We recruit patients across the whole of the East of England to rare autoimmune disease clinical trials.
Vasculitis
Open to recruitment
Safety and Efficacy of Tarperprumig in Adult Participants with ANCA-Associated Vasculitis
- IMP: Tarperprumig (ALXN1820)
- Sponsor: Alexion Pharmaceuticals, Inc.
- Link: https://clinicaltrials.gov/study/NCT07160608 (opens in a new tab)
Rescue of Nephrons with ALE.F02 (RENAL-F02)
- IMP: ALE.F02
- Sponsor: Alentis Therapeutics AG
- Link: Study Details | NCT06047171 | Rescue of Nephrons With ALE.F02 (RENAL-F02) | ClinicalTrials.gov (opens in a new tab)
Phase 2 study evaluating rapcabtagene autoleucel in participants with severe active GPA or MPA
- IMP: Rapcabtagene autoleucel
- Sponsor: Novartis Pharmaceuticals
- Link: https://clinicaltrials.gov/study/NCT06581198 (opens in a new tab)
In follow-up
Study of LNP023 (iptacopan) in patients with ANCA-associated vasculitis
- IMP: Iptacopan
- Sponsor: Novartis Pharmaceuticals
- Link: Study Details | NCT06388941 | Iptacopan in Patients With ANCA Associated Vasculitis | ClinicalTrials.gov (opens in a new tab)
Lupus
Open to recruitment
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus with Active Lupus (AUTO1-SL2)
- IMP: Obecabtagene autoleucel
- Sponsor: Autolus Limited
- Link: Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis (LUMINA) | ClinicalTrials.gov (opens in a new tab)
FT819 in B-cell Mediated Autoimmune Diseases
- IMP: FT819
- Sponsor: Fate Therapeutics
- Link: A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease | ClinicalTrials.gov (opens in a new tab)
In follow up
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis (REGENCY)
- IMP: Obinutuzumab
- Sponsor: Hoffmann-La Roche
- Link: https://clinicaltrials.gov/study/NCT04221477 (opens in a new tab)
Study of efficacy and safety of LNP023 in participants with active lupus nephritis Class III-IV, +/- V
- IMP: LNP023/Iptacopan
- Sponsor: Novartis Pharmaceuticals
- Link: Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V | ClinicalTrials.gov (opens in a new tab)
Efficacy and Safety of Afimetoran Compared with Placebo in Participants with Active Systemic Lupus Erythematosus (SLE)
- IMP: Afimetoran
- Sponsor: Bristol-Myers Squibb
- Link: https://clinicaltrials.gov/study/NCT04895696 (opens in a new tab)
A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus (LAVENDER)
- IMP: Anifrolumab
- Sponsor: AstraZeneca
- Link: Study Details | NCT06015737 | A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus | ClinicalTrials.gov (opens in a new tab)
Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Select Autoimmune Diseases
- IMP: Inebilizumab and Blinatumomab
- Sponsor: AMGEN
- Link: Study Details | NCT06570798 | A Phase 2a Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases | ClinicalTrials.gov (opens in a new tab)
A Single-Arm, Open-Label, Phase 1 Study to Determine the Safety, Tolerability and Preliminary Efficacy of Obecabtagene Autoleucel in Patients with Severe, Refractory Systemic Lupus Erythematosus (AUTO 1 SL1)
- IMP: Obecabtagene autoleucel
- Sponsor: Autolus Limited
- Link: https://clinicaltrials.gov/study/NCT06333483 (opens in a new tab)
Primary Glomerulonephritis
Open to recruitment
A Study of the Safety and Activity of Sparsentan for the Treatment of Patients With Immunoglobulin A Nephropathy (SPARTAN)
- IMP: Sparsentan
- Sponsor: University of Leicester
- Link: https://clinicaltrials.gov/study/NCT04663204 (opens in a new tab)
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept (ORIGIN EXTEND)
- IMP: Atacicept
- Sponsor: Vera Therapeutics, Inc.
- Link: Study Details | NCT06674577 | A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept | ClinicalTrials.gov (opens in a new tab)
Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN) (AUTUMN)
- IMP: ALXN1920
- Sponsor: Alexion Pharmaceuticals, Inc.
- Link: Study Details | NCT07157787 | Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN) | ClinicalTrials.gov (opens in a new tab)
In follow up
The use of rituximab in the treatment of nephrotic glomerulonephritis (TURING)
- IMP: Rituximab
- Sponsor: Cambridge University Hospitals NHSFT
- Link: https://www.isrctn.com/ISRCTN16948923?q=&filters=conditionCategory:Urological%20and%20Genital%20Diseases,publicationStatus:withoutResults&sort=&offset=1&totalResults=386&page=1&pageSize=10&searchType=basic-search (opens in a new tab)
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy (PROTECT)
- IMP: Sparsentan
- Sponsor: Travere Therapeutics, Inc.
- Link: https://clinicaltrials.gov/study/NCT03762850 (opens in a new tab)
A Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept
- IMP: Atacicept
- Sponsor: Vera Therapeutics, Inc.
