Multiple MyelomaPhase 3NCT06980480
A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma
A Phase 3 study testing IGI, 10% in people with Multiple Myeloma and Secondary Immunodeficiency, run by Takeda at 65 sites in 17 countries.
Trial summary
Multiple myeloma is a cancer of the plasma cells in the bone marrow. The main aim of this study is to learn how well the Immune Globulin Infusion (human), 10 percentage (%) (IGI, 10%) can help prevent infections in participants with multiple myeloma receiving B-cell maturation antigen (BCMA) x cluster of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Secondary Immunodeficiency
- What is being tested?
- IGI, 10%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 65 sitesin 17 countries
- Study dates
- 14 Jan 2026to 11 Sep 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participants must have a documented diagnosis of Multiple Myeloma (MM) according to the guidelines by the International Myeloma Working Group (IMWG) before enrollment.
- Participant who recently started teclistamab monotherapy within the first 8 weeks of their planned treatment schedule and are planned to receive teclistamab for the next 12 months.
- The participant has provided informed consent (that is, in writing, documented via a signed and dated Informed Consent Form [ICF]) and any required privacy authorization before the initiation of any study procedures.
- The participant is at least 18 years of age at the time of signing the ICF.
- If a person of childbearing potential engages in sexual relations that carry risk of pregnancy, they agree to the following for the period from screening until 30 days after the last dose of study drug:
- To use a highly effective contraceptive method.
- To avoid donating ova.
Who cannot join
- The participant has not achieved at least a minimal response to teclistamab during the screening period after signing the ICF and within 8 weeks of the first step-up dose of teclistamab.
- The participant has a current serious infection or greater than (>) 1 serious infection in the past 3 months before screening.
- The participant has a documented polyclonal IgG level less than (<) 150 milligrams per deciliter (mg/dL) at the most recent assessment before teclistamab initiation (within 4 weeks) as assessed by the investigator according to the site's standard practice.
- The participant is currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening.
- The participant has received a hyperimmune or specialty high-titer immunoglobulin product (example, cytomegalovirus immune globulin, varicella-zoster immune globulin, hepatitis B immune globulin) within 30 days before screening.
- The participant has received live viral vaccines within 30 days before screening.
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- The participant has an Eastern Cooperative Oncology Group performance status score of >2.
- The participant has an active viral or bacterial infection or symptoms/signs of such an infection requiring treatment with anti-infectives within 1 week before enrollment.
- The participant has received other B Cell Maturation Antigen (BCMA)*Cluster of Differentiation (CD3)-directed Bispecific Antibody therapy (BsAb), BCMA-targeted chimeric antigen receptor T-cell (CAR T-cell), or BCMA-targeted antibody drug conjugate (ADC) therapy within 1 year prior to screening.
- The participant is scheduled to undergo plasmapheresis during the course of study or has undergone plasmapheresis in the last 16 weeks before screening.
- The participant may be excluded from the study if, in the opinion of the investigator, the participant is at high risk for symptomatic hyperviscosity syndrome.
- The participant has major surgery scheduled during the study, or the participant has not fully recovered from a recent major surgery (as judged by the investigator) during screening (participants with planned surgical procedures to be conducted under local anesthesia may participate).
- The participant has an active secondary (non-MM) malignancy or other medical condition with life-expectancy of less than (<) 2 years.
- The participant has a known history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) after Intravenous Immunoglobulin (IVIG) and/or immune serum globulin infusions.
- The participant has a known history or current diagnosis of thromboembolic episodes such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease within 6 months before screening.
- The participant has moderate to severe renal dysfunction based on an estimated glomerular filtration rate less than (<) 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2), as defined by kidney disease: Improving Global Outcomes Clinical Practice Guideline for the Management of Glomerular Diseases, 2021 at the time of screening.
- The participant has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen, Polymerase Chain Reaction (PCR) for hepatitis C virus, PCR for Human Immunodeficiency Virus (HIV) Type 1 and Type 2. Cured participants with a history of hepatitis C infection who have a negative PCR test at screening are eligible.
- The participant has a documented diagnosis of a form of primary immunodeficiency (PID) involving a defect in antibody formation and requiring IgG replacement, as defined according to the International Union of Immunological Societies Committee.
