A Phase 2a Study of Inebilizumab & Blinatumomab in Autoimmune Diseases
Research type
Research Study
Full title
A Phase 2a, Open-label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Select Autoimmune Diseases (Master Protocol)
IRAS ID
1010692
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2024-514382-19
Research summary
Systemic Lupus Erythematosus (SLE) is an autoimmune disease, which means that the body’s immune system mistakenly attacks its own healthy tissues or organs, affecting different parts of the body including skin, joints, kidney, brain, and other organs, causing pain and inflammation in the affected areas. When SLE affects the kidney, it is called lupus nephritis.
There are two sub-protocols; A, investigating the study product Inebilizumab, and B, investigating the study product Blinatumomab.
This study will look at how safe, tolerable, and how well Inebilizumab and Blinatumomab work in adult participants who have active SLE with kidney inflammation and refractory (have not previously responded to the standard treatment for) SLE with kidney inflammation (nephritis), and also how well the side effects of inebilizumab and Blinatumomab can be tolerated.In sub-protocol A, the number of times inebilizumab is administered during the study depends on the cohort (group) participants are assigned to, the dose will not change. In Sub-protocol B the dose participants are administered will changed depending on which cohort they are assigned, but the frequency will not change. Participants will be educated and provide informed consent before being assessed for eligibility and enrolled into a cohort.
The participants may be in the study for up to 56 weeks. This includes a 4-week screening period, followed by a 52 week period which includes treatment and safety follow up visits.Samples, including blood and urine, will be collected to see how the participant's body is responding to treatment and if the results mean they can continue in the study. Samples can also be used for biomarker testing. A biomarker is something in the blood or urine that can be used to measure the status of disease and/ or the effect of the investigational product on the body.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0384
Date of REC Opinion
16 Dec 2024
REC opinion
Further Information Favourable Opinion