Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

NCT04662255 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: 18072J2N-OX-JZNMLOXO-BTK-20019
• Study Type: interventional
• Target: 500
• Locations: 23 countries
• Sites: 184

Brief Summary

This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.

Conditions

Lymphoma, Mantle-Cell

Keywords

Bruton's Tyrosine Kinase Inhibitor; BTKi; Hematologic Disease; Lymphoma, non-Hodgkin's; Lymphoma, B-Cell; Lymphoma; pirtobrutinib

Outcome Measures

Primary Outcomes (1)

• To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL)

  Assessed per Lugano criteria

  Up to approximately 24 months

Secondary Outcomes (7)

• To compare Event Free Survival (EFS) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms

  Up to approximately 24 months

• To compare Time to Treatment Failure (TTTF) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms

  Up to approximately 24 months

• Time to worsening (TTW) of MCL-related symptoms

  Up to approximately 24 months

• Comparative Tolerability as measured by proportion of time with high side effect burden

  Up to approximately 24 months

• To compare Overall Response Rate (ORR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms

  Up to approximately 24 months

Study Arms (2)

Arm A (Pirtobrutinib)

EXPERIMENTAL

Orally

Drug: Pirtobrutinib

Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib)

ACTIVE COMPARATOR

Investigator's choice (based on local availability) of ibrutinib, acalabrutinib or zanubrutinib orally. Options are limited to those that are available/approved in the specific country.

Drug: Ibrutinib; Drug: Acalabrutinib; Drug: Zanubrutinib

Interventions

Pirtobrutinib DRUG

Oral

Also known as: LOXO-305, LY3527727

Arm A (Pirtobrutinib)

Ibrutinib DRUG

Oral

Also known as: Imbruvica

Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib)

Acalabrutinib DRUG

Oral

Also known as: Calquence

Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib)

Zanubrutinib DRUG

Oral

Also known as: Brukinsa

Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib)

Eligibility Criteria

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

You may qualify if:

• Confirmed MCL diagnosis
• Previously treated with at least one prior line of systemic therapy for MCL
• Measurable disease per Lugano criteria
• Eastern Cooperative Oncology Group (ECOG) 0-2
• Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening
• Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 7 days of screening
• Platelets ≥ 50 × 109/L not requiring transfusion support or growth factors within 7 days of screening.
• AST and ALT ≤ 3.0 x upper limit of normal (ULN)
• Total bilirubin ≤ 1.5 x ULN.
• Creatinine clearance of ≥ 30 mL/min according to Cockcroft/Gault Formula

You may not qualify if:

• Prior treatment with an approved or investigational BTK inhibitor
• History of bleeding diathesis
• History of stroke or intracranial hemorrhage within 6 months of randomization
• History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified T-cell (CAR-T) therapy within 60 days of randomization
• Clinically significant cardiovascular disease
• Prolonged QT interval corrected using Fridericia's formula (QTcF) \> 470 ms on 2/3 consecutive ECGs, and mean QTcF\>470 ms on all 3 ECGs
• Known HIV infection or active HBV, HCV, or CMV infections. (Certain participants with controlled HBV infections may still be eligible)
• Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption
• Ongoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment.
• Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
• Vaccination with live vaccine within 28 days prior to randomization

Sponsors & Collaborators

• Loxo Oncology, Inc.: lead
• Eli Lilly and Company: collaborator

Study Sites (189)

Alaska Oncology and Hematology, LLC

Anchorage, Alaska, 99508, United States

Location

Arizona Oncology Associates, P.C. - HOPE

Phoenix, Arizona, 85013, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

USO-Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Oncology-Hematology Associates of West Broward

Tamarac, Florida, 33321, United States

Location

Florida Cancer Specialists East

West Palm Beach, Florida, 33401, United States

Location

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40504, United States

Location

Mercy Health-Paducah Medical Oncology and Hematology

Paducah, Kentucky, 42003, United States

Location

Tulane Cancer Center Office of Clinical Research

New Orleans, Louisiana, 70112, United States

Location

Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

Location

DFCI Lymphoma

Boston, Massachusetts, 02115, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905-0002, United States

Location

Washington University Medical School

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Messino Cancer Center

Asheville, North Carolina, 28806, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157-1045, United States

Location

Oncology Hematology Care Inc

Cincinnati, Ohio, 45219, United States

Location

Willamette Valley Cancer Institute & Research Ctr.

Eugene, Oregon, 97401, United States

Location

Sarah Cannon Research Institute SCRI

Nashville, Tennessee, 37203, United States

Location

Texas Oncology-Austin Midtown

Austin, Texas, 78705, United States

Location

Texas Oncology - Bedford

Bedford, Texas, 76022, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Texas Oncology - McAllen

McAllen, Texas, 78503, United States

Location

Texas Oncology - Sherman

Sherman, Texas, 75090, United States

Location

US Oncology

The Woodlands, Texas, 77380, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

USO-Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705-2254, United States

Location

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

The St. George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Icon Cancer Care - The Wesley Medical Centre

Auchenflower, 4066, Australia

Location

Uniklinikum Salzburg

Salzburg, Osterreich, 5020, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen

Linz, Upper Austria, 4020, Austria

Location

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

AZ Delta

Roeselare, West Flanders, 8800, Belgium

Location

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Hospital São Lucas Copacabana

Rio de Janeiro, CEP, 22061-080, Brazil

Location

Hospital Beneficência Portuguesa de São Paulo

São Paulo, CEP, 01321-001, Brazil

Location

Centro de Oncologia e Hematologia do Ceará LTDA

Aldeota, Fortaliza, 60115-281, Brazil

Location

Hospital das Clínicas da UFGo - Goiânia

Goiânia, Goiás, 74110-020, Brazil

Location

Hospital Sao Domingos

São Luís, Maranhão, 65060-645, Brazil

Location

Instituto Nacional de Câncer - INCA

Rio de Janeiro, Rio de Jan, 20230-130, Brazil

Location

Centro de Pesquisa Clínica São Lucas

Campinas, Sau Paulo, 13060-904, Brazil

Location

Instituto de Ensino e Pesquisas São Lucas - IEP Hemomed

Pacaembu, São Paulo, 01236-030, Brazil

Location

Fundação Faculdade Regional de Medicina de São José do Rio Preto, Dept. CIP - Centro Integrado de Pesquisa

Rio Preto, São Paulo, 15090-000, Brazil

Location

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo André, São Paulo, 09060-650, Brazil

Location

A. C. Camargo Cancer Center

São Paulo, São Paulo, 01509-900, Brazil

Location

HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná

Curitiba- PR, 80060 240, Brazil

Location

IPITEC

São Paulo, 01223-001, Brazil

Location

Hospital da Clinicas da Faculdade de Medicina da USP

São Paulo, 05403-000, Brazil

Location

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, 05652-900, Brazil

Location

Hospital 9 De Julho

São Paulo, Brazil

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3A 1M3, Canada

Location

Anhui Provincial Cancer Hospital

Hefei, Anhui, 233004, China

Location

Beijing ChaoYang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Cancer hospital

Beijing, Beijing Municipality, 100142, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Fujian Provincial Cancer Hospial

Fuzhou, Fujian, 350014, China

Location

Cancer Center of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Southern Medical University Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang, Henan, 471003, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Yichang Central People's Hospital

Yichang, Hubei, 443003, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Jilin Cancer Hospital

Changchun, Jilin, 130000, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Affiliated Tumor Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830002, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Lishui Central Hospital

Lishui, Zhejiang, 323020, China

Location

Chongqing Cancer Hospital

Chongqing, 400030, China

Location

Blood Institute of the Chinese Academy of Medical science

Tianjin, 300020, China

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, Hradec Králové, 500 05, Czechia

Location

Fakultni nemocnice Brno

Brno, 62500, Czechia

Location

Aarhus Universitetshospital, Aarhus Sygehus

Aarhus N, Jutland, 82000, Denmark

Location

Odense Universitetshospital

Odense C, Syd, 5000, Denmark

Location

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, Aquitaine, 33076, France

Location

Hopital de la Pitie Salpetriere

Paris, Cedex 13, 75651, France

Location

Hôpital Saint Vincent-de-Paul

Lille, Hauts-de-France, 59020, France

Location

Chu De Nancy Hop D'Adultes De Brabois

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

Location

Pole Regionalde Cancérologie(CHU de Poitiers)

Politiers, Politiers, 86021, France

Location

Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen

Rouen, Seine-Maritime, 76038, France

Location

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

Nantes, 44093, France

Location

Institut Curie

Paris, 75248, France

Location

Centre hospitalier universitaire de Haut Leveque

Pessac, 33604, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHRU De Tours

Tours, 37044, France

Location

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89075, Germany

Location

Klinikum der Universität München Großhadern

Würzburg, Bavaria, 97080, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH

Giessen, Hesse, 35392, Germany

Location

Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia, 48149, Germany

Location

InVO Institut für Versorgungsforschung in der Onkologie

Koblenz, Rhineland-Palatinate, 56068, Germany

Location

Universitätsmedizin Johannes Gutenberg Universität Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

OncoResearch Lerchenfeld GmbH

Hamburg, D-22081, Germany

Location

Bnai Zion Medical Center

Haifa, 3339419, Israel

Location

Hadassah Medical Center

Jerusalem, 9112001, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 5262100, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Presidio Ospedaliero Civile Santi Antonio e Biagio

