Novartis Pharmaceuticals is conducting a phase 3 multicenter study designed to assess the efficacy and safety of two different doses of ianalumab, a monoclonal antibody, versus placebo with the addition of eltrombopag (Promacta/Revolade), a thrombopoietin receptor agonist, in adults with primary ITP who are over the age of 18 years and have a platelet count less than 30,000, and who have failed previous first-line treatment with corticosteroids with/without IVIG.
After completion of the screening period to ensure eligibility, participants will enter the randomized treatment period where they will receive ianalumab plus eltrombopag, or they will receive the placebo drug with eltrombopag, followed by a period where the eltrombopag will be tapered. Afterwards, all participants will enter a follow-up period where they will be monitored for efficacy and/or safety.
Exclusions include participants who received second-line ITP treatments (other than steroid therapy± IVIG) including splenectomy, and participants with current or history of life-threatening bleeding. Other protocol-defined inclusion/exclusion criteria may apply.
US, Argentina, Australia, Austria, Belgium, China, Czechia, France, Germany, Hungary, India, Italy, Japan, Republic of Korea, Malaysia, Mexico, Netherlands, Norway, Philippines, Romania, Singapore, Spain, Taiwan, Thailand, Turkey, and the United Kingdom
https://www.clinicaltrials.gov/ct2/show/NCT05653219?recrs=a&cond=immune+thrombocytopenia&draw=3&rank=9
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