A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma
NCT ID: NCT06376045
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
317 participants
INTERVENTIONAL
2024-05-24
2026-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment Arm A: Placebo
Participants will receive placebo by subcutaneous (SC) injection during the blinded treatment period.
Placebo
Placebo will be administered by SC injection.
Treatment Arm B: Dose 1 Rocatinlimab
Participants will receive dose 1 rocatinlimab by SC injection during the blinded treatment period.
Rocatinlimab
Rocatinlimab will be administered by SC injection.
Treatment Arm C: Dose 2 Rocatinlimab
Participants will receive dose 2 rocatinlimab by SC injection during the blinded treatment period.
Rocatinlimab
Rocatinlimab will be administered by SC injection.
Treatment Arm D: Dose 3 Rocatinlimab
Participants will receive dose 3 rocatinlimab by SC injection during the blinded treatment period.
Rocatinlimab
Rocatinlimab will be administered by SC injection.
Interventions
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Rocatinlimab
Rocatinlimab will be administered by SC injection.
Placebo
Placebo will be administered by SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Asthma diagnosed by a physician for ≥ 12 months prior to the screening visit.
* Existing therapy with medium-dose to high doses of inhaled corticosteroids (ICS) (defined as \> 250 µg fluticasone propionate or equivalent ICS) in combination with at least 1 additional controller medication (eg, LABA, leukotriene receptor antagonist \[LTRA\], LAMA, methylxanthine, oral corticosteroids up to a daily dose of 10 mg prednisone equivalent) for at least 90 days prior to the screening visit with a stable dose for at least 30 days prior to the screening visit.
* Documented history of ≥ 1 asthma exacerbation in the past year prior to the screening visit, with at least 1 exacerbation during treatment with medium-dose to high doses of ICS (\> 250 μg fluticasone propionate or equivalent ICS).
* Morning pre-BD FEV1 ≥ 35% and ≤ 90% of predicted normal at the screening visit and day 1 pre-randomization visits.
* ACQ-6 score ≥ 1.5 at the day 1 pre randomization visit.
Exclusion Criteria
* Any clinically important pulmonary disease other than asthma.
* Current smoker, including active vaping of any products and/or marijuana, or former smoker with cessation within 6 months of screening, or history of \> 10 pack-years.
* Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the screening period including known history of COVID-19 infection within 4 weeks prior to Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to screening; participants with COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
* Active chronic or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals which has not completely resolved, or for which therapy has not been completed, within 4 weeks before day 1 pre-randomization visit.
* Positive or indeterminate QuantiFERON GOLD from central laboratory at screening.
* Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent
* History of major immunologic reaction to any other biologic product or any excipient of rocatinlimab.
* Diagnosis of a helminth parasitic infection within 6 months prior to day 1 pre-randomization visit that had not been treated with or had failed to respond to standard of care therapy.
* Evidence of human immunodeficiency virus (HIV) infection or positive for HIV antibodies at screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.
* Active and non-virally suppressed hepatitis B infection at initial screening,
* Positive for hepatitis C virus (HCV) antibody at screening with confirmed positive HCV RNA.
18 Years
75 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20220093
Identifier Type: -
Identifier Source: org_study_id
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