CTIS2022-503041-21-00RecruitingPhase 1
A phase 2 study to evaluate the efficacy and safety of ianalumab (VAY736) in patients with primary immune thrombocytopenia (ITP) previously treated with at least a corticosteroid and a thrombopoietin receptor agonist (TPO-RA) - CVAY736Q12201
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- ovartis Pharma AG
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •Signed informed consent obtained prior to participation in the study., Male or female participants aged 18 years and older on the day of signing informed consent., Confirmed diagnosis of primary ITP., Prior treatment with at least a corticosteroid (±Intravenous Immunoglobulin [IVIG]) and a TPO-RA: • Prior additional therapies are allowed; the corticosteroid and TPO-RA do not need to be the last treatment. • Prior response to IVIG/anti-D or a corticosteroid (platelet count =50 G/L) that was not maintained., At last ITP treatment, loss of response, insufficient response, no response or intolerance., Platelet count <30 G/L and assessed as needing treatment (per physician’s discretion) at screening. If concomitant ITP medication is clinically indicated, the platelet assessment showing a value <30 G/L must be performed after at least 14 days on a stable dose of a corticosteroid or/and a TPO-RA (less than 10% variation from current dose) and continue stable thereafter.
Exclusion Criteria
- •Diagnosis of secondary thrombocytopenia., Platelet or whole blood transfusion, plasmapheresis, or use of any other rescue medications within 14 days before first ianalumab infusion., Participants with following conditions at screening: -Neutrophils <1000/mm3 Immunoglobulin G (IgG) <5 g/l, Treatment with a B-cell depleting therapy (e.g., rituximab) or anti-B-cell Activating Factor of the Tumor Necrosis Factor Family (BAFF) (e.g., belimumab) within 12 weeks prior to the first administration of ianalumab., Immunosuppressant drugs other than corticosteroids within 5 times the elimination half-life of the drug or 14 days before first ianalumab infusion, whichever is longer., Prior splenectomy.
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