A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases

Summary

The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part A) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C Part A). The trial will also assess the efficacy of SC blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part B and Subprotocol C Part B).

Timeline

Start

2025-07-16

Primary completion

2028-07-21

Completion

2028-07-21

Publications

• Karam S, Boudhabhay I, Jhaveri KD. Bispecific Antibodies for Glomerular Diseases: Are We Ready for Prime Time? J Am Soc Nephrol. 2026 Apr 14. doi: 10.1681/ASN.0000001120. Online ahead of print. No abstract available.

Drugs

Indications