- The participant has a persistent serum aspartate aminotransferase and alanine aminotransferase >3.0 times the upper limit of normal (ULN) at screening (may be repeated once to determine if it is persistent).
- The participant has an immunoglobulin A (IgA) deficiency (<0.07 grams per liter [g/L]) with antibodies to IgA and a history of hypersensitivity reaction to IVIG.
- Participant with a known systemic hypersensitivity to any of the excipients of IGI, 10% in accordance with the investigator's brochure/package insert/Summary of Product Characteristics.
- Known substance abuse including opiates, psychostimulant agents, or other illicit drugs with the exception of cannabinoids within 12 months of screening.
- The participant has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site, at the discretion of the investigator (may be repeated once to determine if it has resolved).
- The participant has a medical condition, laboratory finding, or physical examination finding that precludes participation or with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with the successful completion of the study or place the participant at undue medical risk.
- The participant is receiving immunosuppressive treatment (other than for MM or corticosteroids) at screening or plans to receive immunosuppressive treatment after study enrollment.
- The participant is not willing and able to comply with the protocol requirements.
- The participant has participated or is scheduled to participate in another clinical study involving an investigational product (IP) or investigational device within 30 days before screening and during the course of the study.
- The participant is a family member or employee of the investigator or the investigator's site staff.
- The participant is pregnant or has a positive pregnancy test or is lactating at the time of screening or enrollment.
Trial locations and contacts
65 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
65 sites in 17 countries
United States7 sites, 7 recruiting
- Recruiting
New York Oncology Hematology
Albany, New York, 12208
Site Contact, 518-262-6696, Courtney.bellomo@nyoh.com
Courtney Marie Bellomo
- Recruiting
University of Maryland | Greenebaum Cancer Center
Baltimore, Maryland, 21201
Site Contact, 410-328-6842, mkocoglu@umm.edu
Mehmet Kocoglu
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Site Contact, 313-916-2772, pkuriak1@hfhs.org
Philip Kuriakose
- Recruiting
Infirmary Health - Diagnostic & Medical Clinic (DMC)
Mobile, Alabama, 36604
Site Contact, 251-435-5710, furhan.yunus@infirmaryhealth.org
Furhan Yunus
- Recruiting
Chao Family Comprehensive Cancer Center UCI
Orange, California, 92868
Site Contact, enelson@uci.edu
Edward Nelson
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63141
Site Contact, 314-454-8304, markschroeder@wustl.edu
Mark Schroeder
- Recruiting
University of Kansas
Westwood, Kansas, 66205
Site Contact, jkort@kumc.edu
Jeries Kort
Australia7 sites, 7 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Site Contact, cindy.lee3@sa.gov.au
Cindy Lee
- Recruiting
Townsville Hospital
Douglas, Queensland, 4814
Site Contact, hock.lai@health.qld.gov.au
Hock-Choong Lai
- Recruiting
Greenslopes Private Hospital
Greenslopes, Queensland, 4120
Site Contact, tzuyang@gmail.com
Tzu-Yang Wang
- Recruiting
St George Private Hospital
Kogarah, New South Wales, 2217
Site Contact, 02 9113 3425, shirjing.ho@health.nsw.gov.au
Shir-Jing Ho
- Recruiting
St Vincents Hospital Melbourne
Melbourne, 3065
Site Contact, hang.quach@svha.org.au
Hang Quach
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Site Contact, Paul.Cannell@health.wa.gov.au
Paul Cannell
- Recruiting
Western Health - Sunshine Hospital
St Albans, Victoria, 3021
