Sibeprenlimab
Sponsors
Otsuka Pharmaceutical Development And Commercialization Inc., Otsuka Pharmaceutical Development & Commercialization Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., Otsuka Beijing Research Institute
Conditions
Healthy Subjects (HS)IgA NephropathySjogren DiseaseTreatment of IgANTreatment of Sjögren’s disease
Phase 1
Phase 2
A Phase 2/3, Multicenter, Open‑label Trial to Evaluate the Long‑term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy.
RecruitingCTIS2023-507233-19-00
Start: 2023-02-16Target: 96Updated: 2025-12-18
Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
RecruitingNCT06740526
Start: 2024-11-19End: 2029-04-17Target: 25Updated: 2025-04-06
A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
Active, not recruitingNCT06928142
Start: 2025-04-23End: 2027-06-04Updated: 2026-03-18
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants with Sjögren’s Disease.
RecruitingCTIS2024-516295-14-00
Start: 2025-09-17Target: 40Updated: 2026-01-26
Phase 3
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy
Active, not recruitingCTIS2022-500079-30-00
Start: 2022-11-03Target: 99Updated: 2025-12-29
Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN)
Not yet recruitingNCT07770815
Start: 2026-09-30End: 2030-02-23Target: 24Updated: 2026-08-18