A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD)

Atopic Dermatitis Clinical Trial

— ROCKET-ASTRO  

Official title:

A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05704738
• Other study ID #: 20210145
• Secondary ID: 2022-501586-50
• Status: Recruiting
• Phase: Phase 3
• Start date: April 20, 2023
• Est. completion date: December 18, 2025

Study information

• Verified date: June 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 18, 2025
• Est. primary completion date: September 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Age = 12 to < 18 years at Day 1.
• Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield et al, 2014]) that has been present for at least 12 months before signing of informed consent.
• Body weight = 40 kg at screening.
• History of inadequate response to TCS of medium to higher potency (with or without TCI).
• EASI score = 12 at initial screening.
• EASI score = 16 at Day 1.
• vIGA-AD score = 3.
• =10% body surface area of AD involvement.
• Worst pruritus NRS = 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:

1. Systemic corticosteroids

2. Non-biologic, non-targeted systemic immunosuppressants

3. Phototherapy

4. Oral or Topical Janus kinase inhibitors

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

Day 1:

1. TCS of any potency

2. TCI

3. Topical phosphodiesterase 4 inhibitors

4. Other topical immunosuppressive agents

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Rocatinlimab
Subcutaneous (SC) injection
• Placebo
SC injection

Locations

Country	Name	City	State
Belgium	Hopital Erasme	Bruxelles
Belgium	Universite Catholique de Louvain Cliniques Universitaires Saint Luc	Bruxelles
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Centre Hospitalier Universitaire de Liege - Sart Tilman	Liege
Belgium	Dermatologie Maldegem	Maldegem
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Irmandade da Santa Casa de Misericordia de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Le Plume Dermatologia- Clinica de Dermatologia Dra Beatriz Elias Eirelli	Ribeirão Preto	São Paulo
Brazil	IBPClin Instituto Brasil de Pesquisa Clinica	Rio de Janeiro
Brazil	Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda	Salvador	Bahia
Brazil	Hospital de Base de Sao Jose do Rio Preto	São José do Rio Preto	São Paulo
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	Sao Paulo	São Paulo
Brazil	Instituto Pesquisa e Ensino em Saúde Infantil	Sao Paulo	São Paulo
Brazil	Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo	Vitória	Espírito Santo
Canada	Rejuvenation Dermatology Laser Calgary North	Calgary	Alberta
Canada	Lynderm Research Inc	Markham	Ontario
Canada	Dr SK Siddha Medicine Professional Corporation	Newmarket	Ontario
Canada	Allergy Research Canada Incorporated	Niagara Falls	Ontario
Canada	Skinsense Medical Research	Saskatoon	Saskatchewan
Canada	XLR8 Medical Research, Incorporated	Windsor	Ontario
Chile	Centro Dermatologico Dermisur	Osorno
Chile	Centro Internacional de Estudios Clinicos	Santiago
Chile	Centro Medico Skinmed Spa	Santiago
Chile	Clinica Dermacross SA	Santiago
Chile	Fundacion Innovacion Cardiovascular	Santiago
China	Beijing Childrens Hospital, Capital Medical University	Beijing	Beijing
China	Childrens Hospital Capital Institute of Pediatrics	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	Hunan Childrens Hospital	Changsha
China	Chengdu Second Peoples Hospital	Chengdu	Sichuan
China	Childrens Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Dalian Women and Childrens Medical Group	Dalian
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	Jiangyin Hospital of Traditional Chinese Medicine	Jiangyin	Jiangsu
China	Kunming Childrens Hospital	Kunming	Yunnan
China	Nanyang First Peoples Hospital	Nanyang	Henan
China	Ningbo NO 2 Hospital	Ningbo	Zhejiang
China	Shanghai Skin Disease Hospital	Shanghai
China	Shenzhen Childrens Hospital	Shenzhen
China	Suining Central Hospital	Suining	Sichuan
China	Taizhou Central Hospital	Taizhou	Zhejiang
China	The Central Hospital of Wuhan	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of science and Technology	Wuhan	Hubei
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
Croatia	Special Hospital for Medical Rehabilitation Naftalan	Ivanic-Grad
Croatia	University Hospital Centre Osijek	Osijek
Croatia	Children s Hospital Zagreb	Zagreb
Croatia	University Hospital Centre Zagreb	Zagreb
