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ACTIVE NOT RECRUITING
NCT06376045
PHASE2

A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

317

Start Date

2024-05-24

Completion Date

2026-12-11

Last Updated

2025-12-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

Rocatinlimab

Rocatinlimab will be administered by SC injection.

DRUG

Placebo

Placebo will be administered by SC injection.

Locations (154)

Kern Research Inc

Bakersfield, California, United States

Orso Health Inc

La Jolla, California, United States

Imax Clinical Trials

La Palma, California, United States

Antelope Valley Clinical Trials

Lancaster, California, United States

Downtown Los Angeles Research Center, Inc

Los Angeles, California, United States

NewportNativeMD, Inc

Newport Beach, California, United States

University of California Irvine

Orange, California, United States

Apex Clinical Research

San Diego, California, United States

Allergy and Asthma Clinical Research

Walnut Creek, California, United States

Allianz Research Institute Westminster

Westminster, California, United States

St Francis Medical Institute

Clearwater, Florida, United States

BioMed Research Institute

Miami, Florida, United States

Bright Research Center LLC

Miami, Florida, United States

Infinity Life Research Group

Tamarac, Florida, United States

Clinical Research Trials of Florida Inc

Tampa, Florida, United States

AllerVie Clinical Research- Columbus

Columbus, Georgia, United States

Treasure Valley Medical Research

Boise, Idaho, United States

Sneeze, Wheeze, and Itch Associates, LLC

Normal, Illinois, United States

Family Allergy and Asthma Research Institute

Louisville, Kentucky, United States

Chesapeake Clinical Research Inc

White Marsh, Maryland, United States

Henry Ford Health System

Detroit, Michigan, United States

Respiratory Medicine Research Institute of Michigan, plc

Ypsilanti, Michigan, United States

Midwest Chest Consultants, PC

Saint Charles, Missouri, United States

Montana Medical Research

Missoula, Montana, United States

Somnos Clinical Research

Lincoln, Nebraska, United States

Hudson County Clinical Trials Research Center

Union City, New Jersey, United States

Northwell Health

New Hyde Park, New York, United States

Duke Asthma Research Center

Durham, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Bernstein Clinical Research Center LLC

Cincinnati, Ohio, United States

OK Clinical Research

Edmond, Oklahoma, United States

Velocity Clinical Research Medford

Medford, Oregon, United States

Clinical Research Associates of Central Pennsylvania

DuBois, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

The Allergy Asthma and Sinus Center

Knoxville, Tennessee, United States

Amarillo Medical Specialists

Amarillo, Texas, United States

TTS Research

Boerne, Texas, United States

TEN20 Clinical Research

Carrollton, Texas, United States

Alina Clinical Trials, LLC

Dallas, Texas, United States

Southwest Family Medicine Associates

Dallas, Texas, United States

University of Texas Medical Branch

Galveston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Sante Clinical Research

Kerrville, Texas, United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas, United States

Ace Proactive

Plano, Texas, United States

South Texas Allergy and Asthma Medical Professionals

San Antonio, Texas, United States

Bandera Family Health Care

San Antonio, Texas, United States

Pioneer Research Solutions Inc

Sugar Land, Texas, United States

Fundacion Respirar - Centro Medico Dra De Salvo

CABA, Buenos Aires, Argentina

Centro de Osteopatias Medicas

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Fundacion Enfisema para el Estudio y Tratamiento de las Enfermedades Cronicas del Aparato Respirador

Mar del Plata, Buenos Aires, Argentina

Ierim Instituto de Enfermedades Respiratorias e Investigacion Clinica

San Juan Bautista, Buenos Aires, Argentina

InAER - Investigaciones en Alergia y Enfermedades Respiratorias

Buenos Aires, Distrito Federal, Argentina

Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion medica

Rosario, Santa Fe Province, Argentina

Centro Integral de Medicina Respiratoria

San Miguel de Tucumán, Tucumán Province, Argentina

Cemer Centro Medico de Enfermedades Respiratorias

Florida, Vicente Lopez, Argentina

Instituto Medico Insares SA

Mendoza, Argentina

Fundacion Scherbovsky

Mendoza, Argentina

Westmead Hospital

Westmead, New South Wales, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Medical Center Pulmo - 2018 EOOD

Haskovo, Bulgaria

Specialized Hospital for Active Treatment of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov

