TAK-755-2001

Recruitment Complete

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

Clinicaltrials.gov

#NCT05714969

|

EU CTIS

#2023-507787-39-00

|

EudraCT

#2022-001940-36

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 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. 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.

US

ES

GR

5+

Interventional Phase 2 clinical trial.

What medical conditions were being studied?

Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)

What was the clinical trial testing?

TAK-755

How many participants were enrolled?

40

Were placebos part of the clinical trial?

No

When was the clinical trial conducted?

Mar 2023 - Mar 2025

How long was participation in the clinical trial?

Each participant may take part in the study for up to 12 weeks.

Sexes

All

Age

18+ Years

Healthy volunteers?

No

Both men and women can take part.

Must be adults 18 years or older.

Must have confirmed diagnosis of immune-mediated thrombotic thrombocytopenic purpura (iTTP).

Cannot have received more than 2 plasma exchange treatments before study start.

Cannot have had an iTTP event within 30 days of study start.

Cannot have congenital thrombotic thrombocytopenic purpura (cTTP).

Additional entry criteria will be discussed with the study doctor.

Primary outcome measures

Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Event of Special Interest (AESIs) After Receiving any Dose of Investigational Product (IP) [Time Frame: Through study completion, approximately 12 weeks]

Secondary outcome measures

Achievement of Clinical Response Without On-Study Plasma Exchange (PEX) [Time Frame: Through study completion, approximately 12 weeks]

Achievement of Clinical Response With Zero or Minimal on-Study PEX [Time Frame: Through study completion, approximately 12 weeks]

Achievement of Clinical Response Overall [Time Frame: Through study completion, approximately 12 weeks]

Time to Clinical Response (Acute Phase) [Time Frame: Through study completion, approximately 12 weeks]

Occurrence of Refractoriness (Acute Phase) [Time Frame: Through study completion, approximately 12 weeks]

Time to First On-Study PEX to Achieve Clinical Response [Time Frame: Through study completion, approximately 12 weeks]

Number of Days of On-study PEX in Participants Who Achieved Clinical Response (Acute Phase) [Time Frame: Through study completion, approximately 12 weeks]

Total Volume of Plasma Administered (Acute Phase) [Time Frame: Through study completion, approximately 12 weeks]

Occurrence of Treatment Failure [Time Frame: Through study completion, approximately 12 weeks]

Occurrence of Immune-Mediated Thrombotic Thrombocytopenic Purpura (iTTP) Recurrence, Exacerbation, or Relapse (Post-acute Phase) [Time Frame: Through study completion, approximately 12 weeks]

Time to iTTP Recurrence, Exacerbation, or Relapse [Time Frame: Through study completion, approximately 12 weeks]

Occurrence of any one of the following events: Clinical Recurrence, iTTP-Related Death, or Major Thromboembolic Event From Time of First IP Administration Through Study Completion [Time Frame: Through study completion, approximately 12 weeks]

Time to Occurrence of Any One of the Following Events: Clinical Recurrence, iTTP-Related Death, or Major Thromboembolic Event From Time of First IP Administration Through Study Completion [Time Frame: Through study completion, approximately 12 weeks]

Change From Baseline in Lactate Dehydrogenase [LDH] Levels at Clinical Response and Study Completion [Time Frame: Through study completion, approximately 12 weeks]

Change From Baseline in Troponin Levels at Clinical Response and Study Completion [Time Frame: Through study completion, approximately 12 weeks]

Achievement of Clinical Remission [Time Frame: Through study completion, approximately 12 weeks]

A Disintegrin and Metalloproteinase With Thrombospondin Motifs 13 (ADAMTS13) Antigen Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases [Time Frame: Through study completion, approximately 12 weeks]

ADAMTS13 Activity Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases [Time Frame: Through study completion, approximately 12 weeks]

Von Willebrand Factor (VWF) Antigen Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases [Time Frame: Through study completion, approximately 12 weeks]

VWF Activity Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases [Time Frame: Through study completion, approximately 12 weeks]

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

About this clinical trial

At a glance