Clinical trial NCT06376045: A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Asthma
Keywords: Moderate to severe asthma
Rocatinlimab
AMG 451
KHK4083
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-04-19
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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 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:

* 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.

Primary outcomes:
measure: Annualized Asthma Exacerbation Rate (AAER) During the Blinded Treatment Period
timeFrame: Up to approximately two years
Secondary outcomes:
measure: Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Up to approximately two years
measure: Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period
timeFrame: Up to approximately two years
measure: Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48
timeFrame: Up to approximately two years
measure: Change From Baseline in Pre-BD FEV1
timeFrame: Up to approximately two years
measure: Change From Baseline in Asthma Symptom Diary (ASD) Score
timeFrame: Up to approximately two years
measure: Number of Participant Achieving ACQ-6 Response at Week 48
timeFrame: Up to approximately two years
measure: Change From Baseline in ACQ-6
timeFrame: Up to approximately two years
measure: Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score
timeFrame: Up to approximately two years
measure: Number of Participants Achieving AQLQ (S) Response at Week 48
timeFrame: Up to approximately two years
measure: Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period
timeFrame: Up to approximately two years
measure: Time to First Asthma Exacerbation Event
timeFrame: Up to approximately two years
measure: Time to First CompEx Event
timeFrame: Up to approximately two years
measure: Number of Participants with a CompEx Event During the Double Blinded Treatment Period
timeFrame: Up to approximately two years
measure: Annualized Rate of CompEx Events
timeFrame: Up to approximately two years
measure: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels
timeFrame: Up to approximately two years
measure: Serum Rocatinlimab Concentrations
timeFrame: Up to approximately two years
measure: Trough Concentration (Ctrough) of Rocatinlimab
timeFrame: Up to approximately two years
measure: Number of Participants with Treatment-emergent Adverse Events
timeFrame: Up to approximately two years
measure: Number of Participants with Serious Adverse Events
timeFrame: Up to approximately two years
measure: Number of Participants with Anti-rocatinlimab Antibody Formation
timeFrame: Up to approximately two years
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Kern Research Inc
state: California
city: La Jolla
country: United States
facility: Orso Health Inc
state: California
city: La Palma
country: United States
facility: Imax Clinical Trials
state: California
city: Lancaster
country: United States
facility: Antelope Valley Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Downtown Los Angeles Research Center, Inc
state: California
city: Newport Beach
country: United States
facility: NewportNativeMD, Inc
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: San Diego
country: United States
facility: Apex Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Allergy and Asthma Clinical Research
state: California
city: Westminster
country: United States
facility: Allianz Research Institute Westminster
state: California
city: Clearwater
country: United States
facility: St Francis Medical Institute
state: Florida
city: Miami
country: United States
facility: BioMed Research Institute
state: Florida
city: Miami
country: United States
facility: Bright Research Center LLC
state: Florida
city: Tamarac
country: United States
facility: Infinity Life Research Group
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida Inc
state: Florida
city: Columbus
country: United States
facility: AllerVie Clinical Research- Columbus
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Normal
country: United States
facility: Sneeze, Wheeze, and Itch Associates, LLC
state: Illinois
city: Louisville
country: United States
facility: Family Allergy and Asthma Research Institute
state: Kentucky
city: White Marsh
country: United States
facility: Chesapeake Clinical Research Inc
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan, plc
state: Michigan
city: Saint Charles
country: United States
facility: Midwest Chest Consultants, PC
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Lincoln
country: United States
facility: Somnos Clinical Research
state: Nebraska
city: Union City
country: United States
facility: Hudson County Clinical Trials Research Center
state: New Jersey
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Durham
country: United States
facility: Duke Asthma Research Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center LLC
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research
state: Oklahoma
city: Medford
country: United States
facility: Velocity Clinical Research Medford
state: Oregon
city: DuBois
country: United States
facility: Clinical Research Associates of Central Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Knoxville
country: United States
facility: The Allergy Asthma and Sinus Center
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Medical Specialists
state: Texas
city: Boerne
country: United States
facility: TTS Research
state: Texas
city: Carrollton
country: United States
facility: TEN20 Clinical Research
state: Texas
city: Dallas
country: United States
facility: Alina Clinical Trials, LLC
state: Texas
city: Dallas
country: United States
facility: Southwest Family Medicine Associates
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Kerrville
country: United States
facility: Sante Clinical Research
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center
state: Texas
city: Plano
country: United States
facility: Ace Proactive
state: Texas
city: San Antonio
country: United States
facility: South Texas Allergy and Asthma Medical Professionals
state: Texas
city: San Antonio
country: United States
facility: Bandera Family Health Care
state: Texas
city: Sugar Land
country: United States
facility: Pioneer Research Solutions Inc
state: Texas
city: Caba
country: Argentina
facility: Fundacion Respirar - Centro Medico Dra De Salvo
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro de Osteopatias Medicas
state: Buenos Aires
city: Florencio Varela
country: Argentina
facility: Ierim Instituto de Enfermedades Respiratorias e Investigacion Clinica
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Fundacion Enfisema para el Estudio y Tratamiento de las Enfermedades Cronicas del Aparato Respirador
