A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)

Last updated: June 10, 2025
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

TAK-755

Clinical Study ID

NCT05714969
TAK-755-2001
2023-507787-39-00
2022-001940-36
  • Ages > 18
  • All Genders

Study Summary

This is a study of TAK-755 in adults with immune-mediated thrombotic thrombocytopenic purpura (iTTP). The main aim of this study is to determine the percentage of participants with a clinical (Part 1) or platelet (Part 2) response without plasma exchange during the study. Participants who have an acute attack of iTTP will receive TAK-755 and immunosuppressive therapy during their stay at the hospital until they achieve a clinical response in Part 1 or platelet response in Part 2. Participants will also be treated with TAK-755 for an additional time of up to 6 weeks after the acute phase. In total, participants will stay in the study for approximately 3 months.

Eligibility Criteria

Inclusion

Key Inclusion Criteria (Part 1 and Part 2)

  1. Participant must provide a signed informed consent form. A fully recognized proxy may be used per local laws for participants unable to provide consent.

  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.

Key Exclusion Criteria (Part 1 and Part 2)

  1. Participant has received more than 2 pre-study PEX prior to randomization in Part 1 or first dose of investigational product in Part 2.

  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.

Study Design

Total Participants: 33
Treatment Group(s): 1
Primary Treatment: TAK-755
Phase: 2
Study Start date:
March 21, 2023
Estimated Completion Date:
June 11, 2026

Study Description

This study consists of 2-parts. Part 1 is a double-blind, randomized study in which participants were randomized 1:1, in a blinded fashion, into 2 TAK-755 dose groups. Part 1, randomization was stratified based on whether the participant had received pre-study PEX and on the participant's Glasgow Coma Scale. Part 2 is an open-label study in which participants with iTTP experiencing an acute iTTP episode will be enrolled and assigned to a single-arm treatment.

Connect with a study center

  • Clinica Zabala

    Buenos Aires,
    Argentina

    Site Not Available

  • Hospital Universitario Austral

    Buenos Aires,
    Argentina

    Site Not Available

  • AKH- Medizinische Universitat Wien

    Vienna,
    Austria

    Site Not Available

  • London Health Sciences Centre

    London, Ontario
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto, Ontario
    Canada

    Site Not Available

  • University Health Network

    Toronto, Ontario
    Canada

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, 45147
    Germany

    Site Not Available

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt, 60590
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln

    Koeln, 50937
    Germany

    Site Not Available

  • General Hospital Of Athens Laiko

    Athens,
    Greece

    Site Not Available

  • University Hospital of Patra

    Patra,
    Greece

    Site Not Available

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloniki,
    Greece

    Site Not Available

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan,
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

    Torino,
    Italy

    Site Not Available

  • Instytut Hematologii i Transfuzjologii

    Warszawa,
    Poland

    Site Not Available

  • Hospital de Cruces

    Barakaldo,
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla,
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    Valencia,
    Spain

    Site Not Available

  • Hospital Universitario Dr. Peset

    Valencia,
    Spain

    Site Not Available

  • Royal Liverpool University Hospital

    Liverpool,
    United Kingdom

    Site Not Available

  • University College London Hospital

    London,
    United Kingdom

    Site Not Available

  • University of Florida Shands

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University if Minnesota Med CAR

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Rutgers University

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Weill Cornell Medical College New York Presbyterian Hospital

    New York, New York 10021
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Leo Jenkins Cancer Center/ECU School of Medicine

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84106
    United States

    Site Not Available

  • Versiti Clinical Trials and Research Office

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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