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

NCT06376045 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20220093
• Study Type: interventional
• Target: 317
• Locations: 19 countries
• Sites: 154

Brief Summary

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

Conditions

Asthma

Keywords

Moderate to severe asthma; Rocatinlimab; AMG 451; KHK4083

Outcome Measures

Primary Outcomes (1)

• Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period

  Up to Week 48

Secondary Outcomes (20)

• Annualized Asthma Exacerbation Rate (AAER)

  Up to Week 48

• Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)

  Baseline and Week 48

• Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48

  Baseline and Week 48

• Change From Baseline in Pre-BD FEV1

  Up to 62 weeks

• Change From Baseline in Asthma Symptom Diary (ASD) Score

  Up to Week 48

Study Arms (4)

Treatment Arm A: Placebo

PLACEBO COMPARATOR

Participants will receive placebo by subcutaneous (SC) injection during the blinded treatment period.

Drug: Placebo

Treatment Arm B: Dose 1 Rocatinlimab

EXPERIMENTAL

Participants will receive dose 1 rocatinlimab by SC injection during the blinded treatment period.

Drug: Rocatinlimab

Treatment Arm C: Dose 2 Rocatinlimab

EXPERIMENTAL

Participants will receive dose 2 rocatinlimab by SC injection during the blinded treatment period.

Drug: Rocatinlimab

Treatment Arm D: Dose 3 Rocatinlimab

EXPERIMENTAL

Participants will receive dose 3 rocatinlimab by SC injection during the blinded treatment period.

Drug: Rocatinlimab

Interventions

Rocatinlimab DRUG

Rocatinlimab will be administered by SC injection.

Also known as: AMG 451

Treatment Arm B: Dose 1 Rocatinlimab; Treatment Arm C: Dose 2 Rocatinlimab; Treatment Arm D: Dose 3 Rocatinlimab

Placebo DRUG

Placebo will be administered by SC injection.

Treatment Arm A: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (154)

Kern Research Inc

Bakersfield, California, 93301, United States

Location

Orso Health Inc

La Jolla, California, 92037, United States

Location

Imax Clinical Trials

La Palma, California, 90623, United States

Location

Antelope Valley Clinical Trials

Lancaster, California, 93534, United States

Location

Downtown Los Angeles Research Center, Inc

Los Angeles, California, 90017, United States

Location

NewportNativeMD, Inc

Newport Beach, California, 92663, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

Apex Clinical Research

San Diego, California, 92120, United States

Location

Allergy and Asthma Clinical Research

Walnut Creek, California, 94598, United States

Location

Allianz Research Institute Westminster

Westminster, California, 92683, United States

Location

St Francis Medical Institute

Clearwater, Florida, 33765, United States

Location

BioMed Research Institute

Miami, Florida, 33126, United States

Location

Bright Research Center LLC

Miami, Florida, 33144, United States

Location

Infinity Life Research Group

Tamarac, Florida, 33321, United States

Location

Clinical Research Trials of Florida Inc

Tampa, Florida, 33607, United States

Location

AllerVie Clinical Research- Columbus

Columbus, Georgia, 31904, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Sneeze, Wheeze, and Itch Associates, LLC

Normal, Illinois, 61761, United States

Location

Family Allergy and Asthma Research Institute

Louisville, Kentucky, 40217, United States

Location

Chesapeake Clinical Research Inc

White Marsh, Maryland, 21162, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Respiratory Medicine Research Institute of Michigan, plc

Ypsilanti, Michigan, 48197, United States

Location

Midwest Chest Consultants, PC

Saint Charles, Missouri, 63301, United States

Location

Montana Medical Research

Missoula, Montana, 59808, United States

Location

Somnos Clinical Research

Lincoln, Nebraska, 68505, United States

Location

Hudson County Clinical Trials Research Center

Union City, New Jersey, 07087, United States

Location

Northwell Health

New Hyde Park, New York, 11042, United States

Location

Duke Asthma Research Center

Durham, North Carolina, 27705, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Bernstein Clinical Research Center LLC

Cincinnati, Ohio, 45236, United States

Location

OK Clinical Research

Edmond, Oklahoma, 73034, United States

Location

Velocity Clinical Research Medford

Medford, Oregon, 97504, United States

Location

Clinical Research Associates of Central Pennsylvania

DuBois, Pennsylvania, 15801, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

