A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Part of paid clinical trials in Los Angeles, California.

Sponsor
Takeda
Study ID
NCT06948318
Phase
PHASE3
Status
Recruiting
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Conditions

  • Immune Thrombocytopenic Purpura (ITP)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mezagitamab — DRUG
    Mezagitamab injection administered SC.

Study Details

Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a lower number of platelets, making it easier to bruise or bleed. The main aim of this study is to check how safe mezagitamab is and how well it is tolerated by adults with chronic primary ITP, if given over a longer time. Other aims are to learn how effective treatment with mezagitamab is and how the body processes it (called pharmacokinetics or PK) over a longer time. Participants of the following previous mezagitamab studies will be invited to join this continuation study: TAK-079-3002 and TAK-079-1004. In this continuation study, participants will receive mezagitamab when certain protocol criteria are met. During the study, participants will visit their study clinic several times.

Key Dates

Start date
Aug 14, 2025
Status verified
Jun 2026
Primary completion
Jul 29, 2029
Completion
Jul 29, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mezagitamab
    Eligible participants who completed the TAK-079-3002 or TAK-079-1004 studies can receive on-demand treatment in this continuation study. The on-demand treatment course may be repeated as needed based on the pre-specified on-demand dosing criteria and investigator's clinical judgement.

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [ Time Frame: Up to approximately 108 weeks ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer Center - Keck Medicine of USCLos AngelesCalifornia90033
Site Contact
Howard Liebman (PRINCIPAL_INVESTIGATOR)
Rocky Mountain Cancer CenterDenverColorado80218-
Georgetown University Medical Center - Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007
Site Contact
Catherine Broome (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30308
Site Contact
Ana Antun (PRINCIPAL_INVESTIGATOR)
The University of IowaIowa CityIowa52242
Site Contact
Steven Lentz (PRINCIPAL_INVESTIGATOR)
University Of Louisville Brown Cancer CenterLouisvilleKentucky40202
Site Contact
Kamila Cisak (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Site Contact
David Kuter (PRINCIPAL_INVESTIGATOR)
University of Massachusetts Chan Medical SchoolWorcesterMassachusetts01655
Site Contact
Daniel Winokur (PRINCIPAL_INVESTIGATOR)
Duke University HospitalDurhamNorth Carolina27710
Site Contact
Ara Metjian (PRINCIPAL_INVESTIGATOR)
East Carolina UniversityGreenvilleNorth Carolina27837
Site Contact
Darla Liles (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Site Contact
Joseph Shatzel (PRINCIPAL_INVESTIGATOR)
Lewis Katz School of Medicine at Temple UniversityPhiladelphiaPennsylvania19140
Site Contact
Michael Bromberg (PRINCIPAL_INVESTIGATOR)
Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders ProgramPhiladelphiaPennsylvania19104
Site Contact
Adam Cuker (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Site Contact
Senthil Sukumar (PRINCIPAL_INVESTIGATOR)
Virginia Oncology AssociatesNorfolkVirginia23502
Site Contact
Bremer Celeste (PRINCIPAL_INVESTIGATOR)
University of WashingtoSeattleWashington98109
Site Contact
Sandhya Panch (PRINCIPAL_INVESTIGATOR)
Versiti Wisconsin, IncMilwaukeeWisconsin53226
Site Contact
Lisa Kreuziger (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
USC Norris Comprehensive Cancer Center - Keck Medicine of USC· Los Angeles, CARocky Mountain Cancer Center· Denver, COGeorgetown University Medical Center - Lombardi Comprehensive Cancer Center· Washington D.C., DCEmory University· Atlanta, GAThe University of Iowa· Iowa City, IAUniversity Of Louisville Brown Cancer Center· Louisville, KY

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