Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

NCT04938830 | Completed Phase 3 DMC FDA Drug

• 6 other identifiers: 1654-007MK-1654-007jRCT20312106642022-500752-39-00U1111-1278-00932020-005996-11
• Study Type: interventional
• Target: 1,003
• Locations: 27 countries
• Sites: 146

Brief Summary

This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).

Conditions

RSV Infection

Outcome Measures

Primary Outcomes (7)

• Participants with solicited injection-site Adverse Events (AEs) in RSV Season 1

  Percentage of participants with solicited injection-site AEs in RSV Season 1

  Up to 5 days

• Participants with solicited daily body temperature with fever in RSV Season 1

  Percentage of participants with solicited daily body temperature with fever in RSV Season 1

  Up to 5 days

• Participants with solicited systemic AEs in RSV Season 1

  Percentage of participants with solicited systemic AEs in RSV Season 1

  Up to 5 days

• Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1

  Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1

  Up to 42 days

• Participants with rash AESI in RSV Season 1

  Percentage of participants with rash AESI in RSV Season 1

  Up to 42 days

• Participants with non-serious AEs in RSV Season 1

  Percentage of participants with non-serious AEs in RSV Season 1

  Up to 42 days

• Participants with serious AEs (SAEs) through the duration of participation in RSV Season 1

  Percentage of participants with serious AEs (SAEs) through the duration of participation in RSV Season 1

  Up to 365 days

Secondary Outcomes (11)

• Participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1

  Up to 150 days

• Participants with RSV-associated hospitalization in RSV Season 1

  Up to 150 days

• Participants with solicited injection-site AEs in RSV Season 2

  From approximately 393 days up to 400 days

• Participants with solicited daily body temperature with fever in RSV Season 2

  From approximately 393 days up to 400 days

• Participants with solicited systemic AEs in RSV Season 2

  From approximately 393 days up to 400 days

Study Arms (2)

Clesrovimab

EXPERIMENTAL

Participants will receive intramuscular (IM) injections of clesrovimab and placebo

Biological: Clesrovimab; Biological: Placebo

Palivizumab

ACTIVE COMPARATOR

Participants will receive IM injections.

Biological: Palivizumab

Interventions

Clesrovimab BIOLOGICAL

IM injection

Also known as: MK-1654

Clesrovimab

Palivizumab BIOLOGICAL

IM injection

Palivizumab

Placebo BIOLOGICAL

IM injection

Clesrovimab

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
• Is available to complete the follow-up period.

You may not qualify if:

• Requires mechanical ventilation at time of enrollment.
• Has a life expectancy \<6 months.
• Has known hepatic or renal dysfunction, or chronic seizure disorder.
• Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
• Has severe immunodeficiency or is severely immunocompromised.
• Has known hypersensitivity to any component of clesrovimab or palivizumab.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (146)

Miller Children's & Women's Hospital Long Beach ( Site 0001)

Long Beach, California, 90806, United States

Location

Children's Hospital of Orange County ( Site 0047)

Orange, California, 92868, United States

Location

Children's Hospital Colorado ( Site 0011)

Aurora, Colorado, 80045, United States

Location

Children's National Medical Center ( Site 0020)

Washington D.C., District of Columbia, 20010, United States

Location

Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M ( Site 0022)

Orlando, Florida, 32806, United States

Location

Nemours Children's Health, Lake Nona Medical City ( Site 0032)

Orlando, Florida, 32827, United States

Location

University of South Florida-Department of Pediatrics ( Site 0045)

Tampa, Florida, 33606, United States

Location

Morehouse School Of Medicine ( Site 0049)

Atlanta, Georgia, 30310, United States

Location

Clinical Research Prime ( Site 0046)

Idaho Falls, Idaho, 83404, United States

Location

University of Kentucky HealthCare - Turfland ( Site 0044)

Lexington, Kentucky, 40536, United States

Location

Our Lady of the Lake Children's Hospital ( Site 0031)

