Unknown Digestion, Kidneys & Other Organs NIHR-supported project Infection & Immunity

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

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AI plain-English summary

A new clinical trial is testing two drugs—inebilizumab and blinatumomab—in adults with lupus nephritis, a severe kidney inflammation caused by the immune system attacking the body’s own tissues. This matters because around half of people with systemic lupus erythematosus develop lupus nephritis, and many do not respond to standard treatments. Current options often fail to control the disease or cause serious side effects. The trial aims to find out whether these two drugs are safe and tolerable, and whether they can reduce kidney inflammation in patients who have not improved with existing therapies. If either drug proves effective, it could offer a new treatment pathway for patients with refractory lupus nephritis—potentially slowing or preventing kidney damage, reducing the need for dialysis or transplantation, and improving long-term outcomes. The trial also collects blood and urine samples for biomarker testing, which may help doctors predict which patients will respond to treatment, making future care more targeted. This is a practical, patient-focused study with direct implications for clinical practice.

View original technical description
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.

Researchers

Rachel Jones (Principal Investigator)

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