A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

Atopic Dermatitis Clinical Trial

— ROCKET-Horizon  

Official title:

A Phase 3, Randomized, 24-week, 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) (ROCKET-Horizon)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05651711
• Other study ID #: 20210143
• Secondary ID: 2022-501538-44
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 14, 2022
• Est. completion date: August 19, 2024

Study information

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

Clinical Trial Summary

The co-primary objectives of the study are to:

• Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).

• Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 726
• Est. completion date: August 19, 2024
• Est. primary completion date: July 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age = 18 years (or = legal adult age within the country if it is older than 18 years at signing of informed consent) 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 or higher potency (with or without topical calcineurin inhibitors [TCI]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).

• 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

• Oral or topical 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 (PDE4) inhibitors

• Other topical immunosuppressive agents

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Rocatinlimab
Rocatinlimab will be administered through a subcutaneous (SC) injection.

Other:
• Placebo
The matching placebo will be administered through a SC injection.

Locations

Country	Name	City	State
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Skin Health Institute	Carlton	Victoria
Australia	St George Dermatology and Skin Cancer Centre	Darlinghurst	New South Wales
Australia	Sinclair Dermatology	East Melbourne	Victoria
Australia	Premier Specialists	Kogarah	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Belgium	Hopital Erasme	Bruxelles
Belgium	Clinique Andre Renard	Herstal
Belgium	Dermatologie Maldegem	Maldegem
Brazil	CETI - Centro de Estudo em Terapias Inovadoras	Curitiba	Paraná
Brazil	Centro Multidisciplinar de Estudos Clinicos - CEMEC	Sao Bernardo do Campo	São Paulo
Brazil	ISPEM - Instituto São José dos Campos em Pesquisas Médicas	São José dos Campos	São Paulo
Canada	Beacon Dermatology	Calgary	Alberta
Canada	Kingsway Clinical Research	Etobicoke	Ontario
Canada	Lynderm Research Inc	Markham	Ontario
Canada	The Centre for Clinical Trials Inc	Oakville	Ontario
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	Centre de Recherche Dermatologique du Quebec Metropolitain	Quebec
Canada	The Centre for Dermatology	Richmond Hill	Ontario
Canada	Clinique Dermatologique de Sherbrooke	Sherbrooke	Quebec
Canada	Doctor Chih-Ho Hong Medical Incorporated	Surrey	British Columbia
Canada	Research Toronto	Toronto	Ontario
Canada	XLR8 Medical Research, Incorporated	Windsor	Ontario
Czechia	Kozni ambulance Kutna Hora sro	Kutna Hora
Czechia	Nemocnice Novy Jicin as	Novy Jicin
Czechia	CCR Czech as	Pardubice
Czechia	Fakultni nemocnice Plzen	Plzen
Czechia	Dermamedest sro	Praha
Czechia	CCR Prague sro	Praha 3
Czechia	Praglandia sro	Praha 5
Czechia	Kozni ambulance Fialova sro	Praha 6
Czechia	Dermatologicka ambulance MUDr Petr Trestik	Svitavy
Denmark	Gentofte Hospital	Hellerup
Denmark	Odense University Hospital	Odense
Estonia	North Estonia Medical Centre	Tallinn
Estonia	Clinical Research Centre	Tartu
Finland	CRST Helsinki	Helsinki
Finland	CRST Turku	Helsinki
Finland	Oulun Yliopistollinen sairaala (OYS)	Oulu
Finland	Terveystalo Tampere	Tampere
Germany	Fachklinik Bad Bentheim	Bad Bentheim
Germany	Clinical Research Services Berlin GmbH	Berlin
Germany	Hautzentrum Friedrichshain - Dermatologie	Berlin
Germany	Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg	Halle (Saale)
Germany	Dermatologikum Hamburg	Hamburg
Germany	Universitaetsklinikum Schleswig-Holstein	Kiel
Germany	Velocity Clinical Research	Leipzig
Germany	Universitaetsklinikum Muenster	Muenster
Germany	KliFOs Klinische Forschung Osnabrueck	Osnabrueck
Germany	Hautarztpraxis Mortazawi	Remscheid
Germany	Helios Klinikum Wuppertal	Wuppertal
Japan	Osaka Habikino Medical Center	Habikino-shi	Osaka
Japan	Hamamatsu University Hospital	Hamamatsu-shi	Shizuoka
Japan	St Marianna University Hospital	Kawasaki-shi	Kanagawa
Japan	Kobe University Hospital	Kobe-shi	Hyogo
Japan	Miyata Dermatology Clinic	Matsudo-shi	Chiba
Japan	Mita Dermatology Clinic	Minato-ku	Tokyo
Japan	Nagasaki University Hospital	Nagasaki-shi	Nagasaki
Japan	International University of Health and Welfare Narita Hospital	Narita-shi	Chiba
Japan	National Hospital Organization Sagamihara National Hospital	Sagamihara-shi	Kanagawa
Japan	Dermatology and Ophthalmology Kume Clinic	Sakai-shi	Osaka
Japan	Showa University Hospital	Shinagawa-ku	Tokyo
Japan	Seibo International Catholic Hospital	Shinjuku-ku	Tokyo
