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AsthmaPhase 2NCT06376045

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

A Phase 2 study testing Rocatinlimab in people with Asthma, run by Amgen at 154 sites in 19 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
Rocatinlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
317 participants
Where
154 sitesin 19 countries
Study dates
24 May 2024to 23 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

154 sites in 19 countries.

154 sites in 19 countries

United States48 sites

  • Amarillo Medical Specialists

    Amarillo, Texas, 79124

  • Kern Research Inc

    Bakersfield, California, 93301

  • TTS Research

    Boerne, Texas, 78006

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • TEN20 Clinical Research

    Carrollton, Texas, 75010

  • Bernstein Clinical Research Center LLC

    Cincinnati, Ohio, 45236

  • St Francis Medical Institute

    Clearwater, Florida, 33765

  • AllerVie Clinical Research- Columbus

    Columbus, Georgia, 31904

  • Alina Clinical Trials, LLC

    Dallas, Texas, 75225

  • Southwest Family Medicine Associates

    Dallas, Texas, 75235

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Clinical Research Associates of Central Pennsylvania

    DuBois, Pennsylvania, 15801

  • Duke Asthma Research Center

    Durham, North Carolina, 27705

  • OK Clinical Research

    Edmond, Oklahoma, 73034

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0158

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Sante Clinical Research

    Kerrville, Texas, 78028

  • The Allergy Asthma and Sinus Center

    Knoxville, Tennessee, 37909

  • Orso Health Inc

    La Jolla, California, 92037

  • Imax Clinical Trials

    La Palma, California, 90623

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534

  • Somnos Clinical Research

    Lincoln, Nebraska, 68505

  • Downtown Los Angeles Research Center, Inc

    Los Angeles, California, 90017

  • Family Allergy and Asthma Research Institute

    Louisville, Kentucky, 40217

  • Metroplex Pulmonary and Sleep Center

    McKinney, Texas, 75069

  • Velocity Clinical Research Medford

    Medford, Oregon, 97504

  • BioMed Research Institute

    Miami, Florida, 33126

  • Bright Research Center LLC

    Miami, Florida, 33144

  • Montana Medical Research

    Missoula, Montana, 59808

  • Northwell Health

    New Hyde Park, New York, 11042

  • NewportNativeMD, Inc

    Newport Beach, California, 92663

  • Sneeze, Wheeze, and Itch Associates, LLC

    Normal, Illinois, 61761

  • University of California Irvine

    Orange, California, 92868

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Ace Proactive

    Plano, Texas, 75093

  • Midwest Chest Consultants, PC

    Saint Charles, Missouri, 63301

  • South Texas Allergy and Asthma Medical Professionals

    San Antonio, Texas, 78229

  • Bandera Family Health Care

    San Antonio, Texas, 78249

  • Apex Clinical Research

    San Diego, California, 92120

  • Pioneer Research Solutions Inc

    Sugar Land, Texas, 77479

  • Infinity Life Research Group

    Tamarac, Florida, 33321

  • Clinical Research Trials of Florida Inc

    Tampa, Florida, 33607

  • Hudson County Clinical Trials Research Center

    Union City, New Jersey, 07087

  • Allergy and Asthma Clinical Research

    Walnut Creek, California, 94598

  • Allianz Research Institute Westminster

    Westminster, California, 92683

  • Chesapeake Clinical Research Inc

    White Marsh, Maryland, 21162

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Respiratory Medicine Research Institute of Michigan, plc

    Ypsilanti, Michigan, 48197

Other trials in United States

China16 sites

  • Changsha Central Hospital

    Changsha, Hunan, 410004

  • The First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341000

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510150

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • Hefei First Peoples Hospital