- Link: Study Details | NCT07020923 | Monthly Dosing of Atacicept in IgAN | ClinicalTrials.gov (opens in a new tab)
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy Who Have Completed Study CLNP023X2203 or CLNP023A2301
- IMP: Iptacopan
- Sponsor: Novartis Pharmaceuticals
- Link: Study Details | NCT04557462 | A Rollover Extension Program to Evaluate the Long-term Safety and Tolerability of Iptacopan/LNP023 in Participants With Primary IgA Nephropathy | ClinicalTrials.gov (opens in a new tab)
Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)
- IMP: Atacicept
- Sponsor: Vera Therapeutics, Inc.
- Link: Atacicept in Subjects With IgA Nephropathy (ORIGIN 3) | ClinicTrials.gov (opens in a new tab)
Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN) (I CAN)
- IMP: Ravulizumab
- Sponsor: Alexion Pharmaceuticals, Inc.
- Link: Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN) (I CAN) | ClinicalTrials.gov (opens in a new tab)
A study of Povetacicept in Adults With Immunoglobulin A Nephropathy (RAINIER)
- IMP: Povetacicept
- Sponsor: Alpine Immune Sciences Inc
- Link: Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN) | ClinicalTrials.gov (opens in a new tab)
Closed Studies
Vasculitis
Acquired immunodeficiency in ANCA Associated vasculitis (ACQUIVAS)
- IMP: Pneumococcal polysaccharide conjugate vaccine and Pneumococcal Polysaccharide Vaccine
- Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
- Link: https://clinicaltrials.gov/study/NCT03514979 (opens in a new tab)
Biologics in refractory vasculitis (BIOVAS)
- IMP: Infliximab, rituximab and tocilizumab
- Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
- Link: https://clinicaltrials.gov/study/NCT05168475 (opens in a new tab)
An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis (RITAZAREM)
- IMP: Rituximab (Mabthera/Rituxan)
- Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
- Link: https://clinicaltrials.gov/study/NCT01697267 (opens in a new tab)
Plasma exchange and glucocorticoid dosing in anti-neutrophil cytoplasm antibody associated vasculitis: a randomized controlled trial (PEXIVAS)
- IMP: n/a adjunctive PLEX
- Sponsor: Cambridge University Hospitals NHS Foundation Trust
- Link: https://clinicaltrials.gov/study/NCT00987389 (opens in a new tab)
ALEmtuzumab for relapsing and refractory primary systemic VasculitIs – a Trial of Efficacy and safety (ALEVIATE)
- IMP: Alemtuzumab
- Sponsor: Cambridge University Hospitals NHS Foundation Trust
- Link: ClinicalTrials.gov (opens in a new tab)
Long-term surveillance study of rituximab (Mabthera)-treated patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) (RIVAS)
- IMP: n/a
- Sponsor: Cambridge University Hospitals NHS Foundation Trust
- Link: https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/rituximab-surveillance-study-in-vasculitis-rivas/ (opens in a new tab)
Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE)
- IMP: Abatacept (CTLA4-Ig)
- Sponsor: University of South Florida
- Link: https://clinicaltrials.gov/study/NCT02108860 (opens in a new tab)
A randomised, double blind, controlled mechanistic study of rituximab and belimumab combination therapy in PR3 ANCA-associated vasculitis (COMBIVAS)
- IMP: Belimumab
- Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
- Link: https://clinicaltrials.gov/study/NCT03967925 (opens in a new tab)
PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V (PROTECT-V)
- IMP: Niclosamide, Ciclesonide, Sotrovimab
- Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
- Link: https://clinicaltrials.gov/study/NCT04870333 (opens in a new tab)
ObiVas
- IMP: Obinutuzumab
- Sponsor: Cambridge University Hospitals NHSFT
- Link: ISRCTN – ISRCTN13069630: Obinutuzumab compared with rituximab for treating ANCA-associated vasculitis (opens in a new tab)
Good Ides 2
- IMP: Imlifidase
- Sponsor: Hansa Biopharma AB
- Link: Study Details | NCT05679401 | A Study With Imlifidase in Anti-GBM Disease | ClinicalTrials.gov (opens in a new tab)
Trial of efficacy and safety of NS-229 versus placebo in patients with Eosinophilic Granulomatosis
- IMP: NS229
- Sponsor: NS Pharma, Inc.
- Link: https://clinicaltrials.gov/study/NCT06046222 (opens in a new tab)
A study of benralizumab in EGPA (also known as Churg-Strauss Syndrome)
- IMP: Benralizumab
- Sponsor: AstraZeneca AB
- Link: A study of benralizumab in EGPA (also known as Churg-Strauss Syndrome) – Health Research Authority (opens in a new tab)
Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With Polyangiitis (RACEMATE)
- IMP: Tezepelumab
- Sponsor: Imperial College London
- Link: https://clinicaltrials.gov/study/NCT06230354 (opens in a new tab)
Lupus
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus (ALLEGORY)
- IMP: Obinutuzumab
- Sponsor: Hoffmann-La Roche
- Link: Study Details | NCT04963296 | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus | ClinicalTrials.gov (opens in a new tab)
Primary Glomerulonephritis
Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) (DUPLEX)
- IMP: Sparsentan
- Sponsor: Travere Therapeutics, Inc.
- Link: https://clinicaltrials.gov/study/NCT03493685 (opens in a new tab)