TAK-755-2001

• Research type

  Research Study

• Full title

  A Phase 2b, multicenter, randomized, double-blind study of safety and efficacy of TAK-755 (rADAMTS13) with minimal to no plasma exchange (PEX) in the treatment of immune-mediated thrombotic thrombocytopenic purpura (iTTP)

• IRAS ID

  1007141

• Contact name

  RoseAnn Murray

• Contact email

  roseann.murray@takeda.com

• Sponsor organisation

  Takeda Development Center Americas, Inc.

• Eudract number

  2022-001940-36

• Research summary

  This is a Phase 2b study is for patients with an autoimmune disorder called immune-mediated thrombotic thrombocytopenic purpura (iTTP). The purpose of this study is to find out if the study drug TAK-755 is safe and effective in treating iTTP with and without PEX (current standard of care for treatment for iTTP). About 40 people, aged 18–75 years, at about 20 study centres across North America, Europe and Latin America are expected to take part in this study. Participants will be in the study for approximately 8 to 12 weeks.
  During the trial, the suitable subjects, are randomly assigned with 1:1 ratio to one of 2 treatment arms. Randomisation will be stratified based on whether the subject has received pre-study PEX and on the subject’s Glasgow Coma Scale, a scale used to objectively describe the extent of impaired consciousness, (≤12 or 13 to 15). This is called the acute phase. During the acute phase, subjects will be randomised to one of 2 treatment arms:
  • Arm 1: TAK-755 40 IU/kg twice daily (BID) until clinical response, intravenous (IV) infusion
  • Arm 2: TAK-755 80 IU/kg BID until clinical response, IV infusion
  In addition to TAK-755, an immunosuppressive regimen consisting of corticosteroids and rituximab is recommended. Subjects will continue TAK-755 until clinical response is achieved.
  Upon obtaining the 48-hour confirmatory results for clinical response, subjects given TAK-755 alone or TAK-755 plus PEX in the acute phase (discontinuing PEX if given) will enter the post-acute phase. During this period, subjects will be given TAK-755 at 80 IU/kg, 3 times a week for 1 week, and then twice a week for 2 weeks.
  Since the TAK-755-2001 study is a double-blinded study, the subjects, site staff, and sponsor will all be blinded to treatment.
  This study is sponsored by Takeda Development Center Americas, Inc

• REC name

  London - South East Research Ethics Committee

• REC reference

  23/LO/0102

• Date of REC Opinion

  23 Oct 2023

• REC opinion

  Further Information Favourable Opinion