NCT06570798

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

A Phase 2, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Systemic Lupus Erythematosus
• Active Refractory Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Inebilizumab	IV Infusion
DRUG	Blinatumomab	SC Injection

Timeline

• Start date: 2025-07-16
• Primary completion: 2028-01-17
• Completion: 2029-03-09
• First posted: 2024-08-26
• Last updated: 2026-02-24

Locations

52 sites across 9 countries: United States, Australia, Belgium, France, Germany, Italy, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study