Clinical trials: Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic, Lupus Nephritis
Study of LJP 394 in Lupus Patients With History of Renal Disease
The primary purpose of this study is to determine whether abetimus sodium is more effective than placebo in delaying time to renal flare in SLE patients with a history of renal disease.
- Trial name
- ASPEN (NCT00089804)
- Testing
- abetimus sodium (LJP 394), Phosphate-buffered saline
- Where
- 201 sites in United States, Argentina and 28 more
- Volunteers
- 943 people
- Sponsor
- La Jolla Pharmaceutical Company
Systemic Lupus Erythematosus
Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects
The study is an open-labeled extension study to continue to assess the safety and tolerability of Epratuzumab in moderate to severe SLE subjects who have previously participated in SL0026 [NCT01449071] phase I/II trial.
- Trial name
- NCT01534403
- Testing
- Epratuzumab
- Where
- 6 sites in Japan
- Volunteers
- 17 people
- Sponsor
- UCB Pharma
Systemic Lupus Erythematosus
Study of CD19 CAR-T Therapy for Refractory SLE
This is an investigator-initiated trial aimed at assessing the safety and efficacy of PTOC1 cells Injection in the treatment of refractory systemic lupus erythematosus.
- Trial name
- NCT07403097
- Testing
- PTOC1
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Systemic Lupus Erythematosus
Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease
The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.
- Trial name
- NCT00660881
- Testing
- Epratuzumab
- Where
- 42 sites in United States, Belgium and 9 more
- Volunteers
- 210 people
- Sponsor
- UCB Pharma
Systemic Lupus Erythematosus
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).
- Trial name
- NCT03252587
- Testing
- BMS-986165
- Where
- 192 sites in United States, Argentina and 15 more
- Volunteers
- 363 people
- Sponsor
- Bristol-Myers Squibb
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
Systemic Lupus Erythematosus
CD19-CART(Relma-cel) for Moderate to Severe Active Systemic Lupus Erythematosus
This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.
- Trial name
- NCT05765006
- Testing
- Relma-cel
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd.
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Clinical Study of YTS109 Cell for R/R Autoimmune Diseases
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc.
- Conditions
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), Systemic Sclerosis (SSc), Inflammatory Myopathy
- Trial name
- NCT07104721
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 18 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Systemic Lupus Erythematosus
Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects
This is a Phase 1 study to investigate the safety, tolerability and pharmacokinetics (PK) of KPG-818 in healthy male and female participants and the effect of food on the PK of KPG-818.
- Trial name
- NCT03949426
- Testing
- KPG-818
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Kangpu Biopharmaceuticals, Ltd.
Lupus Nephritis
A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis Patients
This study is to evaluate efficacy and safety of tacrolimus with steroid by observing remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid monotherapy.
- Trial name
- APPLE (NCT01316133)
- Testing
- tacrolimus
- Where
- 7 sites in South Korea
- Volunteers
- 37 people
- Sponsor
- Astellas Pharma Korea, 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
Lupus Nephritis
Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg
The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with systemic lupus erythematosus…
- Trial name
- NCT00705367
- Testing
- Abatacept
- Where
- China
- Volunteers
- 13 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus, Autoimmune Hemolytic Anemia (AIHA)
Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of Arnovie101, an mRNA-LNP-Based In Vivo CAR-T Therapy, for the Treatment of B Cell-Mediated Autoimmune Diseases (SLE and AIHA)
This is an open lable and single arm study designed to evaluate the safety, PK and PD of Arnovie101 in B cell-mediated Autoimmune Disease
- Trial name
- NCT07629596
- Testing
- Arnovie101 Infusion Intravenous
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Circunited BioPharma (Shenzhen) Co., Ltd.
Systemic Lupus Erythematosus
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus
This first-in-human, multicenter study to evaluate the administration of placebo or AMG 811 single subcutaneous and intravenous dose to subjects with SLE
- Trial name
- NCT02291588
- Testing
- AMG 811
- Volunteers
- 26 people
- Sponsor
- Amgen
Lupus Erythematosus, Systemic, Lupus Erythematosus, Cutaneous
A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.
The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms.
- Trial name
- NCT05879718
- Testing
- PF-06823859
- Where
- 19 sites in United States, Canada and 2 more
- Volunteers
- 8 people
- Sponsor
- Pfizer
Systemic Lupus Erythematosus (SLE)
SG301-SC Injection Safety Study in Subjects With Systemic Lupus Erythematosus
This is a randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single dose in healthy volunteers and multiple doses of SG301 SC…
- Trial name
- NCT06144710
- Testing
- SG301 SC Injection
- Where
- 10 sites in China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
Systemic Lupus Erythematosus (SLE)
Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells
This study will investigate the safety and efficacy of allogeneic umbilical cord-derived stem cell therapy in treating patients with moderate to severe systemic lupus erythematosus.
- Trial name
- NCT07041801
- Testing
- hUC-MSCs treatment (low dose), hUC-MSCs treatment (medium dose), hUC-MSCs treatment (high dose)
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.
Systemic Lupus Erythematosus
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).
- Trial name
- SLE-BRAVE I (NCT03616912)
- Testing
- Baricitinib
- Where
- 184 sites in United States, Australia and 16 more
- Volunteers
- 830 people
- Sponsor
- Eli Lilly and Company
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, Lupus Nephritis
UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis
This is an open-label investigator-initiated trial (IIT) to assess the safety, efficacy, and PK（pharmacokinetic）/PD（pharmacodynamics ） of UB-VV410 in adult subjects with clinically active treatment-refractory SLE.
- Trial name
- NCT07109986
- Testing
- UB-VV410
- Where
- China
- Volunteers
- 21 people
- Sponsor
- Nanjing IASO Biotechnology Co., Ltd.