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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04345367
Other study ID # B7451050
Secondary ID 2019-004013-13
Status Completed
Phase Phase 3
First received
Last updated
Start date June 11, 2020
Est. completion date July 13, 2021

Study information

Verified date June 2022
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 727
Est. completion date July 13, 2021
Est. primary completion date July 13, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Abrocitinib 200 mg
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.
Combination Product:
Dupilumab 300 mg
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.

Locations

Country Name City State
Australia Box Hill Hospital Box Hill Victoria
Australia Emeritus Research Camberwell Victoria
Australia Skin Health Institute Inc. Carlton Victoria
Australia Sinclair Dermatology East Melbourne Victoria
Australia St George Dermatology and Skin Cancer Centre Kogarah New South Wales
Australia Melbourne Health Radiology Pakrville Victoria
Australia The Royal Melbourne Hospital Parkville Victoria
Australia Royal North Shore Hospital St Leonards New South Wales
Bulgaria MHAT Dobrich AD Dobrich
Bulgaria MC Asklepii OOD Dupnitsa
Bulgaria DCC Alexandrovska EOOD Sofia
Bulgaria DCC Fokus-5 - Medical Establishment for Outpatient Care EOOD Sofia
Bulgaria Military Medical Academy MHAT Sofia Sofia
Canada Dermatology Research Institute Calgary Alberta
Canada Intermed groupe santé Chicoutimi Quebec
Canada Alberta DermaSurgery Centre Edmonton Alberta
Canada Kingsway Clinical Research Etobicoke Ontario
Canada DermEffects London Ontario
Canada Lynderm Research Inc. Markham Ontario
Canada DermEdge Research Mississauga Ontario
Canada North Bay Dermatology Centre North Bay Ontario
Canada The Centre for Clinical Trials Oakville Ontario
Canada Dermatology Ottawa Research Centre Ottawa Ontario
Canada SKiN Centre for Dermatology Peterborough Ontario
Canada Centre de Recherche Dermatologique du Quebec metropolitain Quebec
Canada Centre de Recherche Saint-Louis Quebec
Canada CARE Clinic Ltd Red Deer Alberta
Canada The Centre for Dermatology Richmond Hill Ontario
Canada Karma Clinical Trials, Inc. St. John's Newfoundland and Labrador
Canada Medicor Research Inc Sudbury Ontario
Canada Sudbury Skin Clinique Sudbury Ontario
Canada Dr. Chih-ho Hong Medical Inc Surrey British Columbia
Canada Toronto Research Centre Toronto Ontario
Canada Wiseman Dermatology Research Inc. Winnipeg Manitoba
Chile Medicien Las Condes, Santiago Region Metropolitana
Chile MIRES (M Y F Estudios Clinicos Limitada) Nunoa, Santiago Region Metropolitana
Chile Vida lntegra Nunoa, Santiago Region Metropolitana
Chile Centro Internacional de Estudios Clinicos - CIEC Santiago Region Metropolitana
Chile Centro Medico SkinMed Limitada Santiago Region Metropolitana
Chile Centro Radiologico Plaza Baquedano Santiago Region Metropolitana
Chile Clínica Dermacross S.A. Santiago Región Metropolitana
Chile Hospital Clinico Universidad de Chile Santiago Region Metropolitana
Finland Terveystalo Tampere Tampere
Finland Mehiläinen Neo Turku
Finland Turun yliopistollinen keskussairaala Turku
Germany Fachklinik Bad Bentheim Bad Bentheim
Germany Klinikum Bielefeld Rosenhöhe Bielefeld
Germany Klinische Forschung Dresden GmbH Dresden
Germany IKF Pneumologie GmbH & Co KG Frankfurt am Main
Germany SRH Wald-Klinikum Gera GmbH Gera
Germany Studienzentrum Dr. med. Beate Schwarz Langenau
Germany SIBAmed GmbH Leipzig
Germany Universitätsklinikum Schleswig-Holstein, Campus Lübeck Lübeck
Germany Dermatologische Gemeinschaftspraxis Dres. Quist Mainz
Germany University of Muenster Muenster
Hungary Clinexpert Kft. Budapest
Hungary Debreceni Egyetem Klinikai Központ Debrecen
Hungary Trial Pharma Kft. Kaposvár
Hungary Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Szeged
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore Roma
Korea, Republic of Korea University Ansan Hospital Ansan-si Gyeonggi-do
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of The Catholic University of Korea, Incheon St. Mary's Hospital Incheon
Korea, Republic of Chung-Ang University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Latvia Health Centre 4 Ltd. Diagnostics Centre Riga
Latvia LLC J.Kisis Riga
Latvia Outpatient Clinic of Ventspils Ventspils
Poland NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c. Bialystok
Poland DERMAPOLIS Medical Dermatology Center Chorzow
