Clinical trials: SLE - Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).
- Trial name
- EMBODY2 (NCT01261793)
- Testing
- Epratuzumab
- Where
- 133 sites in United States, Brazil and 14 more
- Volunteers
- 791 people
- Sponsor
- UCB Pharma
Systemic Lupus Erythematosus
Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus
The primary purpose of this study is to evaluate the potential effectiveness of 24 weeks of MMF within previously discovered immunologically defined subsets of SLE patients.
- Trial name
- DIVERT (NCT05306873)
- Testing
- Mycophenolate Mofetil, Voclosporin
- Where
- 10 sites in United States
- Volunteers
- 12 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cutaneous Lupus, Systemic Lupus Erythematosus
Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus
This 76-week, 3-part Phase 1b/2 study is intended to evaluate the pharmacological properties (pharmacokinetics and pharmacodynamics), safety, tolerability and preliminary effectiveness of TOFA administrated to young adults (18-45…
- Trial name
- NCT03288324
- Testing
- Tofacitinib
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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)
Systemic Lupus Erythematosus
Single Ascending Dose Study of AMG 570 in Healthy Subjects
The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single…
- Trial name
- NCT02618967
- Testing
- AMG 570
- Where
- 3 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Amgen
Systemic Lupus Erythematosus
A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis
The objective of this study is to assess the safety and tolerability of sifalimumab in adult participants with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who participated in the…
- Trial name
- NCT00979654
- Testing
- Sifalimumab
- Where
- 28 sites in United States, Brazil and 2 more
- Volunteers
- 118 people
- Sponsor
- MedImmune LLC
Systemic Lupus Erythematosus
A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT01283139
- Testing
- Sifalimumab 200 mg, Sifalimumab 600 mg, Sifalimumab 1,200 mg
- Where
- 107 sites in United States, Argentina and 20 more
- Volunteers
- 834 people
- Sponsor
- MedImmune LLC
Systemic Lupus Erythematosus
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active…
- Trial name
- BLISS-76 (NCT00410384)
- Testing
- Belimumab 1 mg/kg, Belimumab 10 mg/kg
- Where
- 146 sites in United States, Austria and 17 more
- Volunteers
- 819 people
- Sponsor
- Human Genome Sciences Inc.
Systemic Lupus Erythematosus
A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus
This study will evaluate the pharmacokinetic characteristics and safety of belimumab subcutaneous (SC) in Chinese pediatric participants with SLE who have completed 48 weeks belimumab Intravenous (IV) treatment in 213560 study…
- Trial name
- NCT05917288
- Testing
- Belimumab, Standard of care
- Where
- 6 sites in China
- Volunteers
- 16 people
- Sponsor
- GlaxoSmithKline
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
Systemic Lupus Erythematosus
Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus
In China, Belimumab (GSK1550188) will be developed for a dosing regimen of once-monthly intravenous (IV) infusion for the treatment of SLE.
- Trial name
- NCT02880852
- Testing
- Belimumab
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
The purpose of this study is to evaluate the safety and efficacy of repeated intravenous infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE) compared with people who receive a placebo.
- Trial name
- BT063 in SLE (NCT02554019)
- Testing
- BT063
- Where
- 14 sites in Belarus, Georgia and 2 more
- Volunteers
- 36 people
- Sponsor
- Biotest
Lupus Erythematosus, Systemic
Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).
- Trial name
- ADDRESS II (NCT01972568)
- Testing
- Atacicept 75 milligram (mg), Atacicept 150 mg
- Where
- 138 sites in United States, Argentina and 16 more
- Volunteers
- 306 people
- Sponsor
- EMD Serono
Systemic Lupus Erythematosus, Connective Tissue Disease
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in participants with active SLE.
- Conditions
- Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease
- Trial name
- NCT01205438
- Testing
- LY2127399
- Where
- 185 sites in United States, Australia and 19 more
- Volunteers
- 1,124 people
- Sponsor
- Eli Lilly and Company
Systemic Lupus Erythematosus, SLE
Vitamin D3 in Systemic Lupus Erythematosus
The purpose of this study is to explore the impact of vitamin D3 on the expression of alpha interferon (IFN alpha) expression in systemic lupus erythematosus (SLE) patients with vitamin D deficiency.
- Conditions
- Systemic Lupus Erythematosus, SLE, Lupus
- Trial name
- NCT00710021
- Testing
- Vitamin D3
- Where
- 8 sites in United States
- Volunteers
- 57 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active…
- Trial name
- BLISS-52 (NCT00424476)
- Testing
- Belimumab 1 mg/kg, Belimumab 10 mg/kg
- Where
- 92 sites in Argentina, Australia and 11 more
- Volunteers
- 865 people
- Sponsor
- Human Genome Sciences Inc.
Systemic Lupus Erythematosus, Systemic Sclerosis
Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)
The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative) chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family donors and matched unrelated cord blood donors)…
- Trial name
- NCT00684255
- Testing
- Reduced Intensity Allogeneic Transplant, Fludarabine, Busulfan
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- New York Medical College
Active Systemic Lupus Erythematosus
Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with moderately to severely active, autoantibody-positive systemic…
- Trial name
- NCT02446912
- Testing
- Anifrolumab
- Where
- 145 sites in United States, Argentina and 16 more
- Volunteers
- 460 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an Autoinjector
The primary objective of this study is to assess the suitability of the autoinjector for self-administration of belimumab by subjects with SLE in real-life conditions.
- Trial name
- NCT02124798
- Testing
- Belimumab autoinjector
- Where
- 27 sites in United States
- Volunteers
- 95 people
- Sponsor
- GlaxoSmithKline