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Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Abrocitinib 200 mg

Dupilumab 300 mg

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, atopic eczema, eczema, JAK, janus kinase

Eligibility Criteria

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

Inclusion Criteria:

18 years of age or older
Diagnosis of chronic atopic dermatitis (AD) for at least 6 months
Moderate to severe AD (BSA at least 10%, IGA at least 3, EASI at least 16, and PP-NRS severity score at least 4)
Recent history of inadequate response to treatment with medicated topical therapy for AD, or who have required systemic therapies for control of their disease

Exclusion Criteria:

Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
Have increased risk of developing venous thromboembolism
Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
Prior treatment with systemic JAK inhibitors or IL-4 or IL-13 antagonists including dupilumab, lebrikizumab or tralokinumab
Other active non-AD inflammatory skin diseases or conditions affecting skin
Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

Sites / Locations

Total Skin & Beauty Dermatology Center, PC
Clinical Research Center Of Alabama
Alliance Dermatology & MOHS Center, PC
First OC Dermatology
Ark Clinical Research
Beach Allergy and Asthma Specialty Group, A Medical Corporation
Wallace Medical Group, Inc
Empire Clinical Research
MedDerm Associates
University of California San Diego Dermatology
University Clinical Trials Inc.
Synergy Dermatology
Wolverine Clinical Trials, Llc
Clinical Science Institute
Skin Care Research, LLC
Olympian Clinical Research
Miami Dermatology & Laser Research, LLC
Clinical Neuroscience Solutions, Inc.
Accel Research Sites - Pure Skin Dermatology & Aesthetics
Clinical Research Trials of Florida, Inc.
Olympian Clinical Research
Integrated Clinical Research
One Health Research Clinic
Sneeze, Wheeze & Itch Associates, LLC
Dundee Dermatology
Dawes Fretzin Clinical Research Group, LLC
The South Bend Clinic Center for Research
Epiphany Dermatology of Kansas, LLC
Avant Research Associates, LLC
MetroBoston Clinical Partners, LLC
Onyx Clinical Research
Linden Road Imaging Center
Hamzavi Dermatology
Regional Medical Imaging, P.C. ( Local X-Ray)
Revival Research Institute, LLC
Skin Specialists, PC
Vivida Dermatology
Psoriasis Treatment Center of Central New Jersey
Boice-Willis Clinic, PA
Carolina Research Center, Inc.
Oregon Medical Research Center
Paddington Testing Co, Inc.
Health Concepts
Clinical Neuroscience Solutions, Inc.
International Clinical Research - Tennessee LLC
Center for Clinical Studies, LTD. LLP
Dermatology Clinical Research Center of San Antonio
Acclaim Dermatology, PLLC
Jordan Valley Dermatology Center
St George Dermatology and Skin Cancer Centre
Royal North Shore Hospital
Box Hill Hospital
Emeritus Research
Skin Health Institute Inc.
Sinclair Dermatology
Melbourne Health Radiology
The Royal Melbourne Hospital
MHAT Dobrich AD
MC Asklepii OOD
DCC Alexandrovska EOOD
DCC Fokus-5 - Medical Establishment for Outpatient Care EOOD
Military Medical Academy MHAT Sofia
Dermatology Research Institute
Alberta DermaSurgery Centre
CARE Clinic Ltd
Dr. Chih-ho Hong Medical Inc
Wiseman Dermatology Research Inc.
Karma Clinical Trials, Inc.
Kingsway Clinical Research
DermEffects
Lynderm Research Inc.
DermEdge Research
North Bay Dermatology Centre
The Centre for Clinical Trials
Dermatology Ottawa Research Centre
SKiN Centre for Dermatology
The Centre for Dermatology
Medicor Research Inc
Sudbury Skin Clinique
Toronto Research Centre
Intermed groupe santé
Centre de Recherche Dermatologique du Quebec metropolitain
Centre de Recherche Saint-Louis
Medicien
MIRES (M Y F Estudios Clinicos Limitada)
Vida lntegra
Centro Radiologico Plaza Baquedano
Centro Medico SkinMed Limitada
Hospital Clinico Universidad de Chile
Centro Internacional de Estudios Clinicos - CIEC
Clínica Dermacross S.A.
Terveystalo Tampere
Mehiläinen Neo
Turun yliopistollinen keskussairaala
Fachklinik Bad Bentheim
Klinikum Bielefeld Rosenhöhe
Klinische Forschung Dresden GmbH
IKF Pneumologie GmbH & Co KG
SRH Wald-Klinikum Gera GmbH
Studienzentrum Dr. med. Beate Schwarz
SIBAmed GmbH
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Dermatologische Gemeinschaftspraxis Dres. Quist
University of Muenster
Clinexpert Kft.
Debreceni Egyetem Klinikai Központ
Trial Pharma Kft.
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore
Korea University Ansan Hospital
Chonnam National University Hospital
The Catholic University of Korea, Incheon St. Mary's Hospital
Severance Hospital, Yonsei University Health System
Chung-Ang University Hospital
Health Centre 4 Ltd. Diagnostics Centre
LLC J.Kisis
Outpatient Clinic of Ventspils
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.
DERMAPOLIS Medical Dermatology Center
Uniwersyteckie Centrum Kliniczne
MCBK
Care Clinic Centrum Medyczne
Krakowskie Centrum Medyczne Sp. z o.o.
Centrum Medyczne Promed
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
Niepubliczny Zaklad Opieki Zdrowotnej "DERMED" Centrum Medyczne
Dermedic Jacek Zdybski
Gabinety Lekarskie Rivermed
Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski, ,,Laser Clinic"
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Medycyna Kliniczna
MTZ Clinical Research Sp. z o.o.
Carpe Diem Centrum Medycyny Estetycznej
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
Centrum Medyczne Oporow
Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii
SUMMIT CLINICAL RESEARCH, s.r.o.
SKINKLINIK s.r.o
BeneDerma s.r.o.
Derma therapy spol. s.r.o.
Dermatovenerologicka ambulancia
SANARE spol.s.r.o.
Hospital Germans Trias i Pujol
Hospital Clinic de Barcelona
Hospital Universitario La Paz
Centro de Especialidades Mollabao (Area Sanitaria de Pontevedra e O Salnes)
Hospital de Montecelo
Taipei Veterans General Hospital
Taipei Medical University-Shuang Ho Hospital
National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Abrocitinib 200 mg plus placebo injection