Poland Uniwersyteckie Centrum Kliniczne Gdansk
Poland MCBK Grodzisk Mazowiecki
Poland Care Clinic Centrum Medyczne Katowice
Poland Centrum Medyczne Promed Krakow
Poland Krakowskie Centrum Medyczne Sp. z o.o. Krakow
Poland Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna Lodz
Poland Niepubliczny Zaklad Opieki Zdrowotnej "DERMED" Centrum Medyczne Lodz
Poland Dermedic Jacek Zdybski Ostrowiec Swietokrzyski
Poland Gabinety Lekarskie Rivermed Poznan
Poland Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski, ,,Laser Clinic" Szczecin
Poland Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin
Poland Carpe Diem Centrum Medycyny Estetycznej Warszawa
Poland Medycyna Kliniczna Warszawa
Poland MTZ Clinical Research Sp. z o.o. Warszawa
Poland Centrum Medyczne Oporow Wroclaw
Poland Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spólka Partnerska Wroclaw
Poland EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej Wroclaw
Poland Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii Zabrze
Slovakia BeneDerma s.r.o. Bratislava
Slovakia Derma therapy spol. s.r.o. Bratislava
Slovakia SKINKLINIK s.r.o Bratislava
Slovakia SUMMIT CLINICAL RESEARCH, s.r.o. Bratislava
Slovakia Dermatovenerologicka ambulancia Nove Zamky
Slovakia SANARE spol.s.r.o. Svidnik
Spain Hospital Germans Trias i Pujol Badalona Barcelona
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitario La Paz Madrid
Spain Centro de Especialidades Mollabao (Area Sanitaria de Pontevedra e O Salnes) Pontevedra
Spain Hospital de Montecelo Pontevedra
Taiwan Taipei Medical University-Shuang Ho Hospital New Taipei City
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei City Taiwan (r.o.c)
United States Clinical Research Center Of Alabama Birmingham Alabama
United States Total Skin & Beauty Dermatology Center, PC Birmingham Alabama
United States Skin Care Research, LLC Boca Raton Florida
United States MetroBoston Clinical Partners, LLC Brighton Massachusetts
United States Avant Research Associates, LLC Crowley Louisiana
United States Psoriasis Treatment Center of Central New Jersey East Windsor New Jersey
United States Linden Road Imaging Center Flint Michigan
United States Onyx Clinical Research Flint Michigan
United States Hamzavi Dermatology Fort Gratiot Michigan
United States First OC Dermatology Fountain Valley California
United States Center for Clinical Studies, LTD. LLP Houston Texas
United States Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
United States Olympian Clinical Research Largo Florida
United States Vivida Dermatology Las Vegas Nevada
United States Ark Clinical Research Long Beach California
United States Beach Allergy and Asthma Specialty Group, A Medical Corporation Long Beach California
United States Wallace Medical Group, Inc Los Angeles California
United States Clinical Neuroscience Solutions, Inc. Memphis Tennessee
United States Miami Dermatology & Laser Research, LLC Miami Florida
United States International Clinical Research - Tennessee LLC Murfreesboro Tennessee
United States One Health Research Clinic Norcross Georgia
United States Sneeze, Wheeze & Itch Associates, LLC Normal Illinois
United States Skin Specialists, PC Omaha Nebraska
United States Accel Research Sites - Pure Skin Dermatology & Aesthetics Orlando Florida
United States Clinical Neuroscience Solutions, Inc. Orlando Florida
United States Epiphany Dermatology of Kansas, LLC Overland Park Kansas
United States Paddington Testing Co, Inc. Philadelphia Pennsylvania
United States Alliance Dermatology & MOHS Center, PC Phoenix Arizona
United States Empire Clinical Research Pomona California
United States Oregon Medical Research Center Portland Oregon
United States Health Concepts Rapid City South Dakota
United States Boice-Willis Clinic, PA Rocky Mount North Carolina
United States Regional Medical Imaging, P.C. ( Local X-Ray) Royal Oak Michigan
United States Dermatology Clinical Research Center of San Antonio San Antonio Texas
United States MedDerm Associates San Diego California
United States University Clinical Trials Inc. San Diego California
United States University of California San Diego Dermatology San Diego California
United States Synergy Dermatology San Francisco California
United States Wolverine Clinical Trials, Llc Santa Ana California
United States Clinical Science Institute Santa Monica California
United States Carolina Research Center, Inc. Shelby North Carolina
United States The South Bend Clinic Center for Research South Bend Indiana
