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New drug could reduce need for plasma exchange in rare blood disorder

NCT ID NCT05714969

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called TAK-755 in 29 adults with a rare blood clotting disorder called immune-mediated thrombotic thrombocytopenic purpura (iTTP). The goal was to see if TAK-755, along with standard immune-suppressing drugs, could control the disease with little or no plasma exchange (a procedure that cleans the blood). Participants received TAK-755 during an acute attack and for up to 6 weeks afterward, and were monitored for about 3 months for safety and response.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

29 people

The number who actually took part.

Started

Jul 2023

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acquired thrombotic thrombocytopenic purpura thrombotic thrombocytopenic purpura

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thrombotic thrombocytopenic purpura (TTP)

Contacts and locations

Locations

  • AKH - Medizinische Universitat Wien

    Vienna, 1090, Austria

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

    Torino, 10126, Italy

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloniki, 57010, Greece

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Sevilla, 41010, Spain

  • Hospital de Cruces

    Barakaldo, Vizcaya, 48903, Spain

  • Leo Jenkins Cancer Center/ECU School of Medicine

    Greenville, North Carolina, 27858, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Royal Liverpool University Hospital

    Liverpool, Merseyside, L7 8XP, United Kingdom

  • Rutgers University

    New Brunswick, New Jersey, 08901, United States

  • University College London Hospital

    London, Greater London, NW1 2PG, United Kingdom

  • University of Florida - Shands

    Gainesville, Florida, 32610, United States

  • University of Minnesota Clinical Research Unit

    Minneapolis, Minnesota, 55455, United States

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84132, United States

  • Versiti Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226, United States

  • Weill Cornell

    New York, New York, 10021, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.