Dupilumab 300 mg plus placebo tablets

Arm Description

Abrocitinib 200 mg daily through Week 26, plus placebo injections every other week through Week 24

Dupilumab 300 mg every other week (2 injections on Day 1) through Week 24, plus placebo tablets daily through Week 26

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2

The severity of itch (pruritus) due to atopic dermatitis (AD) was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4

EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.

Secondary Outcome Measures

Percentage of Participants Achieving EASI-90 Response at Week 16

EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.

Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26

Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26

Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26

IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, except any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation); 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting.

Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15

The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26

Time to Achieve >=4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4)

Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26

The extent (%) to which a body region was involved with AD was determined using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) and lower limbs (including buttocks). Total number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual was derived as sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater severity of AD.

Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26

SCORAD is a scoring index for AD which combined extent (A), severity (B) and subjective symptoms (C). For A, a rule of 9 was used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region was added to determine A (range: 0-100). B: severity of each sign (erythema; edema/papulation; oozing/crusting; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores were added to give B (range: 0-18). C: pruritus and sleep loss, each of these 2 were scored by participant/caregiver using visual analog scale (VAS) where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss were added to give 'C' (range: 0-20). SCORAD total score was calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome.

Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26

HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-A total score was calculated as the sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety.

Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26

HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-D assessed the state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: total score was calculated as the sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26

DLQI is a 10-item questionnaire that measured the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score, ranging from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.

Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26

The EQ-5D-5L is a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS that measured health state. EQ-5D VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state.

Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26

POEM was a 7-item participant reported outcome measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item was scored as: no days=0, 1-2 days=1, 3-4 days=2, 5-6 days=3 and every day=4. The item scores were added to provide a total score ranging from 0 to 28, where higher score indicated greater severity.

Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26

The MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II). An additional single item assessed quantity of sleep. Each of the sleep domains were scored on a range of 0 to 100, and higher scores indicated worse outcomes. The quantity of sleep scores ranged from 0 to 24 (number of hours slept). Change from baseline scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.

Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26

The skin pain NRS was a participant reported outcome where participants were asked to rate the "worst skin pain" in the past 24 hours on a 11-point scale from 0=no skin pain to 10=worst skin pain imaginable. Higher scores indicated worse pain.

Medicated Topical Background Therapy-free Days

Medicated topical background therapy-free days was defined as number of days where a participant maintained a response of EASI-90 or greater without the use of medicated topical background therapy.

Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26

DLQI was a 10-item questionnaire that measured the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.

Full Information

NCT ID

NCT04345367

First Posted

March 27, 2020

Last Updated

June 9, 2022

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT04345367

Brief Title

Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

Official Title

A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND TOPICAL THERAPY WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

June 11, 2020 (Actual)

Primary Completion Date

July 13, 2021 (Actual)

Study Completion Date

July 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will be enrolled from approximately 220 sites globally. Approximately 600 participants will be randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints will be assessed throughout the entire study. Exploratory endpoints related to hand eczema efficacy will be assessed throughout the study.

6. Conditions and Keywords

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

Atopic Dermatitis

Keywords

atopic dermatitis, atopic eczema, eczema, JAK, janus kinase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

727 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Abrocitinib 200 mg plus placebo injection

Arm Type

Experimental

Arm Description

Abrocitinib 200 mg daily through Week 26, plus placebo injections every other week through Week 24

Arm Title

Dupilumab 300 mg plus placebo tablets

Arm Type

Active Comparator

Arm Description

Dupilumab 300 mg every other week (2 injections on Day 1) through Week 24, plus placebo tablets daily through Week 26

Intervention Type

Drug

Intervention Name(s)

Abrocitinib 200 mg

Intervention Description

Abrocitinib 200 mg administered as two 100 mg tablets to be taken orally once daily for 26 weeks. Placebo injections will be administered every other week for 24 weeks.

Intervention Type

Combination Product

Intervention Name(s)

Dupilumab 300 mg

Intervention Description

Dupilumab 300 mg administered as a single subcutaneous injection every other week for 24 weeks (2 injections on day 1). Placebo tablets will be administered daily.

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2

Description

Time Frame

Week 2

Title

Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4

Description

Time Frame

Week 4

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving EASI-90 Response at Week 16

Description

Time Frame

Week 16

Title

Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26

Description

Time Frame

Week 2, 8, 12, 20 and 26

Title

Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26

Description

Time Frame

Week 2, 4, 8, 12, 16, 20 and 26

Title

Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26

Description

Time Frame

Week 2, 4, 8, 12, 16, 20 and 26

Title

Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15

Description

Time Frame

Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

Title

Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26

Description

Time Frame

Week 4, 8, 12, 16, 20 and 26

Title

Time to Achieve >=4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4)

Description

Time Frame

Baseline (Day 1) up to Week 30

Title

Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26

Description

Time Frame

Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26

Title

Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26

Description

Time Frame

Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26

Title

Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26

Description

Time Frame

Baseline (Day 1), Week 12, 16 and 26

Title

Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26

Description

Time Frame

Baseline (Day 1), Week 12, 16 and 26

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26

Description

Time Frame

Baseline (Day 1), Week 2, 12, 16, 20 and 26

Title

Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26

Description

Time Frame

Baseline (Day 1), Week 12, 16 and 26

Title

Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26

Description

Time Frame

Baseline (Day 1), Week 12, 16 and 26

Title

Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26

Description

Time Frame

Baseline (Day 1), Week 12, 16 and 26

Title

Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26

Description

Time Frame

Baseline (Day 1), Week 2, 12, 16, 20 and 26

Title

Medicated Topical Background Therapy-free Days

Description

Medicated topical background therapy-free days was defined as number of days where a participant maintained a response of EASI-90 or greater without the use of medicated topical background therapy.

Time Frame

Day 1 up to Week 26

Title

Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26

Description

Time Frame

Week 2, 12, 16, 20 and 26

Other Pre-specified Outcome Measures:

Title

Number of Participants With Treatment Emergent Adverse Events (AEs)

Description

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent adverse event (TEAE) if the event started on or after the first dosing day until 28 days post last dose of study drug. AEs included both serious and non-serious AEs.

Time Frame