CVAY736Q12202B Phase II Exploratory study of Ianalumab
Research type
Research Study
Full title
Exploratory Study of Ianalumab in Adults with Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) who Have Previously Benefited from Ianalumab (VAY RE-HIT)
IRAS ID
1012065
Contact name
Fiona Morris
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd.
Clinicaltrials.gov Identifier
Research summary
The purpose of this trial is to learn more about the effects of a second round of treatment with VAY736 (ianalumab) in people with primary immune thrombocytopenia (ITP) or warm autoimmune hemolytic anemia (wAIHA). This trial will include participants who had received previous VAY736 treatment for ITP in trials, CVAY736I12301 (VAYHIT1) and CVAY736Q12301 (VAYHIT2), and for wAIHA in trial CVAY736O12301 (VAYHIA) and benefited from VAY736 treatment. The purpose of this trial is to learn more about the effects of a second round of treatment with VAY736 in people with primary ITP or wAIHA. Approximately 60 participants are expected to join this trial. Participants’ age can be 18 years and above.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
25/YH/0196
Date of REC Opinion
15 Dec 2025
REC opinion
Further Information Favourable Opinion