A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

Atopic Dermatitis Clinical Trial

— ROCKET-Ignite  

Official title:

A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05398445
• Other study ID #: 20210142
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 31, 2022
• Est. completion date: March 30, 2025

Study information

• Verified date: June 2024
• Source: Amgen
• Contact: n/a
• 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 treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 769
• Est. completion date: March 30, 2025
• Est. primary completion date: January 6, 2025
• 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 Consensus Criteria (2014) present for at least 12 months

• History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency within 6 months (with or without topical calcineurin inhibitors [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

• Systemic immunosuppressants

• Phototherapy

• Janus kinase inhibitors

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

• TCS of any potency

• TCI

• Topical phosphodiesterase type 4 inhibitors

• Other topical immunosuppressive agents

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Rocatinlimab
Participants will receive Rocatinlimab subcutaneously.
• Placebo
Participants will receive a placebo subcutaneously.

Locations

Country	Name	City	State
Argentina	Cinme - Centro de Investigaciones Metabolicas	Caba	Buenos Aires
Argentina	Conexa Investigacion Clinica SA	Caba	Distrito Federal
Argentina	Fundacion Respirar	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	InAER - Investigaciones en Alergia y Enfermedades Respiratorias	Ciudad Autonoma de Buenos Aires	Distrito Federal
Argentina	Instituto de Neumonologia y Dermatologia	Ciudad Autonoma de Buenos Aires	Distrito Federal
Argentina	Hospital Universitario Austral	Derqui, Pilar	Buenos Aires
Argentina	Fundacion Estudios Clinicos	Rosario	Santa Fe
Argentina	Instituto de Diagnostico Abc American British Cowdray	Rosario	Santa Fe
Argentina	Centro Dermatológico Schejtman	San Miguel	Buenos Aires
Brazil	Upeclin-Pesq Clin FacMed Botucatu	Botucatu	São Paulo
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Ernesto Dornelles	Porto Alegre	Rio Grande Do Sul
Brazil	IBPClin Instituto Brasil de Pesquisa Clinica	Rio de Janeiro
Brazil	Fundacao Abc - Centro Univ Fmabc	Santo Andre	São Paulo
Brazil	Hosp e Maternidade Dr Christovao da Gama	Santo Andre	São Paulo
Brazil	Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia	São Paulo
Brazil	Consultoria Medica e Pesquisa Clinica Cmpc	Sorocaba	São Paulo
Canada	CCA Medical Research Corporation	Ajax	Ontario
Canada	SimcoDerm Medical and Surgical Dermatology Centre	Barrie	Ontario
Canada	Alberta Derma Surgery Centre	Edmonton	Alberta
Canada	Vida Clinical Research	Edmonton	Alberta
Canada	LEADER Research	Hamilton	Ontario
Canada	DermEdge Research Incorporated	Mississauga	Ontario
Canada	Innovaderm Research Inc	Montreal	Quebec
Canada	Canadian Dermatology Centre	North York	Ontario
Canada	Gordon Sussman Clinical Research Incorporated	North York	Ontario
Canada	Recherche Clinique Sigma Incorporated	Quebec
Canada	Oak Ridges Aesthetics Centre	Richmond Hill	Ontario
Canada	Skinsense Medical Research	Saskatoon	Saskatchewan
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	The Second Xiangya Hospital of Central South University	Changsha	Hunan
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	the First Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Provincial Peoples Hospital	Hangzhou	Zhejiang
China	Jiangyin Hospital of Traditional Chinese Medicine	Jiangyin	Jiangsu
China	Dermatology Hospital of Jiangxi Province	Nanchang	Jiangxi
China	Nanyang First Peoples Hospital	Nanyang	Henan
China	Sanmenxia Central Hospital	Sanmenxia	Henan
China	Shanghai Skin Disease Hospital	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The First Hospital Of Hebei Medical University	Shijiazhuang	Hebei