Site Contact, william.renwick@wh.org.au
William Renwick
Spain7 sites, 7 recruiting
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
Site Contact, eanguita@ucm.es
Eduardo Anguita Mandly
- Recruiting
Universidad Complutense de Madrid (UCM)-Hospital Universitario 12 de Octubre (H12O)
Madrid, 28041
Site Contact, jmarti01@med.ucm.es
Joaquin Martinez Lopez
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Site Contact, lopguia@gmail.com
Ana Lopez de la Guia
- Recruiting
Hospital Costa Del Sol
Marbella, 29603
Site Contact, 951976776, Mariacasanova@yahoo.com
Maria Casanova
- Recruiting
Hospital Universitari Son Espases (HUSE) (Hospital Universitario Son Dureta) (HUSD)
Palma de Mallorca, 07120
Site Contact, 34871205000 ex:65122, albert.perez@ssib.es
Albert Perez Montana
- Recruiting
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, 37007
Site Contact, mvmateos@usal.es
Maria Victoria Mateos Manteca
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Site Contact, delarubia_jav@gva.es
Javier de la Rubia Comos
United Kingdom6 sites, 6 recruiting
- Recruiting
Cardiff & Vale University Health Board
Cardiff, South Glamorgan, CF14 4XU
Site Contact, 07538800643, Ceri.Bygrave@wales.nhs.uk
Ceri Bygrave
- Recruiting
Colchester General Hospital
Colcester, Essex, CO4 5JL
Site Contact, KhalidFahad.Saja@esneft.nhs.uk
Khalid Saja
- Recruiting
Royal Devon And Exeter Hospital
Exeter, Devon, EX2 5DH
Site Contact, 01392406210, l.ngu@nhs.net
Loretta Ngu
- Recruiting
Gloucestershire Royal Hospital
Gloucester, Gloucestershire, GL1 3NN
Site Contact, 03004225246, asha.johny@nhs.net
Asha Johny
- Recruiting
Milton Keynes University Hospital NHS Foundation Trust
Milton Keynes, MK6 5LD
Site Contact, kunaal.kaushik@mkuh.nhs.uk
Kunaal Kaushik
- Recruiting
County Hospital (Stafford Hospital)
Stafford, ST16 3SA
Site Contact, 01782671095, kamaraj.karunanithi@uhns.nhs.uk
Kamaraj Karunanithi
Brazil5 sites, 5 recruiting
- Recruiting
Centro de Hematologia e Oncologia (CHO)
Joinville, Santa Catarina, 89201-260
Site Contact, marcelolacerda001@gmail.com
Marcelo Pitombeira de Lacerda
- Recruiting
Sao Jose do Rio Preto Regional Faculty of Medicine FoundationSao Jose do Rio Preto Regional Faculty of Medicine Foundation
Porto Alegre, 90110-270
Site Contact, marcelocapra@hotmail.com
Marcelo Capra
- Recruiting
Instituto Oncoclínicas de Ensino
Rio de Janeiro, 22250040
Site Contact, mnucci@hucff.ufrj.br
Marcio Nucci
- Recruiting
Instituto D'Or de Pesquisa e Ensino
Salvador, 41253-190
Site Contact, edvan.crusoe@oncologiador.com.br
Edvan Crusoe
- Recruiting
Instituto D'Or de Pesquisa e Ensino - Sao Paulo
São Paulo, 01401-002
Site Contact, abel.neto@oncologiador.com.br
Abel Neto
Italy5 sites, 5 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco
Catania, 95124
Site Contact, diraimon@unict.it
Francesco Di Raimondo
- Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, 27100
Site Contact, silvia_mangiacavalli@hotmail.com
Silvia Mangiacavalli
- Recruiting
Azienda Sanitaria Locale di Pescara Ospedale Civile Dello Spirito Santo
Pescara, 65125
Site Contact, carmine.liberatore@asl.pe.it
Carmine Liberatore
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, 161
Site Contact, petrucci@bce.uniroma1.it
Maria Petrucci
- Recruiting
Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
Torrette, 60126
Site Contact, massimo.offidani@ospedaliriuniti.marche.it
Massimo Offidani
Romania5 sites, 5 recruiting
- Recruiting
Colentina Clinical Hospital
Bucharest, 020125
Site Contact, tevetmihaela@gmail.com
Mihaela Andreescu
- Recruiting
Institutul Clinic Fundeni
Bucharest, 22328
Site Contact, sorinabadelita@gmail.com
Sorina Badelita
- Recruiting
Coltea Clinical Hospital
Bucharest, 30171
Site Contact, gabriex2001@yahoo.it
Gabriela Borsaru
- Recruiting
