A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

Atopic Dermatitis Clinical Trial

— ROCKET-SHUTTLE  

Official title:

A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05724199
• Other study ID #: 20210144
• Secondary ID: 2022-501585-22
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 21, 2023
• Est. completion date: January 6, 2025

Study information

• Verified date: April 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The coprimary objectives of the study are to:

• evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™).

• evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 746
• Est. completion date: January 6, 2025
• Est. primary completion date: September 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age = 18 years with a diagnosis of AD according to the AAD (American Academy of Dermatology) Consensus Criteria (2014) present for at least 12 months

• History of inadequate response to TCS of medium or higher potency (with or without TCI)

• EASI score =16

• vIGA-AD score =3

• =10% body surface area (BSA) of AD involvement

• Worst pruritus numerical rating scale = 4

Exclusion Criteria:

• Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1

• Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:

• Systemic corticosteroids

• Nonbiologic, non-targeted Systemic immunosuppressants

• Phototherapy

• Janus kinase inhibitors

• Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

• TCS

• TCI

• Topical phosphodiesterase type 4 inhibitors

• Other topical immunosuppressive agents

• Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Rocatinlimab
Subcutaneous (SC) injection

Other:
• Placebo
SC injection

Locations

Country	Name	City	State
Argentina	Cinme - Centro de Investigaciones Metabolicas	Caba	Buenos Aires
Argentina	Buenos Aires Skin SA	Ciudad Autonoma de Buenos Aires	Distrito Federal
Argentina	Care- Centro de Alergia y Enfermedades Respiratorias	Ciudad Autonoma de Buenos Aires	Distrito Federal
Argentina	Fundacion Cidea	Ciudad Autonoma de Buenos Aires	Distrito Federal
Argentina	Psoriahue Medicina Interdisciplinaria SRL	Ciudad Autonoma de Buenos Aires	Distrito Federal
Argentina	Framingham Centro Medico	La Plata	Buenos Aires
Argentina	Dim Clinica Privada	Ramos Mejia	Buenos Aires
Argentina	Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario	Rosario	Santa Fe
Australia	The Skin Centre	Benowa	Queensland
Australia	Emeritus Research Sydney	Botany	New South Wales
Australia	Emeritus Research Melbourne	Camberwell	Victoria
Australia	Princess Alexandra Hospital	South Brisbane	Queensland
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Veracity Clinical Research	Woolloongabba	Queensland
Austria	Medizinische Universitaet Graz	Graz
Austria	Medizinische Universitaet Innsbruck	Innsbruck
Austria	Landeskrankenhaus Salzburg	Salzburg
Austria	Klinik Hietzing	Wien
Austria	Klinik Landstrasse	Wien
Belgium	Algemeen Ziekenhuis Sint-Jan Brugge-Oostende	Brugge
Belgium	Universitair Ziekenhuis Brussel	Brussel
Belgium	Centre Hospitalier Universitaire Brugmann	Brussels
Belgium	Universite Catholique de Louvain Cliniques Universitaires Saint Luc	Bruxelles
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Clinique Andre Renard	Herstal
Belgium	Dermatologie Handelskaai	Kortrijk
Belgium	Universitaire Ziekenhuizen Leuven Gasthuisberg	Leuven
Belgium	Centre Hospitalier Universitaire de Liege - Sart Tilman	Liege
Belgium	Grand Hopital de Charleroi	Loverval
Bulgaria	Medical Center Asklepii OOD	Dupnitsa
Bulgaria	Medical Center Medconsult Pleven OOD	Pleven
Bulgaria	Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD	Sofia
Bulgaria	Diagnostic-Consultative Center Alexandrovska EOOD	Sofia
Bulgaria	Medical Center Excelsior OOD	Sofia
Canada	Dermatology Research Institute Incorporated	Calgary	Alberta
Canada	SKiN Health	Coburg	Ontario
Canada	Alberta Derma Surgery Centre	Edmonton	Alberta
Canada	Laser Rejuvenation Clinics Edmonton D T Incorporated	Edmonton	Alberta
Canada	Centricity Research London	London	Ontario
Canada	Clinique de Dermatologie Rosemont	Montreal	Quebec
Canada	Innovaderm Research Inc	Montreal	Quebec
Canada	Dr SK Siddha Medicine Professional Corporation	Newmarket	Ontario
Canada	Allergy Research Canada Incorporated	Niagara Falls	Ontario
Canada	North Bay Dermatology Centre	North Bay	Ontario
Canada	Dermatology Ottawa Research Centre	Ottawa	Ontario
Canada	JRB Research Incorporated	Ottawa	Ontario
Canada	Centre de Recherche Saint-Louis	Quebec
Canada	DIEX Recherche Quebec	Quebec
Canada	The Centre for Dermatology	Richmond Hill	Ontario
