At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Inebilizumab (drug), Blinatumomab (drug)
- How long the study runs
- Study runs about 37 months (dates as stated)
- About the drug or intervention
- Inebilizumab — drug: IV Infusion · Blinatumomab — drug: SC Injection
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 220
- Started
- 2025-07-16
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for systemic lupus erythematosus
- • Phase2 - 220 participants
- • 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)
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with systemic lupus erythematosus
Where?
- • Cambridge - Addenbrookes Hospital
- • Edinburgh - Western General hospital
- • Leicester - Leicester General Hospital
- • Newcastle upon Tyne - Royal Victoria Infirmary
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Subprotocol A and B: Diagnosis of SLE according to 2019 European League Against Rheumatism and the American College...
- ✓Subprotocol A and B: Participant must be positive for at least one of the following autoantibodies at screening...
- ✓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).
Who cannot take part
- ✗Subprotocol A and B: Significant likely irreversible organ damage related to SLE (eg, end-stage kidney 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: kidney biopsy showing pure class V.
- ✗Subprotocol B: Active CNS Lupus within one year prior to screening.
See the full criteria
Where Is This Study? (4 UK sites)
Addenbrookes Hospital
Cambridge CB2 0QQ, United Kingdom
Western General hospital
Edinburgh EH4 2XU, United Kingdom
Leicester General Hospital
Leicester LE5 4PW, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Royal Victoria Infirmary
Newcastle upon Tyne NE7 7DN, United Kingdom
How to Get in Touch
Amgen Call Center
Sponsor contactCONTACT