Japan	Shirasaki Dermatology Clinic	Takaoka-shi	Toyama
Japan	Sugamo Kobayashi Derma Clinic	Toshima-ku	Tokyo
Japan	Showa University Northern Yokohama Hospital	Yokohama-shi	Kanagawa
Korea, Republic of	Korea University Ansan Hospital	Ansansi, Gyeonggido
Korea, Republic of	Soon Chun Hyang University Bucheon Hospital	Bucheon-si, Gyeonggi-do
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Chosun University Hospital	Gwangju
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	The Catholic University of Korea Incheon St Marys Hospital	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si, Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
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	Konkuk University Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	National Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic Univ of Korea Seoul St Marys Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon-si, Gyeonggi-do
Mexico	Scientia Investigacion Clinica Sc	Chihuahua
Mexico	Phylasis Clínicas Research S. De R. L. De C. V.	Cuautitlán Izcalli
Mexico	Clínica de Enfermedades Crónicas y de Procedimientos Especiales	Morelia	Michoacán
Poland	ClinicMed Daniluk Nowak Spolka komandytowa	Bialystok
Poland	Dermapolis Medical Dermatology Center dr n med Edyta Gebska	Chorzow
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Centermed krakow sp zoo	Krakow
Poland	Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne	Lodz
Poland	AppleTreeClinics Network Spzoo	Lodz
Poland	Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna	Lodz
Poland	Clinical Best Solutions Sp zoo Spolka Komandytowa	Lublin
Poland	Clinical Research Center Spzoo Medic-R Spolka Komandytowa	Poznan
Poland	Evimed sp zoo centrum medyczne evimed	Warszawa
Portugal	Hospital Garcia de Orta, EPE	Almada
Portugal	Centro Hospitalar e Universitario de Coimbra, EPE	Coimbra
Portugal	Hospital Cuf Descobertas	Lisboa
Portugal	Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao	Porto
Portugal	Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio	Porto
Romania	Spitalul Clinic Colentina	Bucharest
South Africa	Ryexo Clinical Research	Centurion	Gauteng
South Africa	Hiway Medical Centre	Durban
South Africa	About Allergy	Johannesburg	Gauteng
Spain	Hospital General Universitario de Alicante	Alicante	Comunidad Valenciana
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda
Spain	Hospital de Manises	Manises	Comunidad Valenciana
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Virgen Macarena	Sevilla	Andalucía
Spain	Hospital Arnau de Vilanova de Valencia	Valencia	Comunidad Valenciana
Sweden	Karolinska Universitetssjukhuset Solna	Stockholm
Turkey	Hacettepe Universitesi Tip Fakultesi Hastanesi	Ankara
Turkey	Gaziantep Universitesi Tip Fakultesi Hastanesi	Gaziantep
Turkey	Bezmialem Vakif Universitesi Hastanesi	Istanbul
Turkey	Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi	Izmir
Turkey	Erciyes Universitesi Tip Fakultesi Hastanesi	Kayseri
Turkey	Kocaeli Universitesi Tip Fakultesi Hastanesi	Kocaeli
Turkey	Sakarya Egitim ve Arastirma Hastanesi	Sakarya
United Kingdom	Lakeside Healthcare	Corby
United Kingdom	Guys Hospital	London
United Kingdom	Southampton General Hospital	Southampton
United States	Bellaire Dermatology Associates	Bellaire	Texas
United States	MetroBoston Clinical Partners	Brighton	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Renaissance Research and Medical Group	Cape Coral	Florida
United States	Clarity Dermatology	Castle Rock	Colorado
United States	US Dermatology Partners Cedar Park	Cedar Park	Texas
United States	Velocity Clinical Research Chula Vista	Chula Vista	California
United States	Bernstein Clinical Research Center LLC	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Driven Research LLC	Coral Gables	Florida
United States	Alina Clinical Trials, LLC	Dallas	Texas
United States	Zenos Clinical Research, LLC	Dallas	Texas
United States	Velocity Clinical Research - Denver	Denver	Colorado
United States	Saint Jude Clinical Research	Doral	Florida
United States	West Coast Research LLC	Dublin	California
United States	Duke South Durham	Durham	North Carolina
United States	California Dermatology and Clinical Research Institute	Encinitas	California
United States	Wendy Sadoff MD Dermatology PC	Farmington Hills	Michigan
United States	Clinical Trials Institute of Northwest Arkansas	Fayetteville	Arkansas
United States	Center for Dermatology Clinical Research Inc	Fremont	California
United States	The Ohio State University Dermatology East	Gahanna	Ohio
United States	Velocity Clinical Research - Grants Pass	Grants Pass	Oregon
United States	Direct Helpers Research Center	Hialeah	Florida
United States	Corning Center For Clinical Research	Horseheads	New York
