how many days the participant has been bothered by various aspects of their skin condition during the past 7 days. It assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. A negative change from Baseline indicates improvement.

LTS Period: Change From Baseline in POEM Score

VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score

The DLQI is a simple, 10 question (Q) validated quality-of-life questionnaire to measure how much the skin problem has affected the participant. It covers 6 domains including symptoms and feelings (Q1 and Q2), daily activities (Q3 and Q4), leisure (Q5 and Q6), work and school (Q7), personal relationships (Q8 and Q9), and treatment(Q10). The recall Period of this scale is over the last week. Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. Scores range from 0 ("no impact on participant's life") to 30 ("extremely large effect on participant's life"), and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life.

LTS Period: Change From Baseline in DLQI Score

VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score

CDLQI is the youth/children's version of the DLQI. The CDLQI is a simple 10 question (Q) validated quality-of-life questionnaire. It covers 6 domains including symptoms and feelings (Q1 and Q2), leisure (Q4, Q5, and Q6), school or holidays (Q7), personal relationships (Q3 and Q8), sleep (Q9) and treatment (Q10). Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. The total DLQI score is calculated by adding the score of each question resulting in a maximum score of 30 (extremely large effect on participant's life) and a minimum score of 0 (no impact on participant's life) and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life.

LTS Period: Change From Baseline in CDLQI Score

VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8

The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions 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. The lower score indicates improvement.

VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8

VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8

VC Period: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score

EQ-5D-5L questionnaire has 2 parts: EQ-5D-5L descriptive system & EQ-VAS. EQ-5D is a validated, self-administered, generic utility questionnaire wherein participants rate their current health state based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. 5L indicates that for each dimension, there are 5 levels:1=no problems,2=slight problems,3=moderate problems,4=severe problems, and 5=extreme problems. EQ-5D-5L score is assessed using VAS that ranges from 0 to 100 millimetres (mm), where 0 indicates "worst health you can imagine" and 100 indicates "best health you can imagine". The participant was asked to indicate his/her health state over past 7 days in each of the 5 dimensions. Digits for the 5 dimensions can be combined into a 5-digit number that describes the participant's health state. In the EQ-VAS, participants had to record their health state on a scale ranging from 0 to 100. A positive change from Baseline indicates improvement.

VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0)

The WPAI-SHP is a 6-item participant questionnaire developed to measure the effect of overall health and specific symptoms on productivity at work and regular activities outside of it in the past 7 days. The WPAI-SHP consists of 6 questions as follows: 1=currently employed; 2=hours missed due to AD; 3=hours missed other reasons; 4=hours actually worked; 5=degree AD affected productivity while working; 6=degree AD affected regular activities and the computed percentage, range for each sub scale is from 0 to 100, with higher values indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.

LTS Period: Change From Baseline in WPAI-SHP v2.0

VC Period: Trough Plasma Concentrations of Ruxolitinib

Plasma samples were collected just before the morning application of study drug during each specified time point.

LTS Period: Trough Plasma Concentrations of Ruxolitinib

Plasma samples were collected just before the morning application of study drug during each specified time point.

Full Information

NCT ID

NCT03745651

First Posted

November 15, 2018

Last Updated

September 21, 2023

Sponsor

Incyte Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03745651

Brief Title

TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

Official Title

Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 2 (TRuE AD2) - A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

December 20, 2018 (Actual)

Primary Completion Date

November 18, 2019 (Actual)

Study Completion Date

November 9, 2020 (Actual)

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

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess the efficacy of ruxolitinib cream in adolescents and adults with atopic dermatitis (AD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

Atopic dermatitis, pruritus, eczema, topical therapy, JAK inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

618 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vehicle Control (VC) Period: Vehicle Cream BID

Arm Type

Placebo Comparator

Arm Description

Arm Title

VC Period: Ruxolitinib 0.75% Cream BID

Arm Type

Experimental

Arm Description

Arm Title

VC Period: Ruxolitinib 1.5% Cream BID

Arm Type

Experimental

Arm Description

Arm Title

Long-Term Safety (LTS) Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID

Arm Type

Experimental

Arm Description

Arm Title

LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID

Arm Type

Experimental

Arm Description

Arm Title

LTS Period: Ruxolitinib 0.75% Cream BID

Arm Type

Experimental

Arm Description

Arm Title

LTS Period: Ruxolitinib 1.5% Cream BID

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ruxolitinib cream

Other Intervention Name(s)

INCB018424 phosphate cream

Intervention Description

Ruxolitinib 0.75% or 1.5% cream.

