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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Rocatinlimab

• Study Type: Interventional
• Enrollment (Actual): 317
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Florida, Vicente Lopez, Argentina, B1602DQD
    • CEMER Centro Medico de Enfermedades Respiratorias
  • Mendoza, Argentina, M5500AXR
    • Fundacion Scherbovsky
  • Mendoza, Argentina, 5500
    • Instituto Medico Insares SA
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1426ABP
      • Fundacion Respirar - Centro Medico Dra De Salvo
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1128AAF
      • Centro de Osteopatias Medicas
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Fundacion Enfisema para el Estudio y Tratamiento de las Enfermedades Cronicas del Aparato Respirador
    • San Juan Bautista, Buenos Aires, Argentina, 1888
      • Ierim Instituto de Enfermedades Respiratorias e Investigacion Clinica
  • Distrito Federal
    • Buenos Aires, Distrito Federal, Argentina, 1425
      • InAER - Investigaciones en Alergia y Enfermedades Respiratorias
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2002OJN
      • Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion medica
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Centro Integral de Medicina Respiratoria
• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3141
      • The Alfred Hospital
• Bulgaria
  • Haskovo, Bulgaria, 6300
    • Medical Center Pulmo - 2018 EOOD
  • Rousse, Bulgaria, 7002
    • Specialized Hospital for Active Treatment of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov
  • Sofia, Bulgaria, 1407
    • Medical Center Excelsior OOD
  • Sofia, Bulgaria, 1680
    • Diagnostic-Consultative Center Convex OOD
  • Stara Zagora, Bulgaria, 6001
    • Medical Center New rehabilitation center EOOD
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary - Cumming School of Medicine
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Centre for Lung Health
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St Pauls Hospital Pacific Lung Health Centre
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J5
      • Dynamic Drug Advancement Limited
    • Ottawa, Ontario, Canada, K2T 0N7
      • Kanata Allergy Clinic
• Chile
  • Curicó, Chile, 3440000
    • Centro de Investigacion Curico
  • Santiago, Chile, 8241479
    • Icegclinic
  • Santiago, Chile, 7501126
    • Sociedad Medica SyG Limitada
  • Santiago, Chile, 7750495
    • Centro de Investigaciones Medicas Respiratorias
  • Talca, Chile, 346000
    • Centro de Investigacion del Maule
• China
  • Anhui
    • Hefei, Anhui, China, 230061
      • Hefei First Peoples Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510150
      • The Third Affiliated Hospital of Guangzhou Medical University
    • Huizhou, Guangdong, China, 516002
      • The Third Peoples Hospital of Huizhou
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital
  • Hunan
    • Changsha, Hunan, China, 410004
      • Changsha Central Hospital
    • Hengyang, Hunan, China, 421001
      • The Second Hospital University of South China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221009
      • Xuzhou Central Hospital
    • Xuzhou, Jiangsu, China, 221006
      • The Affiliated Hospital of Xuzhou Medical University
  • Jiangxi
    • Ganzhou, Jiangxi, China, 341000
      • The First Affiliated Hospital of Gannan Medical University
    • Nanchang, Jiangxi, China, 330038
      • Jiangxi Provincial Peoples Hospital
    • Pingxiang, Jiangxi, China, 337055
      • Pingxiang Peoples Hospital
  • Shandong
    • Heze, Shandong, China, 274031
      • Heze Municipal Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Shanghai Pulmonary Hospital
    • Shanghai, Shanghai Municipality, China, 200040
      • Huadong Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • First Hospital of Shanxi Medical University
  • Zhejiang
    • Jinhua, Zhejiang, China, 321013
      • Jinhua municipal central hospital
• Colombia
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 110221
      • Solano y Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia Uniendo
    • Bogota, Cundinamarca, Colombia, 11001
      • Corporacion Hospitalaria Juan Ciudad, Mederi
  • Tolima Department
    • Ibagué, Tolima Department, Colombia, 730006
      • Mediservis del Tolima IPS SAS
• Czechia
  • Brandýs nad Labem-Stará Boleslav, Czechia, 250 01
    • MUDr I Cierna Peterova sro
  • Jindřichův Hradec, Czechia, 377 01
    • Meditrial sro
  • Rokycany, Czechia, 337 01
    • MUDr Josef Veverka
  • Tábor, Czechia, 390 02
    • Kasmed sro
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital, The University of Hong Kong
  • Hong Kong, Hong Kong, 999077
    • hong Kong Center for Clinical Research
  • Shatin, New Territories, Hong Kong
    • Prince of Wales Hospital, Chinese University of Hong Kong
• Hungary
  • Edelény, Hungary, 3780
    • Edelenyi Koch Robert Korhaz es Rendelointezet
  • Gödöllő, Hungary, 2100
    • Erzsebet Gondozohaz