state: Buenos Aires
city: Caba
country: Argentina
facility: InAER - Investigaciones en Alergia y Enfermedades Respiratorias
state: Distrito Federal
city: Rosario
country: Argentina
facility: Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion medica
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Centro Integral de Medicina Respiratoria
state: Tucuman
city: Florida, Vicente Lopez
country: Argentina
facility: Cemer Centro Medico de Enfermedades Respiratorias
city: Mendoza
country: Argentina
facility: Instituto Medico Insares SA
city: Mendoza
country: Argentina
facility: Fundacion Scherbovsky
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Haskovo
country: Bulgaria
facility: Medical Center Pulmo - 2018 EOOD
city: Ruse
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior OOD
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center Convex EOOD
city: Stara Zagora
country: Bulgaria
facility: Medical Center New Rehabilitation Center EOOD
city: Calgary
country: Canada
facility: University of Calgary - Cumming School of Medicine
state: Alberta
city: Vancouver
country: Canada
facility: Centre for Lung Health
state: British Columbia
city: Vancouver
country: Canada
facility: St Pauls Hospital Pacific Lung Health Centre
state: British Columbia
city: Ajax
country: Canada
facility: Dynamic Drug Advancement Limited
state: Ontario
city: Ottawa
country: Canada
facility: Kanata Allergy Clinic
state: Ontario
city: Curico
country: Chile
facility: Centro de Investigacion Curico
city: Santiago
country: Chile
facility: Sociedad Medica SyG Limitada
city: Santiago
country: Chile
facility: Centro De Investigaciones Medicas Respiratorias
city: Santiago
country: Chile
facility: Icegclinic
city: Talca
country: Chile
facility: Centro de Investigacion del Maule
city: Hefei
country: China
facility: Hefei First Peoples Hospital
state: Anhui
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Huizhou
country: China
facility: The Third Peoples Hospital of Huizhou
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Changsha
country: China
facility: Changsha Central Hospital
state: Hunan
city: Hengyang City
country: China
facility: The Second Hospital University of South China
state: Hunan
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Ganzhou
country: China
facility: The First Affiliated Hospital of Gannan Medical University
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial Peoples Hospital
state: Jiangxi
city: Pingxiang
country: China
facility: Pingxiang Peoples Hospital
state: Jiangxi
city: Heze
country: China
facility: Heze Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Huadong Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
state: Zhejiang
city: Bogota
country: Colombia
facility: Corporacion Hospitalaria Juan Ciudad, Mederi
state: Cundinamarca
city: Bogota
country: Colombia
facility: Solano y Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia Uniendo
state: Cundinamarca
city: Ibague
country: Colombia
facility: Mediservis del Tolima IPS SAS
state: Tolima
city: Brandys nad Labem - Stara Boleslav
country: Czechia
facility: MUDr I Cierna Peterova sro
city: Jindrichuv Hradec
country: Czechia
facility: Meditrial sro
city: Rokycany
country: Czechia
facility: MUDr Josef Veverka
city: Tabor
country: Czechia
facility: Kasmed sro
city: Hong Kong
country: Hong Kong
facility: Hong Kong Center for Clinical Research
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, The University of Hong Kong
city: Shatin, New Territories
country: Hong Kong
facility: Prince of Wales Hospital, Chinese University of Hong Kong
city: Edeleny
country: Hungary
facility: Edelenyi Koch Robert Korhaz es Rendelointezet
city: Godollo
country: Hungary
facility: Erzsebet Gondozohaz
city: Puspokladany
country: Hungary
facility: Puspokladanyi Egeszsegugyi Szolgaltato Intezmeny
city: Szazhalombatta
country: Hungary
facility: Allergo-Fot Kft
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Mizunami-shi
country: Japan
facility: Medical corporation Syureikai Tohno Chuo Clinic
state: Gifu
city: Sapporo-shi
country: Japan
facility: Idaimae Minami Yojo Naika Clinic
state: Hokkaido
city: Sakaide-shi
country: Japan
facility: Sakaide City Hospital
state: Kagawa
city: Takamatsu-shi
country: Japan
facility: Kamei Internal medicine and Respiratory Clinic
state: Kagawa
city: Kagoshima-shi
country: Japan
facility: Kagoshima University Hospital
state: Kagoshima
city: Yokohama-shi
country: Japan
facility: Yokohama City Minato Red Cross Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Nankoku-shi
country: Japan
facility: Kochi Medical School Hospital
state: Kochi
city: Toyonaka-shi
country: Japan
facility: National Hospital Organization Osaka Toneyama Medical Center
state: Osaka
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai
state: Tokyo
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Eunpyeong St Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Chihuahua
country: Mexico
facility: Icaro Investigaciones en Medicina
city: Chihuahua
country: Mexico
facility: Unidad de Investigacion cima
city: Bialystok
country: Poland
facility: Centrum Medycyny Oddechowej Mroz Spolka Jawna
city: Bialystok
country: Poland
facility: Klimed Marek Klimkiewicz
city: Katowice
country: Poland
facility: GynCentrum Sp zoo NZOZ Holsamed
city: Krakow
country: Poland
facility: Centrum Medyczne All-Med Badania kliniczne
city: Krakow
country: Poland
facility: Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center
city: Ostrowiec Swietokrzyski
country: Poland
facility: Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olech-Cudzik Krzysztof Cudzik
city: Poznan
country: Poland
facility: Ewa Springer Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska
city: Bacau
country: Romania
facility: Spitalul de Pneumoftiziologie Bacau
city: Cluj-Napoca
country: Romania
facility: Spitalul de Pneumoftiziologie Leon Daniello
city: Craiova
country: Romania
facility: Spitalul Clinic de Boli Infecțioase si Pneumoftiziologie Victor Babes Craiova
city: Deva
country: Romania
facility: Medical Center
city: Suceava
country: Romania
facility: Spitalul Judetean de Urgenta Sf Ioan cel Nou Suceava
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Veterans General Hospital - Taichung
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Songkla
country: Thailand
facility: Songklanagarind Hospital
city: Corby
country: United Kingdom
facility: Lakeside Healthcare
city: Glasgow
country: United Kingdom
facility: CPS Research
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: Manchester
country: United Kingdom
facility: 4 Medical Clinical Solutions
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: