Pioneering UK clinical trial could change lives of those living with “devastating” disease
09 May 2025
Hope is on the horizon for lupus patients who don’t respond to current treatments, as a pioneering clinical trial is due to get underway in the UK that could revolutionise treatment approaches across the globe.
Researchers at University College London Hospitals and UCL have developed a biomarker measurable in the blood of patients resistant to conventional treatments, that makes them 17 times more likely to respond to an innovative combination of drugs that are used in the NHS, but not together, for Lupus treatment.
What is lupus?
More than 3,000 people, mainly women, are diagnosed in the UK every year with the incurable and potentially life-threatening autoimmune condition that can attack the body’s major organs. Predominantly affecting women of child-bearing age, with Afro-Caribbean women most severely impacted, it is characterised by arthritis, skin rashes, chronic fatigue and kidney problems.
Professor Michael Ehrenstein, consultant rheumatologist University College London Hospitals and Professor of Experimental Rheumatology at UCL, will lead the trial which is due to begin in Spring 2026 at 16 hospitals across the UK. The £1.7m Stratify Lupus trial is being funded by charity Versus Arthritis and the Efficacy and Mechanism Evaluation (EME) Programme, a partnership between the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC).
Professor Lucy Donaldson, Director of Research at Versus Arthritis, which funds research and provides support services to those living with arthritis and musculoskeletal conditions, believes this will be a significant advance for the treatment of a destructive condition.
“This major trial holds real promise of a better future for those living with lupus, which particularly affects underserved people. Too few advances have been made in tackling the devastating disease which mainly affects women, in particular women of African and Caribbean heritage, in the prime of their lives.”
Pioneering research
Professor Michael Ehrenstein and his team have dedicated many years to advancing lupus research, on which the latest trial will build. The team’s 2021 study BEATLupus found the combination of two advanced immune system targeting “biologic” drugs- rituximab and belimumab - was able to bring disease activity under control and significantly reduce severe flares in some, but not all, patients.
Further laboratory work and advanced analysis methods revealed the new biomarker in the blood – an antibody called IgA2 anti-dsDNA - was found in around 50% of lupus patients resistant to conventional therapy. The team tested blood samples from their own and a US trial and found those who tested positive for the biomarker were 17 times more likely to respond to the combination of rituximab and belimumab, compared to rituximab alone.
Now the team are undertaking an innovative trial where only patients positive for the biomarker will be given the drug combination. If the clinical trial, due to end in 2029, proves successful, patients may not have long to wait to access the new targeted treatment. Professor Ehrenstein said: “If the results are positive then we would apply to allow patients who are positive for the biomarker to receive the combination therapy on the NHS. Targeting the patients most likely to benefit from this treatment should make it deliverable on the NHS and improve patient access and outcomes.”
Those living with Lupus can testify to the challenges of finding treatments that work. Ayo Ogunwumiju was pregnant when she began experiencing shortness of breath, chest pains and fatigue. Initially put down to pregnancy-related complications, Ayo’s symptoms progressed and by the time her daughter reached the age of six months she was struggling to lift her baby due to intense joint pain. “I was eventually diagnosed with Lupus after being hospitalised when I lost mobility in my legs and found it difficult to breathe,” recalls Ayo who has tried many treatments over many years to bring her symptoms under control.
“It took me six years of trying different medications with horrible skin blisters which left me with scars before I was finally put on a treatment that works well for my immune system. Research like this, using a biomarker in blood to target better treatments to control people’s symptoms, would make a world of difference to patients not having to live in pain for a long period of time.”
In terms of achievement, a successful trial would not only improve lives of patients but herald a breakthrough in advancing research aims to deliver personalised medicine – something written into the future direction of the NHS. A potential world-first looks to be within the reach of Professor Ehrenstein and his team. He explains: “To have a positive result in a personalised medicine trial for lupus would be globally significant, not only for the biomarker and treatment combination, but also the success of this targeted approach. Everyone talks about personalised medicine, but so far this goal has not been achieved in inflammatory/autoimmune rheumatic diseases. STRATIFY lupus will be the first biomarker enrichment trial for lupus, which is a real coup for UK research.”
The trial is funded by a collaboration between the charity Versus Arthritis and a major public funder of health research, the National Institute for Health and Care Research (NIHR). Clinical trials for Lupus are notoriously difficult to complete due to the complexity of the disease and need to recruit from many different hospitals. This is where the research infrastructure provided by the NIHR helps to support these complex trials to be conducted within the NHS.
Clinical trials
The NIHR’s research infrastructure enables complex trials within the NHS. The UK Musculoskeletal Translational Research Collaboration (UK MSK-TRC), a joint initiative between the NIHR and Versus Arthritis, plays a key role in providing essential support for recruitment, visibility, and as an interface for industry and academic collaborations, as demonstrated in the BEAT-Lupus trial. Professor Ehrenstein will again work closely with the UK MSK-TRC to support the STRATIFY-Lupus trial, recognising the NIHR’s role in uniting the research community and the vital contributions of principal investigators and their teams at lupus specialist centres across the UK.
Professor John Simpson, NIHR Director of the EME Programme, said: "This innovative trial heralds an important shift towards specifically delivering treatments tailored to patients who are most likely to benefit."
"This raises the real potential to open up future effective treatment options for people with systemic lupus erythematosus, many of whom have limited effective treatment options. It has been a pleasure to partner strategically with Versus Arthritis to make this important trial happen.”
Preparations for set up at the 16 trial sites will begin in June, with patient recruitment through lupus centres to commence in the first quarter of 2026. The trial is scheduled to complete in 2029, with analysis completed by the end of that year.
The trial, and supporting studies, have been aided by Lupus UK, UCLH/UCL Joint Research Office, and GlaxoSmithKline.