Rousse, Bulgaria

Medical Center Excelsior OOD

Sofia, Bulgaria

Diagnostic-Consultative Center Convex OOD

Sofia, Bulgaria

Medical Center New Rehabilitation Center EOOD

Stara Zagora, Bulgaria

University of Calgary - Cumming School of Medicine

Calgary, Alberta, Canada

Centre for Lung Health

Vancouver, British Columbia, Canada

St Pauls Hospital Pacific Lung Health Centre

Vancouver, British Columbia, Canada

Dynamic Drug Advancement Limited

Ajax, Ontario, Canada

Kanata Allergy Clinic

Ottawa, Ontario, Canada

Centro de Investigacion Curico

Curicó, Chile

Sociedad Medica SyG Limitada

Santiago, Chile

Centro De Investigaciones Medicas Respiratorias

Santiago, Chile

Icegclinic

Santiago, Chile

Centro de Investigacion del Maule

Talca, Chile

Hefei First Peoples Hospital

Hefei, Anhui, China

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The Third Peoples Hospital of Huizhou

Huizhou, Guangdong, China

Hainan General Hospital

Haikou, Hainan, China

Changsha Central Hospital

Changsha, Hunan, China

The Second Hospital University of South China

Hengyang, Hunan, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

The First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

Jiangxi Provincial Peoples Hospital

Nanchang, Jiangxi, China

Pingxiang Peoples Hospital

Pingxiang, Jiangxi, China

Heze Municipal Hospital

Heze, Shandong, China

Huadong Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China

Corporacion Hospitalaria Juan Ciudad, Mederi

Bogota, Cundinamarca, Colombia

Solano y Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia Uniendo

Bogota, Cundinamarca, Colombia

Mediservis del Tolima IPS SAS

Ibagué, Tolima Department, Colombia

MUDr I Cierna Peterova sro

Brandýs nad Labem-Stará Boleslav, Czechia

Meditrial sro

Jindřichův Hradec, Czechia

MUDr Josef Veverka

Rokycany, Czechia

Kasmed sro

Tábor, Czechia

Hong Kong Center for Clinical Research

Hong Kong, Hong Kong

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Edelenyi Koch Robert Korhaz es Rendelointezet

Edelény, Hungary

Erzsebet Gondozohaz

Gödöllő, Hungary

Puspokladanyi Egeszsegugyi Szolgaltato Intezmeny

Püspökladány, Hungary

Allergo-Fot Kft

Százhalombatta, Hungary

University of Fukui Hospital

Yoshida-gun, Fukui, Japan

Medical corporation Syureikai Tohno Chuo Clinic

Mizunami-shi, Gifu, Japan

Idaimae Minami Yojo Naika Clinic

Sapporo, Hokkaido, Japan

Sakaide City Hospital

Sakaide-shi, Kagawa-ken, Japan

Kamei Internal medicine and Respiratory Clinic

Takamatsu, Kagawa-ken, Japan

Kagoshima University Hospital

Kagoshima, Kagoshima-ken, Japan

Yokohama City Minato Red Cross Hospital

Yokohama, Kanagawa, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Kochi Medical School Hospital

Nankoku-shi, Kochi, Japan

National Hospital Organization Osaka Toneyama Medical Center

Toyonaka-shi, Osaka, Japan

Teikyo University Hospital

Itabashi-ku, Tokyo, Japan

Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai

Shinagawa-ku, Tokyo, Japan

Centro de investigacion medico biologica y terapia avanzada

Guadalajara, Jalisco, Mexico

cicum San Miguel

Guadalaja, Jalisco, Mexico

Icaro Investigaciones en Medicina

Chihuahua City, Mexico

Unidad de Investigacion cima

Chihuahua City, Mexico

Centrum Medycyny Oddechowej Mroz Spolka Jawna

Bialystok, Poland

Klimed Marek Klimkiewicz

Bychawa, Poland

GynCentrum Sp zoo NZOZ Holsamed

Katowice, Poland

Centrum Medyczne All-Med Badania kliniczne

Krakow, Poland

Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center

Krakow, Poland

Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olech-Cudzik Krzysztof Cudzik

Ostrowiec Świętokrzyski, Poland

Ewa Springer Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej

Poznan, Poland

Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska

Wroclaw, Poland

Spitalul de Pneumoftiziologie Bacau

Bacau, Romania

Spitalul de Pneumoftiziologie Leon Daniello

Cluj-Napoca, Romania

Spitalul Clinic de Boli Infecțioase si Pneumoftiziologie Victor Babes Craiova

Craiova, Romania

Medical Center

Deva, Romania

Spitalul Judetean de Urgenta Sf Ioan cel Nou Suceava

Suceava, Romania

Yeungnam University Medical Center

Daegu, South Korea

Seoul National University Hospital

Seoul, South Korea

The Catholic University of Korea Eunpyeong St Marys Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Konkuk University Medical Center

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Veterans General Hospital - Taichung

Taichung, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Siriraj Hospital

Bangkok, Thailand

Songklanagarind Hospital

Songkhla, Thailand

Lakeside Healthcare

Corby, United Kingdom

CPS Research

Glasgow, United Kingdom

Glasgow Royal Infirmary

Glasgow, United Kingdom

4 Medical Clinical Solutions

Manchester, United Kingdom

John Radcliffe Hospital

Oxford, United Kingdom