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, 400015ro
Site Contact, ciprian.tomuleasa@gmail.com
Ciprian Tomuleasa
- Recruiting
Spitalul Municipal Filantropia Craiova
Craiova, 200143
Site Contact, diaconu_luminita@yahoo.com
Luminita Ocroteala
Denmark4 sites, 4 recruiting
- Recruiting
Aalborg Hospital
Aalborg, 9000
Site Contact, henrik.gregersen@rn.dk
Henrik Gregersen
- Recruiting
Aarhus Universitetshospital
Aarhus, DK-820
Site Contact, majavase@rm.dk
Maja Vase
- Recruiting
Copenhagen University Hospital
Copenhagen, 2100
Site Contact, agoston.gyula.szabo@regionh.dk
Agoston Szabo
- Recruiting
Odense Universitetshospital
Odense, 5000
Site Contact, ida.bruun.kristensen@rsyd.dk
Ida Bruun Kristensen
Austria3 sites, 3 recruiting
- Recruiting
A O Krankenhaus der Elisabethinen
Linz, 4020
Site Contact, irene.strassl@ordensklinikum.at
Irene Strassl
- Recruiting
Universitaetsklinikum St. Poelten
Sankt Pölten, 3100
Site Contact, 43 2742 9004 22181, petra.pichler@stpoelten.lknoe.at
Petra Pichler
- Recruiting
Krankenhaus der Barmherzigen Schwestern Wien
Vienna, 1060
Site Contact, evamaria.autzinger@bhs.at
Eva Maria Autzinger
Hungary3 sites, 3 recruiting
- Recruiting
University of Debrecen DEOEC
Debrecen, 4012
Site Contact, illesarpaddr@gmail.com
Arpad Illes
- Recruiting
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
Site Contact, 368250341, rajnicsp@hotmail.com
Peter Rajnics
- Recruiting
Markusovszky Egyetemi Oktatokorhaz
Szombathely, 9700
Site Contact, planderm@yahoo.com
Mark Plander
Norway3 sites, 3 recruiting
- Recruiting
Helse Nord-Troendelag Thrust
Levanger, 7600
Site Contact, Vidar.Stavseth@helse-nordtrondelag.no
Vidar Stavseth
- Recruiting
Akershus University Hospital
Lorenskog, 1478
Site Contact, anette.loken.eilertsen@ahus.no
Anette Eilertsen
- Recruiting
St.Olavs Hospital
Trondheim, 7491
Site Contact, tobias.s.slordahl@ntnu.no
Tobias Schmidt Slordahl
Canada2 sites, 2 recruiting
- Recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0A9
Site Contact, hugo.chapdelaine.chum@ssss.gouv.qc.ca
Hugo Chapdelaine
- Recruiting
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9
Site Contact, rkotb@cancercare.mb.ca
Rami Kotb
Greece2 sites, 2 recruiting
- Recruiting
Alexandra General Hospital of Athens
Athens, 105 57
Site Contact, mdimop@med.uoa.gr
Meletios-Athanasios Dimopoulos
- Recruiting
University General Hospital of Ioannina
Ioannina, 45500
Site Contact, ehatzim@me.com
Eleftheria Hatzimichael
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam University Medical Center (Amsterdam UMC)
Amsterdam, 1019PE
Site Contact, n.vandedonk@vumc.nl
Niels Van de Donk
- Recruiting
St. Antonius Ziekenhuis
Nieuwegein, 3435
Site Contact, i.nijhof@antoniusziekenhuis.nl
Inger Nijhof
Poland2 sites, 2 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne - Ul. Smoluchowskiego 17
Gdansk, 80-214
Site Contact, atyczynska@uck.gda.pl
Agata Tyczynska
- Recruiting
Aidport sp. z o.o.
Skorzewo, 60-185
Site Contact, michal.kwiatek@aidport.pl
Michal Kwiatek
Czechia1 site, 1 recruiting
- Recruiting
Fakultni Nemocnice Ostrava (FNO) - Neurologicke klinika
Ostrava, 70800
Site Contact, roman.hajek@fno.cz
Roman Hajek
Israel1 site, 1 recruiting
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 91031
Site Contact, nirw@szmc.org.il
Nir Weigert
About this study
Official title: A Multicenter, Randomized, Controlled, Open-label, Group-Sequential, Phase 3 Study to Investigate the Efficacy, Safety, and Tolerability of Intravenous Gammagard Liquid (Immune Globulin Infusion, 10%) for Primary Infection Prophylaxis Compared With Secondary Infection Prophylaxis in Adult Subjects With Multiple Myeloma Receiving B-Cell Maturation AntigenxCD3-Directed Bispecific Antibody Therapy
Multiple myeloma is a cancer of the plasma cells in the bone marrow.
