Clinical trials: Complication in Systemic Lupus Erythematosus
- Condition Complication in Systemic Lupus Erythematosus
- Funder type Industry (pharma, biotech, devices)
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis
This Phase IIa, open-label, single-arm study includes an initial Safety Run-In followed by dose expansion to evaluate the safety, tolerability, cellular kinetics, pharmacodynamics, and preliminary clinical activity of a single…
- Trial name
- NCT07328581
- Testing
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- iCell Gene Therapeutics
Lupus Nephritis, Systemic Lupus Erythematosus
US Zamto-cel Autoimmune Diseases
AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc/dcSSc) after receiving standard…
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Diffuse Cutaneous Systemic Sclerosis
- Trial name
- NCT06708845
- Testing
- zamtocabtagene autoleucel, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Miltenyi Biomedicine GmbH
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
CALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
- Trial name
- CALiPSO-1 (NCT06255028)
- Testing
- CNTY-101, IL-2, Lymphodepleting Chemotherapy
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Century Therapeutics, Inc.
Lupus Nephritis
A Phase II Study to Evaluate the Efficacy and Safety of SHR-1314 in Lupus Nephritis
To demonstrate the efficacy of SHR-1314 at Week 12 in subjects with proliferation lupus nephritis in terms of improvement of 24h UPCR, compared to placebo.
- Trial name
- NCT04924296
- Testing
- SHR-1314
- Volunteers
- 60 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Systemic Lupus Erythematosus
A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the safety and tolerability of P-CD19CD20-ALLO1 in participants with highly active, severe, refractory SLE with or without lupus nephritis (LN).
- Trial name
- NCT06984341
- Testing
- P-CD19CD20-ALLO1 Cells, Cyclophosphamide, Fludarabine
- Where
- 2 sites in United States
- Sponsor
- Genentech, Inc.
Lupus Nephritis
Aurinia Early Urinary Protein Reduction Predicts Response
An exploratory study assessing the ability of biomarkers measured at 8 weeks to predict clinical response over 24 and 48 weeks in subjects taking voclosporin 23.7 mg twice daily (BID) in combination with standard of care in…
- Trial name
- AURION (NCT02949973)
- Testing
- voclosporin
- Where
- 2 sites in Malaysia
- Volunteers
- 10 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
Systemic Lupus Erythematosus
CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have autoantibody positive, clinically-active…
- Trial name
- NCT02074020
- Testing
- Blisibimod
- Sponsor
- Anthera Pharmaceuticals
Lupus Nephritis, Lupus Nephritis - World Health Organization (WHO) Class III
KYSA-1: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis
- Conditions
- Lupus Nephritis, Lupus Nephritis - World Health Organization (WHO) Class III, Lupus Nephritis - WHO Class IV
- Trial name
- NCT05938725
- Testing
- KYV-101 anti-CD19 CAR-T cell therapy, Standard lymphodepletion regimen
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Kyverna Therapeutics
IgA Nephropathy, Lupus Nephritis (LN)
A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy…
- Conditions
- IgA Nephropathy, Lupus Nephritis (LN), C3 (Complement Component 3) Glomerulopathy
- Trial name
- NCT06419205
- Testing
- ADX-097
- Where
- 4 sites in United States, Brazil
- Volunteers
- 30 people
- Sponsor
- Akebia Therapeutics
Lupus Nephritis
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients
The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis.
- Trial name
- NCT01342016
- Testing
- tacrolimus capsule, leflunomide tablet, prednisone
- Where
- 12 sites in China
- Volunteers
- 84 people
- Sponsor
- Astellas Pharma Inc
Lupus Nephritis
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus…
- Trial name
- REGENCY (NCT04221477)
- Testing
- Obinutuzumab, MMF, Prednisone
- Where
- 74 sites in United States, Argentina and 13 more
- Volunteers
- 271 people
- Sponsor
- Hoffmann-La Roche
Lupus Nephritis
An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
The main objectives of this trial are to evaluate the long term efficacy and safety of different doses of BI 655064 versus placebo as add-on therapy to Standard of Care (SOC) during maintenance therapy for lupus nephritis.
- Trial name
- NCT03385564
- Testing
- BI 655064
- Where
- 36 sites in United States, Australia and 14 more
- Volunteers
- 69 people
- Sponsor
- Boehringer Ingelheim
Lupus Nephritis
Aurinia Renal Response in Active Lupus With Voclosporin
The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.
- Trial name
- AURORA (NCT03021499)
- Testing
- Voclosporin
- Where
- 185 sites in United States, Argentina and 29 more
- Volunteers
- 358 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
Lupus Nephritis
A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)
The purpose of the study is to evaluate the efficacy and safety of efgartigimod IV in Chinese patients with active lupus nephritis (LN).
- Trial name
- NCT05810948
- Testing
- efgartigimod IV
- Where
- 31 sites in China
- Volunteers
- 73 people
- Sponsor
- argenx
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
The primary objective of this multicenter observational registry is to characterize the clinical, epidemiological, and biological profiles of individuals of Middle Eastern, North African, and Levantine ancestry, including…
- Conditions
- Antiphospholipid (aPL)-Positive, Rheumatic Arthritis, Celiac Disease, Focal Segmental Glomerulosclerosis (FSGS)
- Trial name
- MERIT (NCT07892651)
- Where
- Jordan
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Axiom Bioregistry
Membranous Nephropathy, Lupus Nephritis (LN)
A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis
The primary objectives of this clinical trial is to evaluate the safety and tolerability of HLX79 in combination with HLX01 versus placebo in combination with HLX01 in the treatment of glomerulonephritis.
- Trial name
- NCT07038382
- Where
- 17 sites in China
- Volunteers
- 24 people
- Sponsor
- Shanghai Henlius Biotech
Lupus Erythematosus, Systemic, Lupus Nephritis
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active…
- Trial name
- NCT06581198
- Testing
- rapcabtagene autoleucel
- Where
- 107 sites in United States, Argentina and 24 more
- Volunteers
- 179 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Nephritis
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis
The objective of this study is to evaluate the efficacy and safety of Tacrolimus capsules for induction remission in patients with lupus nephritis, and compare the efficacy and safety with Cyclophosphamide injections.
- Trial name
- NCT02457221
- Testing
- Tacrolimus capsules, Cyclophosphamide injections, Prednisone
- Where
- 35 sites in China
- Volunteers
- 314 people
- Sponsor
- Astellas Pharma China, Inc.
Lupus Nephritis
RY_SW01 Cell Injection Therapy in Active Lupus Nephritis
RY_SW01 Cell Injection's preclinical research results have shown that the injection significantly improved urine biochemical indicators and tissue damage in two lupus nephritis animal models after MSC administration, with no…
- Trial name
- NCT06058078
- Testing
- RY_SW01 cell injection, Basic treatment
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Renocell Biotech Company
Lupus Nephritis
Zanubrutinib in Participants With Active Proliferative Lupus Nephritis
The primary objective of this study is to evaluate the efficacy of zanubrutinib added to standard of care as measured by complete renal response for participants with active proliferative lupus nephritis
- Trial name
- NCT04643470
- Testing
- Zanubrutinib
- Where
- 44 sites in China
- Volunteers
- 177 people
- Sponsor
- BeiGene