Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

— JADE Mono-2  

Official title:

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04965842 MONOTHERAPY IN SUBJECTS AGED 12 YEARS AND OLDER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03575871
• Other study ID #: B7451013
• Secondary ID: MONO-22018-00113
• Status: Completed
• Phase: Phase 3
• Start date: June 29, 2018
• Est. completion date: August 13, 2019

Study information

• Verified date: April 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: August 13, 2019
• Est. primary completion date: August 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 12 years of age or older with a minimum body weight of 40 kg

• Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)

• Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control

Exclusion Criteria:

• Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study

• Prior treatment with JAK inhibitors

• Other active nonAD inflammatory skin diseases or conditions affecting skin

• Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, 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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• PF-04965842 100 mg
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks
• PF-04965842 200 mg
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks
• Placebo
Placebo, administered as two tablets to be taken orally once daily for 12 weeks

Locations

Country	Name	City	State
Australia	The Skin Centre	Benowa	Queensland
Australia	Skin and Cancer Foundation Inc	Carlton	Victoria
Australia	Sinclair Dermatology	East Melbourne	Victoria
Australia	Australian Clinical Research Network	Maroubra	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	The Royal Children's Hospital (RCH)	Parkville	Victoria
Australia	Veracity Clinical Research Pty Ltd	Woolloongabba	Queensland
Bulgaria	Medical Centre Asklepii OOD	Dupnitsa
Bulgaria	MHAT Dr. Tota Venkova AD	Gabrovo
Bulgaria	"Acibadem City Clinic MHAT Tokuda" EAD	Sofia
Bulgaria	"DCC Aleksandrovska" EOOD	Sofia
Bulgaria	Diagnostic Consultative Center Fokus-5	Sofia
Bulgaria	Medical Centre Synexus Sofia EOOD	Sofia
Canada	North York Research Inc.	North York	Ontario
Canada	Oshawa Clinic Dermatology Trials	Oshawa	Ontario
Canada	York Dermatology Clinic and Research Centre	Richmond Hill	Ontario
Canada	Diex Recherche Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Research Toronto	Toronto	Ontario
Canada	University of British Columbia Department of Dermatology and Skin Science	Vancouver	British Columbia
Canada	Winnipeg Clinic	Winnipeg	Manitoba
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	The Second Affiliated Hospital of Army Medical University, PLA	Chongqing	Chongqing
China	The University of Hong Kong - Shenzhen Hospital	Shenzhen	Guangdong
China	Tianjin Medical University General Hospital, Dermatological Department	Tianjin
Czechia	Dermamedica S.R.O.	Nachod
Czechia	Lekarna u Stribrneho orla	Nachod
Czechia	Oblastni nemocnice Nachod a.s., Radiodiagnosticke oddeleni	Nachod
Czechia	Sanatorium profesora Arenbergera	Praha 1
Czechia	Lekarna U sv. Ignace	Praha 2
Czechia	Dermatologicka Ambulance	Svitavy
Czechia	Lekarna na Hranicni	Svitavy
Germany	Fachklinik Bad Bentheim	Bad Bentheim
Germany	ISA GmbH	Berlin
Germany	Fachärztliche Gemeinschaftspraxis für Dermatologie und Venerologie, Allergologie,	Blankenfelde-Mahlow
Germany	IKF Pneumologie GmbH & Co KG	Frankfurt
Germany	Klinische Forschung Hamburg GmbH	Hamburg
Germany	Universitaet Muenster	Münster
Germany	Klinische Forschung Schwerin GmbH	Schwerin
Hungary	Budapest Fováros XIX. Kerületi Önkormányzat Kispesti Egészsegügyi Intézete	Budapest
Hungary	SE AOK Bor, Nemikortani es Boronkologiai Klinika	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	ALLERGO-DERM BAKOS Kft.	Szolnok
Japan	Sumire Dermatology Clinic	Edogawa-ku	Tokyo
Japan	Hoshikuma Dermatology·Allergy Clinic	Fukuoka
Japan	Noguchi Dermatology Clinic	Kamimashiki-gun	Kumamoto
Japan	Matsuyama Dermatology Clinic	Nakano-ku	Tokyo
Japan	Yoshioka Dermatology Clinic	Neyagawa	Osaka
Japan	Sanrui Hifuka	Saitama
Japan	Kume Clinic	Sakai	Osaka
Japan	Queen's square Medical Facilities Queen's square Dermatology and Allergology	Yokohama	Kanagawa
Korea, Republic of	Soon Chun Hyang University Bucheon Hospital	Bucheon-si	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea, Incheon St.Mary's Hospital	Bupyeong-gu	Incheon
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Inha University Hospital	Jung-gu	Incheon
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Hallym university Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei Univ. Health System	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Latvia	Selga Freiberga private practice in dermatovenerology and cosmetology	Jelgava
Latvia	Aesthetic dermatology clinic of Prof. J. Kisis	Riga
Latvia	Health Centre 4 Ltd	Riga
Latvia	Health Centre 4 Ltd. Diagnostics Centre	Riga
Latvia	Riga 1st Hospital, Clinic for Dermatology and STD	Riga
Poland	KLIMED Marek Klimkiewicz	Bialystok
Poland	NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.	Bialystok
Poland	Centrum Nowoczesnych Terapii "DOBRY LEKARZ" sp. z o. o.	Krakow
Poland	Centrum Badan Klinicznych JCI	Kraków
Poland	Krakowskie Centrum Medyczne Sp. z o.o.	Kraków
Poland	Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna	Lodz
Poland	KO-MED Centra Kliniczne Lublin II	Lublin
Poland	Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.	Poznan
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin
Poland	Centrum Medyczne AMED	Warszawa
Poland	Klinika Ambroziak Sp. z o.o.	Warszawa
Poland	MTZ Clinical Research Sp. z o.o.	Warszawa
Poland	Synexus Polska Sp. z o. o. Oddzial w Warszawie	Warszawa
Poland	Lukasz Matusiak "4HEALTH"	Wroclaw
Poland	Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroclaw
United Kingdom	Barnsley Hospital NHS Foundation Trust	Barnsley	South Yorkshire
United Kingdom	MAC Clinical Research	Blackpool	Lancashire
United Kingdom	University Hospital Bristol NHS Foundation Trust	Bristol
United Kingdom	MAC Clinical Research Ltd	Cannock	South Staffordshire
United Kingdom	MAC Clinical Research Ltd	Manchester
United Kingdom	Plymouth Hospitals NHS Trust, Derriford Hospital	Plymouth	Devon
United States	Emmaus Research Center, Inc.	Anaheim	California
United States	Austin Institute for Clinical Research, Inc. - Central	Austin	Texas