Alessandria, AL, 15100, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Emilia-Romagna, 47014, Italy

Location

Ospedale Santa Maria delle Croci

Ravenna, Emilia-Romagna, 48121, Italy

Location

Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

IRCCS - AOU di Bologna

Bologna, 40138, Italy

Location

IRCCS Ospedale Policlinico San Martino

Genova, 16132, Italy

Location

Ospedale Vincenzo Cervello

Palermo, 90100, Italy

Location

Irccs Crob

Potenza, 85028, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, 42123, Italy

Location

Ospedale Di Circolo E Fondazione Macchi

Varese, 21100, Italy

Location

Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Kindai University Hospital

Osaka Sayama-shi, Osaka, 589 8511, Japan

Location

Saitama Medical Center

Kawagoe, Saitama, 350-8550, Japan

Location

Japanese Foundation for Cancer Research

Koto, Tokyo, 135-8550, Japan

Location

Chugoku Central Hospital

Hiroshima, 720-0001, Japan

Location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Kyoto Furitsu Medical University Hospital

Kyoto, 602-8566, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Bravis Ziekenhuis

Bergen op Zoom, North Brabant, 4624 VT, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands

Location

Ziekenhuisapotheek HagaZiekenhuis

The Hague, 2545 AA, Netherlands

Location

Christchurch Hospital

Addington, Christchurch, 8011, New Zealand

Location

Middlemore Clinical Trials

Auckland, 2025, New Zealand

Location

Centrum Onkologii Ziemi Lubelskiej

Lublin, Lublin Voivodeship, 20-090, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-952, Poland

Location

Pratia MCM Krakow

Krakow, 30-510, Poland

Location

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii

Lodz, 93510, Poland

Location

AIDPORT Sp. z o.o.

Skorzewo, 60-185, Poland

Location

Uniwersytecki Szpital Kliniczny Klinika

Wroclaw, 50-367, Poland

Location

IPOFG - Lisboa

Lisbon, 1099-035, Portugal

Location

Champalimaud Foundation

Lisbon, 1400-038, Portugal

Location

GUZ of Moscow City Clinical Hospital n.a. S.P. Botkin

Moscow, 125101, Russia

Location

Fed. State Budgetary Institution "Russian Scientific & Research Institute of Hemat. & Transfusiology of Fed. Medico-Bio. Agency

Saint Petersburg, 191024, Russia

Location

State Medical University named after I.P. Pavlov

Saint Petersburg, 197022, Russia

Location

Gachon University Gil Medical Center

Namdong-gu, Incheon-gwangyeoksi [Incheon], 21565, South Korea

Location

Seoul National University Hospital

Seoul, Korea, 03080, South Korea

Location

Kosin University Gospel Hospital

Busan, Seogu, 49267, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea

Location

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

Location

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, 29010, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 8035, Spain

Location

Hospital Duran I Reynals

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Palma de Mallorca(Baleares), 07120, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Kantonsspital Luzern

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Tri-Service General Hospital

Taipei City, Taipei, 114, Taiwan

Location

Chang Gung Memorial Hospital - Chiayi

Chiayi County, 61363, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng-Kung Uni. Hosp.

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang Gung Memorial Hospital - Linkou

Taoyuan, 33305, Taiwan

Location

Aberdeen Royal Infirmary

Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom

Location

Derriford Hospital

Plymouth, Devon, PL6 8DH, United Kingdom

Location

GenesisCare

Newmarket, Suffolk, CB8 7XN, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G120YN, United Kingdom

Location

City Hospital, Nottingham University Hospitals

Nottingham, NG5 1PB, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

GenesisCare, Windsor

Windsor, SL4 3HD, United Kingdom

Location

Related Publications (1)

• Eyre TA, Shah NN, Dreyling M, Jurczak W, Wang Y, Cheah CY, Song Y, Gandhi M, Chay C, Sharman J, Andorsky DJ, Messersmith HM, Ruppert AS, Muthig VA, Ito R, Wang ML. BRUIN MCL-321: phase III study of pirtobrutinib versus investigator choice of BTK inhibitor in BTK inhibitor naive mantle cell lymphoma. Future Oncol. 2022 Nov;18(36):3961-3969. doi: 10.2217/fon-2022-0976. Epub 2022 Nov 15.

  PMID: 36377973 DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Hematologic Diseases; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma

Interventions

pirtobrutinib; ibrutinib; acalabrutinib; zanubrutinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Patient Advocacy

  Loxo Oncology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 10, 2020
• Study Start: April 8, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (12); AU (2); US (36); PL (6); NZ (2); GB (7); TW (8); BR (16); IT (10); CN (27); FR (11); CZ (2); CA (3); DE (8); RU (3); KR (5); PT (2); ES (11); NL (3); BE (3); DK (2); CH (1); IL (4)