Intervention Type

Drug

Intervention Name(s)

Vehicle cream

Intervention Description

Ruxolitinib matching vehicle cream.

Primary Outcome Measure Information:

Title

VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8

Description

Time Frame

Baseline to Week 8

Secondary Outcome Measure Information:

Title

VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Week 8

Description

Time Frame

Baseline to Week 8

Title

VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8

Description

Time Frame

Baseline to Week 8

Title

Description

Time Frame

Baseline to Week 8

Title

VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a - 24-Hour Recall) Score at Week 8

Description

Time Frame

Baseline to Week 8

Title

VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE)

Description

Time Frame

From date of randomization up to Week 8

Title

LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE

Description

Time Frame

From first dose date in LTS Period (Week 8) until last follow-up visit (up to 52 weeks)

Title

VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4

Description

Time Frame

Baseline to Weeks 2 and 4

Title

VC Period: Percentage of Participants Achieving an IGA of 0 or 1

Description

Time Frame

Weeks 2, 4 and 8

Title

LTS Period: Percentage of Participants Achieving an IGA of 0 or 1

Description

Time Frame

Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

Title

VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4

Description

Time Frame

Baseline to Weeks 2 and 4

Title

VC Period: Percentage of Participants Who Achieved EASI50

Description

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI50 responder was defined as a participant achieving 50% or greater improvement from Baseline in EASI score.

Time Frame

Baseline to Weeks 2, 4 and 8

Title

VC Period: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4

Description

Time Frame

Baseline to Weeks 2 and 4

Title

VC Period: Percentage of Participants Who Achieved EASI90

Description

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI90 responder was defined as a participant achieving 90% or greater improvement from Baseline in EASI score.

Time Frame

Baseline to Weeks 2, 4 and 8

Title

VC Period: Percent Change From Baseline in EASI Score

Description

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. A negative change from Baseline indicates improvement.

Time Frame

Baseline, Weeks 2, 4 and 8

Title

VC Period: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score

Description

Time Frame

Baseline, Weeks 2, 4 and 8

Title

VC Period: Change From Baseline in Itch NRS Score

Description

Time Frame

Baseline, Weeks 2, 4 and 8

Title

VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points

Description

Time Frame

Up to Week 8

Title

VC Period: Change From Baseline in Skin Pain NRS Score

Description

Time Frame

Baseline, Weeks 2, 4 and 8

Title

VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score at Weeks 2 and 4

Description

Time Frame

Weeks 2 and 4

Title

VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score at Weeks 2 and 4

Description

Time Frame

Weeks 2 and 4

Title

VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score

Description

Time Frame

Baseline, Weeks 2, 4 and 8

Title

VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score

Description

The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement.

Time Frame

Baseline, Weeks 2, 4 and 8

Title

LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score

Description

The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement.

Time Frame

Baseline, Weeks 12, 24, and 52

Title

LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score

Description

Time Frame

Baseline, Weeks 12, 24, and 52

Title

VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA)