Baton Rouge, Louisiana, 70809, United States

Location

Tulane University School of Medicine ( Site 0010)

New Orleans, Louisiana, 70112, United States

Location

M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank-Peds Research ( Site 0037)

Minneapolis, Minnesota, 55454, United States

Location

Rutgers University-Pediatric Clinical Research Center ( Site 0007)

New Brunswick, New Jersey, 08901, United States

Location

NYU Langone Hospital - Long Island-Pediatrics ( Site 0028)

Mineola, New York, 11501, United States

Location

University of Rochester Medical Center ( Site 0017)

Rochester, New York, 14642, United States

Location

The University of North Carolina at Chapel Hill ( Site 0035)

Chapel Hill, North Carolina, 27514, United States

Location

Duke University ( Site 0021)

Durham, North Carolina, 27710, United States

Location

Dayton Children's Hospital ( Site 0053)

Dayton, Ohio, 45449, United States

Location

Tribe Clinical Research, LLC ( Site 0002)

Greenville, South Carolina, 29607, United States

Location

Driscoll Children's Hospital ( Site 0025)

Corpus Christi, Texas, 78411, United States

Location

DHR Health Institute for Research and Development ( Site 0029)

Edinburg, Texas, 78539, United States

Location

Christus Children's-Clinical Research Center ( Site 0038)

San Antonio, Texas, 78207, United States

Location

University Hospital-Pediatrics ( Site 0019)

San Antonio, Texas, 78229, United States

Location

Road Runner Research, Ltd ( Site 0052)

San Antonio, Texas, 78249, United States

Location

Intermountain - Primary Children's Hospital ( Site 0026)

Salt Lake City, Utah, 84113, United States

Location

Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004)

Spokane, Washington, 99202, United States

Location

Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030)

Spokane, Washington, 99204, United States

Location

MultiCare Health System-Baker Center ( Site 0036)

Tacoma, Washington, 98405, United States

Location

Mater Misericordiae Limited-Neonatalogy ( Site 0102)

Brisbane, Queensland, 4101, Australia

Location

Telethon Kids Institute-Vaccine Trials Group ( Site 0101)

Nedlands, Western Australia, 6009, Australia

Location

Alberta Children's Hospital-Department of Pediatrics ( Site 0180)

Calgary, Alberta, T3B 6A8, Canada

Location

Canadian Center for Vaccinology ( Site 0179)

Halifax, Nova Scotia, B3K 6R8, Canada

Location

CHU Sainte-Justine ( Site 0178)

Montreal, Quebec, H3T 1C5, Canada

Location

Clínica Alemana de Santiago-Neonatology department ( Site 0207)

Santiago, Region M. de Santiago, 8320325, Chile

Location

Hospital Roberto del Río-Infectología Pediátrica ( Site 0205)

Santiago, Region M. de Santiago, 8380418, Chile

Location

Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201)

Santiago, Region M. de Santiago, 8880465, Chile

Location

Fundación Hospitalaria San Vicente de Paúl ( Site 0233)

Medellín, Antioquia, 050010, Colombia

Location

Clínica Universitaria Bolivariana ( Site 0227)

Medellín, Antioquia, 50036, Colombia

Location

Ciensalud Ips S A S ( Site 0235)

Barranquilla, Atlántico, 08001, Colombia

Location

Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0230)

Bogotá, Bogota D.C., 111411, Colombia

Location

Clínica Imbanaco S.A.S ( Site 0229)

Cali, Valle del Cauca Department, 760042, Colombia

Location

Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252)

Ostrava, Moravskoslezský kraj, 708 52, Czechia

Location

Institute for the Care of Mother and Child ( Site 0251)

Prague, Praha 4, 14700, Czechia

Location

FVR, Kokkolan rokotetutkimusklinikka ( Site 0304)

Kokkola, Keski-Pohjanmaa, 67100, Finland

Location

FVR, Oulun rokotetutkimusklinikka ( Site 0303)

