A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

February 23, 2026 updated by: Genentech, Inc.

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1334

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Centro Médico Dra de Salvo
      • Buenos Aires, Argentina, B7600FZN
        • Instituto de Investigaciones Clinicas-Mar del Plata
      • Buenos Aires, Argentina, C1121ABE
        • Fundacion CIDEA
      • Buenos Aires, Argentina, 7240
        • Centro de Investigaciones Clínicas Belgrano
      • CABA, Argentina, C1414AIF
        • CARE - Centro de Alergia y Enfermedades Respiratorias
      • Córdoba, Argentina, X5003DCE
        • Instituto de Medicina Respiratoria, IMeR
      • Lobos, Argentina, B7240AAN
        • Centro de Especialidades Medicas Lobos
      • Mar del Plata, Argentina, 7600
        • Centro de Investigaciones Medicas Mar Del Plata
      • Mar del Plata, Argentina, B7602DCK
        • Instituto Ave Pulmo
      • Mendoza, Argentina, M5500CCG
        • INSARES
      • Quilmes, Argentina, B1878FNR
        • Centro Respiratorio Quilmes
      • Rosario, Argentina, S2013OJN
        • Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica
      • San Fernando, Argentina, B1646EBJ
        • Centro Médico Respire
      • San Juan Bautista, Argentina, CP 1888
        • Instituto De Enfermedades Respiratorias E Investigacion Medica
      • San Miguel de Tucumán, Argentina, 4000
        • Investigaciones en Patologias Respiratorias
      • San Miguel de Tucumán, Argentina, T4000CBC
        • Centro Integral de Medicina Respiratoria (CIMER)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2001SBK
        • Centro Medico IPAM
  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
    • Western Australia
      • Spearwood, Western Australia, Australia, 6163
        • TrialsWest Pty Ltd
  • Belgium
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Erpent, Belgium, 5101
        • Private Practice Dr Jean Benoit Martinot
      • Roeselare, Belgium, 8800
        • AZ Delta
      • Thuin, Belgium, 6534
        • Office of Marc De Meulemeester
      • Yvoir, Belgium, 5530
        • CHU UCl Namur asbl - Site Godinne
    • Antwerpen
      • Mechelen, Antwerpen, Belgium, 2800
        • AZ Sint-Maarten
  • Bulgaria
      • Dupnitsa, Bulgaria, 2600
        • Medical Centre "Asklepii", OOD
      • Haskovo, Bulgaria, 6300
        • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
      • Pazardzhik, Bulgaria, 4400
        • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Dr.Nikola Penchev-Paza
      • Pernik, Bulgaria, 2300
        • Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
      • Pleven, Bulgaria, 5800
        • Medical Center Medconsult Pleven OOD
      • Plovdiv, Bulgaria, 4023
        • Medical Center Unimed Eood
      • Plovdiv, Bulgaria, 4001
        • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
      • Razgrad, Bulgaria, 7200
        • Medical Centre Respiro OOD
      • Sofia, Bulgaria, 1510
        • Medical Center Hera EOOD
      • Sofia, Bulgaria, 1606
        • University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
      • Stara Zagora, Bulgaria, 6003
        • Medical Center New Rehabilitation Center EOOD
      • Vratsa, Bulgaria, 3000
        • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa
  • Canada
    • Ontario
      • Burlington, Ontario, Canada, L7N 3V2
        • Burlington Lung Clinic
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton- Charlton Campus
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clinical Research Group
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • University of Saskatchewan, Royal University Hospital
  • Chile
      • Curicó, Chile, 3340000
        • Centro de Investigacion Curico
      • Providencia, Chile, 7500000
        • Sociedad Médica SyG SpA
      • Providencia, Chile, 7500587
        • Enroll SpA - PPDS
      • Santiago, Chile, 8320000
        • Meditek Ltda
      • Talca, Chile
        • Centro de Investigación del Maule
      • Valparaíso, Chile, 2340000
        • Hospital Carlos Van Buren
      • Ñuñoa, Chile, 7750495
        • MIRES/MYF estudios clinicos
    • Región-MetropolitanadeSantiago
      • Providencia, Región-MetropolitanadeSantiago, Chile, 7500000
        • Centro De Investigaciones Medicas Respiratorias
  • Czechia
      • Jind?ich?v Hradec, Czechia, 377 01
        • MediTrial s.r.o.
      • Kralupy nad Vltavou, Czechia, 278 01
        • Plicni Ambulance Kralupy nad Vltavou
      • Miroslav, Czechia, 671 72
        • MUDr. Ilona Pavlisova s.r.o.
      • Nový Bor, Czechia, 473 01
        • Pneumologie Varnsdorf s.r.o.
      • Tábor, Czechia, 390 02
        • KASMED s.r.o.
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Universitetshospital
      • Hellerup, Denmark, 2900
        • Gentofte Hospital
      • Hvidovre, Denmark, DK-2650
        • Hvidovre Hospital
      • Odense, Denmark, 5000
        • Odense Universitetshospital
      • Vejle, Denmark, 7100
