Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05714969
Other study ID # TAK-755-2001
Secondary ID 2022-001940-36
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 21, 2023
Est. completion date March 15, 2025

Study information

Verified date March 2024
Source Takeda
Contact Takeda Contact
Phone +1-877-825-3327
Email medinfoUS@takeda.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 15, 2025
Est. primary completion date March 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria 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 1. Participant has received more than 2 pre-study PEX prior to randomization. 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


Related Conditions & MeSH terms


Intervention

Biological:
TAK-755
TAK-755 IV infusion

Locations

Country Name City State
Argentina Clinica Zabala Buenos Aires
Argentina Hospital Universitario Austral Buenos Aires
Austria AKH- Medizinische Universitat Wien Vienna
Greece General Hospital Of Athens Laiko Athens
Greece University Hospital of Patra Patra
Greece General Hospital of Thessaloniki "G. Papanikolaou" Thessaloniki
Italy Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico Milan
Italy Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino Torino
Poland Instytut Hematologii i Transfuzjologii Warszawa
Spain Hospital de Cruces Barakaldo
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Universitario Virgen del Rocio Sevilla
Spain Hospital Universitari i Politecnic La Fe Valencia
Spain Hospital Universitario Dr. Peset Valencia
United Kingdom Royal Liverpool University Hospital Liverpool
United States Brigham and Women's Hospital Boston Massachusetts
United States Ohio State University Columbus Ohio
United States Duke University Medical Center Durham North Carolina
United States University of Florida Shands Gainesville Florida
United States Leo Jenkins Cancer Center/ECU School of Medicine Greenville North Carolina
United States Versiti Clinical Trials and Research Office Milwaukee Wisconsin
United States University if Minnesota Med CAR Minneapolis Minnesota
United States University of Minnesota Minneapolis Minnesota
United States Rutgers University New Brunswick New Jersey
United States Weill Cornell Medical College New York Presbyterian Hospital New York New York
United States University of Utah Salt Lake City Utah

Sponsors (2)

Lead Sponsor Collaborator
Takeda Takeda Development Center Americas, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Greece,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Event of Special Interest (AESIs) After Receiving any Dose of Investigational Product (IP) An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. SAE: Signs, symptoms or outcomes which results in death, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event. Adverse events of special interest include thromboembolic events and treatment-related bleeding events. Through study completion, approximately 12 weeks
Secondary Achievement of Clinical Response Without On-Study Plasma Exchange (PEX) Clinical response is defined as normalization of platelets and no clinical evidence of new or progressive ischemic organ injury. Normalization of platelets: First occurrence of normal platelet count (=150,000/microliter [µL]) that is followed by a confirmatory platelet count of =150,000/µL and a lactate dehydrogenase (LDH) <1.5×upper limit of normal (ULN) at 48±12 hours after the first occurrence. Through study completion, approximately 12 weeks
Secondary Achievement of Clinical Response With Zero or Minimal on-Study PEX The number of PEX administered considered Zero when no PEX is administered and considered Minimal when 1 to 3 PEX are administered. Through study completion, approximately 12 weeks
Secondary Achievement of Clinical Response Overall Overall indicates clinical response regardless of whether on-study PEX is administered, or the number of PEX administered. Through study completion, approximately 12 weeks
Secondary Time to Clinical Response (Acute Phase) Through study completion, approximately 12 weeks
Secondary Occurrence of Refractoriness (Acute Phase) Through study completion, approximately 12 weeks
Secondary Time to First On-Study PEX to Achieve Clinical Response Through study completion, approximately 12 weeks
Secondary Number of Days of On-study PEX in Participants Who Achieved Clinical Response (Acute Phase) Through study completion, approximately 12 weeks
Secondary Total Volume of Plasma Administered (Acute Phase) Through study completion, approximately 12 weeks
Secondary Occurrence of Treatment Failure Treatment failure is defined as failure to achieve or maintain clinical response, including refractory iTTP and recurrent iTTP. Through study completion, approximately 12 weeks
Secondary Occurrence of Immune-Mediated Thrombotic Thrombocytopenic Purpura (iTTP) Recurrence, Exacerbation, or Relapse (Post-acute Phase) iTTP recurrence comprised of exacerbation or relapse. Clinical exacerbation: Occurs <30 days after achieving initial clinical response (i.e., before clinical remission) and recurrent thrombocytopenia (platelet levels <150,000/µL), with or without clinical evidence of new or progressive ischemic organ damage, requiring daily PEX or rescue therapy. Clinical relapses: Occurs =30 days after achieving initial clinical response (i.e., after clinical remission) and recurrent thrombocytopenia (platelet levels <150,000/µL), with or without clinical evidence of new or progressive ischemic organ damage, requiring daily PEX or rescue therapy. Through study completion, approximately 12 weeks
Secondary Time to iTTP Recurrence, Exacerbation, or Relapse Through study completion, approximately 12 weeks
Secondary 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 Through study completion, approximately 12 weeks
Secondary 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 Through study completion, approximately 12 weeks
Secondary Change From Baseline in Lactate Dehydrogenase [LDH] Levels at Clinical Response and Study Completion Through study completion, approximately 12 weeks
Secondary Change From Baseline in Troponin Levels at Clinical Response and Study Completion Through study completion, approximately 12 weeks
Secondary Achievement of Clinical Remission Clinical remission is defined as achieving and maintaining clinical response for =30 days. Through study completion, approximately 12 weeks
Secondary A Disintegrin and Metalloproteinase With Thrombospondin Motifs 13 (ADAMTS13) Antigen Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases Through study completion, approximately 12 weeks
Secondary ADAMTS13 Activity Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases Through study completion, approximately 12 weeks
Secondary Von Willebrand Factor (VWF) Antigen Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases Through study completion, approximately 12 weeks
Secondary VWF Activity Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases Through study completion, approximately 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT03393975 - A Study of BAX 930 in Children, Teenagers, and Adults Born With Thrombotic Thrombocytopenic Purpura (TTP) Phase 3
Withdrawn NCT05393999 - SABRE: A Single-arm Prospective Study Measuring Safety and Tolerability of SARS-CoV-2 Neutralising Antibodies in High-risk Populations Phase 2
Not yet recruiting NCT06441578 - A Survey of Recombinant ADAMTS13 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
Terminated NCT00411801 - Safety and Efficacy Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP) Phase 3
Completed NCT00937131 - The Use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura (TTP) Phase 2
Recruiting NCT04683003 - A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura Phase 3
Available NCT05770219 - Expanded Access Program of TAK-755 for Congenital Thrombotic Thrombocytopenic Purpura (cTTP)