Oulu, North Ostrobothnia, 90220, Finland

Location

FVR, Tampereen rokotetutkimusklinikka ( Site 0301)

Tampere, Pirkanmaa, 33100, Finland

Location

FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305)

Seinäjoki, South Ostrobothnia, 60100, Finland

Location

FVR, Turun rokotetutkimusklinikka ( Site 0302)

Turku, Southwest Finland, 20520, Finland

Location

MeVac - Meilahti Vaccine Research Center ( Site 0306)

Helsinki, Uusimaa, 00290, Finland

Location

Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332)

Bordeaux, Aquitaine, 33076, France

Location

Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq ( Site 0330)

Caen, Calvados, 14033, France

Location

Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331)

Le Chesnay, Yvelines, 78157, France

Location

Universitaetsklinikum Freiburg ( Site 0365)

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366)

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Dr. von Haunersches Kinderspital ( Site 0358)

Munich, Bavaria, 80337, Germany

Location

München Klinik Harlaching ( Site 0351)

Munich, Bavaria, 81545, Germany

Location

Medizinische Hochschule Hannover ( Site 0364)

Hanover, Lower Saxony, 30625, Germany

Location

Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359)

Oberhausen, North Rhine-Westphalia, 46145, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin ( Site 0363)

Dresden, Saxony, 01307, Germany

Location

Universitätsklinikum Leipzig-Neonatology ( Site 0354)

Leipzig, Saxony, 04103, Germany

Location

Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361)

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 0852)

Athens, Attica, 115 27, Greece

Location

Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854)

Athens, Attica, 115 27, Greece

Location

ATTIKON GENERAL UNIVERSITY HOSPITAL-3rd Department of Pediatrics ( Site 0855)

Chaïdári, Attica, 124 62, Greece

Location

Hippokration University Hopsital-3rd Pediatric Department ( Site 0851)

Thessaloniki, Central Macedonia, 54642, Greece

Location

Prince of Wales Hospital ( Site 0926)

Shatin, Hong Kong

Location

Tuen Mun Hospital ( Site 0927)

Tuenmen, 999077, Hong Kong

Location

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház-Újszülött Intenzív Osztály ( Site 0388)

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

Location

Bajai Szent Rókus Kórház ( Site 0386)

Baja, Bács-Kiskun county, Hungary

Location

Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380)

Kecskemét, Bács-Kiskun county, 6000, Hungary

Location

Szabolcs-Szatmar-Bereg Varmegyei Korhazak es Egyetemi Oktatokorhaz - Gyermekosztaly ( Site 0376)

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

Location

Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet-PIC ( Site 0384)

Budapest, 1076, Hungary

Location

Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381)

Budapest, 1082, Hungary

Location

Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383)

Budapest, 1096, Hungary

Location

Debreceni Egyetem Klinikai Kozpont ( Site 0378)

Debrecen, 4032, Hungary

Location

Ospedale Pediatrico Bambino Gesù IRCCS-UOC Broncopneumologia ( Site 0427)

Rome, Lazio, 00165, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426)

Rome, Lazio, 00168, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432)

Milan, Lombardy, 20122, Italy

Location

ASST Fatebenefratelli Sacco ( Site 0434)

Milan, Lombardy, 20154, Italy

Location

Azienda Ospedaliera di Padova-Department of Women and Child Health ( Site 0428)

Padua, Veneto, 35128, Italy

Location

Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433)

Parma, 43126, Italy

Location

Fukuoka Children's Hospital ( Site 0452)

Fukuoka, Fukuoka, 813-0017, Japan

Location

Iizuka Hospital ( Site 0457)

Iizuka, Fukuoka, 820-8505, Japan

Location

Japan Community Healthcare Organization Kyushu Hospital ( Site 0454)

Kitakyushu-shi, Fukuoka, 806-8501, Japan

Location

Maebashi Red Cross Hospital ( Site 0451)

Maebashi, Gunma, 371-0811, Japan

Location

Ibaraki Children's Hospital ( Site 0458)