        • Sygehus Lillebælt, Vejle
  • France
      • Lyon, France, 69004
        • Hopital de la croix rousse
      • Nice, France, 06001
        • CHU de Nice
      • Strasbourg, France, 67091
        • Nouvel Hopital Civil
  • Germany
      • Augsburg, Germany, 86150
        • Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako
      • Bamberg, Germany
        • CIMS-Studienzentrum Bamberg,
      • Bendorf, Germany, 56170
        • KPPK Studienzentrum Kroker-Schmidt
      • Berlin, Germany, 12203
        • MECS Research GmbH
      • Berlin, Germany, 13187
        • Praxis Dr. Med Evelin Liefring
      • Deggingen, Germany, 73326
        • Gemeinscharftspraxis Dres Jung - Deggingen
      • Essen, Germany, 45355
        • Medizentrum Essen Borbeck
      • Frankfurt am Main, Germany, 60389
        • Praxis Dr med Claus Keller
      • Giessen, Germany, 35392
        • Universitätsklinikum Gießen und Marburg GmbH
      • Landsberg, Germany, 86899
        • Asklepios MVZ Bayern GmbH
      • Leipzig, Germany, 04207
        • Salvus-Klinische Studien GmbH
      • Marburg, Germany, 35037
        • Zentrum fuer ambulante pneumologische Forschung Marburg GbR
      • Peine, Germany, 31224
        • Studienzentrum Dr Med Schlenska
  • Hong Kong
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital
  • Israel
      • Ashdod, Israel, 7747629
        • Assuta Ashdod Medical Center
      • Ashkelon, Israel, 7830604
        • Barzilai Medical Center
      • Beer Jacob, Israel, 0073100
        • Shamir Medical Center Assaf Harofeh
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 90000
        • Tel Aviv Sourasky Medical Center PPDS
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Litwinsky, Israel, 52621
        • Sheba Medical Center - PPDS
  • Mexico
      • Durango, Mexico, 34080
        • Centro de Investigacion y Atencion Integral Durango CIAID
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44130
        • Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
      • Guadalajara, Jalisco, Mexico, 44100
        • Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
      • Guadalajara, Jalisco, Mexico, 44220
        • Unidad Medica de Occidente
      • Guadalajara Centro, Jalisco, Mexico, 44100
        • cicum San Miguel
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64718
        • Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
  • Netherlands
      • Breda, Netherlands, 4819 EV
        • Amphia Ziekenhuis
      • Zwolle, Netherlands, 8011 JW
        • Isala Klinieken
  • New Zealand
      • Auckland, New Zealand, 2025
        • Aotearoa Clinical Trials Trust
      • Christchurch, New Zealand, 8011
        • Canterbury Respiratory Research Group
  • Peru
      • Lima, Peru, Lima 27
        • Clinica Ricardo Palma
      • Lima, Peru, 32
        • Clinica Providencia (Inverconsult Sociedad Anonima)
      • Lima, Peru, Lima 01
        • Clinica Internacional
      • Lima Cercado, Peru, 000000
        • Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Centrum Medyczne Bydgoszcz- PRATIA - PPDS
      • Kielce, Poland, 25-751
        • Indywidualna Specjalistyczna Praktyka Lekarska lek.
      • Krakow, Poland, 30-033
        • Centrum Medyczne ALL-MED
      • Krakow, Poland, 31-559
        • Diamond Clinic
      • Krakow, Poland, 31-637
        • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
      • Lublin, Poland, 20-412
        • ETG Lublin
      • Lódz, Poland, 90-302
        • ETG Lodz
      • Nowa Sól, Poland, 67-100
        • Twoja Przychodnia Centrum Medyczne Nowa Sol
      • Ostrowiec Swietokrzysk, Poland, 27-400
        • Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik
      • Poznan, Poland, 60-214
        • Centrum Alergologii Teresa Hofman
      • Rzeszów, Poland, 35-205
        • EMED Centrum Uslug Medycznych Ewa Smialek
      • Siedlce, Poland, 08-110
        • ETG Siedlce
      • Sosnowiec, Poland, 41-208
        • PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
      • Warsaw, Poland, 02-793
        • ETG Warszawa- PPDS
      • Wroclaw, Poland, 53-301
        • Dobrostan Gabinety Lekarskie
  • Romania
      • Brasov, Romania, 500283
        • Neomed Out-Patient Treatment and Diagnosis Medical Center SRL
      • Bucharest, Romania, 030303
        • Dr. Victor Babes Foundation
      • Cluj-Napoca, Romania, 400371
        • Leon Daniello Pneumophthisiology Clinical Hospital
      • Constanța, Romania, 900002
        • Spitalul Clinic de Pneumoftiziologie Constanta
      • Suceava, Romania, 720237
        • Sf. Ioan cel Nou Emergency County Hospital
  • South Africa
      • Cape Town, South Africa, 7700
        • University of Cape Town Lung Institute
      • City of Tshwane, South Africa, 0186
        • Clinical Trial Systems
      • Durban, South Africa, 4001
        • St Augustines Hospital
      • Ekurhuleni, South Africa, 1459
        • Dr A.C Wilhase practice-Reimed
      • Ekurhuleni, South Africa, 1501
        • Lakeview Hospital
      • Kraaifontein, South Africa, 7570
