A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma
- Registration Number
- NCT06376045
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 428
- Participants must be between the ages of 18 and 75.
- 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, 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 ≥ 40% and ≤ 80% 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.
- Asthma exacerbation that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 30 days prior to the day 1 pre randomization visit.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Arm B: Dose 1 Rocatinlimab Rocatinlimab Participants will receive dose 1 rocatinlimab by SC injection during the blinded treatment period. Treatment Arm A: Placebo Placebo Participants will receive placebo by subcutaneous (SC) injection during the blinded treatment period. Treatment Arm C: Dose 2 Rocatinlimab Rocatinlimab Participants will receive dose 2 rocatinlimab by SC injection during the blinded treatment period. Treatment Arm D: Dose 3 Rocatinlimab Rocatinlimab Participants will receive dose 3 rocatinlimab by SC injection during the blinded treatment period.
- Primary Outcome Measures
Name Time Method Annualized Asthma Exacerbation Rate (AAER) During the Blinded Treatment Period Up to approximately two years
- Secondary Outcome Measures
Name Time Method Serum Rocatinlimab Concentrations Up to approximately two years Annualized Rate of CompEx Events Up to approximately two years Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period Up to approximately two years Change From Baseline in Pre-BD FEV1 Up to approximately two years Change From Baseline in Asthma Symptom Diary (ASD) Score Up to approximately two years Number of Participant Achieving ACQ-6 Response at Week 48 Up to approximately two years Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score Up to approximately two years Number of Participants Achieving AQLQ (S) Response at Week 48 Up to approximately two years Time to First CompEx Event Up to approximately two years Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48 Up to approximately two years Number of Participants with a CompEx Event During the Double Blinded Treatment Period Up to approximately two years Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1) Up to approximately two years Change From Baseline in ACQ-6 Up to approximately two years Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period Up to approximately two years Time to First Asthma Exacerbation Event Up to approximately two years Trough Concentration (Ctrough) of Rocatinlimab Up to approximately two years Number of Participants with Serious Adverse Events Up to approximately two years Number of Participants with Anti-rocatinlimab Antibody Formation Up to approximately two years Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels Up to approximately two years Number of Participants with Treatment-emergent Adverse Events Up to approximately two years
Trial Locations
- Locations (150)
Centro de Investigacion del Maule
🇨🇱Talca, Chile
Erzsebet Gondozohaz
🇭🇺Godollo, Hungary
Klimed Marek Klimkiewicz
🇵🇱Bialystok, Poland
GynCentrum Sp zoo NZOZ Holsamed
🇵🇱Katowice, Poland
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
Edelenyi Koch Robert Korhaz es Rendelointezet
🇭🇺Edeleny, Hungary
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
Cemer Centro Medico de Enfermedades Respiratorias
🇦🇷Florida, Vicente Lopez, Argentina
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
Ierim Instituto de Enfermedades Respiratorias e Investigacion Clinica
🇦🇷Florencio Varela, Buenos Aires, Argentina
Fundacion Enfisema para el Estudio y Tratamiento de las Enfermedades Cronicas del Aparato Respirador
🇦🇷Mar Del Plata, Buenos Aires, Argentina
InAER - Investigaciones en Alergia y Enfermedades Respiratorias
🇦🇷Caba, Distrito Federal, Argentina
Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion medica
🇦🇷Rosario, Santa Fe, Argentina
Centro Integral de Medicina Respiratoria
🇦🇷San Miguel de Tucuman, Tucuman, 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
🇧🇬Ruse, Bulgaria
Medical Center Excelsior OOD
🇧🇬Sofia, Bulgaria
Diagnostic-Consultative Center Convex EOOD
🇧🇬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
Dynamic Drug Advancement Limited
🇨🇦Ajax, Ontario, Canada
Kanata Allergy Clinic
🇨🇦Ottawa, Ontario, Canada
Centro de Investigacion Curico
🇨🇱Curico, Chile
Centro De Investigaciones Medicas Respiratorias
🇨🇱Santiago, Chile
Sociedad Medica SyG Limitada
🇨🇱Santiago, Chile
Icegclinic
🇨🇱Santiago, 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 City, 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, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, 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
🇨🇴Ibague, Tolima, Colombia
MUDr I Cierna Peterova sro
🇨🇿Brandys nad Labem - Stara Boleslav, Czechia
Meditrial sro
🇨🇿Jindrichuv Hradec, Czechia
MUDr Josef Veverka
🇨🇿Rokycany, Czechia
Kasmed sro
🇨🇿Tabor, 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
Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft
🇭🇺Puspokladany, Hungary
Allergo-Fot Kft
🇭🇺Szazhalombatta, 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-shi, Hokkaido, Japan
Sakaide City Hospital
🇯🇵Sakaide-shi, Kagawa, Japan
Kamei Internal medicine and Respiratory Clinic
🇯🇵Takamatsu-shi, Kagawa, Japan
Kagoshima University Hospital
🇯🇵Kagoshima-shi, Kagoshima, Japan
Yokohama City Minato Red Cross Hospital
🇯🇵Yokohama-shi, Kanagawa, Japan
Yokohama City University Hospital
🇯🇵Yokohama-shi, 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
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Eunpyeong St Marys Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St Marys Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Icaro Investigaciones en Medicina
🇲🇽Chihuahua, Mexico
Unidad de Investigacion cima
🇲🇽Chihuahua, Mexico
Centrum Medycyny Oddechowej Mroz Spolka Jawna
🇵🇱Bialystok, 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 Swietokrzyski, 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
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, 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
🇹🇭Songkla, Thailand
Lakeside Healthcare
🇬🇧Corby, United Kingdom
CPS Research
🇬🇧Glasgow, United Kingdom
Glasgow Royal Infirmary
🇬🇧Glasgow, United Kingdom
4 Medical Clinical Solutions
🇬🇧Manchester, United Kingdom