  • Püspökladány, Hungary, 4150
    • Puspokladanyi Egeszsegugyi Szolgaltato Intezmeny
  • Százhalombatta, Hungary, 2440
    • Allergo-Fot Kft
• Japan
  • Fukui
    • Yoshida-gun, Fukui, Japan, 910-1193
      • University of Fukui Hospital
  • Gifu
    • Mizunami-shi, Gifu, Japan, 509-6134
      • Medical corporation Syureikai Tohno Chuo Clinic
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 064-0804
      • Idaimae Minami Yojo Naika Clinic
  • Kagawa-ken
    • Sakaide-shi, Kagawa-ken, Japan, 762-8550
      • Sakaide City Hospital
    • Takamatsu, Kagawa-ken, Japan, 761-8073
      • Kamei Internal Medicine and Respiratory Clinic
  • Kagoshima-ken
    • Kagoshima, Kagoshima-ken, Japan, 890-8520
      • Kagoshima University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital
    • Yokohama, Kanagawa, Japan, 231-8682
      • Yokohama City Minato Red Cross Hospital
  • Kochi
    • Nankoku-shi, Kochi, Japan, 783-8505
      • Kochi Medical School Hospital
  • Osaka
    • Toyonaka-shi, Osaka, Japan, 560-8552
      • National Hospital Organization Osaka Toneyama Medical Center
  • Tokyo
    • Itabashi-ku, Tokyo, Japan, 173-8606
      • Teikyo University Hospital
    • Shinagawa-ku, Tokyo, Japan, 140-8522
      • Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai
• Mexico
  • Chihuahua City, Mexico, 31000
    • Icaro Investigaciones en Medicina
  • Chihuahua City, Mexico, 31200
    • Unidad de Investigacion cima
  • Jalisco
    • Guadalaja, Jalisco, Mexico, 44160
      • CICUM San Miguel
    • Guadalajara, Jalisco, Mexico, 44130
      • Centro de Investigacion Medico Biologica y Terapia Avanzada
• Poland
  • Bialystok, Poland, 15-044
    • Centrum Medycyny Oddechowej Mroz Spolka jawna
  • Bychawa, Poland, 23100
    • KLIMED Marek Klimkiewicz
  • Katowice, Poland, 40-600
    • GynCentrum Sp zoo NZOZ Holsamed
  • Krakow, Poland, 31-559
    • Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center
  • Krakow, Poland, 30-033
    • Centrum Medyczne ALL-MED Badania Kliniczne
  • Ostrowiec Świętokrzyski, Poland, 27-400
    • Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olech-Cudzik Krzysztof Cudzik
  • Poznan, Poland, 60-693
    • Ewa Springer Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej
  • Wroclaw, Poland, 51-162
    • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
• Romania
  • Bacau, Romania, 600252
    • Spitalul de Pneumoftiziologie Bacau
  • Cluj-Napoca, Romania, 400332
    • Spitalul de Pneumoftiziologie Leon Daniello
  • Craiova, Romania, 200515
    • Spitalul Clinic de Boli Infecțioase si Pneumoftiziologie Victor Babes Craiova
  • Deva, Romania, 330162
    • Medical Center
  • Suceava, Romania, 720224
    • Spitalul Judetean de Urgenta Sf Ioan cel Nou Suceava
• South Korea
  • Daegu, South Korea, 42415
    • Yeungnam University Medical Center
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Marys Hospital
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Seoul, South Korea, 05030
    • Konkuk University Medical Center
  • Seoul, South Korea, 03312
    • The Catholic University of Korea Eunpyeong St Marys Hospital
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Veterans General Hospital - Taichung
  • Taipei, Taiwan, 11031
    • Taipei Medical University Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Songkhla, Thailand, 90110
    • Songklanagarind Hospital
• United Kingdom
  • Corby, United Kingdom, NN17 2UR
    • Lakeside Healthcare
  • Glasgow, United Kingdom, G31 2ER
    • Glasgow Royal Infirmary
  • Glasgow, United Kingdom, G20 7BE
    • CPS Research
  • Manchester, United Kingdom, M27 8FF
    • 4 Medical Clinical Solutions
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital
• United States
  • California
    • Bakersfield, California, United States, 93301
      • Kern Research Inc
    • La Jolla, California, United States, 92037
      • Orso Health Inc
    • La Palma, California, United States, 90623
      • IMAX Clinical Trials
    • Lancaster, California, United States, 93534
      • Antelope Valley Clinical Trials
    • Los Angeles, California, United States, 90017
      • Downtown Los Angeles Research Center, Inc
    • Newport Beach, California, United States, 92663
      • NewportNativeMD, Inc
    • Orange, California, United States, 92868
      • University of California Irvine
    • San Diego, California, United States, 92120
      • Apex Clinical Research
    • Walnut Creek, California, United States, 94598
      • Allergy and Asthma Clinical Research
    • Westminster, California, United States, 92683
      • Allianz Research Institute Westminster
  • Florida
    • Clearwater, Florida, United States, 33765
      • St Francis Medical Institute
    • Miami, Florida, United States, 33126
      • BioMed Research Institute
    • Miami, Florida, United States, 33144
      • Bright Research Center LLC
    • Tamarac, Florida, United States, 33321
      • Infinity Life Research Group
    • Tampa, Florida, United States, 33607
      • Clinical Research Trials of Florida Inc
