A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon) (ROCKET-Horizon)
Atopic Dermatitis
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, AMG 451, KHK 4083, Eczema, Rocatinlimab
Eligibility Criteria
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 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 inhibitors Other topical immunosuppressive agents Phototherapy
Sites / Locations
- Research Solutions of Arizona, PCRecruiting
- Center for Dermatology and Plastic SurgeryRecruiting
- Clinical Trials Institute of Northwest ArkansasRecruiting
- Burke Pharmaceutical ResearchRecruiting
- Velocity Clinical Research Chula VistaRecruiting
- West Coast Research LLCRecruiting
- California Dermatology and Clinical Research InstituteRecruiting
- Center for Dermatology Clinical Research IncRecruiting
- Velocity Clinical Research - San DiegoRecruiting
- Velocity Clinical Research - North HollywoodRecruiting
- Cura Clinical ResearchRecruiting
- University of California at San Francisco, Dermatology Clinic at Mount ZionRecruiting
- Clinical Science InstituteRecruiting
- Clarity DermatologyRecruiting
- Velocity Clinical Research - DenverRecruiting
- Foxhall Research CenterRecruiting
- Renaissance Research and Medical GroupRecruiting
- Driven Research LLCRecruiting
- Saint Jude Clinical ResearchRecruiting
- Direct Helpers Research CenterRecruiting
- Glick Skin InstituteRecruiting
- Miami Dade Medical Research Institute, LLCRecruiting
- Innovation Medical Research Center IncRecruiting
- University of South Florida Health Morsani Center for Advanced HealthcareRecruiting
- Advanced Medical Research PCRecruiting
- Sneeze, Wheeze, and Itch Associates, LLCRecruiting
- The South Bend Clinic LLPRecruiting
- Options Research Group LLCRecruiting
- Dermatology and Skin Cancer Center of Overland ParkRecruiting
- DS ResearchRecruiting
- Kentucky Advanced Medical Research LLCRecruiting
- MetroBoston Clinical PartnersRecruiting
- Wendy Sadoff MD Dermatology PCRecruiting
- Revival Research Institute LLCRecruiting
- Somerset Skin CentreRecruiting
- Advanced Dermatology of the MidlandsRecruiting
- James Del Rosso Dermatology ResearchRecruiting
- Skin Cancer and Dermatology InstituteRecruiting
- Weiss MedicalRecruiting
- Montefiore Medical CenterRecruiting
- Corning Center For Clinical Research
- Forest Hills Dermatology GroupRecruiting
- Crystal Run HealthcareRecruiting
- Ace Clinical TrialsRecruiting
- Icahn School of Medicine at Mount SinaiRecruiting
- OptiSkin MedicalRecruiting
- Duke South DurhamRecruiting
- University of CincinnatiRecruiting
- The Ohio State University Dermatology EastRecruiting
- Velocity Clinical Research - Grants PassRecruiting
- Oregon Medical Research CenterRecruiting
- Asthma and Allergy Physicians of Rhode Island Clinical Research InstituteRecruiting
- Bellaire Dermatology AssociatesRecruiting
- US Dermatology Partners Cedar ParkRecruiting
- Alina Clinical Trials, LLCRecruiting
- Zenos Clinical Research, LLCRecruiting
- The University of Texas Health Science Center at HoustonRecruiting
- FMCScience LLCRecruiting
- Epic Clinical Research IncorporatedRecruiting
- Texas Dermatology and Laser SpecialistsRecruiting
- Andante ResearchRecruiting
- Dermatology Clinical Research Center of San AntonioRecruiting
- University of Utah MidValley DermatologyRecruiting
- Eastern Virginia Medical SchoolRecruiting
- MultiCare Institute for Research and InnovationRecruiting
- St George Dermatology and Skin Cancer CentreRecruiting
- Premier SpecialistsRecruiting
- Box Hill HospitalRecruiting
- Skin Health InstituteRecruiting
- Sinclair DermatologyRecruiting
- The Alfred HospitalRecruiting
- The Royal Melbourne HospitalRecruiting
- Hopital ErasmeRecruiting
- Clinique Andre RenardRecruiting
- Dermatologie MaldegemRecruiting
- CETI - Centro de Estudo em Terapias InovadorasRecruiting
- Centro Multidisciplinar de Estudos Clinicos - CEMECRecruiting
- ISPEM - Instituto São José dos Campos em Pesquisas MédicasRecruiting
- Beacon DermatologyRecruiting
- Doctor Chih-Ho Hong Medical IncorporatedRecruiting
- Kingsway Clinical ResearchRecruiting
- Lynderm Research IncRecruiting
- The Centre for Clinical Trials IncRecruiting
- SKiN Centre for DermatologyRecruiting
- The Centre for DermatologyRecruiting
- Research TorontoRecruiting
- XLR8 Medical Research, IncorporatedRecruiting
- Clinique Dermatologique de SherbrookeRecruiting
