A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases (NCT06570798) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
United States220 participantsStarted 2025-07-16
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Antinuclear antibodies (ANA) ≥ 1:80
✓. Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range (ie, positive results)
✓. AntiSmith antibodies elevated to above normal (ie, positive results).
✓. Prednisone dose ≤ 20 mg/day (or its equivalent in other corticosteroid forms) and at a stable dose for 5 days
✓. Hydroxychloroquine dose ≤ 400 mg/day and at a stable dose for 4 weeks. Other equivalent antimalarials (chloroquine, quinacrine) are also accepted at a stable dose for 4 weeks.
✓. MMF dose ≤ 3 g/day or MPA dose ≤ 2160 mg/day and at a stable dose for 2 weeks.
✓. AZA dose ≤ 2 mg/kg/day and at a stable dose for 2 weeks.
✓. Methotrexate \> 25 mg/week and at a stable dose for 2 weeks
Exclusion criteria
✕. B-cell directed CAR T-cell and T-cell engager therapies
What they're measuring
1
Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Timeframe: Day 1 to Week 52
2
Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Serious TEAE
Timeframe: Day 1 to Week 52
3
Subprotocol B Part B Subgroup 1: Number of Participants With Complete Renal Response (CRR)
Timeframe: Week 52
4
Subprotocol B Part B Subgroup 2: Number of Participants With Remission in SLE as Defined by Definition of Remission in SLE (DORIS)
Timeframe: Week 26
5
Subprotocol C Part B: Percentage of Participants Achieving Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP) Remission