France	Hopital Prive d Antony	Antony
France	Centre Hospitalier Regional Universitaire Brest Hopital Morvan	Brest
France	Hôpital Saint-Joseph	Marseille Cedex 8
France	Centre Hospitalier Universitaire de Nantes Hôtel Dieu	Nantes
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 de Toulouse, Hopital Larrey	Toulouse
Germany	Fachklinik Bad Bentheim	Bad Bentheim
Germany	Universitaetsklinikum Bonn	Bonn
Germany	Rosenpark Research GmbH	Darmstadt
Germany	Universitaetsklinikum Dresden	Dresden
Germany	Universitaetsklinikum Erlangen	Erlangen
Germany	Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main	Frankfurt am Main
Germany	Velocity Clinical Research	Leipzig
Germany	Johannes Gutenberg Universitaet Mainz	Mainz
Greece	Athens General Childrens Hospital Panagioti And Aglaia Kyriakou	Athens
Greece	Athens Naval Hospital	Athens
Greece	Thoracic General Hospital Of Athens Sotiria	Athens
Greece	Ippokratio General Hospital of Thessaloniki	Thessaloniki
Hungary	Clinexpert Kft	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Derma-B Egeszsegugyi es Szolgaltato Kft	Debrecen
Hungary	Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milano
Italy	Azienda Ospedaliera Universitaria Luigi Vanvitelli	Napoli
Italy	Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia	Perugia
Italy	Presidio Molinette Azienda Ospedaliera Citta della Salute e della Scienza di Torino	Torino
Japan	Yoshimura Child Clinic	Akashi-shi	Hyogo
Japan	Asahikawa City Hospital	Asahikawa-shi	Hokkaido
Japan	Matsuo Clinic	Fukuoka-shi	Fukuoka
Japan	Hamamatsu University Hospital	Hamamatsu-shi	Shizuoka
Japan	Katahira Dermatology Urology Clinic	Kagoshima-shi	Kagoshima
Japan	Jouzan Hihuka Hinyoukika Clinic	Kumamoto-shi	Kumamoto
Japan	Suizenji Dermatology Clinic	Kumamoto-shi	Kumamoto
Japan	Miyata Dermatology Clinic	Matsudo-shi	Chiba
Japan	Central Clinic	Nagoya-shi	Aichi
Japan	Yoshioka Dermatology Clinic	Neyagawa-shi	Osaka
Japan	Takagi Dermatological Clinic	Obihiro-shi	Hokkaido
Japan	Dermatology and Ophthalmology Kume Clinic	Sakai-shi	Osaka
Japan	Naoko Dermatology Clinic	Setagaya-ku	Tokyo
Japan	NTT Medical Center Tokyo	Shinagawa-ku	Tokyo
Japan	Nomura Dermatology Clinic	Yokohama-shi	Kanagawa
Japan	Yokohama City Minato Red Cross Hospital	Yokohama-shi	Kanagawa
Korea, Republic of	Korea University Ansan Hospital	Ansansi, Gyeonggido
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Ewha Womans University Seoul Hospital	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	National Medical Center	Seoul
Korea, Republic of	Nowon Eulji Medical Center, Eulji University	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St Marys Hospital	Seoul
Poland	AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy	Gdansk
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Centrum Medyczne Angelius Provita	Katowice
Poland	Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center	Krakow
Poland	Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna	Krakow
Poland	Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne	Lodz
Poland	AppleTreeClinics Network Spzoo	Lodz
Poland	Clinical Best Solutions Sp zoo Spolka Komandytowa	Lublin
Poland	Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych	Sosnowiec
Poland	Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo	Tarnow
Poland	High Med Przychodnia Specjalistyczna	Warszawa
Poland	Klinika Ambroziak Dermatologia	Warszawa
Poland	Klinika Osipowicz and Turkowski Sp zoo	Warszawa
Poland	Royalderm Agnieszka Nawrocka	Warszawa
Poland	Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych	Wroclaw
Puerto Rico	Clinical Research of Puerto Rico	San Juan
Puerto Rico	gcm Medical Group, Psc	San Juan
Romania	Dr Leventer Centre Clinica Dermatologie Bucuresti	Bucharest
Romania	Derma Cluj	Cluj-Napoca
Romania	Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor	Cluj-Napoca
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Cataluña
Spain	Hospital Sant Joan de Deu	Esplugues de Llobregat	Cataluña
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok
United States	University of New Mexico	Albuquerque	New Mexico
United States	Oakland Hills Dermatology	Auburn Hills	Michigan
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Cahaba Dermatology and Skin Health Center	Birmingham	Alabama
United States	Optima Research	Boardman	Ohio
United States	Treasure Valley Medical Research	Boise	Idaho
United States	The Dermatology Center of New Jersey	Bridgewater	New Jersey