Description

Time Frame

Baseline, Weeks 2, 4 and 8

Title

LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA

Description

Time Frame

Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Title

VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score

Description

Time Frame

Baseline, Weeks 2, 4 and 8

Title

LTS Period: Change From Baseline in POEM Score

Description

Time Frame

Baseline, Weeks 12, 24 and 52

Title

VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score

Description

Time Frame

Baseline, Weeks 2, 4, and 8

Title

LTS Period: Change From Baseline in DLQI Score

Description

Time Frame

Baseline, Weeks 12, 24, and 52

Title

VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score

Description

Time Frame

Baseline, Weeks 2, 4, and 8

Title

LTS Period: Change From Baseline in CDLQI Score

Description

Time Frame

Baseline, Weeks 12, 24, and 52

Title

VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8

Description

Time Frame

Weeks 2, 4 and 8

Title

VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8

Description

Time Frame

Weeks 2, 4 and 8

Title

VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8

Description

Time Frame

Weeks 2, 4 and 8

Title

VC Period: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score

Description

Time Frame

Baseline, Weeks 2, 4 and 8

Title

VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0)

Description

Time Frame

Baseline, Weeks 2, 4, and 8

Title

LTS Period: Change From Baseline in WPAI-SHP v2.0

Description

Time Frame

Baseline, Weeks 12, 24, 36, and 52

Title

VC Period: Trough Plasma Concentrations of Ruxolitinib

Description

Plasma samples were collected just before the morning application of study drug during each specified time point.

Time Frame

Pre-dose at Weeks 2, 4 and 8

Title

LTS Period: Trough Plasma Concentrations of Ruxolitinib

Description

Plasma samples were collected just before the morning application of study drug during each specified time point.

Time Frame

Pre-dose at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adolescents aged ≥ 12 to 17 years, inclusive, and men and women aged ≥ 18 years. Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria. AD duration of at least 2 years. Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at Screening and Baseline (VC Period) and 0 to 4 at Week 8 (LTS Period). Participants with percentage body surface area (%BSA) (excluding scalp) of AD involvement of 3% to 20% at Screening and Baseline (VC Period) and 0% to 20% at Week 8 (LTS Period). Participants who agree to discontinue all agents used to treat AD from Screening through the final follow-up visit. Participants who have at least 1 "target lesion" that measures approximately 10 cm^2 or more at Screening and Baseline. Lesion must be representative of the participant's disease state and not be located on the hands, feet, or genitalia. Willingness to avoid pregnancy or fathering of children. Exclusion Criteria: Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Baseline. Concurrent conditions and history of other diseases: Immunocompromised. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline. Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline. Any other concomitant skin disorder, 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 classical areas of involvement such as the face or the folds. Other types of eczema. 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 drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. Use of any of the following treatments within the indicated washout period before Baseline: 5 half-lives or 12 weeks, whichever is longer - biologic agents (e.g. dupilumab). 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (e.g. mycophenolate or tacrolimus). 2 weeks - immunizations and sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted). 1 week - use of other topical treatments for AD (other than bland emollients). 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. Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical. Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 2 weeks prior to Baseline and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD. Positive serology test results at screening for human immunodeficiency virus (HIV) antibody. Liver function tests: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN); alkaline phosphatase and/or bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%). Pregnant or lactating participants, or those considering pregnancy. History of alcoholism or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the administration schedule and study assessments. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael E. Kuligowski, MD, PhD, MBA

Organizational Affiliation

Incyte Corporation

Official's Role

Study Director

Facility Information:

Facility Name

University Of Alabama At Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Center For Dermatology Cosmetic And Laser Surgery

City

Fremont

State/Province

California

ZIP/Postal Code

94538

Country

United States

Facility Name

Marvel Clinical Research - Clinedge - PPDS

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92647

Country

United States

Facility Name

Allergy And Asthma Associates Of Southern California - CRN

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Synexus Clinical Research US Inc. Santa Rosa

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95405

Country

United States

Facility Name

Olympian Clinical Research

City

Largo

State/Province

Florida

ZIP/Postal Code

33770

Country

United States

Facility Name

San Marcus Research Clinic Inc

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Well Pharma Medical Research Corporation

