A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
NCT ID: NCT05714969
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
33 participants
INTERVENTIONAL
2023-03-21
2026-06-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part 1: TAK-755 Dose 1 in Acute Phase and Dose 2 in Post-acute Phase
TAK-755 Dose 1, IV infusion, in the acute phase until clinical response is achieved. All participants achieving clinical response will receive TAK-755 at Dose 2, for up to 6 weeks during the post-acute phase.
TAK-755
TAK-755 IV infusion
Part 1: TAK-755 Dose 2 in Both Acute and Post-Acute Phase
TAK-755 Dose 2, IV infusion, in the acute phase until clinical response is achieved. All participants achieving clinical response will receive TAK-755 at Dose 2, for up to 6 weeks during the post-acute phase.
TAK-755
TAK-755 IV infusion
Part 2: TAK-755 Dose 3 in Acute Phase and Dose 2 in Post-acute Phase
TAK-755 Dose 3, IV infusion, in the acute phase until 48-hour platelet response is achieved. All participants achieving platelet response will receive TAK-755 at Dose 2, 4 times per week for Week 1 and 3 times per week for Week 2 and 3 during the post-acute phase based on investigator judgement as high-risk for developing iTTP recurrence.
TAK-755
TAK-755 IV infusion
Interventions
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TAK-755
TAK-755 IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant is 18 years or older at time of screening.
3. Participant has been diagnosed with de novo or relapsed iTTP.
4. Participant must be willing to fully comply with study procedures and requirements.
5. Female participants of childbearing potential must present with a negative pregnancy test and agree to employ highly effective birth control measures for duration of study. Sexually active male participants must agree to use an effective method of contraception for the duration of the study.
Exclusion Criteria
2. Participant has been diagnosed with cTTP or another cause of thrombotic microangiopathy (TMA).
3. Participant has been exposed to another investigational product within 30 days prior to enrollment or is scheduled to participate in another clinical study involving investigational product or investigational device during the course of the study.
4. Participant has received caplacizumab within 30 days prior to study enrollment.
5. Participant has had a previous iTTP event within the past 30 days.
6. Participant is positive for human immunodeficiency virus (HIV) with unstable disease or cluster of differentiation (CD)4+ count ≤200 cells/mm\^3 within 3 months of screening.
7. Participant has condition of severe immunodeficiency.
8. Participant has a severe systemic acute infection.
9. Participant has another underlying progressive fatal disease and/or life expectancy \<3 months.
10. Participant is identified by the investigator as being unable or unwilling to cooperate with study procedures.
11. Participant is pregnant or lactating.
12. Participant has any condition in which methylprednisolone or other steroid equivalent is contraindicated as per prescribing information.
13. Participant has known life-threatening hypersensitivity reaction, including anaphylaxis, to the parent molecule ADAMTS13, Chinese hamster ovary (CHO) cell proteins, or other constituents of TAK-755.
18 Years
ALL
No
Sponsors
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Takeda Development Center Americas, Inc.
INDUSTRY
Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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University of Florida - Shands
Gainesville, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Minnesota Clinical Research Unit
Minneapolis, Minnesota, United States
Rutgers University
New Brunswick, New Jersey, United States
Weill Cornell
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Leo Jenkins Cancer Center/ECU School of Medicine
Greenville, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Versiti Wisconsin, Inc.
Milwaukee, Wisconsin, United States
AKH - Medizinische Universitat Wien
Vienna, , Austria
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, , Greece
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, , Italy
Hospital Universitario Virgen del Rocio
Seville, Sevilla, Spain
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
University College London Hospital
London, Greater London, United Kingdom
Royal Liverpool University Hospital
Liverpool, Merseyside, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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To obtain more information on the study, click here/on this link.
Other Identifiers
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2023-507787-39-00
Identifier Type: CTIS
Identifier Source: secondary_id
TAK-755-2001
Identifier Type: -
Identifier Source: org_study_id
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