The Allergy Asthma and Sinus Center

Knoxville, Tennessee, 37909, United States

Location

Amarillo Medical Specialists

Amarillo, Texas, 79106, United States

Location

TTS Research

Boerne, Texas, 78006, United States

Location

TEN20 Clinical Research

Carrollton, Texas, 75010, United States

Location

Alina Clinical Trials, LLC

Dallas, Texas, 75225, United States

Location

Southwest Family Medicine Associates

Dallas, Texas, 75235, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0158, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Sante Clinical Research

Kerrville, Texas, 78028, United States

Location

Metroplex Pulmonary and Sleep Center

McKinney, Texas, 75069, United States

Location

Ace Proactive

Plano, Texas, 75093, United States

Location

South Texas Allergy and Asthma Medical Professionals

San Antonio, Texas, 78229, United States

Location

Bandera Family Health Care

San Antonio, Texas, 78249, United States

Location

Pioneer Research Solutions Inc

Sugar Land, Texas, 77479, United States

Location

Fundacion Respirar - Centro Medico Dra De Salvo

CABA, Buenos Aires, C1426ABP, Argentina

Location

Centro de Osteopatias Medicas

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF, Argentina

Location

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

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Ierim Instituto de Enfermedades Respiratorias e Investigacion Clinica

San Juan Bautista, Buenos Aires, 1888, Argentina

Location

InAER - Investigaciones en Alergia y Enfermedades Respiratorias

Buenos Aires, Distrito Federal, 1425, Argentina

Location

Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion medica

Rosario, Santa Fe Province, S2002OJN, Argentina

Location

Centro Integral de Medicina Respiratoria

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Cemer Centro Medico de Enfermedades Respiratorias

Florida, Vicente Lopez, B1602DQD, Argentina

Location

Instituto Medico Insares SA

Mendoza, 5500, Argentina

Location

Fundacion Scherbovsky

Mendoza, M5500AXR, Argentina

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3141, Australia

Location

Medical Center Pulmo - 2018 EOOD

Haskovo, 6300, Bulgaria

Location

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

Rousse, 7002, Bulgaria

Location

Medical Center Excelsior OOD

Sofia, 1407, Bulgaria

Location

Diagnostic-Consultative Center Convex OOD

Sofia, 1680, Bulgaria

Location

Medical Center New Rehabilitation Center EOOD

Stara Zagora, 6001, Bulgaria

Location

University of Calgary - Cumming School of Medicine

Calgary, Alberta, T2N 4Z6, Canada

Location

Centre for Lung Health

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St Pauls Hospital Pacific Lung Health Centre

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Dynamic Drug Advancement Limited