Canada	Saskatoon Dermatology Centre	Saskatoon	Saskatchewan
Canada	Enverus Medical Research	Surrey	British Columbia
Canada	North York Research Incorporated	Toronto	Ontario
Canada	Toronto Research Centre Inc	Toronto	Ontario
Canada	Alliance Clinical Trials	Waterloo	Ontario
Canada	Wiseman Dermatology Research Incorporated	Winnipeg	Manitoba
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Peking University Peoples Hospital	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Chengdu Second Peoples Hospital	Chengdu	Sichuan
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Dermatology Hospital of Southern Medical University	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital Sun Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital ,Sun-Yat Sen University	Guangzhou	Guangdong
China	Affiliated Hangzhou First Peoples Hospital,Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	the First Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Dermatology Hospital of Jiangxi Province	Nanchang	Jiangxi
China	Nanyang First Peoples Hospital	Nanyang	Henan
China	The First Affiliation Hospital Of Ningbo University	Ningbo	Zhejiang
China	Shanghai Skin Disease Hospital	Shanghai
China	The Fist Affiliated Hospital of Shantou University Medical College	Shantou	Guangdong
China	Shenzhen Qianhai Shekou Free Trade Zone Hospital	Shenzhen	Guangdong
China	Taizhou Central Hospital	Taizhou	Zhejiang
China	Union Hospital Tongji Medical College Huazhong University of science and Technology	Wuhan	Hubei
China	Wuxi Second Peoples Hospital	Wuxi	Jiangsu
France	Hopital Prive d Antony	Antony
France	Centre Hospitalier Universitaire de Bordeaux - Hôpital Saint André	Bordeaux
France	Centre Hospitalier Regional Universitaire Brest Hopital Morvan	Brest
France	Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez	Lille
France	Centre Hospitalier de Bretagne Sud - Hopital du Scorff	Lorient Cedex
France	Hôpital La Timone	Marseille cedex 05
France	Cabinet du Docteur Ruer-Mulard Mireille	Martigues
France	Centre Hospitalier Universitaire de Nantes Hôtel Dieu	Nantes
France	Centre Hospitalier Universitaire Archet 2	Nice
France	Hopital Bichat Claude Bernard	Paris
France	Hopital Tenon	Paris
France	Hopital Saint Louis	Paris Cedex 10
France	Polyclinique de Courlancy	Reims
France	Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou	Rennes Cedex 9
France	Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle	Rouen Cedex
France	Centre Hospitalier Universitaire Saint Etienne Hopital Nord	Saint Priest en Jarez
France	Hopital d instruction des armees sainte anne	Toulon
Germany	Universitaetsklinikum Frankfurt	Frankfurt am Main
Germany	Universitaetsmedizin Goettingen - Georg-August-Universitaet	Goettingen
Germany	MensingDerma research GmbH	Hamburg
Germany	TFS Trial Form Support GmbH	Hamburg
Germany	Hautaerzte Zentrum Hannover	Hannover
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitaetsmedizin Mainz	Mainz
Germany	Beldio Research GmbH	Memmingen
Germany	Hautmedizin Saar	Merzing
Germany	Klinikum rechts der Isar der TUM	Muenchen
Greece	401 General Military Hospital Of Athens	Athens
Greece	Andreas Syngros Hospital Of Venereal And Dermatological Diseases	Athens
Greece	University General Hospital of Heraklion	Heraklion
Greece	General Hospital Of Nea Ionia Konstantopouleio Patision	Nea Ionia
Greece	Geniko Nosokomeio Peiraia Tzaneio	Piraeus
Greece	Ippokratio General Hospital of Thessaloniki	Thessaloniki
Hungary	Trial Pharma Kft	Bekescsaba
Hungary	Clinexpert Kft	Budapest
Hungary	Csalogany Orvosi Kozpont	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Gyongyosi Bugat Pal Korhaz	Gyongyos
Hungary	Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar
Hungary	DermaMed Research Kft	Oroshaza
Hungary	Allergo-Derm Bakos Kft	Szolnok
Hungary	Obudai Egeszsegugyi Centrum Kft	Zalaegerszeg
Italy	Ospedale Policlinico San Martino IRCCS	Genova
Italy	Ospedale San Salvatore	LAquila
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma
Italy	IRCCS Istituto Clinico Humanitas	Rozzano MI
Japan	Mildix Skin Clinic	Adachi-ku	Tokyo
Japan	Ekihigashi Dermatology Allergy Clinic	Fukuoka-shi	Fukuoka
Japan	JA Shizuoka Kohseiren Enshu Hospital	Hamamatsu-shi	Shizuoka
Japan	Katahira Dermatology Urology Clinic	Kagoshima-shi	Kagoshima
Japan	Kosugi Dermatology Clinic	Kawasaki-shi	Kanagawa
Japan	Jouzan Hihuka Hinyoukika Clinic	Kumamoto-shi	Kumamoto
Japan	Suizenji Dermatology Clinic	Kumamoto-shi	Kumamoto
Japan	Fukui Dermatology Clinic	Nagoya-shi	Aichi
Japan	Yoshioka Dermatology Clinic	Neyagawa-shi	Osaka
Japan	Takagi Dermatological Clinic Branch	Obihiro-shi	Hokkaido
