CVAY736I12301
Research type
Research Study
Full title
A phase III, randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to first-line corticosteroids in primary immune thrombocytopenia (VAYHIT1)
IRAS ID
1006600
Contact name
Abigail Spiteri
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2022-001672-34
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to evaluate the effect of ianalumab in two different doses versus placebo in addition to first-line corticosteroids in maintaining platelet count at 30G/L or higher in adult participants with primary ITP who responded to corticosteroids prior to randomisation.
• Study treatment will be administered in a double-blinded manner for 16 weeks (in total 4 doses of ianalumab 3 mg/kg or 9 mg/kg or placebo together with corticosteroids).
• During the 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 EOT disposition and will enter the follow-up period.
• Participants who did not meet Treatment failure criteria by the end of treatment period will enter in safety and efficacy follow-up, whereas participants who met treatment failure criteria during treatment period will enter in safety follow-up.
• For efficacy and safety follow-up, visits occur every 4 weeks until treatment failure or up to 2 years; after that, visits will occur every 12 weeks until treatment failure or up to 39 months after randomisation 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 dose.
• The estimated study duration is 39 months post-randomisation of the last participant.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0415
Date of REC Opinion
24 Jan 2023
REC opinion
Further Information Favourable Opinion