United States	Yeshiva University - Montefiore Medical Center	Bronx	New York
United States	Ace Clinical Trials	Brooklyn	New York
United States	US Dermatology Partners Cedar Park	Cedar Park	Texas
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Epic Medical Research - Oklahoma	Chickasha	Oklahoma
United States	Academic Alliance in Dermatology - Saint Petersburg Office	Clearwater	Florida
United States	Corazon United States of America, LLC doing business as Life Clinical Trials	Coral Springs	Florida
United States	AllerVie Clinical Research- Cullman	Cullman	Alabama
United States	Studies in Dermatology LLC	Cypress	Texas
United States	Palm Beach Dermatology Group	Delray Beach	Florida
United States	Velocity Clinical Research - Denver	Denver	Colorado
United States	Henry Ford Medical Center - New Center One	Detroit	Michigan
United States	Angels Clinical Research Institute	Doral	Florida
United States	Duke South Durham	Durham	North Carolina
United States	Empire Dermatology	East Syracuse	New York
United States	Onyx Clinical Research	Flint	Michigan
United States	Maria M Ona MD PC	Franklin	Virginia
United States	Center for Dermatology Clinical Research Inc	Fremont	California
United States	Doc1 Healthcare Systems Incorporated	Fullerton	California
United States	Velocity Clinical Research - Grants Pass	Grants Pass	Oregon
United States	Direct Helpers Research Center	Hialeah	Florida
United States	MedCare Pharma - Houston	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Tranquil Clinical Research	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Axon Clinical Research	Inglewood	California
United States	Sante Clinical Research	Kerrville	Texas
United States	Forest Hills Dermatology Group	Kew Gardens	New York
United States	Avance Clinical Trials	Laguna Niguel	California
United States	Somnos Clinical Research	Lincoln	Nebraska
United States	Long and Harris Dermatology pllc	Lubbock	Texas
United States	Glick Skin Institute	Margate	Florida
United States	Apex Clinical Research Center LLC	Mayfield Heights	Ohio
United States	Velocity Clinical Research - Boise	Meridian	Idaho
United States	Sms Clinical Research Limited Liability Company	Mesquite	Texas
United States	Miami Clinical Research	Miami	Florida
United States	Deluxe Health Care LLC	Miami Lakes	Florida
United States	Savin Medical Group LLC	Miami Lakes	Florida
United States	Sienna Dermatology Research	Missouri City	Texas
United States	Industrial Medicine Associates Clinical Research Advanced Dermatology Care	Monroe	Louisiana
United States	HealthStar Physicians Dermatology	Morristown	Tennessee
United States	Kentucky Advanced Medical Research LLC	Murray	Kentucky
United States	Tanner Clinic	Murray	Utah
United States	Southern Indiana Clinical Trials	New Albany	Indiana
United States	Cornell University - Weill Cornell Medicine	New York	New York
United States	Pioneer Clinical Research New York	New York	New York
United States	National Allergy and Asthma Research, LLC	North Charleston	South Carolina
United States	Arkansas Research Trials, LLC	North Little Rock	Arkansas
United States	Dermatology and Aesthetics of Oklahoma	Oklahoma City	Oklahoma
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Optimal Research Sites, LLC	Orange City	Florida
United States	Clinical Associates of Orlando Limited Liability Company	Orlando	Florida
United States	Clinical Research Investments	Orlando	Florida
United States	Cura Clinical Research	Palmdale	California
United States	Paddington Testing Company Inc	Philadelphia	Pennsylvania
United States	The Indiana Clinical Trials Center PC	Plainfield	Indiana
United States	Oregon Health and Science University	Portland	Oregon
United States	Allcutis Research	Portsmouth	New Hampshire
United States	Dermatology Research of Utah, dba Providence Dermatology	Providence	Utah
United States	Rhode Island Hospital, Lifespan	Providence	Rhode Island
United States	Skin Cancer and Dermatology Institute	Reno	Nevada
United States	Rochester Clinical Research	Rochester	New York
United States	Aesthetic and Dermatology Center	Rockville	Maryland
United States	Derm Associates, PC	Rockville	Maryland
United States	Integrative Skin Science and Research	Sacramento	California
United States	University of California at Davis Medical Center	Sacramento	California
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	Saint Louis University	Saint Louis	Missouri