Mito, Ibaraki, 311-4145, Japan

Location

Nihon University Itabashi Hospital ( Site 0453)

Itabashiku, Tokyo, 173-8610, Japan

Location

Shizuoka Saiseikai General Hospital ( Site 0456)

Shizuoka, 422-8527, Japan

Location

National Center for Child Health and Development ( Site 0455)

Tokyo, 157-8535, Japan

Location

Hospital Raja Perempuan Zainab II-Department of Pediatric ( Site 0477)

Kota Bharu, Kelantan, 15586, Malaysia

Location

University Malaya Medical Centre-Department of Paediatrics ( Site 0480)

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

Location

Hospital Pulau Pinang ( Site 0482)

George Town, Pulau Pinang, 10450, Malaysia

Location

Sabah Women and Children Hospital ( Site 0478)

Kota Kinabalu, Sabah, 88996, Malaysia

Location

Hospital Sibu ( Site 0476)

Sibu, Sarawak, 96000, Malaysia

Location

Hospital Tunku Azizah-Paediatric ( Site 0481)

Kuala Lumpur, 50300, Malaysia

Location

Morales Vargas Centro de Investigacion ( Site 0509)

León, Guanajuato, 37000, Mexico

Location

Centro de Investigación Médico Biológica y Terapia Avanzada ( Site 0502)

Guadalajara, Jalisco, 44650, Mexico

Location

Instituto Nacional de Pediatria ( Site 0506)

Mexico City, Mexico City, 04530, Mexico

Location

Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508)

Durango, 34000, Mexico

Location

Oaxaca Site Management Organization ( Site 0504)

Oaxaca City, 68000, Mexico

Location

ONCOLOGICO POTOSINO, S.C. ( Site 0505)

San Luis Potosí City, 78209, Mexico

Location

Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527)

Newtown, Wellington Region, 6021, New Zealand

Location

Middlemore Clinical Trials ( Site 0526)

Auckland, 2025, New Zealand

Location

Oslo Universitetssykehus Ullevål ( Site 0551)

Oslo, 0450, Norway

Location

Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 0577)

Jesús María, Lima, 15072, Peru

Location

HOSPITAL DOCENTE MADRE-NIÑO SAN BARTOLOME-NEUMOLOGIA PEDIATRICA ( Site 0576)

Lima, 15001, Peru

Location

UPR Medical Sciences Campus-Pediatrics ( Site 0626)

San Juan, 00935, Puerto Rico

Location

KK Women's and Children's Hospital-Department of Neonatology ( Site 0877)

Singapore, South West, 229899, Singapore

Location

Reimed ( Site 0706)

Boksburg, Gauteng, 1459, South Africa

Location

Chris Hani Baragwanath Academic Hospital ( Site 0701)

Soweto, Gauteng, 2013, South Africa

Location

King Edward VIII Hospital ( Site 0704)

Durban, KwaZulu-Natal, 4001, South Africa

Location

Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703)

Cape Town, Western Cape, 7500, South Africa

Location

Panorama Medical Centre ( Site 0702)

Cape Town, Western Cape, 7500, South Africa

Location

MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710)

Cape Town, Western Cape, 7700, South Africa

Location

2 Military Hospital ( Site 0708)

Cape Town, Western Cape, 7824, South Africa

Location

Hospital Germans Trias i Pujol ( Site 0738)

Badalona, Barcelona, 08916, Spain

Location

Hospital Sant Joan de Déu ( Site 0730)

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Universitary General de Catalunya-Pediatrics ( Site 0737)

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731)

Santiago de Compostela, La Coruna, 15706, Spain

Location

Hospital Universitario HM Monteprincipe-pediatric ( Site 0743)

Boadilla del Monte, Madrid, 28660, Spain

Location

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739)

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 0728)

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Hospital Universitario Central de Asturias ( Site 0740)

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Universitario La Paz ( Site 0726)

Madrid, 28046, Spain

Location

Grupo Pediatrico Uncibay ( Site 0734)

