Clinical trials: Systemic Lupus
Lupus
Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE)
The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients with SLE and who are…
- Trial name
- NCT00299819
- Testing
- MEDI-545, MEDI 545
- Where
- 21 sites in United States, Canada
- Volunteers
- 45 people
- Sponsor
- MedImmune LLC
Refractory Systemic Lupus Erythematosus
A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus
This is a single-arm, open-label, multicenter, phase 1/2 clinical study to assess the safety and efficacy of GC012F Injection in subjects with refractory Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT06530849
- Testing
- GC012F Injection
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- Gracell Biotechnologies (Shanghai) Co., Ltd.
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLE
The primary objective of this phase Ib study is to evaluate the safety and tolerability of multiple-ascending, subcutaneous (SC) doses of HC022 in SLE/CLE subjects.
- Trial name
- NCT07306585
- Testing
- HC022
- Where
- China
- Volunteers
- 32 people
- Sponsor
- HC Biopharma Inc.
Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants..
This study is a Phase Ia, single-center, randomized, double-blind, dose-escalation, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profile of ACT100 in…
- Trial name
- NCT07408908
- Testing
- ACT100 Injection
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE)
BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE), Dermatomyositis (DM), Systemic Sclerosis (SSc)
- Trial name
- NCT07729995
- Testing
- LMY-922
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Luminary Therapeutics
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
CALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
- Trial name
- CALiPSO-1 (NCT06255028)
- Testing
- CNTY-101, IL-2, Lymphodepleting Chemotherapy
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Century Therapeutics, Inc.
Lupus Nephritis
Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
This was a pivotal, randomized, double-blind, placebo-controlled trial evaluating at Week 52 the efficacy and safety of secukinumab versus placebo in patients with active lupus nephritis (ISN/RPS Class III or IV, with or without…
- Trial name
- SELUNE (NCT04181762)
- Testing
- secukinumab
- Where
- 105 sites in United States, Argentina and 32 more
- Volunteers
- 275 people
- Sponsor
- Novartis Pharmaceuticals
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
A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7507062 in participants with systemic lupus erythematosus (SLE).
- Trial name
- NCT05835986
- Testing
- RO7507062, Tocilizumab
- Where
- 18 sites in Colombia, France and 11 more
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
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
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 to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
- Trial name
- NCT04976322
- Testing
- Dapirolizumab pegol
- Where
- 123 sites in United States, Argentina and 22 more
- Volunteers
- 760 people
- Sponsor
- UCB Biopharma SRL
Lupus Nephritis
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Lupus Nephritis Previously Enrolled in Study U2970g
This is a Phase III, multicenter, extension study to evaluate the safety of rituximab administered on a scheduled basis approximately every 6 months.
- Trial name
- NCT00404157
- Testing
- Rituximab
- Sponsor
- Genentech, Inc.
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.
Lupus Nephritis
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).
- Trial name
- NCT03943147
- Testing
- BMS-986165, Mycophenolate Mofetil
- Where
- 100 sites in United States, Australia and 14 more
- Volunteers
- 16 people
- Sponsor
- Bristol-Myers Squibb
ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
FT839 in Autoimmune Diseases
The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or…
- Conditions
- ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT07800871
- Testing
- FT839
- Where
- United States
- Volunteers
- 446 people
- Sponsor
- Fate Therapeutics
Systemic Lupus Erythematosus, Rheumatoid Arthritis
A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity. Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint…
- Trial name
- NCT07607964
- Testing
- ABBV-519
- Where
- 15 sites in United States, Japan
- Volunteers
- 30 people
- Sponsor
- AbbVie
Lupus Nephritis
Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis.
This study was to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic efficacy of multiple doses of CFZ533 anti-CD40 monoclonal antibody in patients with moderately active lupus…
- Trial name
- NCT03610516
- Testing
- CFZ533
- Where
- 21 sites in Argentina, China and 8 more
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus
To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE).
- Trial name
- NCT03451422
- Testing
- Efavaleukin Alfa
- Where
- 15 sites in United States, France and 2 more
- Volunteers
- 35 people
- Sponsor
- Amgen
Lupus Erythematosus, Systemic
A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
This current Phase 3 study will evaluate the efficacy and safety of administration of subcutaneous (sc) IPP-201101 in patients with active SLE.
- Trial name
- LUPUZOR (NCT02504645)
- Testing
- IPP-201101, Standard of Care
- Where
- 30 sites in United States, Czechia and 6 more
- Volunteers
- 202 people
- Sponsor
- ImmuPharma