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Forward Clinical Trials Inc

City

Tampa

State/Province

Florida

ZIP/Postal Code

33624

Country

United States

Facility Name

Clinical Research Atlanta - ERN - PPDS

City

Stockbridge

State/Province

Georgia

ZIP/Postal Code

30281

Country

United States

Facility Name

Northwest Clinical Trials Clinedge

City

Boise

State/Province

Idaho

ZIP/Postal Code

83704

Country

United States

Facility Name

Randall Dermatology

City

West Lafayette

State/Province

Indiana

ZIP/Postal Code

47906

Country

United States

Facility Name

Derm Research LLC

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

Dermatology Specialists PSC

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40241

Country

United States

Facility Name

Michael W Simon MD Office

City

Nicholasville

State/Province

Kentucky

ZIP/Postal Code

40356

Country

United States

Facility Name

Delricht Clinical Research - Clinedge - PPDS Baton Rouge

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

Hamzavi Dermatology

City

Fort Gratiot

State/Province

Michigan

ZIP/Postal Code

48059

Country

United States

Facility Name

Jubilee Clinical Research - BTC - PPDS

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

ActivMed Practices & Research Inc

City

Portsmouth

State/Province

New Hampshire

ZIP/Postal Code

03801

Country

United States

Facility Name

Hassman Research Institute

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

Facility Name

Skin Laser and Surgery specialists of New York and New Jersey LLC

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Derm Research Center Of New York Inc

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11790

Country

United States

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27516

Country

United States

Facility Name

Synexus Clinical Research US, Inc. - Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45236

Country

United States

Facility Name

Ohio Pediatric Research Association

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45414

Country

United States

Facility Name

Synexus Clinical Research US, Inc. - Anderson

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

International Clinical Research Tennessee LLC

City

Murfreesboro

State/Province

Tennessee

ZIP/Postal Code

37130

Country

United States

Facility Name

Epiphany Dermatology Fort Worth

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76244

Country

United States

Facility Name

Dermatology Clinical Research Center of San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Center for Clinical Studies

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Tanner Clinic

City

Layton

State/Province

Utah

ZIP/Postal Code

84041

Country

United States

Facility Name

Advanced Research Institute

City

Ogden

State/Province

Utah

ZIP/Postal Code

84405

Country

United States

Facility Name

PI Coor Clinical Research LLC

City

Burke

State/Province

Virginia

ZIP/Postal Code

22015

Country

United States

Facility Name

Clinical Research Partners LLC

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23220

Country

United States

Facility Name

Dermatology Specialists of Spokane

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Medical Center Unimed EOOD

City

Sevlievo

State/Province

Gabrovo

ZIP/Postal Code

5400

Country

Bulgaria

Facility Name

Medical Center Excelsior OOD - PPDS

City

Sofia

ZIP/Postal Code

1421

Country

Bulgaria

Facility Name

Diagnostic Consultative Center XXVIII - Sofia - EOOD

City

Sofia

ZIP/Postal Code

1592

Country

Bulgaria

Facility Name

Synexus - Medical Center Synexus Sofia EOOD

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Synexus - Medical Centre Synexus Sofia EOOD (branch - Stara Zagora)

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Wiseman Dermatology Research Inc.

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3M 3Z4

Country

Canada

Facility Name

The Centre For Clinical Trials Inc.

City

Oakville

ZIP/Postal Code

L617W5

Country

Canada

Facility Name

Dermatology Ottawa Research Centre

City

Ottawa

ZIP/Postal Code

K2C 3N2

Country

Canada

Facility Name

Dermamedica, s.r.o. - Kozni Ambulance Nachod

City

Nachod

ZIP/Postal Code

547 01

Country

Czechia

Facility Name

CTCenter MaVe s.r.o.

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

CCR Ostrava, s.r.o.

City

Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

Synexus Czech s.r.o.

City

Prague 2

ZIP/Postal Code

120 00

Country

Czechia

Facility Name

Synexus Affiliate - CLINTRIAL s.r.o.

City

Praha

ZIP/Postal Code

100 00

Country

Czechia

Facility Name

Charité - Universitätsmedizin Berlin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Hautarztpraxis Mahlow

City

Brandenburg

ZIP/Postal Code

15831

Country

Germany

Facility Name

Universitatsklinikum Schleswig-Holstein

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Centrum Medyczne Matusiak

City

Wroclaw

State/Province

Dolnoslaskie

ZIP/Postal Code

50-566

Country

Poland

Facility Name

Synexus Affiliate - Bialystok - ClinicMed Daniluk, Nowak Spółka Jawna

City

Bialystok

ZIP/Postal Code

15-879

Country

Poland

Facility Name

Centrum Badan Klinicznych PI-House sp. z o.o.