- Centre de Recherche Dermatologique du Quebec MetropolitainRecruiting
- Kozni ambulance Kutna Hora sroRecruiting
- Nemocnice Novy Jicin asRecruiting
- CCR Czech asRecruiting
- Fakultni nemocnice PlzenRecruiting
- CCR Prague sroRecruiting
- Praglandia sroRecruiting
- Kozni ambulance Fialova sroRecruiting
- Dermamedest sroRecruiting
- Dermatologicka ambulance MUDr Petr TrestikRecruiting
- Gentofte HospitalRecruiting
- Odense University HospitalRecruiting
- North Estonia Medical CentreRecruiting
- Clinical Research CentreRecruiting
- Terveystalo TampereRecruiting
- Fachklinik Bad BentheimRecruiting
- Hautzentrum Friedrichshain - DermatologieRecruiting
- Clinical Research Services Berlin GmbHRecruiting
- Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-WittenbergRecruiting
- Dermatologikum HamburgRecruiting
- Universitaetsklinikum Schleswig-HolsteinRecruiting
- Velocity Clinical ResearchRecruiting
- Universitätsklinikum MuensterRecruiting
- KliFOs Klinische Forschung OsnabrueckRecruiting
- Hautarztpraxis MortazawiRecruiting
- Helios Klinikum WuppertalRecruiting
- Miyata Dermatology ClinicRecruiting
- International University of Health and Welfare Narita HospitalRecruiting
- Kobe University HospitalRecruiting
- St Marianna University HospitalRecruiting
- National Hospital Organization Sagamihara National HospitalRecruiting
- Showa University Northern Yokohama HospitalRecruiting
- Nagasaki University HospitalRecruiting
- Osaka Habikino Medical CenterRecruiting
- Dermatology and Ophthalmology Kume ClinicRecruiting
- Hamamatsu University HospitalRecruiting
- Mita Dermatology ClinicRecruiting
- Showa University HospitalRecruiting
- Seibo International Catholic HospitalRecruiting
- Sugamo Kobayashi Derma ClinicRecruiting
- Shirasaki Dermatology ClinicRecruiting
- Korea University Ansan HospitalRecruiting
- Soon Chun Hyang University Bucheon HospitalRecruiting
- Pusan National University HospitalRecruiting
- Kyungpook National University HospitalRecruiting
- Chosun University HospitalRecruiting
- The Catholic University of Korea Incheon St Marys HospitalRecruiting
- Inha University HospitalRecruiting
- Seoul National University Bundang HospitalRecruiting
- Korea University Anam HospitalRecruiting
- Seoul National University HospitalRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- National Medical CenterRecruiting
- Konkuk University Medical CenterRecruiting
- Kyung Hee University Hospital at GangdongRecruiting
- Asan Medical CenterRecruiting
- The Catholic Univ of Korea Seoul St Marys HospitalRecruiting
- Chung-Ang University HospitalRecruiting
- Hallym University Kangnam Sacred Heart HospitalRecruiting
- Ewha Womans University Seoul HospitalRecruiting
- Ajou University HospitalRecruiting
- Clínica de Enfermedades Crónicas y de Procedimientos EspecialesRecruiting
- Scientia Investigacion Clinica ScRecruiting
- Phylasis Clínicas Research S. De R. L. De C. V.Recruiting
- AppleTreeClinics Network SpzooRecruiting
- Hospital Garcia de Orta, EPERecruiting
- Centro Hospitalar e Universitario de Coimbra, EPERecruiting
- Hospital Cuf DescobertasRecruiting
- Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo AntonioRecruiting
- Centro Hospitalar de Sao Joao EPE - Hospital de Sao JoaoRecruiting
- Spitalul Clinic ColentinaRecruiting
- Ryexo Clinical ResearchRecruiting
- About AllergyRecruiting
- Hiway Medical CentreRecruiting
- Hospital Universitario Virgen MacarenaRecruiting
- Hospital General Universitario de AlicanteRecruiting
- Hospital de ManisesRecruiting
- Hospital Arnau de Vilanova de ValenciaRecruiting
- Clinica Universidad de NavarraRecruiting
- Hospital Universitario Ramon y CajalRecruiting
- Hospital Universitario La PazRecruiting
- Hospital Universitario Puerta de Hierro MajadahondaRecruiting
- Karolinska Universitetssjukhuset SolnaRecruiting
- Hacettepe Universitesi Tip Fakultesi HastanesiRecruiting
- Gaziantep Universitesi Tip FakultesiRecruiting
- Bezmialem Vakıif Universitesi Tip FakultesiRecruiting
- Bakircay Universitesi Cigli Egitim ve Arastirma HastanesiRecruiting
- Erciyes Universitesi Tip FakultesiRecruiting
- Kocaeli Universitesi Tip FakultesiRecruiting
- Sakarya Universitesi Egitim ve Arastirma HastanesiRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Rocatinlimab
Placebo
Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Placebo Q4W for 24 weeks with a loading dose at Week 2.