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	MedCare Pharma - Houston	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Forest Hills Dermatology Group	Kew Gardens	New York
United States	Velocity Clinical Research - San Diego	La Mesa	California
United States	FMCScience LLC	Lampasas	Texas
United States	James Del Rosso Dermatology Research	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Epic Clinical Research Incorporated	Lewisville	Texas
United States	Research Solutions of Arizona, PC	Litchfield Park	Arizona
United States	DS Research	Louisville	Kentucky
United States	Glick Skin Institute	Margate	Florida
United States	Miami Dade Medical Research Institute, LLC	Miami	Florida
United States	Sienna Dermatology Research	Missouri City	Texas
United States	Crystal Run Healthcare	Monroe	New York
United States	Kentucky Advanced Medical Research LLC	Murray	Kentucky
United States	University of Utah MidValley Dermatology	Murray	Utah
United States	Ace Clinical Trials	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	OptiSkin Medical	New York	New York
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Sneeze, Wheeze, and Itch Associates, LLC	Normal	Illinois
United States	Velocity Clinical Research - North Hollywood	North Hollywood	California
United States	Advanced Dermatology of the Midlands	Omaha	Nebraska
United States	Dermatology and Skin Cancer Center of Overland Park	Overland Park	Kansas
United States	Cura Clinical Research	Palmdale	California
United States	Innovation Medical Research Center Inc	Palmetto Bay	Florida
United States	Oregon Medical Research Center	Portland	Oregon
United States	Skin Cancer and Dermatology Institute	Reno	Nevada
United States	Weiss Medical	Riverdale	New Jersey
United States	Andante Research	San Antonio	Texas
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	University of California at San Francisco, Dermatology Clinic at Mount Zion	San Francisco	California
United States	Advanced Medical Research PC	Sandy Springs	Georgia
United States	Clinical Science Institute	Santa Monica	California
United States	Center for Dermatology and Plastic Surgery	Scottsdale	Arizona
United States	The South Bend Clinic LLP	South Bend	Indiana
United States	MultiCare Institute for Research and Innovation	Spokane	Washington
United States	University of South Florida Health Morsani Center for Advanced Healthcare	Tampa	Florida
United States	Revival Research Institute LLC	Troy	Michigan
United States	Somerset Skin Centre	Troy	Michigan
United States	Asthma and Allergy Physicians of Rhode Island Clinical Research Institute	Warwick	Rhode Island
United States	Foxhall Research Center	Washington	District of Columbia
United States	Options Research Group LLC	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Czechia,  Denmark,  Estonia,  Finland,  Germany,  Japan,  Korea, Republic of,  Mexico,  Poland,  Portugal,  Romania,  South Africa,  Spain,  Sweden,  Turkey,  United Kingdom, 

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 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 Participants 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 = 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 to Week 24
Secondary	Achievement of 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 and Week 24
Secondary	Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline		Baseline and Week 24
Secondary	Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline		Baseline and Week 24
Secondary	Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16		Baseline and Week 16
Secondary	Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24		Baseline and Week 24
Secondary	Change from Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16		Baseline and Week 16
Secondary	Change From Baseline in SCORAD Itch VAS Score at Week 24		Baseline and 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		Baseline and Week 24
Secondary	Change From Baseline in DLQI Score at Week 24		Baseline and 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 and Week 24
Secondary	Achievement of = 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 to Week 16
Secondary	Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24		Baseline to 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 = 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 to Week 24
Secondary	Achievement of = 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 to Week 16
Secondary	Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24		Baseline to Week 24
Secondary	Achievement of 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	Achievement of 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-anxiety Subscale Score at Week 24		Baseline and Week 24
Secondary	Change From Baseline in HADS-depression Subscale Score at Week 24		Baseline and 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 and Week 24

External Links

•   AmgenTrials clinical trials website