Clinical Trials

The LUMC has a large clinical, multidisciplinary team that provides expert care to patients with (severe) systemic autoimmune diseases. We have clinical experts in our team at the departments of Nephrology, Rheumatology, Vascular Medicine, Obstetrics & Gynecology, Hematology, Ear, Nose and Throat (ENT), Pulmonology, and Immunology. Within the LuVaCs center of expertise, the focus lies on the treatment of patients with systemic lupus erythematosus (SLE), ANCA-associated vasculitis (AAV), and complement-associated diseases. To enhance patient care to the fullest extent, we actively initiate and participate in innovative clinical trials.

Below you find an overview of the ongoing and completed clinical trials of the LuVaCs center of expertise, sorted by disease group.

Ongoing Clinical Trials

ANCA-associated Vasculitis

The AVAC-EUR study is an investigator-initiated, observational study to evaluate the clinical practice of (early access) avacopan treatment for ANCA-associated vasculitis (AVV) in European countries. We created a joint database to conduct a meta-analysis on individual patient data of AAV patients treated with avacopan. AVAC-EUR is an observational study open for European centres. If you are interested to participate, please contact us via avac-eur@lumc.nl.

The ENDURRANCE study is an investigator-initiated, multicentre, randomised study evaluating combination treatment of rituximab with low-dose cyclophosphamide compared to standard-of-care with rituximab only in ANCA-associated vasculitis patients. This Phase III study is coordinated by the LUMC in collaboration with principal investigators from Dutch academic and non-academic hospitals Meander Medical Center (Amersfoort), Haga Hospital (The Hague), Amsterdam UMC, Amphia Hospital (Breda) and Franciscus Hospital (Rotterdam). All centres are members of the ARCH Vasculitis Working Party, where ARCH is the national Autoimmune Research & Collaboration Hub for systemic auto-immune diseases (https://www.arch.nl/vasculitis). Read more details of the study on https://clinicaltrials.gov/study/NCT03942887

Systemic lupus erythematosus (SLE) & Lupus Nephritis (LN)

The Auto-Graph study is an open-label, randomised study to evaluate the efficacy and safety of anti-CD19 CAR-T cell therapy (Rapcabtagene Autoleucel, YTB323) versus standard of care in patients suffering from refractory lupus nephritis. The LUMC is a participating center of this pharma-initiated, Phase II study. Read more on https://clinicaltrials.gov/study/NCT06581198

The Synbiose-2 is an investigator-initiated, multicenter, randomised study investigating the combination of belimumab and rituximab in patients with severe systemic lupus erythematosus (SLE) compared to standard-of-care with mycophenolate and steroids. The Synbiose-2 study is a follow-up study to Synbiose-1 (PMID: 32591783). The study is coordinated by the LUMC in collaboration with principal investigators from Dutch academic and non-academic hospitals UMC Utrecht (UMCU), Haga Hospital (The Hague), Radboud UMC (Nijmegen) and UMC Groningen (UMCG). All centres are members of the ARCH SLE/APS Working Party, where ARCH is the national Autoimmune Research & Collaboration Hub for systemic auto-immune diseases. (https://www.arch.nl/sle-aps/). Read more details of the study on https://clinicaltrials.gov/study/NCT03747159

Complement-associated disease

The CUREiHUS study is an observational study to monitor the effects of discontinuation of eculizumab treatment (C5 inhibitor) in patients with atypical haemolytic uremic syndrome (aHUS). The study is initiated and coordinated by the Radboud University Medical Center in Nijmegen, and the LUMC is a participating center. Read more details of the study on: https://atypischehus.nl/patient/onderzoek/cureihus/

The Compcure study is an observational European biobank study for patients with C3 Glomerolopathy (C3G) and Membranoproliferative glomerulonephritis (MGPN). The study aims to gather as much data and biobank material in a centralised biobank and in the ERKReg-register, which is part of the European Rare Kidney Network (ERKNet). The LUMC is one of the participating centers. Read more on: https://www.compcure.org/

Completed Clinical Trials

ANCA-associated vasculitis

MoRiA
ADVOCATE
Clear-study

SLE & LN

VOCOVID
  • Voclosporin against SARS-COV-2 in kidney transplant recipients and patients with Lupus Nephritis
  • Completed: 2024
  • Investigator initiated
  • Single center, RCT
  • Sponsor: Aurinia
  • Read more: https://pubmed.ncbi.nlm.nih.gov/38106593/
AURORA-2
  • Efficacy and safety of long-term voclosporin treatment in lupus nephritis patients
  • Completed: 2021
  • Phase III, RCT
  • Participating center, study steering committee (SSC)
  • Sponsor: Aurinia
  • Read more: https://pubmed.ncbi.nlm.nih.gov/37466424/
BLISS-BELIEVE
  • Efficacy and safety of belimumab and rituximab in SLE patients
  • Completed: 2021
  • Phase III RCT
  • Participating center, study steering committee (SSC)
  • Sponsor: GSK
  • Read more: https://pubmed.ncbi.nlm.nih.gov/39159997/
BLISS-LN
  • Safety and efficacy of Belimumab in Lupus Nephritis patients
  • Completed: 2020
  • Phase III, RCT
  • Participating center, study steering committee (SSC)
  • Sponsor: GSK
  • Read more: https://pubmed.ncbi.nlm.nih.gov/36302567/
AURORA1
Synbiose-1
  • Efficacy of belimumab and rituximab combination treatment in SLE patients: focus on autoantibodies.
  • Completed: 2018
  • Investigator initiated
  • Phase II, single arm open label
  • Sponsor: GSK
  • Read more: https://pubmed.ncbi.nlm.nih.gov/32591783/

Complement-associated disease

APPEAR-C3G
Good-Ides

Scroll to Top