China	Taizhou Central Hospital	Taizhou	Zhejiang
China	Union Hospital Tongji Medical College Huazhong University of science and Technology	Wuhan	Hubei
China	Wuxi Peoples Hospital	Wuxi	Jiangsu
Croatia	Special Hospital for Medical Rehabilitation Naftalan	Ivanic-Grad
Croatia	Sestre milosrdnice University Hospital Center	Zagreb
Croatia	University Hospital Centre Zagreb	Zagreb
Czechia	Dermamedica, sro	Nachod
Czechia	CCR Ostrava sro	Ostrava
Czechia	Pratia Pardubice as	Pardubice
Czechia	Clintrial sro	Praha 10
Czechia	Pratia Prague sro	Praha 3
Czechia	Fakultni nemocnice Bulovka	Praha 8
Czechia	Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz	Usti nad Labem
Germany	Charite - Universitaetsmedizin Berlin, Campus Mitte	Berlin
Germany	Dermatologische Gemeinschaftspraxis-Mahlow	Blankenfelde-Mahlow
Germany	Hautarztpraxis Dr Niesmann und Dr Othlinghaus	Bochum
Germany	Rosenpark Research GmbH	Darmstadt
Germany	Universitaetsklinikum Dresden	Dresden
Germany	Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf	Duesseldorf
Germany	Universitaetsklinikum Essen	Essen
Germany	Institute for Health Services Research in Dermatology and Nursing	Hamburg
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Hautarztpraxis Dres Leitz und Kollegen	Stuttgart
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Germany	CentroDerm GmbH	Wuppertal
Greece	Andreas Syngros Hospital Of Venereal And Dermatological Diseases	Athens
Greece	Athens Naval Hospital	Athens
Greece	Thoracic General Hospital Of Athens Sotiria	Athens
Greece	University General Hospital Attikon	Athens
Greece	University General Hospital of Ioannina	Ioannina
Greece	General University Hospital of Larissa	Larissa
Greece	Papageorgiou General Hospital	Thessaloniki
Hungary	Medmare Bt	Veszprem
Italy	Universita degli Studi Gabriele D Annunzio di Chieti e Pescara	Chieti
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milano
Italy	Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia	Perugia
Italy	Azienda Ospedaliera Policlinico Umberto I	Roma
Italy	Azienda Ospedaliera Citta della Salute e della Scienza di Torino	Torino
Japan	Asahikawa City Hospital	Asahikawa-shi	Hokkaido
Japan	Fukuoka University Hospital	Fukuoka-shi	Fukuoka
Japan	Matsuo Clinic	Fukuoka-shi	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima-shi	Fukushima
Japan	Tokyo Medical University Ibaraki Medical Center	Inashiki-gun	Ibaraki
Japan	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo
Japan	Teikyo University Hospital	Itabashi-ku	Tokyo
Japan	Mochida Dermatology Clinic	Izumiotsu-shi	Osaka
Japan	Nippon Medical School Musashikosugi Hospital	Kawasaki-shi	Kanagawa
Japan	Rakuwakai Otowa Hospital	Kyoto-shi	Kyoto
Japan	University Hospital Kyoto Prefectural University of Medicine	Kyoto-shi	Kyoto
Japan	Takeoka Dermatology Clinic	Marugame-shi	Kagawa
Japan	Iwate Medical University Uchimaru Medical Center	Morioka-shi	Iwate
Japan	Aichi Medical University Hospital	Nagakute-shi	Aichi
Japan	Central Clinic	Nagoya-shi	Aichi
Japan	Japan Community Healthcare Organization Chukyo Hospital	Nagoya-shi	Aichi
Japan	Nagoya City University Hospital	Nagoya-shi	Aichi
Japan	Kaji Dermatology Clinic	Nonoichi-shi	Ishikawa
Japan	Dokkyo Medical University Hospital	Shimotsuga-gun	Tochigi
Korea, Republic of	Korea University Ansan Hospital	Ansansi, Gyeonggido
Korea, Republic of	The Catholic University of Korea Incheon St Marys Hospital	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	National Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Latvia	Outpatient clinic Veselibas Centrs 4	Riga
Latvia	Outpatient clinic Veselibascentrs 4	Riga
Latvia	Smite Aija practice in dermatology and venerology	Talsi
Netherlands	PreCare Trial and Recruitment	Born
Poland	AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy	Gdansk
Poland	Centrum Medyczne Angelius Provita	Katowice
Poland	Centrum Zdrowia i Urody Maxxmed	Lublin
