A Phase 2, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases
Amgen
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).
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
\*Subprotocol B is no longer recruiting participants\* Inclusion Criteria: * Subprotocol A and B: Diagnosis of SLE according to 2019 European League Against Rheumatism and the American College of Rheumatology (ACR) classification criteria. * Subprotocol A and B: Participant must be positive for at least one of the following autoantibodies at screening (performed by central laboratory) or through documented history: 1. Antinuclear antibodies (ANA) ≥ 1:80 2. Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range (ie, positive results) 3. AntiSm…
Interventions
- DrugInebilizumab
IV Infusion
- DrugBlinatumomab
SC Injection
Locations (54)
- HonorHealth Research and Innovation InstituteScottsdale, Arizona
- University of ColoradoAurora, Colorado
- Vida Research CenterHialeah, Florida
- Homestead Associates In Research IncHomestead, Florida
- Vitaly Clinical ResearchMiami, Florida
- Bioresearch Partner Coral TerraceSouth Miami, Florida