    Hefei, Anhui, 230061

  • The Second Hospital University of South China

    Hengyang, Hunan, 421001

  • Heze Municipal Hospital

    Heze, Shandong, 274031

  • The Third Peoples Hospital of Huizhou

    Huizhou, Guangdong, 516002

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, 321013

  • Jiangxi Provincial Peoples Hospital

    Nanchang, Jiangxi, 330038

  • Pingxiang Peoples Hospital

    Pingxiang, Jiangxi, 337055

  • Huadong Hospital

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221006

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

Other trials in China

Japan12 sites

  • Teikyo University Hospital

    Itabashi-ku, Tokyo, 173-8606

  • Kagoshima University Hospital

    Kagoshima, Kagoshima-ken, 890-8520

  • Medical corporation Syureikai Tohno Chuo Clinic

    Mizunami-shi, Gifu, 509-6134

  • Kochi Medical School Hospital

    Nankoku-shi, Kochi, 783-8505

  • Sakaide City Hospital

    Sakaide-shi, Kagawa-ken, 762-8550

  • Idaimae Minami Yojo Naika Clinic

    Sapporo, Hokkaido, 064-0804

  • Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai

    Shinagawa-ku, Tokyo, 140-8522

  • Kamei Internal medicine and Respiratory Clinic

    Takamatsu, Kagawa-ken, 761-8073

  • National Hospital Organization Osaka Toneyama Medical Center

    Toyonaka-shi, Osaka, 560-8552

  • Yokohama City Minato Red Cross Hospital

    Yokohama, Kanagawa, 231-8682

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

  • University of Fukui Hospital

    Yoshida-gun, Fukui, 910-1193

Other trials in Japan

Argentina10 sites

  • InAER - Investigaciones en Alergia y Enfermedades Respiratorias

    Buenos Aires, Distrito Federal, 1425

  • Fundacion Respirar - Centro Medico Dra De Salvo

    CABA, Buenos Aires, C1426ABP

  • Centro de Osteopatias Medicas

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF

  • Cemer Centro Medico de Enfermedades Respiratorias

    Florida, Vicente Lopez, B1602DQD

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

    Mar del Plata, Buenos Aires, 7600

  • Instituto Medico Insares SA

    Mendoza, 5500

  • Fundacion Scherbovsky

    Mendoza, M5500AXR

  • Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion medica

    Rosario, Santa Fe Province, S2002OJN

  • Ierim Instituto de Enfermedades Respiratorias e Investigacion Clinica

    San Juan Bautista, Buenos Aires, 1888

  • Centro Integral de Medicina Respiratoria

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Poland8 sites

  • Centrum Medycyny Oddechowej Mroz Spolka Jawna

    Bialystok, 15-044

  • Klimed Marek Klimkiewicz

    Bychawa, 23100

  • GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero

    Katowice, 40-600

  • Centrum Medyczne All-Med Badania kliniczne

    Krakow, 30-033

  • Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center

    Krakow, 31-559

  • Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olech-Cudzik Krzysztof Cudzik