Ajax, Ontario, L1S 2J5, Canada

Location

Kanata Allergy Clinic

Ottawa, Ontario, K2T 0N7, Canada

Location

Centro de Investigacion Curico

Curicó, 3440000, Chile

Location

Sociedad Medica SyG Limitada

Santiago, 7501126, Chile

Location

Centro De Investigaciones Medicas Respiratorias

Santiago, 7750495, Chile

Location

Icegclinic

Santiago, 8241479, Chile

Location

Centro de Investigacion del Maule

Talca, 346000, Chile

Location

Hefei First Peoples Hospital

Hefei, Anhui, 230061, China

Location

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510150, China

Location

The Third Peoples Hospital of Huizhou

Huizhou, Guangdong, 516002, China

Location

Hainan General Hospital

Haikou, Hainan, 570311, China

Location

Changsha Central Hospital

Changsha, Hunan, 410004, China

Location

The Second Hospital University of South China

Hengyang, Hunan, 421001, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

Location

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

Location

The First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, 341000, China

Location

Jiangxi Provincial Peoples Hospital

Nanchang, Jiangxi, 330038, China

Location

Pingxiang Peoples Hospital

Pingxiang, Jiangxi, 337055, China

Location

Heze Municipal Hospital

Heze, Shandong, 274031, China

Location

Huadong Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030000, China

Location

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, 321013, China

Location

Corporacion Hospitalaria Juan Ciudad, Mederi

Bogota, Cundinamarca, 11001, Colombia

Location

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

Bogota, Cundinamarca, 110221, Colombia

Location

Mediservis del Tolima IPS SAS

Ibagué, Tolima Department, 730006, Colombia

Location

MUDr I Cierna Peterova sro

Brandýs nad Labem-Stará Boleslav, 250 01, Czechia

Location

Meditrial sro

Jindřichův Hradec, 377 01, Czechia

Location

MUDr Josef Veverka

Rokycany, 337 01, Czechia

Location

Kasmed sro

Tábor, 390 02, Czechia

Location

Hong Kong Center for Clinical Research

Hong Kong, 999077, Hong Kong

Location

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Location

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Location

Edelenyi Koch Robert Korhaz es Rendelointezet

Edelény, 3780, Hungary

Location

Erzsebet Gondozohaz

Gödöllő, 2100, Hungary

Location

Puspokladanyi Egeszsegugyi Szolgaltato Intezmeny

Püspökladány, 4150, Hungary

Location

Allergo-Fot Kft

Százhalombatta, 2440, Hungary

Location

University of Fukui Hospital

Yoshida-gun, Fukui, 910-1193, Japan

Location

Medical corporation Syureikai Tohno Chuo Clinic

Mizunami-shi, Gifu, 509-6134, Japan

Location

Idaimae Minami Yojo Naika Clinic

Sapporo, Hokkaido, 064-0804, Japan

Location

Sakaide City Hospital

Sakaide-shi, Kagawa-ken, 762-8550, Japan

Location

Kamei Internal medicine and Respiratory Clinic

Takamatsu, Kagawa-ken, 761-8073, Japan

Location

Kagoshima University Hospital

Kagoshima, Kagoshima-ken, 890-8520, Japan

Location

Yokohama City Minato Red Cross Hospital

Yokohama, Kanagawa, 231-8682, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

Location

Kochi Medical School Hospital

Nankoku-shi, Kochi, 783-8505, Japan

Location

National Hospital Organization Osaka Toneyama Medical Center

Toyonaka-shi, Osaka, 560-8552, Japan

Location

Teikyo University Hospital

Itabashi-ku, Tokyo, 173-8606, Japan

Location

Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai

Shinagawa-ku, Tokyo, 140-8522, Japan

Location

Centro de investigacion medico biologica y terapia avanzada

Guadalajara, Jalisco, 44130, Mexico

Location

cicum San Miguel

Guadalaja, Jalisco, 44160, Mexico

Location

Icaro Investigaciones en Medicina

Chihuahua City, 31000, Mexico

Location

Unidad de Investigacion cima

Chihuahua City, 31200, Mexico

Location

Centrum Medycyny Oddechowej Mroz Spolka Jawna

Bialystok, 15-044, Poland

Location

Klimed Marek Klimkiewicz

Bychawa, 23100, Poland

Location

GynCentrum Sp zoo NZOZ Holsamed

Katowice, 40-600, Poland

Location

Centrum Medyczne All-Med Badania kliniczne

Krakow, 30-033, Poland

Location

Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center

Krakow, 31-559, Poland

Location

Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olech-Cudzik Krzysztof Cudzik

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Ewa Springer Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej

Poznan, 60-693, Poland

Location

Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska

Wroclaw, 51-162, Poland

Location

Spitalul de Pneumoftiziologie Bacau

Bacau, 600252, Romania

Location

Spitalul de Pneumoftiziologie Leon Daniello

Cluj-Napoca, 400332, Romania

Location

Spitalul Clinic de Boli Infecțioase si Pneumoftiziologie Victor Babes Craiova

Craiova, 200515, Romania

Location

Medical Center

Deva, 330162, Romania

Location

Spitalul Judetean de Urgenta Sf Ioan cel Nou Suceava

Suceava, 720224, Romania

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

The Catholic University of Korea Eunpyeong St Marys Hospital

Seoul, 03312, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Veterans General Hospital - Taichung

Taichung, 40705, Taiwan

Location

Taipei Medical University Hospital

Taipei, 11031, Taiwan

Location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

Lakeside Healthcare

Corby, NN17 2UR, United Kingdom

Location

CPS Research

Glasgow, G20 7BE, United Kingdom

Location

Glasgow Royal Infirmary

Glasgow, G31 2ER, United Kingdom

Location

4 Medical Clinical Solutions

Manchester, M27 8FF, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 19, 2024
• Study Start: May 24, 2024
• Primary Completion (Estimated): October 19, 2026
• Study Completion (Estimated): December 11, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

AU (2); US (48); CL (5); CO (3); AR (10); ME (4); RO (5); HK (3); CZ (4); TH (3); HU (4); BU (5); CN (16); PL (8); KR (8); JP (12); TW (4); GB (5); CA (5)