A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) (EPCORE DLBCL-1)

May 21, 2026 updated by: Genmab

A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

The purpose of this trial is to find out if epcoritamab, also known as EPKINLY™ and GEN3013, is safe and works well as treatment for participants with DLBCL that are not responding to treatment, have grown in size, or have come back following treatment with at least 1 prior systemic cancer therapy. All participants in this trial will be randomly assigned to receive either epcoritamab or a pre-specified investigator's choice (standard of care) chemotherapy (either rituximab + gemcitabine + oxaliplatin [R-GemOx], or bendamustine + rituximab [BR]). Participants must have failed or be ineligible to receive an autologous stem cell transplant (ASCT).

Epcoritamab will be injected under the skin. Investigator's choice chemotherapy will be given intravenously.

Trial details include:

  • The trial duration will be up to 5 years after last participant is randomized.
  • All trial participants have a 21-day screening period, a treatment period, and a follow-up period that continues until death.

  • The estimated trial duration for an individual participant depends upon the treatment arm assigned:

    • Participants who receive epcoritamab will have 28-day treatment cycles. Epcoritamab will be given once weekly for the first 3 months, then every other week for 6 months, then every 28 days until lymphoma progression or unacceptable adverse events.

    • Participants who receive investigator's choice (standard of care) chemotherapy will receive treatments either:

      • R-GemOx: On Day 1 (or Day 1 & Day 2), and Day 15 (or Day 15 & Day 16) every 28 days, for up to 4 months; or
      • BR: On Day 1 and Day 2 every 3 weeks for up to 4.5 months.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The trial is an open label, multi-center, global phase-3 randomized trial of epcoritamab. The goal of this randomized trial is to evaluate the efficacy of epcoritamab (GEN3013, DuoBody®-CD3xCD20) compared to investigator's choice of chemotherapy, in participants with relapsed, refractory DLBCL who have failed or are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). No change in chemotherapy is permitted for participants during the treatment phase of the trial.

Overall Survival (OS) is the primary endpoint in USA and in China, with the analysis population including all randomized participants. OS/Progression Free Survival (PFS) are dual-primary endpoints for rest of the world (outside US and China), with the analysis population also including all participants randomized.

The China sub-study of GCT3013-05 is registered under NCT07226752.

Study Type

Interventional

Enrollment (Actual)

