Clinical trials: SLE - Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus
The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without…
- Trial name
- SUNFLOWER (NCT07430306)
- Testing
- Anifrolumab
- Where
- 107 sites in United States, Canada and 7 more
- Volunteers
- 245 people
- Sponsor
- AstraZeneca
Childhood-onset Systemic Lupus Erythematous, ANCA-Associated Vasculitis (AAV)
Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders
Safety, tolerability and efficacy of Descarte-08 in children, adolescents and young adults with childhood-onset systemic lupus erythematosus, ANCA-associated vasculitis, juvenile myasthenia gravis, and juvenile dermatomyositis
- Conditions
- Childhood-onset Systemic Lupus Erythematous, ANCA-Associated Vasculitis (AAV), Juvenile Myasthenia Gravis, Juvenile Dermatomyositis
- Trial name
- NCT07089121
- Testing
- Descartes-08
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cartesian Therapeutics
Lupus Erythematosus, Systemic
A Study of Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Mod-severe Systemic Lupus Erythematosus
This study aims to describe clinical outcomes, with focus on remission, achieved with use of anifrolumab participants with SLE on standard-of-care (as recommended by 2025 China SLE guidelines).
- Trial name
- LOTUS (NCT07751848)
- Testing
- Anifrolumab
- Where
- 74 sites in China
- Volunteers
- 417 people
- Sponsor
- AstraZeneca
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
Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy…
- Trial name
- PRIMULA_Preg (NCT06659029)
- Testing
- Anifrolumab
- Where
- United States
- Volunteers
- 442 people
- Sponsor
- AstraZeneca
Autoimmune Diseases
A Study to Investigate the Safety and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Male and Female Participants Aged 18 to 75 With Autoimmune Disease
The goal of this clinical trial is to assess the safety and tolerability profile of belantamab. The study will also assess how the levels of belantamab change over time and body's reaction to it in participants with stable but…
- Trial name
- NCT06413511
- Testing
- Belantamab
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease
- Trial name
- PEARL-SC (NCT01162681)
- Testing
- A-623
- Where
- 74 sites in United States, Argentina and 9 more
- Volunteers
- 547 people
- Sponsor
- Anthera Pharmaceuticals
Lupus Nephritis, Autoimmune Diseases
A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease
ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease.
- Conditions
- Lupus Nephritis, Autoimmune Diseases, Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06375993
- Testing
- ADI-001, Fludarabine, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 180 people
- Sponsor
- Adicet Therapeutics
Systemic Lupus Erythematosus
A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the cutaneous manifestations in subjects with systemic lupus erythematosus.
- Trial name
- NCT02660944
- Testing
- RSLV-132
- Where
- 16 sites in United States
- Volunteers
- 64 people
- Sponsor
- Resolve Therapeutics
System; Lupus Erythematosus
FLARE Lupus Research Study Systemic Lupus Erythematosus
The first phase of this pilot study will assess changes in quality of life at the end of a 16-week Mymee program in patients with moderate to severe SLE.
- Trial name
- FLARE (NCT03426384)
- Testing
- Mymee Program
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mymee Inc.
Systemic Lupus Erythematosus (SLE)
Descartes-08 for Patients With Systemic Lupus Erythematosus
This is a Phase II study to evaluate the safety, tolerability and manufacturing feasibility of Descartes-08 CAR T-cells in patients with Systematic Lupus erythematosus (SLE).
- Trial name
- SLE-001 (NCT06038474)
- Testing
- Descartes-08
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Cartesian Therapeutics
Systemic Lupus Erythematosus
Anifrolumab Malignancy and Serious Infections Study
This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate/severe SLE patients who receive anifrolumab compared with a comparable population…
- Trial name
- SIMA (NCT07000110)
- Testing
- Anifrolumab
- Where
- 4 sites in Denmark, France and 2 more
- Volunteers
- 3,506 people
- Sponsor
- AstraZeneca
Healthy Volunteers
First Safety Study in Humans of a Single Dose of CPG 52364
Determine the safety and tolerability of the study drug, CPG 52364, when given as liquid or capsule. Another purpose is to determine how the drug enters and leaves the blood stream and body tissues over time.
- Trial name
- NCT00547014
- Testing
- 52364 3 mg, 52364 10 mg, 52364 30 mg
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Pfizer
Autoimmune Disorder, Rheumatoid Arthritis
Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis
The purpose of this study is to evaluate the safety and effectiveness of treatment with branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or Primary Sjögren's Syndrome (pSS), or branebrutinib…
- Conditions
- Autoimmune Disorder, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Primary Sjögren's Syndrome
- Trial name
- NCT04186871
- Testing
- branebrutinib, abatacept
- Where
- 81 sites in United States, Argentina and 8 more
- Volunteers
- 119 people
- Sponsor
- Bristol-Myers Squibb
Inflammation, Systemic Lupus Erythematosus
Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects
This trial is conducted in Europe. The aim of this trial is to develop a complement system targeted monoclonal antibody (mAb) to be used in treatment of subjects with chronic autoimmune diseases.
- Conditions
- Inflammation, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Healthy
- Trial name
- NCT02151409
- Testing
- NNC 0151-0000-0000
- Where
- Netherlands
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Systemic Lupus Erythematosus
Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients
Primary Objective: To assess the tolerability and safety of SAR113244 in male and female lupus patients after every 4 (Q4) weeks repeated ascending subcutaneous doses of SAR113244.
- Trial name
- NCT02321709
- Testing
- SAR113244
- Where
- Germany
- Volunteers
- 21 people
- Sponsor
- Sanofi
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
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 participants with active SLE.
- Conditions
- Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease
- Trial name
- NCT01196091
- Testing
- LY2127399, Standard of Care
- Where
- 192 sites in United States, Argentina and 21 more
- Volunteers
- 1,164 people
- Sponsor
- Eli Lilly and Company
Systemic Lupus Erythematosus, Rheumatoid Arthritis
A Study to Learn About a Medicine Called PF-08154225 in Participants With Autoimmune Diseases
The purpose of this study is to learn about the safety and effects of the study medication called PF-08154225 for the potential treatment of autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Idiopathic Inflammatory Myositis, Systemic Sclerosis
- Trial name
- NCT07782450
- Testing
- PF-08154225
- Volunteers
- 54 people
- Sponsor
- Pfizer
Systemic Lupus Erythematosus
A Phase II Study of M2951 in SLE
M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus…
- Trial name
- NCT02975336
- Testing
- M2951
- Where
- 157 sites in United States, Argentina and 17 more
- Volunteers
- 469 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.