Japan	Medical Corporation Kojinkai Sapporo Skin Clinic	Sapporo-shi	Hokkaido
Japan	Naoko Dermatology Clinic	Setagaya-ku	Tokyo
Japan	NTT Medical Center Tokyo	Shinagawa-ku	Tokyo
Japan	Yamate Dermatology Clinic	Shinjuku-ku	Tokyo
Japan	Nomura Dermatology Clinic	Yokohama-shi	Kanagawa
Malaysia	Hospital Pulau Pinang	Georgetown	Pinang
Malaysia	Hospital Raja Permaisuri Bainun	Ipoh	Perak
Malaysia	Hospital Sultan Ismail	Johor Bahru	Johor
Malaysia	Queen Elizabeth Hospital	Kota Kinabalu	Sabah
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur	Wilayah Persekutuan
Malaysia	Pusat Perubatan Universiti Kebangsaan Malaysia	Kuala Lumpur	Wilayah Persekutuan
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan
Netherlands	Bravis Ziekenhuis	Bergen op Zoom
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Poland	Dermapolis Medical Dermatology Center dr n med Edyta Gebska	Chorzow
Poland	GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero	Katowice
Poland	Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna	Krakow
Poland	AppleTreeClinics Network Spzoo	Lodz
Poland	Ip Clinic Sp zoo	Lodz
Poland	Twoja Przychodnia Scm	Szczecin
Poland	DermMedica Spzoo Centrum Columbus	Wroclaw
Puerto Rico	Doctor Samuel Sanchez PSC	Caguas
Romania	Theramed Healthcare SRL	Brasov
Romania	Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor	Cluj-Napoca
Romania	Spitalul Clinic Judetean Mures	Targu Mures
Singapore	National Skin Centre	Singapore
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Slovakia	Maxderm, sro	Bardejov
Slovakia	Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto	Bratislava
Slovakia	Fakultna nemocnica s poliklinikou JA Reimana Presov	Presov
Slovakia	Sanare spol sro	Svidnik
Slovenia	Univerzitetni klinicni center Ljubljana	Ljubljana
Slovenia	Univerzitetni Klinicni Center Maribor	Maribor
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona	Cataluña
Spain	Hospital Universitario Basurto	Bilbao	País Vasco
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Complexo Hospitalario Universitario de Pontevedra	Pontevedra
Spain	Hospital General Universitario de Valencia	Valencia	Comunidad Valenciana
Switzerland	Inselspital Bern	Bern
Switzerland	Hopitaux Universitaires de Geneve	Geneve 14
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Kantonsspital Sankt Gallen	Sankt Gallen
Switzerland	Universitaetsspital Zuerich	Zuerich
Turkey	Ankara Bilkent Sehir Hastanesi	Ankara
Turkey	Acibadem Altunizade Hastanesi	Istanbul
Turkey	Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi	Istanbul
Turkey	Marmara Universitesi Tip Fakultesi Hastanesi	Istanbul
Turkey	Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi	Samsun
United Kingdom	Royal United Hospitals Bath NHS Foundation Trust	Bath
United Kingdom	Russells Hall Hospital	Dudley
United Kingdom	West Middlesex University Hospital	Isleworth
United Kingdom	The Royal Free Hospital	London
United Kingdom	Salford Royal Hospital	Salford
United Kingdom	Accellacare Yorkshire	Shipley
United States	Albuquerque Clinical Trials Incorporated	Albuquerque	New Mexico
United States	Atlanta Dermatology, Vein and Research Center, PC	Alpharetta	Georgia
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Divine Dermatology and Aesthetics	Atlanta	Georgia
United States	Oakland Hills Dermatology	Auburn Hills	Michigan
United States	US Dermatology Partners Jollyville	Austin	Texas
United States	Kern Research Inc	Bakersfield	California
United States	Bexley Dermatology Research	Bexley	Ohio
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Chear Center LLC	Bronx	New York
United States	DS Research	Clarksville	Indiana
United States	Newco 3A Research LLC	El Paso	Texas
United States	Schweiger Dermatology Group, PC Research Division	Hackensack	New Jersey
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Sante Clinical Research	Kerrville	Texas
United States	Vivida Dermatology	Las Vegas	Nevada
United States	Dermatology and Skin Cancer Center Leawood	Leawood	Kansas
United States	Somnos Clinical Research	Lincoln	Nebraska
United States	Keck Medicine of University of Southern California	Los Angeles	California
United States	Wallace Medical Group Inc	Los Angeles	California
United States	Velocity Clinical Research Inc	Medford	Oregon
United States	Industrial Medicine Associates Clinical Research Advanced Dermatology Care	Monroe	Louisiana
United States	Virginia Dermatology and Skin Cancer Center	Norfolk	Virginia
United States	Las Vegas Clinical Trials	North Las Vegas	Nevada
United States	Arkansas Research Trials, LLC	North Little Rock	Arkansas
United States	Skin Specialists PC	Omaha	Nebraska
