Clinical trials: Systemic Lupus Erythematosus
Sjögrens Disease, Systemic Lupus Erythematosus
Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease
The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL…
- Conditions
- Sjögrens Disease, Systemic Lupus Erythematosus, Rheumatoid Arthritis
- Trial name
- NCT06293365
- Testing
- VAY736 1ml PFS, VAY736 2 ml PFS, VAY736 2ml AI
- Where
- 37 sites in United States, Argentina and 6 more
- Volunteers
- 155 people
- Sponsor
- Novartis Pharmaceuticals
SLE (Systemic Lupus), Lupus Erythematosus, Systemic
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus…
- Conditions
- SLE (Systemic Lupus), Lupus Erythematosus, Systemic, Lupus Nephritis, Systemic Sclerosis
- Trial name
- NCT06925542
- Testing
- CTX112
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 80 people
- Sponsor
- CRISPR Therapeutics
Lupus Nephritis
BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis
The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in participants with lupus nephritis (LN).
- Trial name
- NCT01930890
- Testing
- BIIB023, mycophenolate mofetil, oral corticosteroids
- Where
- 33 sites in United States, Argentina and 17 more
- Volunteers
- 87 people
- Sponsor
- Biogen
Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis
Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE
The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in children and adults with macrophage activation syndrome (sHLH/MAS) in Still's disease (including systemic juvenile idiopathic arthritis…
- Conditions
- Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, Systemic Lupus Erythematosus
- Trial name
- EMERALD (NCT05001737)
- Testing
- Emapalumab
- Where
- 44 sites in United States, Belgium and 11 more
- Volunteers
- 33 people
- Sponsor
- Swedish Orphan Biovitrum
Sjogren Disease, Systemic Lupus Erythematosus
Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases
The purpose of this pharmacokinetic (PK) study is to describe the PK profile of ianalumab following s.c. administration in Chinese participants with systemic lupus erythematosus (SLE) and/or Sjögren's disease (SjD).
- Trial name
- NCT06411639
- Testing
- ianalumab
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus
A Study of DS-7011a in Patients With Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a systemic chronic autoimmune disease characterized by autoantibody production, inflammation, and tissue damage in multiple organs.
- Trial name
- NCT05638802
- Testing
- DS-7011a
- Where
- 20 sites in United States, China and 2 more
- Volunteers
- 26 people
- Sponsor
- Daiichi Sankyo
Lupus Nephritis
A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis
This study will compare the efficacy of CellCept [0.5-2 grams per day (g/day) orally (p.o.)] and cyclophosphamide [0.5-1 grams per square meter (g/m2) quarterly] as maintenance treatment for patients with lupus nephritis.
- Trial name
- NCT02081183
- Testing
- Mycophenolate mofetil (MMF), Cyclophosphamide, Maintenance Phase, Cyclophosphamide, Induction Phase
- Where
- 2 sites in Venezuela
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
Lupus Nephritis, Lupus Erythematosus
Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) obtained from bone marrow for the treatment of adults with active proliferative lupus nephritis.
- Trial name
- MSV_LE (NCT03673748)
- Testing
- Mesenchymal stem cells (MSC)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Red de Terapia Celular
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic
A Non-drug Study Profiling Cutaneous Lupus
The purpose of this study is to characterize the clinical and molecular profiles of patients with cutaneous lupus.
- Conditions
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid
- Trial name
- NCT01923415
- Testing
- No intervention, skin biopsy, No intervention, blood collection, No intervention, urine collection
- Where
- 3 sites in United States, Poland
- Volunteers
- 29 people
- Sponsor
- Janssen Research & Development, LLC
Lupus Erythematosus, Systemic
Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)
This is an open label study to determine the association of the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical involvement, SLEDAI score…
- Trial name
- ReLATE (NCT05845593)
- Testing
- Decision Support Test
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Ampel BioSolutions, LLC
Systemic Lupus Erythematosus
A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard…
- Trial name
- NCT01438489
- Testing
- Anifrolumab 300 mg, Anifrolumab 1000 mg
- Where
- 79 sites in United States, Brazil and 12 more
- Volunteers
- 626 people
- Sponsor
- MedImmune LLC
Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc
A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734 in adult subjects with type I interferon-mediated autoimmune diseases.
- Trial name
- NCT02780674
- Testing
- MEDI7734
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Amgen
Long-Term Organ Damage in Adult Patients With Active Systemic Lupus Erythematosus
Long-Term Organ Damage: Anifrolumab Versus Real-World Standard of Care in Adult Patients With Active Systemic Lupus Erythematosus
This is an External control arm study to generate evidence on the comparative effect of anifrolumab plus Standard of Care in TULIP versus Real World Standard of Care on organ damage in adult patients with moderately to severely…
- Trial name
- LASER (NCT06485674)
- Where
- Canada
- Volunteers
- 561 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM)
Safety Study of CC312 in Autoimmune Disease Patients
This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune…
- Conditions
- Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM), Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA)
- Trial name
- NCT06888960
- Testing
- CC312
- Where
- China
- Volunteers
- 18 people
- Sponsor
- CytoCares Inc
Lupus Nephritis, Lupus Nephritis - WHO Class III
KYSA-3: 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 - WHO Class III, Lupus Nephritis - WHO Class IV
- Trial name
- NCT06342960
- Testing
- KYV-101 anti-CD19 CAR-T cell therapy, Standard lymphodepletion regimen
- Where
- 6 sites in Germany
- Volunteers
- 2 people
- Sponsor
- Kyverna Therapeutics
Lupus Erythematosus, Systemic Lupus Erythematosus
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)
SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.
- Conditions
- Lupus Erythematosus, Systemic Lupus Erythematosus, SLE (Systemic Lupus), Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06294236
- Testing
- SC291
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Sana Biotechnology
Systemic Lupus Erythematosus
The Anifrolumab PRIM Program
Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program
- Trial name
- PRIM (NCT06795893)
- Testing
- Anifrolumab
- Where
- Sweden
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus, Lupus Erythematosus
A Study of Imvotamab in Severe Systemic Lupus Erythematosus
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with severe systemic lupus erythematosus who have failed prior therapies.
- Trial name
- NCT06041568
- Testing
- Imvotamab
- Where
- 10 sites in United States, Poland and 1 more
- Volunteers
- 17 people
- Sponsor
- IGM Biosciences, Inc.
Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus
Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion
Primary Objective: To investigate the efficacy on skin manifestation of 16 weeks treatment of once daily regimen of hydroxychloroquine sulphate (HCQ) in patients with cutaneous lupus erythematosus (CLE) and systemic lupus…
- Trial name
- NCT01551069
- Testing
- hydroxychloroquine (Z0188)
- Where
- 22 sites in Japan
- Volunteers
- 103 people
- Sponsor
- Sanofi
Systemic Lupus Erythematosus
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetic of TQB3702 Tablets in Healthy Adult Subjects
This is a phase I, randomized, double-blind, placebo-controlled, dose-escalating clinical study aimed at evaluating the safety of TQB3702 tablets following single and multiple doses administered to healthy subjects
- Trial name
- NCT06448273
- Testing
- TQB3702 tablets
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.