Málaga, 29015, Spain

Location

Taichung Veterans General Hospital ( Site 0754)

Taichung, 407, Taiwan

Location

National Taiwan University Hospital ( Site 0751)

Taipei, 10002, Taiwan

Location

Mackay Memorial Hospital-Pediatrics ( Site 0753)

Taipei, 10449, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch ( Site 0752)

Taoyuan District, 33305, Taiwan

Location

Chulalongkorn University-Pediatrics ( Site 0777)

Bangkok, Bangkok, 10330, Thailand

Location

Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0778)

Bangkok, Bangkok, 10700, Thailand

Location

Songklanagarind hospital-Department of Pediatrics ( Site 0776)

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

cukurova universty ( Site 0805)

Sarçam, Adana, 01030, Turkey (Türkiye)

Location

Ankara University Hospital Cebeci ( Site 0801)

Ankara, 06100, Turkey (Türkiye)

Location

Gazi Universitesi ( Site 0806)

Ankara, 06560, Turkey (Türkiye)

Location

Ankara Bilkent Şehir Hastanesi. ( Site 0807)

Ankara, 06800, Turkey (Türkiye)

Location

Erciyes University Medical Faculty-pediatric infection ( Site 0804)

Kayseri, 38039, Turkey (Türkiye)

Location

Whipps Cross University Hospital ( Site 0846)

London, England, E11 1NR, United Kingdom

Location

St. George's Hospital ( Site 0845)

London, England, SW17 0RE, United Kingdom

Location

Queen Elizabeth University Hospital ( Site 0842)

Glasgow, Glasgow City, G51 4TF, United Kingdom

Location

Evelina London Children's Hospital ( Site 0829)

London, Great Britain, SE1 7EH, United Kingdom

Location

Southampton General Hospital ( Site 0826)

Southampton, Hampshire, SO16 0YD, United Kingdom

Location

Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844)

London, London, City of, E1 1BB, United Kingdom

Location

The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827)

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843)

Liverpool, L12 2AP, United Kingdom

Location

Related Publications (2)

• Zar HJ, Bont LJ, Manzoni P, Munoz FM, Ramilo O, Chen PY, Novoa JM, Ordonez GA, Tsolia M, Tapiero B, Acuna-Avila MI, Castellanos JM, Meyer M, Morioka I, Chen Z, Railkar RA, Zang X, Maas BM, Likos A, Lee AW, Castagnini LA, Sinha A; SMART (MK-1654-007) Study Group. Clesrovimab in Infants and Children at Increased Risk for Severe RSV Disease. N Engl J Med. 2025 Oct 2;393(13):1343-1345. doi: 10.1056/NEJMc2506107. Epub 2025 Sep 17. No abstract available.

  PMID: 40961423 RESULT

• Sinha A, Railkar RA, Castagnini L, Guerra A, Likos A, Lutkiewicz J, Maas BM, Zang X, Roadcap BA, Choi Y, Nahhas GJ, Arriola CS, Bont L, Manzoni P, Ramilo O, Munoz FM, Finelli L, Lee AW. Evaluation of a monoclonal antibody against respiratory syncytial virus, clesrovimab, in infants and children: Comprehensive rationale and study design for the late-stage clinical trials. Contemp Clin Trials. 2025 Oct;157:107995. doi: 10.1016/j.cct.2025.107995. Epub 2025 Jun 30.

  PMID: 40602662 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

MK-1654; Palivizumab

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 24, 2021
• Study Start: November 30, 2021
• Primary Completion: April 28, 2025
• Study Completion: August 1, 2025
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

CL (3); TH (3); JP (8); TW (4); PR (1); AU (2); ES (10); NO (1); CA (3); CZ (2); PE (2); US (29); ME (6); HK (2); NZ (2); FI (6); IT (6); HU (8); DE (9); ZA (7); CO (5); GB (8); GR (4); TU (5); MY (6); SG (1); FR (3)