    Ostrowiec Świętokrzyski, 27-400

  • Ewa Springer Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej

    Poznan, 60-693

  • Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska

    Wroclaw, 51-162

Other trials in Poland

South Korea8 sites

  • Yeungnam University Medical Center

    Daegu, 42415

  • Seoul National University Hospital

    Seoul, 03080

  • The Catholic University of Korea Eunpyeong St Marys Hospital

    Seoul, 03312

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center

    Seoul, 05505

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Bulgaria5 sites

  • Medical Center Pulmo - 2018 EOOD

    Haskovo, 6300

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

    Rousse, 7002

  • Medical Center Excelsior OOD

    Sofia, 1407

  • Diagnostic-Consultative Center Convex OOD

    Sofia, 1680

  • Medical Center New Rehabilitation Center EOOD

    Stara Zagora, 6001

Other trials in Bulgaria

Canada5 sites

  • Dynamic Drug Advancement Limited

    Ajax, Ontario, L1S 2J5

  • University of Calgary - Cumming School of Medicine

    Calgary, Alberta, T2N 4Z6

  • Kanata Allergy Clinic

    Ottawa, Ontario, K2T 0N7

  • Centre for Lung Health

    Vancouver, British Columbia, V5Z 1M9

  • St Pauls Hospital Pacific Lung Health Centre

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Chile5 sites

  • Centro de Investigacion Curico

    Curicó, 3440000

  • Sociedad Medica SyG Limitada

    Santiago, 7501126

  • Centro De Investigaciones Medicas Respiratorias

    Santiago, 7750495

  • Icegclinic

    Santiago, 8241479

  • Centro de Investigacion del Maule

    Talca, 346000

Other trials in Chile

Romania5 sites

  • Spitalul de Pneumoftiziologie Bacau

    Bacau, 600252

  • Spitalul de Pneumoftiziologie Leon Daniello

    Cluj-Napoca, 400332

  • Spitalul Clinic de Boli Infecțioase si Pneumoftiziologie Victor Babes Craiova

    Craiova, 200515

  • Medical Center

    Deva, 330162

  • Spitalul Judetean de Urgenta Sf Ioan cel Nou Suceava

    Suceava, 720224

Other trials in Romania

United Kingdom5 sites

  • Lakeside Healthcare

    Corby, NN17 2UR

  • CPS Research

    Glasgow, G20 7BE

  • Glasgow Royal Infirmary

    Glasgow, G31 2ER

  • 4 Medical Clinical Solutions

    Manchester, M27 8FF

  • John Radcliffe Hospital

    Oxford, OX3 9DU

Other trials in United Kingdom

Czechia4 sites

  • MUDr I Cierna Peterova sro

    Brandýs nad Labem-Stará Boleslav, 250 01

  • Meditrial sro

    Jindřichův Hradec, 377 01

  • MUDr Josef Veverka

    Rokycany, 337 01

  • Kasmed sro

    Tábor, 390 02

Other trials in Czechia

Hungary4 sites

  • Edelenyi Koch Robert Korhaz es Rendelointezet

    Edelény, 3780

  • Erzsebet Gondozohaz

    Gödöllő, 2100

  • Puspokladanyi Egeszsegugyi Szolgaltato Intezmeny

    Püspökladány, 4150

  • Allergo-Fot Kft

    Százhalombatta, 2440

Other trials in Hungary

Mexico4 sites

  • Icaro Investigaciones en Medicina

    Chihuahua City, 31000

  • Unidad de Investigacion cima

    Chihuahua City, 31200

  • cicum San Miguel

    Guadalaja, Jalisco, 44160

  • Centro de investigacion medico biologica y terapia avanzada

    Guadalajara, Jalisco, 44130

Other trials in Mexico

Taiwan4 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • China Medical University Hospital

    Taichung, 40447

  • Veterans General Hospital - Taichung

    Taichung, 40705

  • Taipei Medical University Hospital

    Taipei, 11031

Other trials in Taiwan

Colombia3 sites

  • Corporacion Hospitalaria Juan Ciudad, Mederi

    Bogota, Cundinamarca, 11001

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

    Bogota, Cundinamarca, 110221

  • Mediservis del Tolima IPS SAS

    Ibague, Tolima Department, 730006

Other trials in Colombia

Hong Kong3 sites

  • Hong Kong Center for Clinical Research

    Hong Kong, 999077

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

  • Prince of Wales Hospital, Chinese University of Hong Kong

    Shatin, New Territories

Other trials in Hong Kong

Thailand3 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Siriraj Hospital

    Bangkok, 10700

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

Australia2 sites

  • The Alfred Hospital

    Melbourne, Victoria, 3141

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

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

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

Conditions
Asthma
Being tested
Rocatinlimab, Placebo
Keywords
Moderate to severe asthma, Rocatinlimab, AMG 451, KHK4083
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RocatinlimabDrug

    Also called AMG 451

    Rocatinlimab will be administered by SC injection.

  • PlaceboDrug

    Placebo will be administered by SC injection.

Study groups in NCT06376045
Study groupRoleWhat they receive
Treatment Arm A: PlaceboPlacebo comparatorParticipants will receive placebo by subcutaneous (SC) injection during the blinded treatment period.
Receives: Drug: Placebo
Treatment Arm B: Dose 1 RocatinlimabExperimentalParticipants will receive dose 1 rocatinlimab by SC injection during the blinded treatment period.
Receives: Drug: Rocatinlimab
Treatment Arm C: Dose 2 RocatinlimabExperimentalParticipants will receive dose 2 rocatinlimab by SC injection during the blinded treatment period.
Receives: Drug: Rocatinlimab
Treatment Arm D: Dose 3 RocatinlimabExperimentalParticipants will receive dose 3 rocatinlimab by SC injection during the blinded treatment period.
Receives: Drug: Rocatinlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to Week 48

Secondary outcomes (17)

  1. Annualized Asthma Exacerbation Rate (AAER)

    Measured: Up to Week 48

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

    Measured: Baseline and Week 48

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

    Measured: Baseline and Week 48

  4. Change From Baseline in Pre-BD FEV1

    Measured: Baseline and Week 56

  5. Change From Baseline in Asthma Symptom Diary (ASD) Score

    Measured: Baseline and Week 48

  6. Number of Participant Achieving ACQ-6 Response at Week 48

    Measured: Week 48

  7. Change From Baseline in ACQ-6

    Measured: Baseline and Week 48

  8. Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score

    Measured: Baseline, Weeks 12, 24, 36 and 48

  9. Number of Participants Achieving AQLQ (S) Response at Week 48

    Measured: Week 48

  10. Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period

    Measured: Up to Week 48

  11. Time to First Asthma Exacerbation Event

    Measured: Up to 62 weeks

  12. Time to First CompEx Event

    Measured: Up to Week 48

  13. Number of Participants with a CompEx Event During the Double Blinded Treatment Period

    Measured: Up to Week 48

  14. Annualized Rate of CompEx Events

    Measured: Up to Weeks 12, 24 and 36

  15. Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels

    Measured: Baseline and Week 56

  16. Serum Rocatinlimab Concentrations

    Measured: Up to 56 weeks

  17. Trough Concentration (Ctrough) of Rocatinlimab

    Measured: Up to 56 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2024
  2. Study start24 May 2024
  3. Primary completion14 May 2026
  4. Study completion23 Jun 2026

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06376045
Sponsor's protocol ID
20220093
Status last verified
Aug 2026
First submitted
17 Apr 2024
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rocatinlimab in people with Asthma, run by Amgen at 154 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in United States, China, Japan, Argentina, Poland and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period (time frame: Up to Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06376045.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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