Systemic lupus erythematosus (SLE) affects around 50,000 people in the UK, predominantly women of childbearing age. It is a complex autoimmune disease that can affect virtually any organ — skin, joints, kidneys, brain, heart, and lungs. For decades, treatment options were limited to broad immunosuppression. Now, a new generation of targeted therapies is emerging, with over 80 active trials recruiting across the UK.
Until recently, lupus was one of the most challenging autoimmune diseases to research. The landmark approval of belimumab (Benlysta) in 2011 was the first new lupus drug in over 50 years. The pace has since accelerated dramatically — anifrolumab, obinutuzumab, and many more agents are now in Phase 2 and 3 trials.
UK centres are major contributors to international lupus trials, with specialist lupus units in London, Birmingham, Manchester, and Edinburgh. The BILAG (British Isles Lupus Assessment Group) scoring system, developed in the UK, is used worldwide to measure disease activity in clinical trials.
Biologic Therapy Trials
The biologic revolution in lupus is gathering pace:
Belimumab (anti-BAFF) — the first lupus biologic, now being studied in combination with other agents, in earlier disease stages, and in paediatric lupus
Anifrolumab (anti-IFN-α receptor) — blocks type I interferon signalling, a key driver of lupus. UK trials are expanding its use beyond moderate-to-severe disease
Obinutuzumab (anti-CD20) — depletes B cells, studied primarily in lupus nephritis but expanding to broader SLE populations
Rituximab (anti-CD20) — despite mixed results in formal trials, remains widely used in UK practice; ongoing studies explore which patients benefit most
Daratumumab (anti-CD38) — originally a myeloma drug, now being tested in lupus for its effects on plasma cells producing autoantibodies
Anti-TL1A — targeting a novel pathway involved in both inflammation and fibrosis
Lupus Nephritis Studies
Lupus nephritis — kidney inflammation caused by SLE — affects up to 60% of lupus patients and is one of the most serious complications. It has its own dedicated trial pipeline:
Voclosporin — a next-generation calcineurin inhibitor approved for lupus nephritis, with UK trials studying long-term outcomes and combination strategies
Belimumab + standard of care — combination approaches adding belimumab to mycophenolate or cyclophosphamide
Obinutuzumab — B-cell depletion for refractory lupus nephritis
Novel complements inhibitors — targeting the complement cascade that drives kidney damage in lupus
Biopsy-guided therapy — using repeat kidney biopsies to guide treatment decisions
Small Molecule and Oral Therapies
Oral drugs offer convenience for a condition that requires long-term management:
JAK inhibitors — baricitinib and tofacitinib being studied in SLE skin and joint manifestations
BTK inhibitors — Bruton's tyrosine kinase inhibitors that target B-cell receptor signalling, reducing autoantibody production
Proteasome inhibitors — targeting the plasma cells that produce autoantibodies
IL-2 therapy — low-dose IL-2 to restore regulatory T-cell function, an immunological approach unique to autoimmune diseases
Organ-Specific Lupus Trials
SLE can affect different organs in different patients. Trials are increasingly targeting specific manifestations:
Cutaneous Lupus
Skin-directed trials including topical JAK inhibitors, anti-IFN therapies, and photoprotection strategies for discoid and subacute cutaneous lupus.
Neuropsychiatric Lupus
One of the most challenging manifestations. Trials exploring blood-brain barrier penetration, neuroinflammation targeting, and cognitive rehabilitation.
Haematological Lupus
Autoimmune haemolytic anaemia and thrombocytopenia in SLE. Trials studying targeted B-cell therapies and complement inhibitors.
Antiphospholipid Syndrome
Often co-occurs with SLE. Trials for thrombosis prevention, pregnancy outcomes, and direct oral anticoagulants in APS.
Lupus and Pregnancy
Since lupus predominantly affects women of childbearing age, pregnancy-related research is critical:
Medication safety in pregnancy — which treatments can be continued during conception, pregnancy, and breastfeeding
Neonatal lupus prevention — strategies to prevent the rare but serious condition where maternal anti-Ro/SSA antibodies affect the baby
Pre-eclampsia prevention — lupus patients are at higher risk; trials studying aspirin prophylaxis and biomarker monitoring
Pregnancy planning in lupus nephritis — optimal timing and management strategies
Active disease measured by SLEDAI or BILAG scoring systems
Positive autoantibodies — anti-dsDNA, ANA, anti-Sm, or antiphospholipid antibodies
Complement levels (C3, C4) — often low during active disease
Current medication record — many trials require stable background therapy
Organ involvement documentation — kidney biopsy results for nephritis trials, skin assessment for cutaneous trials
For nephritis trials: proteinuria thresholds (typically ≥0.5g/day or ≥1g/day)
💡 Your Autoantibody Profile Matters
Many lupus trials select patients based on their autoantibody profile. Know your results: ANA titre, anti-dsDNA, anti-Sm, anti-Ro/SSA, anti-La/SSB, and antiphospholipid antibodies. These are typically tested at diagnosis and periodically thereafter.
UK Trial Centres
Major UK lupus trial centres include:
London — Guy's and St Thomas' (Louise Coote Lupus Unit), UCLH, Hammersmith, St Mary's
Birmingham — University Hospitals Birmingham, Sandwell and West Birmingham
Manchester — Manchester University NHS Foundation Trust
Leeds — Leeds Teaching Hospitals
Edinburgh — Royal Infirmary of Edinburgh
Glasgow — Queen Elizabeth University Hospital
Cambridge — Addenbrooke's Hospital
Liverpool — Aintree University Hospital
How to Find Your Match
Our Smart Matcher can help you find lupus trials based on your organ involvement, autoantibody profile, and treatment history.
Find Lupus Trials For You
Our Smart Matcher uses your lupus type, organ involvement, and autoantibody profile to find the most relevant clinical trials.