Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura

About the trial

Sponsor

Sanofi

Tested

Caplacizumab (drug), Corticosteroids (drug), anti-CD20 antibody (biological)

Dates

Started 2022-11-21; completion 2024-12-26

Results posted

Yes

This is a single group, treatment, Phase 3, open-label, single-arm study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy (IST) without firstline therapeutic plasma exchange (TPE) with primary endpoint of remission in male and female participants aged 18 to 80 years with immune-mediated thrombotic thrombocytopenic purpura (iTTP). The anticipated study duration per participant without a recurrence while on therapy is maximum 24 weeks (ie, approximately 1 day for screening + maximum 12 weeks of treatment for the presenting episode + 12 weeks of follow-up). Participants will have daily assessments during hospitalization and weekly visits for assessments durin…

From ClinicalTrials.gov, last updated 2025-12-30. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Genzyme Corporation reported $176,308 in research payments for this study in 2025 (19 payments).

Products named: Cablivi

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.