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	Allergy and Asthma Medical Group and Research Center	San Diego	California
United States	University of California at San Diego Rady Childrens Hospital San Diego	San Diego	California
United States	Advanced Medical Research PC	Sandy Springs	Georgia
United States	Clinical Science Institute	Santa Monica	California
United States	Divine Dermatology and Aesthetics	Savannah	Georgia
United States	Cura Clinical Research Sherman Oaks	Sherman Oaks	California
United States	NorthShore University HealthSystem Clinical Trials Center	Skokie	Illinois
United States	Epiphany Dermatology	Southlake	Texas
United States	Pioneer Research Solutions	Sugar Land	Texas
United States	Coastal Pediatric Research	Summerville	South Carolina
United States	University of South Florida	Tampa	Florida
United States	McIntosh Clinic PC	Thomasville	Georgia
United States	Eclipse Clinical Research	Tucson	Arizona
United States	Dermatology Research Center of Oklahoma, PLLC	Tulsa	Oklahoma
United States	Essential Medical Research LLC	Tulsa	Oklahoma
United States	Childrens National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  Chile,  China,  Croatia,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Poland,  Puerto Rico,  Romania,  Spain,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis Score of 0 (Clear) or 1 (Almost Clear) with a = 2 Point Reduction From Baseline (vIGA-AD 0/1) at Week 24		Baseline and Week 24
Primary	Achievement of = 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24		Baseline and Week 24
Secondary	Achievement of EASI 75 at Week 16		Baseline and Week 16
Secondary	Achievement of a vIGA-AD 0/1 at Week 16		Baseline and 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 and Week 16
Secondary	Achievement of a = 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Partiipants with Baseline Weekly Average of Daily Worst Pruritus NRS Score = 4		Baseline and Week 24
Secondary	Achievement of = 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24		Baseline and 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 and Week 24
Secondary	Achievement of a vIGA-AD Score of 1 with Presence of Only Barely Perceptible Erythema or vIGA-AD Score of 0 (revised Investigator's Global Assessment [rIGA™] 0/1) at Week 24		Baseline and Week 24
Secondary	Initiation of rescue therapy for AD at or before Week 16		Baseline to Week 16
Secondary	Initiation of rescue therapy for AD at or before Week 24		Baseline to Week 24
Secondary	Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16		Baseline to Week 16
Secondary	Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24		Baseline to Week 24
Secondary	Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) Itch Visual Analog Scale (VAS) Score at Week 16		Baseline to Week 16
Secondary	Change From Baseline in SCORAD Itch VAS Score at Week 24		Baseline to Week 24
Secondary	Achievement of a = 4-point Reduction from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants with Baseline DLQI = 4 (Children's Dermatology Life Quality Index [CDLQI] in Participants < 16 Years of Age at Screening)		Baseline and Week 24
Secondary	Change From Baseline in DLQI or CDLQI Score at Week 24		Baseline to 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 and Week 24
Secondary	Change From Baseline in POEM Score at Week 24		Baseline to 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 and Week 16
Secondary	Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24		Baseline and Week 24
Secondary	Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16		Baseline and 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 and 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 and Week 16
Secondary	Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24		Baseline to 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 and Week 24
Secondary	Change From Baseline in HADS-anxiety Subscale Score at Week 24		Baseline to Week 24
Secondary	Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score = 8		Baseline and Week 24
Secondary	Change From Baseline in HADS-depression Subscale Score at Week 24		Baseline to Week 24
Secondary	Achievement of a = 8.7-point Reduction from Baseline in Severity SCORAD Score at Week 24 in Participants with Baseline SCORAD Score = 8.7		Baseline and Week 24

External Links

•   AmgenTrials clinical trials website