483

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

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

  • Australia
      • Bedford Park, Australia
        • Flinders Medical Centre
      • Concord, Australia
        • Concord Repatriation General Hospital
      • Frankston, Australia
        • Peninsula Private Hospital Clinical Trials Unit
      • South Brisbane, Australia
        • Icon Cancer Centre Corporate Office
      • Waratah, Australia
        • Calvary Mater Newcastle
      • Westmead, Australia
        • Westmead Hospital
  • Austria
      • Linz, Austria
        • Ordensklinikum Linz Barmherzige Schwestern
      • Linz, Austria
        • Ordensklinikum Linz Gmbh Elisabethinen
      • Salzburg, Austria
        • Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU
  • Belgium
      • Antwerp, Belgium
        • Zna Middelheim
      • Bruges, Belgium
        • AZ Sint-Jan
      • Brussels, Belgium
        • Institut Jules Bordet
      • Ghent, Belgium
        • Universitair Ziekenhuis Gent
      • Jette, Belgium
        • UZ Brussel
      • La Louvière, Belgium
        • Hopital de Jolimont
      • Leuven, Belgium
        • Universitair Ziekenhuis gasthuisberg Leuven
      • Sint-Niklaas, Belgium
        • AZ Nikolaas- Verenigde Ziekenhuizen van Waas en Durme
      • Turnhout, Belgium
        • AZ Turnhout, Campus Sint-Elisabeth
  • Canada
      • Québec, Canada
        • CHU de Quebec-Universite Laval
  • Denmark
      • Aalborg, Denmark
        • Aalborg Universitetshospital
      • Aarhus, Denmark
        • Aarhus University Hospital, Department of Hematology, Clinical Research Unit C116
      • Roskilde, Denmark
        • Clinical Research Unit, Roskilde Sygehus
      • Vejle, Denmark
        • Vejle Hospital
  • Finland
      • Helsinki, Finland
        • HUS Cancer Center/ Clinical Trial Unit
      • Oulu, Finland
        • Oulu university hospital, Department of hematology
  • France
      • Amiens, France
        • Audrey ALEME
      • Bayonne, France
        • Centre Hospitalier de La Cote Basque
      • Brest, France
        • CHRU de Brest - Hospital Morvan
      • Caen, France
        • CHU Caen - IHBN
      • La Rochelle, France
        • Groupe Hospitalier de La Rochelle
      • Limoges, France
        • CHU de Limoges
      • Lyon, France
        • Centre Léon Bérard
      • Marseille, France
        • Hopital de la Conception APHM
      • Nantes, France
        • CHU de Nantes - Hotel Dieu
      • Nice, France
        • Centre Antoine Lacassagne
      • Paris, France
        • Hôpital Saint-Louis
      • Paris, France
        • Clinique Victor Hugo
      • Pessac, France
        • CHU de Bordeaux HOPITAL HAUT-LEVEQUE
      • Pierre-Bénite, France
        • Centre Hospitalier Lyon Sud
      • Poitiers, France
        • CHU de Poitiers - Hôpital la Milétrie
      • Pontoise, France
        • Centre Hospitalier Rene Dubos
      • Quimper, France
        • CH Cornouaille
      • Rouen, France
        • Centre Henri Becquerel
      • Tours, France
        • CHRU Tours Hôpital Bretonneau
  • Germany
      • Cologne, Germany
        • Uniklinik Köln, Klinik I für Innere Medizin, CIO Gebäude 70, 5.094
      • Essen, Germany
        • Universitaetsklinikum Essen
      • Kiel, Germany
        • Universitätsklinikum Schleswig-Holstein Medizinische Klinik II Hämatologie und Onkologie
      • Würzburg, Germany
        • Universitätsklinikum Würzburg
  • Hungary
      • Budapest, Hungary
        • National Institute of Oncology
      • Budapest, Hungary
        • Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika
      • Debrecen, Hungary
        • Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia
      • Eger, Hungary
        • Belgyógyászati osztály Markhot Ferenc Kórház
      • Győr, Hungary
        • Petz Aladar Egyetemi Oktato Korhaz
      • Nyíregyháza, Hungary
        • Josa Andras Teaching Hospital, Hematology Dept
      • Pécs, Hungary
        • University of Pecs 1st. Internal medicine Clinic Dept. Hematology
      • Szeged, Hungary
        • Szegedi Tudományegyetem II. sz. Belgyogyaszat, Hematologia
      • Székesfehérvár, Hungary
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Israel
      • Haifa, Israel
        • Bnai Zion Medical Center
      • Haifa, Israel
        • Rambam Health Care Center
      • Jerusalem, Israel
        • Shaare Zedek Medical Center
      • Jerusalem, Israel
        • Hadassah University Hospital
      • Tel Aviv, Israel
        • Sourasky Medical Center
  • Italy
      • Bari, Italy
        • IRCCS Istituto Tumori Giovanni Paolo II Bari
      • Bergamo, Italy
        • Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi)
      • Brescia, Italy
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Meldola, Italy
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
      • Milan, Italy
        • San Raffaele Hospital
      • Milan, Italy
        • Istituto Oncologico Europeo
      • Novara, Italy
        • Azienda Ospedaliero - Universitaria Maggiore delle Carita SCDU Ematologia building C
      • Pavia, Italy
        • Fondazione IRCCS Policlinico San Matteo
      • Ravenna, Italy
        • Ospedale Santa Maria delle Croci
      • Rome, Italy
        • Azienda Ospedaliera Universitaria Policlinico Umberto I Università di Roma La Sapienza, Dip Med Tra
      • San Giovanni Rotondo, Italy
        • IRCCS Ospedale Casa Sollievo della Sofferenza
      • Trieste, Italy
        • Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) Ospedale Maggiore di Trieste
      • Venezia, Italy
        • SC di Ematologia - AON SS Antonio e Biagio e Cesare Arrigo
  • Japan
      • Fukuoka, Japan
        • Kyushu University Hospital
      • Fukushima, Japan
        • Fukushima Medical University Hospital
      • Fukuyama, Japan
        • Chugoku Central Hospital
      • Hokkaido, Japan
        • Hokkaido University Hospital
      • Kashiwa, Japan
        • National Cancer Center Hospital East
      • Kyoto, Japan
        • Kyoto University Medical Hospital
      • Matsuyama, Japan
        • Matsuyama Red Cross Hospital
      • Mie, Japan
        • Mie University Hospital
      • Nagoya, Japan
        • Japanese Red Cross Nagoya Daini Hospital
      • Nagoya, Japan
        • NHO Nagoya Medical Center
      • Okayama, Japan
        • Okayama University Hospital
      • Sendai, Japan
        • Tohoku University Hospital
      • Tokyo, Japan
        • Keio University Hospital
      • Tokyo, Japan
        • National Cancer Center Hospital
      • Tokyo, Japan
        • Tokai University Hospital
      • Toyoake, Japan
        • Fujita Health University Hospital
      • Yamagata, Japan
        • Yamagata University Hospital
      • Ōsaka-sayama, Japan
        • Kindai University Hospital
  • Netherlands