Poland	Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo	Malbork
Poland	Twoja przychodnia Ncm	Nowa Sol
Poland	Twoja przychodnia Pcm	Poznan
Poland	Twoja Przychodnia Scm	Szczecin
Poland	Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo	Tarnow
Poland	Royalderm Agnieszka Nawrocka	Warszawa
Poland	Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych	Wroclaw
Portugal	Hospital Cuf Descobertas	Lisboa
Portugal	Hospital Lusiadas Lisboa	Lisboa
Portugal	Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano	Matosinhos
Portugal	Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio	Porto
Puerto Rico	Clinical Research of Puerto Rico	San Juan
Slovakia	Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica	Banska Bystrica
Slovakia	Derma therapy, spol s ro	Bratislava
Slovakia	Sanare spol sro	Svidnik
Slovakia	Kaderma Majtan, sro	Topolcany
Slovakia	Fakultna nemocnica Trnava	Trnava
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Cataluña
Spain	Hospital Universitario Reina Sofia	Cordoba	Andalucía
Spain	Hospital Universitari de Bellvitge	Hospitalet de LLobregat	Cataluña
Spain	Hospital Universitario de Gran Canaria Doctor Negrin	Las Palmas de Gran Canaria	Canarias
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Clinico Universitario de Santiago	Pontevedra	Galicia
Spain	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcon	Madrid
Spain	Hospital Universitari i Politecnic La Fe	Valencia	Comunidad Valenciana
Spain	Hospital Universitario Miguel Servet	Zaragoza	Aragón
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Mackay Memorial Hospital Taipei Branch	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan
United States	Anaheim Clinical Trials	Anaheim	California
United States	Cahaba Dermatology and Skin Health Center	Birmingham	Alabama
United States	Optima Research	Boardman	Ohio
United States	Skin Care Research Incorporated	Boca Raton	Florida
United States	Treasure Valley Medical Research	Boise	Idaho
United States	IMMUNOe Research Centers	Centennial	Colorado
United States	Dermatology Specialists of Charlotte	Charlotte	North Carolina
United States	Onsite Clinical Solutions	Charlotte	North Carolina
United States	Continental Clinical Solutions - Cherry Hill	Cherry Hill	New Jersey
United States	Institute for Asthma and Allergy	Chevy Chase	Maryland
United States	DeNova Research	Chicago	Illinois
United States	ClinOhio Research Services	Columbus	Ohio
United States	Dermatology Treatment and Research Center PA	Dallas	Texas
United States	Palm Beach Dermatology Group	Delray Beach	Florida
United States	Henry Ford Health System	Detroit	Michigan
United States	Onyx Clinical Research	Flint	Michigan
United States	First OC Dermatology	Fountain Valley	California
United States	Kaiser Permanente - Glendale Medical Center	Glendale	California
United States	Industrial Medicine Associates Ima Clinical Research Inc	Hartsdale	New York
United States	Cumberland Skin Center	Hermitage	Tennessee
United States	Global Research Associates	Homestead	Florida
United States	Jubilee Clinical Research Inc	Las Vegas	Nevada
United States	Dermatology and Skin Cancer Center of Lees Summit	Lee's Summit	Missouri
United States	Long Beach Research Institute	Long Beach	California
United States	Dermatology Research Associates	Los Angeles	California
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	Education and Research Foundation Inc	Lynchburg	Virginia
United States	Healthy Life Research	Miami	Florida
United States	Savin Medical Group LLC	Miami Lakes	Florida
United States	Frontier Derm Partners	Mill Creek	Washington
United States	West Virginia Research Institute	Morgantown	West Virginia
United States	Kirsch Dermatology LLC	Naples	Florida
United States	Sadick Research Group	New York	New York
United States	Unity Clinical Research	Oklahoma City	Oklahoma
United States	Pure Skin Dermatology and Aesthetics	Orlando	Florida
United States	Alliance Dermatology and Mohs Center	Phoenix	Arizona