United States Acclaim Dermatology, PLLC Sugar Land Texas
United States Clinical Research Trials of Florida, Inc. Tampa Florida
United States Olympian Clinical Research Tampa Florida
United States Revival Research Institute, LLC Troy Michigan
United States Dundee Dermatology West Dundee Illinois
United States Jordan Valley Dermatology Center West Jordan Utah
United States Integrated Clinical Research West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Chile,  Finland,  Germany,  Hungary,  Italy,  Korea, Republic of,  Latvia,  Poland,  Slovakia,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants With Treatment Emergent Adverse Events (AEs) 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. From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Other Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; a congenital anomaly/birth defect and other important medical events. From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Other Number of Participants With Laboratory Abnormalities Meeting Pre-Defined Criteria The pre-defined criteria for laboratory parameters included: hemoglobin (<9 grams per deciliter or decreases to >=2 below baseline); platelets (<75*10^3 cells per millimeter cube [mm^3]); lymphocytes (<0.5*10^3 cells per mm^3); neutrophils (<1*10^3 cells per mm^3); aspartate aminotransferase and alanine aminotransferase (>3* upper limit of normal). From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Other Number of Participants With Clinically Significant Change From Baseline in Vital Signs Vital signs including temperature, systolic and diastolic blood pressure, and pulse rate were measured in a seated position after 5 minutes rest. Clinically significant change from baseline in vital signs were determined by the investigator. From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Other Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Data A single 12-lead ECG was performed after the participant has rested for at least 10 minutes quietly in the supine position. Clinically significant change from baseline in ECG data was determined by the investigator. From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Primary 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. Week 2
Primary 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. Week 4
Secondary 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. Week 16
Secondary Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 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. Week 2, 8, 12, 20 and 26
Secondary Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 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. Week 2, 4, 8, 12, 16, 20 and 26
Secondary 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. Week 2, 4, 8, 12, 16, 20 and 26
Secondary 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. Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Secondary Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 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. Week 4, 8, 12, 16, 20 and 26
Secondary Time to Achieve >=4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) 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. Baseline (Day 1) up to Week 30
Secondary 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. Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26
Secondary 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. Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26
Secondary 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. Baseline (Day 1), Week 12, 16 and 26
Secondary 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. Baseline (Day 1), Week 12, 16 and 26
Secondary 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. Baseline (Day 1), Week 2, 12, 16, 20 and 26
Secondary 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. Baseline (Day 1), Week 12, 16 and 26
Secondary 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. Baseline (Day 1), Week 12, 16 and 26
Secondary 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. Baseline (Day 1), Week 12, 16 and 26
Secondary 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. Baseline (Day 1), Week 2, 12, 16, 20 and 26
Secondary 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. Day 1 up to Week 26
Secondary 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. Week 2, 12, 16, 20 and 26
See also
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