A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
← catalyst calendarNCT06570798 · readout in 718 d
Sponsored by Amgen (industry) · AMGN — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
220estimated
Sites
57
Countries
Australia, Belgium, France +7
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-07-16 | actual | When the study began enrolling |
| Primary completion | 2028-08-06 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-08-06 | estimated | The whole study's end, after follow-up |
| First posted | 2024-08-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Systemic Lupus Erythematosus
- Active Refractory Rheumatoid Arthritis
Interventions
- Drug: Inebilizumab — also filed as Uplizna®
- Drug: Blinatumomab
Primary outcomes
what the primary-completion date above is the date OFSubprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
measured Day 1 to Week 52
Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Serious TEAE
measured Day 1 to Week 52
Subprotocol B Part B Subgroup 1: Number of Participants With Complete Renal Response (CRR)
measured Week 52
Subprotocol B Part B Subgroup 2: Number of Participants With Remission in SLE as Defined by Definition of Remission in SLE (DORIS)
measured Week 26
Subprotocol C Part B: Percentage of Participants Achieving Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP) Remission
measured Week 12
Publications
- PMID 41979896 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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