City

Gdansk

ZIP/Postal Code

80-546

Country

Poland

Facility Name

Synexus - Gdynia

City

Gdynia

ZIP/Postal Code

81-537

Country

Poland

Facility Name

Centrum Medyczne Angelius Provita

City

Katowice

ZIP/Postal Code

40-611

Country

Poland

Facility Name

Synexus Affiliate - Krakowskie Centrum Medyczne

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Twoja Przychodnia - Szczecińskie Centrum Medyczne

City

Szczecin

ZIP/Postal Code

71-434

Country

Poland

Facility Name

Synexus - Warsaw

City

Warszawa

ZIP/Postal Code

01-192

Country

Poland

Facility Name

EMC Instytut Medyczny S.A.

City

Wroclaw

ZIP/Postal Code

50-220

Country

Poland

Facility Name

Wro Medica

City

Wroclaw

ZIP/Postal Code

51-685

Country

Poland

Facility Name

Hospital de Manises

City

Manises

State/Province

Valencia

ZIP/Postal Code

46940

Country

Spain

Facility Name

Hospital General Universitario de Alicante

City

Alicante

ZIP/Postal Code

3010

Country

Spain

Facility Name

Hospital de La Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Hospital General Universitario Reina Sofia

City

Cordoba

ZIP/Postal Code

14001

Country

Spain

Facility Name

Hospital Universitario La Paz - PPDS

City

Madrid

ZIP/Postal Code

28046

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36264430

Citation

Bloudek L, Eichenfield LF, Silverberg JI, Joish VN, Lofland JH, Sun K, Augustin M, Migliaccio-Walle K, Sullivan SD. Impact of Ruxolitinib Cream on Work Productivity and Activity Impairment and Associated Indirect Costs in Patients with Atopic Dermatitis: Pooled Results From Two Phase III Studies. Am J Clin Dermatol. 2023 Jan;24(1):109-117. doi: 10.1007/s40257-022-00734-8. Epub 2022 Oct 20.

Results Reference

derived

PubMed Identifier

33982267

Citation

Gong X, Chen X, Kuligowski ME, Liu X, Liu X, Cimino E, McGee R, Yeleswaram S. Pharmacokinetics of Ruxolitinib in Patients with Atopic Dermatitis Treated With Ruxolitinib Cream: Data from Phase II and III Studies. Am J Clin Dermatol. 2021 Jul;22(4):555-566. doi: 10.1007/s40257-021-00610-x. Epub 2021 May 12.

Results Reference

derived

PubMed Identifier

33957195

Citation

Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield LF, Leung DYM, Forman SB, Venturanza ME, Sun K, Kuligowski ME, Simpson EL. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies. J Am Acad Dermatol. 2021 Oct;85(4):863-872. doi: 10.1016/j.jaad.2021.04.085. Epub 2021 May 4.

Results Reference

derived

PubMed Identifier

33658996

Citation

Scuron MD, Fay BL, Connell AJ, Peel MT, Smith PA. Ruxolitinib Cream Has Dual Efficacy on Pruritus and Inflammation in Experimental Dermatitis. Front Immunol. 2021 Feb 15;11:620098. doi: 10.3389/fimmu.2020.620098. eCollection 2020.

Results Reference

derived

Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217471&parentIdentifier=INCB%2018424-304&attachmentIdentifier=061851fa-a439-4436-8d9f-0b252f3007e6&fileName=INCB18424-304_Plain_Language_Summary.pdf&versionIdentifier=90e1fe05-9680-4580-ab7d-6aadf96820fd

Description

Plain Language Summary of Results

Learn more about this trial

TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

We'll reach out to this number within 24 hrs