Clinical trials: System Lupus Erythematosus
System; Lupus Erythematosus, Lupus Erythematosus
Translation of a Diagnostic Test for Lupus Flare Prediction From Bench to Clinic
This study is investigating the development of a diagnostic test intended to predict flares in patients with Systemic Lupus Erythematosus.
- Conditions
- System; Lupus Erythematosus, Lupus Erythematosus, SLE, Lupus Flare
- Trial name
- TOTAL FEEDBACK (NCT04018222)
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Progentec Diagnostics, Inc.
Lupus Erythematosus, Systemic
Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus
The Polish multicentre observational (non-interventional) study aiming to collect data on the characteristic of patients with systemic lupus erythematosus and clinical outcomes of anifrolumab administered in the scope of routine…
- Trial name
- SLE-ARTEMIS (NCT06673043)
- Testing
- Anifrolumab
- Where
- 11 sites in Poland
- Volunteers
- 105 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of KITE-363 in Participants With Refractory Autoimmune Diseases
This study will have two Phases: Phase 1a and Phase 1b. The goal of this clinical study is to learn more about the study drug KITE-363, to establish dosing, tolerability, safety, and preliminary efficacy of KITE-363 in…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathy
- Trial name
- NCT07038447
- Testing
- KITE-363, Fludarabine, Cyclophosphamide
- Where
- 10 sites in United States, Australia and 2 more
- Volunteers
- 52 people
- Sponsor
- Kite, A Gilead Company
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]
The purpose of this study is to evaluate the long-term safety and efficacy of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908_0001)…
- Trial name
- NCT07840287
- Testing
- Enpatoran
- Where
- 2 sites in United States, Germany
- Volunteers
- 404 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus (SLE)
A Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and it's Effects on Symptoms in Adults With Systemic Lupus Erythematosus (SLE)
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE).
- Trial name
- EMERALD (NCT05352919)
- Testing
- Litifilimab
- Where
- 214 sites in United States, Argentina and 26 more
- Volunteers
- 864 people
- Sponsor
- Biogen
Systemic Lupus Erythematosus
A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus
The purpose of this study is to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while…
- Trial name
- NCT07630714
- Testing
- Anifrolumab + APFS
- Where
- 39 sites in Australia, Belgium and 8 more
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and pharmacodynamics (PD) of repeat doses of 200 milligrams per milliliter (mg/mL) belimumab administered via SC injection in pediatric participants 5 to…
- Trial name
- NCT04179032
- Testing
- Belimumab
- Where
- 11 sites in United States, Argentina and 5 more
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7507062 in participants with systemic lupus erythematosus (SLE).
- Trial name
- NCT05835986
- Testing
- RO7507062, Tocilizumab
- Where
- 18 sites in Colombia, France and 11 more
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
Lupus Erythematosus, Systemic
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of…
- Trial name
- VOYAGER (NCT00381810)
- Testing
- Rituximab, Methylprednisolone, Acetaminophen
- Where
- 11 sites in United States
- Volunteers
- 31 people
- Sponsor
- Genentech, Inc.
Systemic Lupus Erythematosus, SLE
Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus
This is a phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of orelabrutinib in adult subjects with SLE who are receiving standard of care (SOC) therapy.
- Trial name
- NCT05688696
- Testing
- Orelabrutinib (Low Dose), Orelabrutinib (High Dose)
- Where
- 41 sites in China
- Volunteers
- 186 people
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
Systemic Lupus Erythematosus, Rheumatoid Arthritis
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA). The main goal of the study is to learn about the safety of MK-1045 and if people tolerate it when they receive it at…
- Trial name
- NCT07363590
- Testing
- MK-1045
- Where
- 21 sites in Australia, Belgium and 9 more
- Volunteers
- 21 people
- Sponsor
- Merck Sharp & Dohme LLC
SLE
A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.
To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).
- Trial name
- NCT06182969
- Testing
- APG-2575
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Ascentage Pharma Group Inc.
Systemic Lupus Erythematosus
Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20 milligrams [mg], 60 mg, and 120 mg) administered subcutaneously in adult participants with moderately to…
- Trial name
- NCT03371251
- Testing
- BOS161721
- Where
- 68 sites in United States, Argentina and 10 more
- Volunteers
- 143 people
- Sponsor
- Boston Pharmaceuticals
Lupus Erythematosus, Systemic
Double-Blinded, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Biochemical Activity of Intravenous Cpn10 Administration in Subjects With Mild to Moderate SLE.
The primary objective of the study is to evaluate the safety, tolerability, and efficacy of 4 weeks intravenous treatment with Cpn10 in subjects with mild to moderate active SLE.
- Trial name
- NCT01838694
- Testing
- Ala-Cpn10
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Invion, Inc.
Systemic Lupus Erythematosus, Lupus
Lupus Interval Monitoring to Manage Disease Flare and Enable Treatment Optimization
To develop a test to characterize and monitor SLE disease activity status from a participant's home by analyzing the gene expression from participant self-collected blood samples using a novel fingerstick collection kit.
- Conditions
- Systemic Lupus Erythematosus, Lupus, Lupus Erythematosus, Lupus Erythematosus, Systemic
- Trial name
- LIFT (NCT03142412)
- Where
- United States
- Volunteers
- 2,500 people
- Sponsor
- DxTerity Diagnostics
Systemic Lupus Erythematosus
Study of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)
This is a Phase 1b, double blind, randomized, placebo-controlled study of the safety and tolerability, pharmacokinetics and pharmacodynamics of AC0058TA in patients with systemic lupus erythematosus (SLE).
- Trial name
- NCT03878303
- Testing
- AC0058TA
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- ACEA Therapeutics, Inc.
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic
A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
The purpose of this study is to obtain skin, blood, and urine samples from patients with active cutaneous lupus lesions and from healthy participants.
- Conditions
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid, Healthy
- Trial name
- NCT02034344
- Testing
- Skin biopsy, Blood collection, Urine collection
- Where
- 21 sites in United States, Germany and 4 more
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.
The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA Study details include: The study duration will be a minimum of 180…
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Rheumatoid Arthritis
- Trial name
- TITAN (NCT06916806)
- Testing
- AZD5492
- Where
- 38 sites in United States, Canada and 8 more
- Volunteers
- 72 people
- Sponsor
- AstraZeneca
Healthy Subjects (HS), SLE (Systemic Lupus)
First-in-Human Study of ISH0613: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
The goal of this clinical trial is to learn about a study drug called ISH0613 and how it behaves in healthy adults. This study will also evaluate the safety and tolerability of ISH0613 after a single intravenous (IV) dose.
- Trial name
- NCT07516639
- Testing
- ISH0613 for injection
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE)
BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE), Dermatomyositis (DM), Systemic Sclerosis (SSc)
- Trial name
- NCT07729995
- Testing
- LMY-922
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Luminary Therapeutics