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About
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 nephritis (Subprotocol B) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C).
Enrollment
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Inclusion criteria
Subprotocol A and B: Diagnosis of SLE and lupus nephritis (LN) 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:
Subprotocol A and B: SLEDAI-2K ≥ 8.
Subprotocol A and B: Active, biopsy-proven, proliferative LN demonstrating class III or class IV with or without co-existing features of Class V LN according to 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria. Renal biopsy must have been performed within 6 months before enrollment. The local biopsy report will be used. A central review center will confirm the eligibility.
Subprotocol A and B: Inadequate response, for lack of efficacy or intolerance after 6 months to at least 1 therapy (Subprotocol A) or 2 therapies (Subprotocol B) at the maximally tolerated doses as recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (KDIGO, 2024). Inadequate response is defined as:
Subprotocol C: Diagnosis of RA according to the 2010 ACR/ European Alliance of Associations for Rheumatology (EULAR) classification criteria.
Subprotocol C: Active disease defined as having all the following criteria:
Subprotocol C: Refractory disease defined as:
Moderate to severe active disease despite having received treatment with:
Inadequate response or intolerance to csDMARDs, bDMARDs, and tsDMARDs should be defined as:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
110 participants in 8 patient groups
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Amgen Call Center
Data sourced from clinicaltrials.gov
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