Benlysta 200 mg solution for injection in pre-filled pen.
Sponsors
Academisch Ziekenhuis Leiden, Academisch Ziekenhuis Leiden, Glaxosmithkline Research & Development Limited, Glaxosmithkline Research & Development Limited, Glaxosmithkline Research & Development Limited, Assistance Publique Hopitaux De Paris, Amsterdam UMC Stichting
Conditions
Adult patients with persistent or chronic immune thrombocytopeniaLupus ErythematosusSystemicSystemic Lupus ErythematosusSystemic lupus erythematodesconnective tissue diseases
Phase 2
A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE)
CompletedCTIS2023-509413-37-00
Start: 2020-01-17End: 2025-10-23Target: 9Updated: 2025-07-17
(Synbiose-2 )Synergetic B-cell immunomodulation in SLE – 2 nd study
RecruitingCTIS2023-507867-20-00
Start: 2018-10-04Target: 30Updated: 2024-08-28
Phase 3
RITUX-PLUS 2 : A phase 3 randomized and double-blind controlled trial comparing the efficacy and safety of rituximab combined with subcutaneous belimumab versus rituximab + placebo in adult patients with persistent or chronic immune thrombocytopenia (ITP)
RecruitingCTIS2024-516168-27-00
Start: 2022-11-10Target: 132Updated: 2025-11-14
An open-label study to investigate the long-term safety and efficacy of belimumab in adults with interstitial lung disease (ILD) associated with systemic sclerosis (SSc) and other connective tissue diseases (CTD)
RecruitingCTIS2023-509370-39-00
Start: 2025-06-03Target: 158Updated: 2026-01-14
Phase 4
A Phase 4, multicenter, prospective, open-label study describing the efficacy and safety of belimumab administered subcutaneously in adult participants with early systemic lupus erythematosus
RecruitingCTIS2023-509146-35-00
Start: 2025-01-30Target: 93Updated: 2026-01-22
The effects of belimumab on synovial inflammation and composition of lymph nodes in SLE patients
Not yet recruitingCTIS2024-518966-28-00
Target: 15Updated: 2024-11-25