VAYHIT2

• Research type

  Research Study

• Full title

  A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment (VAYHIT2)

• IRAS ID

  1006595

• Contact name

  Severine BERARD

• Contact email

  Severine_karine.berard@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2022-001627-32

• Research summary

  The purpose of this study is to assess the efficacy and safety of ianalumab (VAY736) compared to placebo in addition to second-line eltrombopag in adults with primary immune thrombocytopenia.
  Study medication will be administered in a double-blinded manner for 16 weeks (a total of 4 doses of ianalumab 3 mg/kg or 9 mg/kg or placebo) together with daily eltrombopag open label treatment.
  After the 16-week of randomized combination treatment period with eltrombopag + ianalumab/placebo, eltrombopag will be tapered until discontinuation for a maximum of 8 weeks (Weeks 17 to 24) in participants with at least 2 consecutive assessments with platelet count ≥ 50 G/L at the end of the combination treatment period (W15D1 and W17D1).
  During treatment period visit frequency will be once a week (QW) up to W9D1 visit, and every other week (q2w) thereafter.
  Participants who complete the study treatment or discontinue the treatment prematurely will complete end of treatment (EOT) disposition. To evaluate the primary efficacy endpoint, all visits until W25D1 should be performed even if a participant prematurely discontinues study treatment.
  Participants who do not meet Treatment failure criteria during treatment period will enter safety and efficacy follow-up, whereas participants with treatment failure during the treatment period (including also the tapering period) will enter the safety follow-up only. For efficacy and safety follow-up, visits occur every 4 weeks until treatment failure or up to 39 months after randomization of the last participant, whichever occurs first. For safety follow-up, visits will occur every 4 weeks for 20 weeks and then every 12 weeks up to 2 years after the last ianalumab/placebo dose.
  Estimated study duration is 39 months post randomization of the last participant

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  22/SC/0421

• Date of REC Opinion

  17 Jan 2023

• REC opinion

  Further Information Favourable Opinion