Phase 2 Study of Inebilizumab and Blinatumomab for Autoimmune Diseases
This study is testing two medications, inebilizumab and blinatumomab, in adults aged 18 to 75 with certain autoimmune diseases. The main goals are to see how safe these medications are and if people can tolerate them. Inebilizumab is being studied for systemic lupus erythematosus (SLE) with kidney involvement. Blinatumomab is being studied for SLE (with or without kidney involvement) and for active, difficult-to-treat rheumatoid arthritis (RA). For some parts of the study, researchers will also look at how well blinatumomab works. You may be eligible if you have a diagnosis of SLE and specific autoantibodies. Please note that two parts of this study (Subprotocol A and B) are no longer enrolling new participants.
- Study design
- This is an interventional study with a planned enrollment of 220 participants. It is designed to assess the safety and tolerability of the medications.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events for up to 52 weeks (about one year).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06570798
A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
Recruiting
PHASE2Ages 18–75InterventionalTreatmentAmgen
~220 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:InebilizumabBlinatumomab
At a glance
Recruiting sites
49 of 58 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Measured over Day 1 to Week 52
+4 more outcomes measured
Conditions
Where it's being run
58 sites across 21 statesFrance12
Florida4
New York4
Belgium4
Germany4
United Kingdom4
Ohio3
Italy3
Study leadership
- MD · STUDY_DIRECTOR · Amgen
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
Subprotocol A and B (Subgroup 1): Active, biopsy-proven, proliferative LN demonstrating class III or class IV with or without co-existing features of Class V LN (or pure Class V LN for Subprotocol B only) according to 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria. The local biopsy report will be used.
Subprotocol A and B: SLE Disease Activity Index 2K ≥ 6.
Subprotocol A and B (Subgroup 1): Inadequate response, loss of response or intolerance to at least 1 therapy (Subprotocol A) or 2 immunosuppressive therapies (Subprotocol B Subgroup 1) at the maximally tolerated doses as recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (KDIGO, 2024). Inadequate response is defined as: UPCR ≥ 1.0 mg/mg.
Subprotocol B (Subgroup 2): Refractory SLE participants with inadequate response to multiple therapies (excluding hydroxychloroquine or corticosteroids) and have failed either a biologic agent or cyclophosphamide.
Subprotocol B (Part B Subgroup 2): British Isles Lupus Assessment Group (BILAG)-2004 level A disease in 1 organ system or BILAG-2004 level B disease in ≥ 2 organ systems
Subprotocol B (Part B Subgroup 2): Physician Global Assessment (PGA) ≥ 1
Subprotocol A and B: If receiving any of the following medications, participants must be on these doses prior to Day 1:
Subprotocol C (Part A and Part B): Diagnosis of RA according to the 2010 ACR/European Alliance of Associations for Rheumatology (EULAR) classification criteria.
Subprotocol C (Part A and Part B): Moderate to severe disease activity as defined by DAS28-CRP \> 3.2 with ≥ 3 swollen joints and ≥ 3 tender joints (based on 28 joint counts) at screening.
Subprotocol C (Part A and Part B): Refractory disease defined as:
Active disease despite having received treatment with:
Inadequate response or intolerance to csDMARDs, bDMARDs, and tsDMARDs should be defined as:
Subprotocol C (Part B): High sensitivity C-Reactive Protein (hsCRP) level ≥ upper limit of normal per the central laboratory at screening.
Exclusion
Subprotocol A, B and C: Receipt of a live and/or live attenuated vaccine within 4 weeks prior to first dose of trial drug, during the treatment period, or until B-cell repletion after the end of the treatment period. Administration of inactivated (killed) vaccines is acceptable.
Subprotocol A and B: Estimated glomerular filtration rate (eGFR) of \< 30 mL per minute per 1.73 m\^2 of body surface area (calculated using the Modification of Diet in Renal Disease \[MDRD\] formula, with screening laboratory results for serum creatinine value).
Subprotocol A and B: Significant likely irreversible organ damage related to SLE (eg, end-stage renal disease \[ESRD\]).
Subprotocol A and B: Any acute, severe lupus related flare during screening that needs immediate treatment.
Subprotocol A and B: A previous kidney transplant or planned transplant within trial treatment period.
Subprotocol A and B: History of or current renal diseases (Parts A and B, Subgroup 1) that in the opinion of the investigator could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy).
Subprotocol A: Renal biopsy showing pure class V.
Subprotocol B: Active CNS Lupus within one year prior to screening.
Subprotocol B and C: History or presence of clinically relevant central nervous system (CNS) pathology or event such as seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or organic brain syndrome.
Subprotocol C: Prior history of current inflammatory joint disease other than RA including but not limited to SLE, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (eg, vasculitis, pulmonary fibrosis, or Felty's syndrome).
Subprotocol C: Functional Class IV as defined by the ACR classification of functional status in RA.
Subprotocol A, B and C: Receipt of the following medications or treatments at any time prior to Day 1:
What this trial measures
- Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)Day 1 to Week 52
- Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Serious TEAEDay 1 to Week 52
- Subprotocol B Part B Subgroup 1: Number of Participants With Complete Renal Response (CRR)Week 52
- Subprotocol B Part B Subgroup 2: Number of Participants With Remission in SLE as Defined by Definition of Remission in SLE (DORIS)Week 26
- Subprotocol C Part B: Percentage of Participants Achieving Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP) RemissionWeek 12