Clinical trials: Lupus Erythematosus, Systemic
Refractory Autoimmune Diseases
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory…
- Trial name
- NCT07115745
- Testing
- BMS-986515, Fludarabine, Cyclophosphamide
- Where
- 28 sites in United States, Australia and 8 more
- Volunteers
- 125 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Systemic Lupus Erythematosus
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.
- Trial name
- NCT02708095
- Testing
- Baricitinib
- Where
- 84 sites in United States, Argentina and 10 more
- Volunteers
- 314 people
- Sponsor
- Eli Lilly and Company
Lupus Nephritis
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN
- Trial name
- SIRIUS-LN (NCT05126277)
- Testing
- ianalumab s.c. q4w, ianalumab s.c. q12w
- Where
- 145 sites in United States, Argentina and 25 more
- Volunteers
- 452 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus
A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Self-Administered Subcutaneously (SC) by Healthy Subjects
This will be a randomized, parallel-group, open-label, single-dose study of belimumab in healthy subjects to estimate the relative bioavailability, tolerability and safety of a single dose of belimumab 200 milligram (mg) when…
- Trial name
- NCT01894360
- Testing
- Belimumab 200 mg/mL
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus (SLE)
A Study of CD19 Redirected Autologous T Cells for CD19 Positive Systemic Lupus Erythematosus (SLE)
CAR-T therapy was therefore proposed and has been recently used for cancer treatment. It has been hailed for its promising remission rates after early stage clinical trials for acute lymphoblastic leukemia.
- Trial name
- NCT03030976
- Testing
- cyclophosphamide, anti-CD19-CAR-T cells
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Shanghai GeneChem Co., Ltd.
Systemic Lupus Erythematosus
Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
The trial will evaluate efficacy, safety and tolerability of ianalumab compared to placebo, given as monthly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus…
- Trial name
- SIRIUS-SLE 2 (NCT05624749)
- Testing
- ianalumab
- Where
- 90 sites in United States, Argentina and 13 more
- Volunteers
- 288 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Erythematosus, Systemic
A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy of ustekinumab in Chinese participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard-of-care treatments.
- Trial name
- NCT04060888
- Testing
- Ustekinumab (approximately 6 mg/kg), Ustekinumab 90 milligram (mg)
- Sponsor
- Janssen Research & Development, LLC
Systemic Lupus Erythematosus, Sjögren's Disease
A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases
The purpose of this study is to evaluate the safety and tolerability of BMS-986553, CD19 in vivo Chimeric Antigen Receptor (CAR) T cells, in participants with refractory autoimmune diseases including systemic lupus erythematosus…
- Conditions
- Systemic Lupus Erythematosus, Sjögren's Disease, Rheumatoid Arthritis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07873931
- Testing
- BMS-986553
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 60 people
- Sponsor
- Bristol-Myers Squibb
Age-Related Macular Degeneration, Allergies
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and…
- Conditions
- Age-Related Macular Degeneration, Allergies, Alpha-Gal Syndrome, Alzheimer Disease
- Trial name
- NCT05635266
- Testing
- Specimen sample
- Where
- United States
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Sanguine Biosciences
Systemic Lupus Erythematosus
Observational Study Investigating Demographic and Clinical Characteristics of SLE Patients in Egypt
Systemic lupus erythematosus (SLE) is an autoimmune condition characterized by a complicated, unclear etiology that involves various complex factors.
- Trial name
- ROSE (NCT07144514)
- Volunteers
- 276 people
- Sponsor
- AstraZeneca
Lupus Erythematosus, Systemic
Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT00714116
- Testing
- SBI-087
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Pfizer
Systemic Lupus Erythematosus
Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
The ERYTHRO study is a retrospective medical chart review study of patients in the AMANA and ATUc Early Access Programs (EAPs) across a number of countries, to assess anifrolumab usage and patient experience in treating SLE in a…
- Trial name
- ERYTHRO (NCT06046534)
- Testing
- None (Observational study)
- Where
- 15 sites in France, Greece and 5 more
- Volunteers
- 46 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
A Study of E6742 in Participants With Systemic Lupus Erythematosus
The main purpose of the study is to demonstrate the efficacy based on dose response of E6742 compared with placebo as defined by the proportion of participants achieving a response using the British Isles Lupus Assessment Group…
- Trial name
- NCT07515014
- Testing
- E6742
- Where
- 54 sites in China, Japan and 2 more
- Volunteers
- 256 people
- Sponsor
- Eisai Co., Ltd.
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
Immune System Diseases, Autoimmune Diseases
Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus
To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.
- Conditions
- Immune System Diseases, Autoimmune Diseases, Lupus Erythematosus, Systemic, Skin and Connective Tissue Diseases
- Trial name
- NCT01764594
- Testing
- CDP7657
- Where
- 21 sites in Belgium, Bulgaria and 5 more
- Volunteers
- 24 people
- Sponsor
- UCB Pharma
Lupus Erythematosus, Systemic
BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)
The main objective of this study is to assess the safety, tolerability and pharmacokinetics of orally administered BI 705564 in patients with systemic lupus erythematosus
- Trial name
- NCT03771885
- Testing
- BI 705564
- Sponsor
- Boehringer Ingelheim
Systemic Lupus Erythematosus
Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and…
- Trial name
- SABLE (NCT01729455)
- Testing
- Benlysta, Standard of Care (SoC) Therapy
- Where
- 179 sites in United States, Argentina and 11 more
- Volunteers
- 3,138 people
- Sponsor
- GlaxoSmithKline
Lupus Nephritis
BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active…
- Trial name
- ATLAS (NCT01499355)
- Testing
- BIIB023, mycophenolate mofetil, oral corticosteroids
- Where
- 58 sites in United States, Argentina and 19 more
- Volunteers
- 276 people
- Sponsor
- Biogen
Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Study of M5049 in CLE and SLE Participants
This study is to evaluate the safety, tolerability and pharmacokinetics (PK) of orally administered M5049 in participants with systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE).
- Trial name
- NCT04647708
- Testing
- M5049
- Where
- 12 sites in Bulgaria, Germany and 4 more
- Volunteers
- 25 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Systemic Lupus Erythematosus
Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344 in comparison with placebo in the treatment of participants aged 18…
- Trial name
- APATURA (NCT05039840)
- Testing
- SAR441344 IV, SAR441344 SC
- Where
- 73 sites in United States, Argentina and 14 more
- Volunteers
- 109 people
- Sponsor
- Sanofi