      • Arnhem, Netherlands
        • Rijnstate Arnhem
      • Breda, Netherlands
        • Amphia Ziekenhuis, Interne Geneeskunde, Oncologie. Route 43
      • Dordrecht, Netherlands
        • Albert Schweitzer Ziekenhuis
      • Goes, Netherlands
        • Admiraal de Ruyter Ziekenhuis
      • Roosendaal, Netherlands
        • Bravis Ziekenhuis
      • Rotterdam, Netherlands
        • Erasmus MC
      • Rotterdam, Netherlands
        • Franciscus Gasthuis and Vlietland
  • Norway
      • Oslo, Norway
        • Oslo University Hospital location Radium hospital
      • Trondheim, Norway
        • St. Olavs hospital HF
  • Poland
      • Gdansk, Poland
        • Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
      • Katowice, Poland
        • Pratia Onkologia Katowice
      • Krakow, Poland
        • Pratia MCM Krakow
      • Lodz, Poland
        • Instytut Centrum Zdrowia Matki Polki
      • Lodz, Poland
        • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
      • Skorzewo, Poland
        • Centrum Medyczne Pratia Poznan
      • Wroclaw, Poland
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • Russia
      • Kazan', Russia
        • State Autonomous Institution of Healthcare Republican Clinical Oncological Dispensary of the Ministr
      • Moscow, Russia
        • Federal State Budgetary Institution of Science
      • Moscow, Russia
        • Federal State Budgetary Institution
      • Nizhny Novgorod, Russia
        • State Budgetary Institution of Healthcare of Nizhniy Novgorod region, 1st inpatient facility, 5th fl
      • Saint Petersburg, Russia
        • Federal State Budgetary Institution V.A. Almazov National Medical Research Center of the Ministry of
      • Saint Petersburg, Russia
        • State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital
  • Singapore
      • Kent Ridge, Singapore
        • National University Hospital
      • Singapore, Singapore
        • National Cancer Centre Singapore
      • Singapore, Singapore
        • Clinical Trials and Research Centre
  • South Korea
      • Busan, South Korea
        • Dong-A University Hospital
      • Busan, South Korea
        • Pusan National University Hospital
      • Busan, South Korea
        • Pusan National University Hosptial
      • Daegu, South Korea
        • Keimyung University Dongsan Hospital
      • Geumam, South Korea
        • Chonbuk National University Hospital
      • Seoul, South Korea
        • Asan Medical Center
      • Seoul, South Korea
        • Samsung Medical Center
      • Seoul, South Korea
        • Seoul National University Hospital
      • Seoul, South Korea
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea
        • Seoul National University Bundang Hospital
      • Seoul, South Korea
        • The Catholic University of Korea Seoul St. Marys Hospital
      • Ulsan, South Korea
        • Ulsan University Hospital
  • Spain
      • Badalona, Spain
        • ICO Badalona - Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain
        • ICO L'Hospitalet - Hospital Duran i Reynals
      • Cadiz, Spain
        • Hospita Universitario Puerta Del Mar
      • Cáceres, Spain
        • Hospital San Pedro de Alcantara
      • Córdoba, Spain
        • Hospital Universitario Reina Sofía
      • Lleida, Spain
        • Hospital Arnau de Vilanova
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain
        • MD Anderson Cancer Center
      • Salamanca, Spain
        • Hospital Universitario de Salamanca
      • Santander, Spain
        • Hospital Universitario Marqués de Valdecilla
      • Seville, Spain
        • Hospital Universitario Virgen Macarena
      • Seville, Spain
        • Hospital Universitario Virgen del Rocio
      • Seville, Spain
        • Hospital Universitario Virgen de Valme
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital
  • Taiwan
      • Kaohsiung City, Taiwan
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • Tri-Service General Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Ankara University Medical Faculty
      • Ankara, Turkey (Türkiye)
        • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
      • Ankara, Turkey (Türkiye)
        • Gazi University Medical Faculty
      • Istanbul, Turkey (Türkiye)
        • Amerikan Hospital
      • Istanbul, Turkey (Türkiye)
        • Iqvia Tibbi Istatistik
      • Istanbul, Turkey (Türkiye)
        • Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi
      • Istanbul, Turkey (Türkiye)
        • Istanbul University Medical Faculty
      • Izmir, Turkey (Türkiye)
        • Dokuz Eylul University Medical Faculty
      • Izmir, Turkey (Türkiye)
        • Ege University Medical Faculty
      • Tekirdağ, Turkey (Türkiye)
        • Tekirdag Namik Kemal University
      • Trabzon, Turkey (Türkiye)
        • Karadeniz Technical University
  • United Kingdom
      • Birmingham, United Kingdom
        • Haematology - University Hospitals Birmingham NHS Foundation Trust
      • London, United Kingdom
        • Hammersmith Hospital
      • London, United Kingdom
        • Guys and St Thomas NHS Foundation Trust
      • Norwich, United Kingdom
        • Norfolk and Norwich University Hospitals NHS Foundation Trust
      • Nottingham, United Kingdom
        • Nottingham University Hospitals NHS Trust
      • Plymouth, United Kingdom
        • Derriford Hospital
      • Southampton, United Kingdom
        • University Hospital Southampton
      • Sutton, United Kingdom
        • Royal Marsden NHS Foundation Trust (Sutton)
      • Truro, United Kingdom
        • Royal Cornwall Hospital
  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indiana Blood and Marrow Transplantation
      • Indianapolis, Indiana, United States, 46250
        • Community Health Network Cancer Center North
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Markey Cancer Center
    • Michigan
      • Jackson, Michigan, United States, 49201
        • Henry Ford Health System
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • MMCORC Attn Delaney Anderson
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • MD Anderson Cancer Center at Cooper
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • The Christ Hospital Cancer Center
      • Cincinnati, Ohio, United States, 45247
        • TriHealth Cancer Institute- Good Samaritan Hospital
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
    • Utah
      • Ogden, Utah, United States, 84405
        • Community Cancer Trials of Utah
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University (Vcu) Massey Cancer Center
    • Washington
      • Yakima, Washington, United States, 98902
        • North Star Lodge Cancer Center
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • Waukesha Memorial Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

