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 States, Australia, Belgium220 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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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