United States	Meridian Clinical Research	Baton Rouge	Louisiana
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Imaging Center of Idaho	Caldwell	Idaho
United States	Olympian Clinical Research	Clearwater	Florida
United States	Asthma and Allergy Associates, PC	Colorado Springs	Colorado
United States	Colorado Springs Dermatology Clinic, PC	Colorado Springs	Colorado
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Summit Clinical Research, LLC	Franklin	Virginia
United States	The Ohio State University Dermatology East	Gahanna	Ohio
United States	Center for Clinical Studies, LTD. LLP	Houston	Texas
United States	West Houston Dermatology, PA	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Precision Imaging	Jacksonville	Florida
United States	Solutions Through Advanced Research, Inc.	Jacksonville	Florida
United States	Advanced Research Center, Inc. - Los Alamitos Site	Los Alamitos	California
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Tanenbaum Dermatology Center	Memphis	Tennessee
United States	ASR, LLC	Nampa	Idaho
United States	Sadick Research Group	New York	New York
United States	Virginia Dermatology and Skin Cancer Center	Norfolk	Virginia
United States	Clinical Neuroscience Solutions, Inc	Orlando	Florida
United States	Peninsula Research Associates, Inc.	Rolling Hills Estates	California
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	Clinical Science Institute	Santa Monica	California
United States	ForCare Clinical Research	Tampa	Florida
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  China,  Czechia,  Germany,  Hungary,  Japan,  Korea, Republic of,  Latvia,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12	IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 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. Assessment excluded soles, palms and scalp.	Baseline, Week 12
Primary	Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI-75) From Baseline at Week 12	EASI evaluates severity of participants AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks] on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % 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, higher scores = greater severity of AD.	Baseline, Week 12
Secondary	Percentage of Participants Who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12	Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.	Baseline, Weeks 2, 4, 8 and 12
Secondary	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12	PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.	Baseline, Week 12
Secondary	Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) for Severity of Pruritus	Participants were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity.	Baseline up to Day 15
Secondary	Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8	EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % 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, higher scores = greater severity of AD.	Baseline, Weeks 2, 4, and 8
Secondary	Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Weeks 2, 4 and 8	IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 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. Assessment excluded sole, palms and scalp.	Baseline, Weeks 2, 4, and 8
Secondary	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) at Week 2, 4, 8 and 12	IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 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. Assessment excluded soles, palms and scalp.	Weeks 2, 4, 8 and 12
Secondary	Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI-50) From Baseline at Weeks 2, 4, 8 and 12	EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % 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, higher scores = greater severity of AD.	Baseline, Weeks 2, 4, 8, and 12
Secondary	Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI-90) From Baseline at Weeks 2, 4, 8 and 12	EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % 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, higher scores = greater severity of AD.	Baseline, Weeks 2, 4, 8, and 12
Secondary	Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI-100) From Baseline at Weeks 2, 4, 8 and 12	EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % 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, higher scores = greater severity of AD.	Baseline, Weeks 2, 4, 8, and 12
Secondary	Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 8 and 12	EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % 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, higher scores = greater severity of AD.	Baseline, Weeks 2, 4, 8, and 12
Secondary	Change From Baseline in the Percentage Body Surface Area (%BSA) Affected at Week 2, 4, 8, and 12	4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated 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. Maximum 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: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.	Baseline, Weeks 2, 4, 8, and 12
Secondary	Percentage of Participants With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 2, 4, 8 and 12	4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated 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. Maximum 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 limb, 3.33% for trunk and 2.5% for lower limb. % 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: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.	Weeks 2, 4, 8, and 12
Secondary	Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8 and 12	SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.	Baseline, Weeks 2, 4, 8, and 12
Secondary	Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=75% Improvement From Baseline at Week 2, 4, 8 and 12	SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.	Baseline, Weeks 2, 4, 8, and 12
Secondary	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 2, 4, 8 and 12	SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.	Baseline, Weeks 2, 4, 8, and 12
Secondary	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 2, 4, 8 and 12	SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.	Baseline, Weeks 2, 4, 8, and 12
Secondary	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8 and 12	SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.	Baseline, Weeks 2, 4, 8, and 12

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