Clinical trials: Active Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus Erythematosus (SLE) disease activity improvement achieved by a brief course of disease-suppressing steroid therapy
- Trial name
- NCT02725515
- Testing
- XmAb5871
- Where
- 23 sites in United States
- Volunteers
- 105 people
- Sponsor
- Xencor, Inc.
SLE
Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus
The purpose of this study is to assess the clinical efficacy, safety, PK, and PD of multiple dose levels of ESK-001 compared with placebo in adult patients with SLE.
- Trial name
- LUMUS (NCT05966480)
- Testing
- Envudeucitinib
- Where
- 169 sites in United States, Argentina and 19 more
- Volunteers
- 408 people
- Sponsor
- Alumis Inc
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.
Lupus Erythematosus, Systemic, Lupus Nephritis
A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)
The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at…
- Trial name
- NCT07015983
- Testing
- CC-97540, Fludarabine, Cyclophosphamide
- Where
- 97 sites in United States, Argentina and 14 more
- Volunteers
- 89 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Systemic Lupus Erythematosus
Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.
- Trial name
- NCT01559090
- Testing
- MEDI-546
- Where
- 6 sites in Japan
- Volunteers
- 17 people
- Sponsor
- AstraZeneca
Lupus Erythematosus, Lupus Nephritis
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis
- Trial name
- EQUALISE (NCT04128579)
- Testing
- Itolizumab [Bmab 600]
- Where
- 25 sites in United States, India and 1 more
- Volunteers
- 52 people
- Sponsor
- Biocon Limited
Systemic Lupus Erythematosus
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
This is a Phase II, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rontalizumab compared with placebo in patients with moderately to severely active systemic lupus…
- Trial name
- NCT00962832
- Testing
- Rontalizumab
- Where
- 79 sites in United States, Argentina and 4 more
- Volunteers
- 238 people
- Sponsor
- Genentech, Inc.
Lupus Nephritis
Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis
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 active proliferative lupus nephritis (LN).
- Trial name
- TULIP-LN1 (NCT02547922)
- Testing
- Anifrolumab
- Where
- 80 sites in United States, Argentina and 15 more
- Volunteers
- 147 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of IMPT-514 in Active Refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE)
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-514, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with active…
- Trial name
- NCT06153095
- Testing
- IMPT-514
- Where
- 4 sites in United States, Australia
- Sponsor
- Lyell Immunopharma, Inc.
Lupus Nephritis
A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis
The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).
- Trial name
- NCT04883619
- Testing
- Nipocalimab, Standard-of-care treatment
- Sponsor
- Janssen Research & Development, LLC
Lupus Erythematosus, Discoid
A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies
Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients with Higher Disease Activity (anti-dsDNA positive and low complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and…
- Trial name
- NCT01858792
- Testing
- Belimumab 1 mg/kg, Belimumab 10 mg/kg
- Volunteers
- 1 people
- Sponsor
- Human Genome Sciences Inc., a GSK Company
Lupus Erythematosus, Systemic, Lupus Erythematosus
Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals
OASIS: A mobile study to measure and predict lupus (SLE) disease activity using digital signals The OASIS study is exploring how patient reported data and digital biomarkers, like activity level and heart rate variability, can be…
- Trial name
- OASIS (NCT04449653)
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Progentec Diagnostics, Inc.
Systemic Lupus Erythematosus
Clinical and Demographic Features of Patients With Moderate to Severe Active Systemic Lupus Erythematosus in Russia
This is a multicenter observational retrospective-prospective study consisting of retrospective and prospective phases. Trial will include 2 visits for obtaining the patient's demographic and clinical data: the 1st is…
- Trial name
- SEVERUS (NCT06759519)
- Where
- 32 sites in Russia
- Volunteers
- 637 people
- Sponsor
- AstraZeneca
Lupus Nephritis
Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.
- Trial name
- NCT05268289
- Testing
- Iptacopan (part 1), Iptacopan (part 2)
- Where
- 74 sites in United States, Argentina and 17 more
- Volunteers
- 81 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Nephritis
A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.
This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of MMF compared to azathioprine in…
- Trial name
- NCT00377637
- Testing
- Mycophenolate mofetil (MMF), Cyclophosphamide, Azathioprine
- Where
- 108 sites in United States, Argentina and 15 more
- Volunteers
- 370 people
- Sponsor
- Hoffmann-La Roche
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE).
- Trial name
- AMETHYST LTE (NCT06044337)
- Testing
- BIIB059 (litifilimab)
- Where
- 104 sites in United States, Argentina and 23 more
- Volunteers
- 306 people
- Sponsor
- Biogen
Lupus Nephritis
Aurinia Early Urinary Protein Reduction Predicts Response
An exploratory study assessing the ability of biomarkers measured at 8 weeks to predict clinical response over 24 and 48 weeks in subjects taking voclosporin 23.7 mg twice daily (BID) in combination with standard of care in…
- Trial name
- AURION (NCT02949973)
- Testing
- voclosporin
- Where
- 2 sites in Malaysia
- Volunteers
- 10 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
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
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
Lupus Nephritis
RY_SW01 Cell Injection Therapy in Active Lupus Nephritis
RY_SW01 Cell Injection's preclinical research results have shown that the injection significantly improved urine biochemical indicators and tissue damage in two lupus nephritis animal models after MSC administration, with no…
- Trial name
- NCT06058078
- Testing
- RY_SW01 cell injection, Basic treatment
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Renocell Biotech Company