Clinical trials: System Lupus Erythematosus
Vasculitis, Systemic Lupus Erythematosus (SLE)
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants
The primary objective of this study will be to evaluate the safety and tolerability of single and multiple oral doses of CCX168, over a range of dose levels, in healthy male and female participants.
- Trial name
- NCT05984251
- Testing
- CCX168
- Where
- Switzerland
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Amgen
System Lupus Erythematosus(SLE), Scleroderma
Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases
A FIH, single arm, open-label, Investigator Initiated Trial (IIT) study to evaluate the safety and tolerability of EVM18001 in the treatment of active refractory autoimmune diseases (SLE, MG, and SSc), and determine the…
- Conditions
- System Lupus Erythematosus(SLE), Scleroderma, Myasthenia Gravis (MG)
- Trial name
- NCT07470151
- Testing
- EVM18001 Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Systemic Lupus Erythematosus
Phase I Study of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK1550188 in Japanese subjects with Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT01381536
- Testing
- GSK1550188 1mg/kg or 10mg/kg
- Where
- 2 sites in Japan
- Volunteers
- 12 people
- Sponsor
- GlaxoSmithKline
Lupus Arthritis, Systemic Lupus Erythematosus
Safety Study of AMG 557 in Subjects With Lupus Arthritis
This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.
- Trial name
- NCT01683695
- Testing
- AMG 557
- Where
- 13 sites in United States, Australia and 6 more
- Volunteers
- 20 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus, Quality of Life
Peer Approaches to Lupus Self-management
The Peer Approaches to Lupus Self-Management (PALS) study is a randomized, controlled in which 360 African American women with lupus will be recruited from the MUSC SLE database (60 mentors and 300 mentees).
- Conditions
- Systemic Lupus Erythematosus, Quality of Life, Behavior, Health
- Trial name
- PALS (NCT03734055)
- Testing
- Peer Mentoring, Social Support Group
- Where
- United States
- Volunteers
- 314 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Lupus Nephritis, Autoimmune Diseases
A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease
ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease.
- Conditions
- Lupus Nephritis, Autoimmune Diseases, Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06375993
- Testing
- ADI-001, Fludarabine, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 180 people
- Sponsor
- Adicet Therapeutics
Systemic Lupus Erythematosus
Regulatory BCells in Systemic Lupus Erythematosus
Systemic lupus erythematosus , the archetypal multisystem autoimmune disease, presents many diagnostic and management challenges.
- Trial name
- NCT03178721
- Testing
- blood sample
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Assiut University
Lupus Nephritis
Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety 1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response [CRR] or…
- Trial name
- SIRIUS-LN ext (NCT06711887)
- Testing
- Ianalumab
- Where
- 51 sites in United States, Brazil and 16 more
- Volunteers
- 348 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Nephritis
Phase IIa Study for IPG11406 in Patients With Lupus Nephritis
A multi-center, multi-dose phase Ib/IIa clinical study evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics, and impact on biomarkers of IPG11406 in patients with Lupus Nephritis
- Trial name
- NCT06717815
- Testing
- IPG11406
- Where
- 17 sites in China
- Volunteers
- 24 people
- Sponsor
- Nanjing Immunophage Biotech Co., Ltd
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid
Autologous Polyclonal Tregs for Lupus
The primary purpose of this Phase 1 study is to evaluate the safety, tolerability, and effect of 3 different doses of Treg therapy in adults with skin (cutaneous) involvement of their lupus.
- Conditions
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic
- Trial name
- NCT02428309
- Testing
- Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Lupus Erythematosus, Systemic
Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE). The doctor will assign eligible patients to one of two groups (like flipping a coin).
- Trial name
- NCT02953821
- Testing
- Acthar Gel
- Where
- 39 sites in United States, Argentina and 3 more
- Volunteers
- 172 people
- Sponsor
- Mallinckrodt
Systemic Lupus Erythematosus, Nephritis
The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria
Glomerulonephritis and renal failure represent one of the most life-threatening manifestations of systemic lupus erythematosus (SLE).
- Conditions
- Systemic Lupus Erythematosus, Nephritis, Proteinuria
- Trial name
- NCT00508898
- Testing
- Calcitriol, Multivitamin
- Sponsor
- Chinese University of Hong Kong
Systemic Lupus Erythematosus (SLE)
3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2
The natural history of Systemic lupus erythematosus (SLE) is characterized by relapses or flares alternated with periods of remission.
- Trial name
- 3TR-SLE2 (NCT05747651)
- Testing
- Blood sample, Urine sample, Saliva sample
- Where
- France
- Volunteers
- 6 people
- Sponsor
- University Hospital, Brest
Lupus Nephritis
Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis
The aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.
- Trial name
- NCT00709722
- Testing
- NKT-01
- Where
- 6 sites in Czechia, Germany
- Volunteers
- 21 people
- Sponsor
- Nippon Kayaku Co., Ltd.
SLE, and Organ Damage Index
The 2019 EULAR/ACR Classification Criteria as Predictor of Organ Damage in Systemic Lupus Erythematosus Patients
The goal of this observational study is to investigate if the 2019 EULAR/ACR classification criteria can be used to assess organ damage in patients with systemic lupus erythematosus (SLE) and as predictor for prognosis .
- Trial name
- NCT06313151
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- Sohag University
REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS, Lupus Nephritis
SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus
study evaluates a biomarker-guided strategy to assign adults with refractory SLE to autologous CAR-T therapy targeting either CD19 or BCMA.
- Trial name
- SELECT-SLE (NCT07523542)
- Testing
- Autologous anti-CD19 CAR-T cells, intravenous single infusion at protocol-defined dose level (1 x 10^6 or 3 x 10^6 CAR-positive viable T cells/kg)., Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Beijing Biotech
Lupus Nephritis (LN), Lupus Nephritis - WHO Class III
Safety and Efficacy of ONT01 in Lupus
ONT01 is a drug that is being studied for the treatment of Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) and is not approved by the FDA.
- Conditions
- Lupus Nephritis (LN), Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV, Lupus Nephritis - World Health Organization (WHO) Class III
- Trial name
- NCT07107659
- Testing
- ONT01 is a small molecule CD11b modulator.
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Hospital for Special Surgery, New York
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
Antiphospholipid Syndrome, Thrombophilia Due to Antiphospholipid Antibody
Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)
This 12 week study will observe patients with and without systemic lupus erythematosus who have persistent antiphospholipid antibodies in the blood who are starting a medicine called hydroxychloroquine.
- Conditions
- Antiphospholipid Syndrome, Thrombophilia Due to Antiphospholipid Antibody, Systemic Lupus Erythematosus
- Trial name
- NCT01475149
- Testing
- Phlebotomy
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Hospital for Special Surgery, New York
Systemic Lupus Erythematous (SLE)
Autologous CD19 Car T-Cell Therapy For Severe Refractory Systemic Lupus Erythematosus (SLE)
This pilot clinical study aims to evaluate the effectiveness of Chimeric Antigen Receptor (CAR) T-cell therapy in treating severe, refractory systemic lupus erythematosus (SLE), an autoimmune disease driven by autoreactive…
- Trial name
- NCT06710717
- Testing
- CD19 CAR-T cells
- Where
- Malaysia
- Volunteers
- 5 people
- Sponsor
- National University of Malaysia
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