        • Langeberg Clinical Trials
  • South Korea
      • Incheon, South Korea, 21431
        • Catholic Univ. of Incheon St.Mary's Hospital
      • Jeonju, South Korea, 54907
        • Chonbuk National University Hospital
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, South Korea, 05030
        • Konkuk University Medical Center
  • Spain
      • Barcelona, Spain, 000000
        • Hospital De La Santa Creu I Sant Pau
      • Cáceres, Spain, 10003
        • Hospital de San Pedro de Alcantara
      • Granada, Spain, 18012
        • Hospital Universitario Virgen de Las Nieves
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz.
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
    • Badajoz
      • Mérida, Badajoz, Spain, 06800
        • Hospital de Mérida
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • LA Coruna
      • Santiago de Compostela, LA Coruna, Spain, 15706
        • CHUS H Clinico U de Santiago
  • Sweden
      • Lidingö, Sweden, 181 29
        • Fysikalisk Medicin i Stockholm AB
      • Lund, Sweden, 222 22
        • ProbarE i Lund AB
      • Malmo, Sweden, 211 52
        • PharmaSite
      • Stockholm, Sweden, 113 29
        • ProbarE i Stockholm AB
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Leicester, United Kingdom, LE3 9QP
        • Glenfield Hospital
    • London, City of
      • London, London, City of, United Kingdom, W1T6AH
        • Queen Anne Street Medical Centre
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
      • Jasper, Alabama, United States, 35501
        • Jasper Summit Research LLC
      • Mobile, Alabama, United States, 36608-3135
        • Pulmonary Associates of Mobile PC
    • California
      • Poway, California, United States, 92064-2021
        • Cadena Care Institute, Llc
      • San Diego, California, United States, 92120
        • Inst. of Healthcare Assessment, Inc.
      • Westminster, California, United States, 92683
        • Allianz Research Institute Inc
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Florida
      • Leesburg, Florida, United States, 34748-5077
        • Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS
      • Orlando, Florida, United States, 32825-4454
        • Florida Institute for Clinical Research, LLC
      • Winter Park, Florida, United States, 32789-4681
        • Clinical Site Partners - Winter Park - HyperCore - PPDS
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Center for Clinical Research
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
    • Massachusetts
      • Fall River, Massachusetts, United States, 20723
        • Exordia Medical Research, Inc.
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Northern Pines Health Center PC
      • Lathrup Village, Michigan, United States, 48076
        • Revive Research Institute
    • Missouri
      • Chesterfield, Missouri, United States, 63017-3627
        • Cardio-Pulmonary Associates
      • Hannibal, Missouri, United States, 63401
        • Blessing Health Hannibal
      • Saint Charles, Missouri, United States, 63301
        • Midwest Chest Consultants
      • St Louis, Missouri, United States, 63141-6823
        • CARE Clinical Research
      • St Louis, Missouri, United States, 63141
        • Midwest Clinical Research LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89106-4159
        • Sierra Clinical Research - ClinEdge - PPDS
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • American Health Research Inc.
      • Gastonia, North Carolina, United States, 28054-7481
        • Clinical Research of Gastonia
      • Shelby, North Carolina, United States, 28150-3803
        • Carolina Research Center
      • Winston-Salem, North Carolina, United States, 27103-4029
        • Southeastern Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Lowcountry Lung and Critical Care
      • Rock Hill, South Carolina, United States, 29732-1160
        • Clinical Research of Rock Hill
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
      • Spartanburg, South Carolina, United States, 29303-4225
        • Velocity Clinical Research Spartanburg PPDS
    • Texas
      • Boerne, Texas, United States, 78006-1993
        • South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • McKinney, Texas, United States, 75069
        • Metroplex Pulmonology & Sleep Center
      • Sherman, Texas, United States, 75092
        • Sherman Clinical Research - ClinEdge - PPDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Documented physician diagnosis of COPD for at least 12 months
  • History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening
  • Post-bronchodilator FEV1 >=20 and <80% of predicted normal value at screening
  • Modified Medical Research Council (dyspnea scale) (mMRC) score >=2
  • Current or former smoker with a minimum of 10 pack-year history
  • History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); Long-acting muscarinic antagonist (LAMA) plus LABA; ICS plus LAMA plus LABA

