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Clinical Trial Summary

Primary immune thrombocytopenia (ITP) is an autoimmune disease mainly mediated by autoreactive B cells and the presence of pathogenic anti-platelet auto-antibodies that enhance platelet destruction and impair platelet production. There are approximately 4,000 newly diagnosed ITP cases each year in France. For patients with a platelet count of less than 30x109/L and/or bleeding symptoms, corticosteroids alone or in combination with intravenous immunoglobulin (IVIg) is the standard first-line treatment. However, approximately two-thirds of adult patients responding to this first-line treatment relapse within days or weeks after corticosteroids withdrawal and overall, the course of the disease is chronic in about 70% of the cases. The anti-CD20 monoclonal antibody rituximab is commonly used off-label as a second-line therapy in many European countries including France for adults with persistent (i.e., disease duration of more than 3 months) or chronic (disease duration of more than 12 months) ITP. Rituximab leads to an overall response rate of only 40 % at 1 year but 29.5% of lasting (5 years and more) response The investigators have shown that the absence of response to rituximab in ITP could be explained by the settlement and expansion of long-lived autoreactive plasma cells in the spleen made possible by the high amount of BAFF. Belimumab is a fully humanized anti-BAFF/Blys monoclonal Ab licensed for SLE. Based on the preliminary results of a phase 2 open prospective pilot study performed in our center combining rituximab with i.v belimumab seems highly promising We hypothesized that combining subcutaneous belimumab weekly over a 24 weeks period (Arm A) with rituximab is superior to rituximab and subcutaneous placebo weekly over 24 weeks period (Arm B) to achieve an overall response at W52. The study design will be a prospective randomized, double-blind, multicenter (international), superiority phase III clinical study


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Primary Immune Thrombocytopenia (ITP)
  • Purpura, Thrombocytopenic, Idiopathic
  • Thrombocytopenia

NCT number NCT05338190
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Matthieu MAHEVAS, Professor of medicine
Phone 0 1 49 81 20 76
Email matthieu.mahevas@aphp.fr
Status Recruiting
Phase Phase 3
Start date November 14, 2022
Completion date November 14, 2027

See also
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Active, not recruiting NCT05029635 - Phase III Study on HMPL-523 for Treatment of ITP Phase 3
Completed NCT06408324 - Evaluation of the Use of Thrombopoietin Receptor Agonists in Adults With Primary ITP in Europe
Completed NCT02042560 - Study of Immune Thrombocytopenia Pathogenesis: N/A
Recruiting NCT05653349 - Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP) Phase 3
Withdrawn NCT04274452 - A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP) Phase 3
Recruiting NCT05718856 - TPO-RAs Combining Anti-CD 20 Monoclonal Antibody Versus TPO-RAs in the Management of Pediatric Primary Immune Thrombocytopenia (ITP) Phase 4
Recruiting NCT05885555 - A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies Phase 2
Recruiting NCT04518475 - Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults Phase 4