The main aim of this study is to learn how well the Immune Globulin Infusion (human), 10 percentage (%) (IGI, 10%) can help prevent infections in participants with multiple myeloma receiving B-cell maturation antigen (BCMA) x cluster of differentiation 3 (CD3) directed bispecific antibody therapy.
Read more
Participants will be randomly assigned to one of two groups:
- Primary infection prevention group: They will receive IGI, 10% for 12 months.
- Secondary infection prevention group: They will only receive IGI, 10% if they develop a serious infection during the 12 months study period.
During the study, participants will visit their study clinic 15 times (for 4-week dosing interval) or 19 times (for 3-week dosing interval) and their total participation duration will be up to 14 months (including screening period approximately 8 weeks).
- Conditions
- Multiple Myeloma, Secondary Immunodeficiency
- Being tested
- IGI, 10%
- Keywords
- Drug Therapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGI, 10%Biological
Also called TAK-339, Gammagard Liquid, KIOVIG
IGI, 10% IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Primary Infection Prophylaxis: IGI, 10% | Experimental | Participants randomized to primary infection prophylaxis will receive a 400 milligrams per kilogram (mg/kg) dose of IGI, 10% in accordance with the standard of care (SOC), intravenously (IV) every 3 or 4 weeks within 3 days after randomization up to 12 months. Receives: Biological: IGI, 10% |
| Secondary Infection Prophylaxis: IGI, 10% | Active comparator | Participants randomized to secondary infection prophylaxis will receive a 400 mg/kg dose of IGI, 10% in accordance with the SOC, IV every 3 or 4 weeks only after experiencing at least one serious infection, as determined by the investigator, for the remainder of the 12 months observational period. Receives: Biological: IGI, 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To the First Serious Infection
Measured: Up to 12 months
Secondary outcomes (23)
Number of Participants With at Least 1 Serious Infection
Measured: Up to 12 months
Annualized Rate of Days on Antibiotics for Treatment of Bacterial Infections
Measured: Up to 12 months
Annualized Rate of Bacterial Infections
Measured: Up to 12 months
Annualized Rate of Serious Infections
Measured: Up to 12 months
Annualized Rate of Acute Serious Bacterial Infections (ASBIs)
Measured: Up to 12 months
Number of Participants With Any Infections
Measured: Up to 12 months
Duration of Infections
Measured: Up to 12 months
Time To Any First Infection
Measured: Up to 12 months
Annualized Rate of Any Infections
Measured: Up to 12 months
Number of Participants With Bacterial/Viral Infection/Fungal Infection
Number of participants with bacterial/viral infection, including covid/fungal infection diagnosed clinically and via microbiology (culture, polymerase chain reaction [PCR], other imaging will be reported.
Measured: Up to 12 months
Annualized Rate of Episodes of Fever due to Infections
Measured: Up to 12 months
Total Immunoglobulin G (IgG) Levels in Serum
Measured: 3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) Levels in Serum
Measured: 3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
Antigen-specific Antibody Levels in Serum
Measured: 3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
Number of Participants With Adverse Event (AEs) and Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to 12 months
Number of Participants With TEAEs Related to IGI, 10%
Measured: Up to 12 months
Number of Participants With TEAEs Temporally Associated to the IGI, 10% Within 72 hours of Administration
Measured: Within 72 hours of IGI, 10% administration (up to 12 months)
Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TEAEs Related to IGI, 10%
Measured: Up to 12 months
Number of Participants With at Least 1 Hospitalization due to Infection
Measured: Up to 12 months
Number of Hospitalizations, Including Intensive Care Unit (ICU) and Non-ICU due to Infection
Measured: Up to 12 months
Number of Participants With Outpatient Visits, Including Emergency Room (ER) Visits due to Infection
Measured: Up to 12 months
Duration of Hospitalizations, Including ICU and Non-ICU due to Infection
Measured: Up to 12 months
Number of Days of Hospitalization per Participant-year, Including ICU and Non-ICU due to Infection or Other Reasons
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start14 Jan 2026
- Primary completion11 Sep 2028 (estimated)
- Study completion11 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc., Baxalta Innovations GmbH, now part of Takeda
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980480
- Sponsor's protocol ID
- TAK-339-3001
- Other IDs
- 2024-518420-80-00
- Status last verified
- Oct 2026
- First submitted
- 13 May 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.