  • Georgia
    • Columbus, Georgia, United States, 31904
      • AllerVie Clinical Research- Columbus
  • Idaho
    • Boise, Idaho, United States, 83706
      • Treasure Valley Medical Research
  • Illinois
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze, and Itch Associates, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Family Allergy and Asthma Research Institute
  • Maryland
    • White Marsh, Maryland, United States, 21162
      • Chesapeake Clinical Research Inc
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Ypsilanti, Michigan, United States, 48197
      • Respiratory Medicine Research Institute of Michigan, PLC
  • Missouri
    • Saint Charles, Missouri, United States, 63301
      • Midwest Chest Consultants, PC
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68505
      • Somnos Clinical Research
  • New Jersey
    • Union City, New Jersey, United States, 07087
      • Hudson County Clinical Trials Research Center
  • New York
    • New Hyde Park, New York, United States, 11042
      • Northwell Health
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Asthma Research Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Bernstein Clinical Research Center LLC
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • OK Clinical Research
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research Medford
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Clinical Research Associates of Central Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • The Allergy Asthma and Sinus Center
  • Texas
    • Amarillo, Texas, United States, 79106
      • Amarillo Medical Specialists
    • Boerne, Texas, United States, 78006
      • TTS Research
    • Carrollton, Texas, United States, 75010
      • TEN20 Clinical Research
    • Dallas, Texas, United States, 75235
      • Southwest Family Medicine Associates
    • Dallas, Texas, United States, 75225
      • Alina Clinical Trials, LLC
    • Galveston, Texas, United States, 77555-0158
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Kerrville, Texas, United States, 78028
      • Sante Clinical Research
    • McKinney, Texas, United States, 75069
      • Metroplex Pulmonary and Sleep Center
    • Plano, Texas, United States, 75093
      • Ace Proactive
    • San Antonio, Texas, United States, 78249
      • Bandera Family Health Care
    • San Antonio, Texas, United States, 78229
      • South Texas Allergy and Asthma Medical Professionals
    • Sugar Land, Texas, United States, 77479
      • Pioneer Research Solutions Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Treatment Arm A: Placebo; Participants will receive placebo by subcutaneous (SC) injection during the blinded treatment period.	Drug: Placebo; Placebo will be administered by SC injection.
Experimental: Treatment Arm B: Dose 1 Rocatinlimab; Participants will receive dose 1 rocatinlimab by SC injection during the blinded treatment period.	Drug: Rocatinlimab; Rocatinlimab will be administered by SC injection.; Other Names: AMG 451
Experimental: Treatment Arm C: Dose 2 Rocatinlimab; Participants will receive dose 2 rocatinlimab by SC injection during the blinded treatment period.	Drug: Rocatinlimab; Rocatinlimab will be administered by SC injection.; Other Names: AMG 451
Experimental: Treatment Arm D: Dose 3 Rocatinlimab; Participants will receive dose 3 rocatinlimab by SC injection during the blinded treatment period.	Drug: Rocatinlimab; Rocatinlimab will be administered by SC injection.; Other Names: AMG 451

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period	Up to Week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Number of Participant Achieving ACQ-6 Response at Week 48	Week 48
Change From Baseline in ACQ-6	Up to Week 48
Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score	Baseline, Weeks 12, 24, 36 and 48
Number of Participants Achieving AQLQ (S) Response at Week 48	Up to Week 48
Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period	Up to Week 48
Time to First Asthma Exacerbation Event	Up to 62 weeks
Time to First CompEx Event	Up to 62 weeks
Number of Participants with a CompEx Event During the Double Blinded Treatment Period	Up to Week 48
Annualized Rate of CompEx Events	Weeks 12, 24 and 36
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels	Up to 62 weeks
Serum Rocatinlimab Concentrations	Up to 62 weeks
Trough Concentration (Ctrough) of Rocatinlimab	Up to 62 weeks
Number of Participants with Treatment-emergent Adverse Events	Up to 62 weeks
Number of Participants with Serious Adverse Events	Up to 62 weeks
Number of Participants with Anti-rocatinlimab Antibody Formation	Up to 62 weeks

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2024
• Primary Completion (Estimated): October 19, 2026
• Study Completion (Estimated): December 11, 2026

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: AMG 451; KHK4083; Rocatinlimab; Moderate to severe asthma
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 20220093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No