United States	Antelope Valley Clinical Trials	Palmdale	California
United States	Paddington Testing Company Inc	Philadelphia	Pennsylvania
United States	Medical Dermatology Specialists	Phoenix	Arizona
United States	Southwest Skin Specialists	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Texas Dermatology Research Center	Plano	Texas
United States	Health Concepts	Rapid City	South Dakota
United States	Aesthetic and Dermatology Center	Rockville	Maryland
United States	Kaiser Permanente South Sacramento Medical Center	Sacramento	California
United States	University of California at Davis Medical Center	Sacramento	California
United States	Acclaim Clinical Research	San Diego	California
United States	Kaiser Permanente Medical Center - Oakland	San Francisco	California
United States	Kaiser Permanente Medical Center - San Francisco	San Francisco	California
United States	Synergy Dermatology	San Francisco	California
United States	NorthShore University HealthSystem	Skokie	Illinois
United States	US Dermatology Partners Sun City West	Sun City West	Arizona
United States	Olympian Clinical Research - Tampa	Tampa	Florida
United States	TrueBlue Clinical Research	Tampa	Florida
United States	Accellacare of Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  China,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Malaysia,  Netherlands,  Poland,  Puerto Rico,  Romania,  Singapore,  Slovakia,  Slovenia,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of a vIGA-AD Score of 0 or 1 with a =2 Point Reduction From Baseline at Week 24		Baseline, Week 24
Primary	Achievement of = 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24		Baseline, Week 24
Secondary	Achievement of EASI 75 at Week 16		Baseline, Week 16
Secondary	Achievement of vIGA-AD 0/1 at Week 16		Baseline, Week 16
Secondary	Achievement of a = 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score = 4		Baseline, Week 16
Secondary	Achievement of a = 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score = 4		Baseline, Week 24
Secondary	Achievement of = 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24		Baseline, Week 24
Secondary	Achievement of a = 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score = 4		Baseline, Week 24
Secondary	Achievement of vIGA-AD 1 Response with a Presence of Only Barely Perceptible Erythema or vlGA-AD 0 Response (Revised IGA [rIGA™] 0/1) at Week 24		Baseline, Week 24
Secondary	Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline		Baseline, Week 24
Secondary	Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline		Baseline, Week 24
Secondary	Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16		Baseline, Week 16
Secondary	Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24		Baseline, Week 24
Secondary	Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16		Baseline, Week 16
Secondary	Change From Baseline in SCORAD Itch VAS Score at Week 24		Baseline, Week 24
Secondary	Achievement of = 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI Score = 4		Baseline, Week 24
Secondary	Change from Baseline in DLQI Score at Week 24		Baseline, Week 24
Secondary	Achievement of a = 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants with Baseline POEM Score = 4		Baseline, Week 24
Secondary	Change From Baseline in POEM Score at Week 24		Baseline, Week 24
Secondary	Achievement of a = 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD skin pain NRS Score = 4		Baseline, Week 16
Secondary	Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24		Baseline, Week 24
Secondary	Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16		Baseline, Week 16
Secondary	Achievement of a = 3-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score = 3		Baseline, Week 24
Secondary	Achievement of a = 3-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score = 3		Baseline, Week 16
Secondary	Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24		Baseline, Week 24
Secondary	Achievement of a Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score < 8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score = 8		Baseline, Week 24
Secondary	Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score = 8		Baseline, Week 24
Secondary	Change From Baseline in HADS-anxiety Subscale Score at Week 24		Baseline, Week 24
Secondary	Change From Baseline in HADS-depression Subscale Score at Week 24		Baseline, Week 24
Secondary	Achievement of a = 8.7-point Reduction from Baseline in SCORAD Score at Week 24 in Participants with Baseline SCORAD Score = 8.7		Baseline, Week 24

External Links

•   AmgenTrials clinical trials website