  1. Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 monoclonal antibody (mAb)-containing combination chemotherapy since lymphoma diagnosis

  2. One of the confirmed histologies below with CD20-positivity:

    1. DLBCL, not otherwise specified (NOS), including de novo or histologically transformed from follicular lymphoma (FL)
    2. "Double-hit" or "triple-hit" DLBCL (technically classified in World Health Organization (WHO) 2016 as high-grade B-cell lymphoma (HGBCL), with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL
    3. FL Grade 3B
    4. T-cell/histiocyte-rich large B-cell lymphoma
  3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2
  4. Failed previous HDT-ASCT or not eligible for high-dose therapy autologous stem cell transplant (HDT-ASCT) at screening
  5. Participants must have detectable disease by positron emission tomography (PET) scan and measurable by computed tomography (CT) scan or magnetic resonance imaging (MRI)
  6. Acceptable renal and liver function
  7. Life expectancy >2 months on standard of care treatment

Main Exclusion Criteria:

  1. Primary Central Nervous System (CNS) tumor or known CNS involvement
  2. Any prior therapy with a bispecific antibody targeting CD3 and CD20
  3. Major surgery within 4 weeks prior to randomization
  4. Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
  5. Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
  6. Autologous stem cell transplant (ASCT) within 100 days of randomization
  7. Treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to randomization
  8. Seizure disorder requiring anti-epileptic therapy
  9. Clinically significant cardiac disease

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epcoritamab (GEN3013; DuoBody®CD3xCD20)
Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met
Biological: Epcoritamab
Following mandatory pre-medication, participants will be administered epcoritamab as a subcutaneous injection.
Other Names:
  • GEN3013
  • DuoBody®-CD3xCD20
  • EPKINLY™
Active Comparator: Investigator's choice of chemotherapy

R-GemOx will be administrated in Cycles of 28 days until maximum cycles completion or any of the discontinuation criteria is met

BR will be administrated in Cycles of 21 days until maximum cycles completion or any of the discontinuation criteria is met
Drug: Investigator's Choice Chemotherapy
Following mandatory pre-medication, participants will be administered intravenously either BR or R-GemOx.
Other Names:
  • BR or R-GemOx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 5 years
Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate (ORR)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Time to Response (TTR)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Duration of Response (DOR)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Progression Free Survival (PFS)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Number of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Complete Response (CR) Rate
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Duration of Minimal Residual Disease (MRD) Negative Status
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Rate of MRD Negative Status
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Time to Next Anti-lymphoma Therapy (TTNT)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Number of Participants with Dose Interruptions and Delays
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Number of Participants with an Anti-epcoritamab Antibody Response
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Changes from Baseline in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
Time Frame: Baseline up to approximately 5 years
Baseline up to approximately 5 years

Collaborators and Investigators

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

Sponsor

Genmab

Collaborators

AbbVie

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)

January 13, 2021

Primary Completion (Actual)

October 13, 2025

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

November 9, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCT3013-05
  • 2020-003016-27 (EudraCT Number)
  • jRCT2021220017 (Registry Identifier: Japan Registry for Clinical Trials (jRCT))
  • CTR20221558 (Registry Identifier: ChinaDrugTrials.org.cn)
  • MOH_2021-01-18_009672 (Registry Identifier: Clinical Research Site - mytrial)
  • 286972 (Other Identifier: IRAS ID; UK Research Summaries Database)
  • 2023-504830-23-00 (Ctis: EU CTIS)
  • NL75079.056.20 (Registry Identifier: CCMO (the Netherlands))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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