Exclusion Criteria

  • Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
  • History of clinically significant pulmonary disease other than COPD
  • History of long-term treatment with oxygen at >4.0 liters/minute
  • Lung volume reduction surgery or procedure within 12 months prior to screening
  • Participation in or planned participation in a new pulmonary rehabilitation program. Patients who are in the maintenance phase of a rehabilitation program are eligible
  • History of lung transplant
  • Occurrence of moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of 24 hours duration within 4 weeks prior to initiation of study drug
  • Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
  • Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks prior to screening
  • Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Astegolimab Q2W
Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W).
Drug: Astegolimab
Participants will receive SC astegolimab Q2W or Q4W.
Experimental: Astegolimab Q4W
Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).
Drug: Astegolimab
Participants will receive SC astegolimab Q2W or Q4W.
Placebo Comparator: Placebo
Participants will receive SC placebo Q2W.
Drug: Placebo
Participants will receive SC placebo Q2W.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period
Time Frame: Baseline up to Week 52
Baseline up to Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Absolute Change from Baseline in Health-Related Quality of Life (HRQoL) at Week 52 as Assessed Through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) Total Score
Time Frame: Baseline to Week 52
Baseline to Week 52
Proportion of SGRQ-C Responders at Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Absolute Change from Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (liters) at Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Absolute Change from Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Absolute Change from Baseline in Five-Repetition Sit-to-Stand (5STS) time (seconds) at Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2021

Primary Completion (Actual)

February 24, 2025

Study Completion (Actual)

July 7, 2025

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 8, 2021

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GB43311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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