United States	The Indiana Clinical Trials Center PC	Plainfield	Indiana
United States	Oregon Health and Science University	Portland	Oregon
United States	Allcutis Research, Llc - Portsmouth	Portsmouth	New Hampshire
United States	Industrial Medicine Associates Ima Clinical Research Inc	Saint Petersburg	Florida
United States	Cura Clinical Research	Sherman Oaks	California
United States	DermDox Dermatology, LLC	Sugarloaf	Pennsylvania
United States	Genesis Clinical Research LLC	Tampa	Florida
United States	The Woodlands Dermatology Associates	The Woodlands	Texas
United States	Continental Clinical Solutions, LLC	Towson	Maryland
United States	Dermatology Research Center of Oklahoma, PLLC	Tulsa	Oklahoma
United States	Essential Medical Research LLC	Tulsa	Oklahoma
United States	Dundee Dermatology	West Dundee	Illinois
United States	Wilmington Dermatology Center	Wilmington	North Carolina
United States	The Skin Surgery Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  China,  Croatia,  Czechia,  Germany,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Latvia,  Netherlands,  Poland,  Portugal,  Puerto Rico,  Slovakia,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with =2 point reduction from baseline at Week 24		Baseline, Week 24
Primary	Achievement of =75% reduction from baseline in Eczema Area and Severity Index (EASI) score at Week 24		Baseline, Week 24
Secondary	Achievement of =75% reduction from baseline in EASI score at Week 16		Baseline, Week 16
Secondary	Achievement of a vIGA-AD score of 0 or 1 from baseline at Week 16		Baseline, Week 16
Secondary	Achievement of a = 4-point reduction from baseline in weekly average of daily worst pruritus numerical rating scale (NRS) score at Week 16 in subjects 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 subjects with baseline weekly average of daily worst pruritus NRS score = 4		Baseline, Week 24
Secondary	Achievement of =90% reduction from baseline in EASI score at Week 24		Baseline, Week 24
Secondary	Achievement of a = 4-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 24 in subjects with baseline weekly average of AD skin pain NRS score = 4		Baseline, Week 24
Secondary	Achievement of a vIGA-AD 1 response with presence of only barely perceptible erythema or vIGA-AD 0 response (revised Investigator's Global Assessment [rIGA™] 0/1) at Week 24		Baseline, Week 24
Secondary	Achievement of Facial AD Severity Score (FASS) of clear at Week 24 for subjects with facial AD at baseline		Baseline, Week 24
Secondary	Achievement of Hand AD Severity Score (HASS) of clear at Week 24 for subjects 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 DLQI score at Week 24 in subjects with baseline DLQI score = 4		Baseline, Week 24
Secondary	Change from baseline in DLQI score at Week 24		Baseline, Week 24
Secondary	Achievement of = 4-point reduction from baseline in POEM score at Week 24 in subjects 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 daily AD skin pain NRS score at Week 16 in subjects 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 daily AD skin pain NRS score at Week 24 in subjects 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 daily AD skin pain NRS score at Week 16 in subjects with baseline weekly average of AD skin pain NRS score = 3		Baseline, Week 16
Secondary	Change from baseline in weekly average of daily sleep disturbance NRS score at Week 24		Baseline, Week 24
Secondary	Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety subscale score < 8 at Week 24 in subjects with baseline HADS-anxiety subscale score = 8		Baseline, Week 24
Secondary	Change from baseline in HADS-anxiety subscale score at Week 24		Baseline, Week 24
Secondary	Achievement of HADS-depression subscale score < 8 at week 24 in subjects with baseline HADS-depression subscale score = 8		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