Clinical trials: SLE - Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice.
Anifrolumab Study of Treatment Effectiveness in the Real World (ASTER) study will collect real world data to obtain a good understanding of the (sustained) clinical effect and patient quality of life outcomes among diagnosed SLE…
- Trial name
- ASTER (NCT05637112)
- Testing
- None (Observational study)
- Where
- 74 sites in Austria, Belgium and 7 more
- Volunteers
- 551 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 LY3361237 in Participants With Systemic Lupus Erythematosus
The main purpose of this study is to learn more about the safety of LY3361237 and any side effects that might be associated with it when given to participants with systemic lupus erythematosis (SLE).
- Trial name
- NCT03933943
- Testing
- LY3361237
- Where
- 9 sites in United States
- Volunteers
- 28 people
- Sponsor
- Eli Lilly and Company
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.
Lupus Erythematosis
F01 in the Treatment of Moderate-to-severe Refractory Systemic Lupus Erythematosus
This is a phase I clinical study to evaluate the safety , pharmacokinetic profile, and preliminary efficacy of F01 in patients with moderate-to-severe refractory systemic lupus erythematosus.
- Trial name
- NCT06468683
- Testing
- After preconditioning with chemotherapy, F01 will be evaluated.
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanghai Simnova Biotechnology Co.,Ltd.
Systemic Lupus Erythematosus
Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects
This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to characterize the pharmacokinetic profile and safety profile of 200 mg single dose of belimumab…
- Trial name
- NCT04136145
- Testing
- Belimumab for IV, Belimumab for SC
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Systemic Lupus Erythematosus
Anifrolumab Pregnancy Study
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
- Trial name
- ROSE (NCT07049653)
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- AstraZeneca
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
A First Time in Human Study to Evaluate the Safety and Tolerability of GSK3996401 Following Dosing With GSK4347859 in Healthy Participants
This is a first time in human (FTiH) study which means that this is the first time that GSK4347859 is given to humans. The study is designed to investigate the safety, tolerability, and concentration of GSK3996401 (the activated…
- Trial name
- NCT06188507
- Testing
- GSK4347859
- Where
- 2 sites in United Kingdom
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)
This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE.
- Trial name
- NCT07409181
- Testing
- BI 3000202
- Where
- 139 sites in United States, Argentina and 19 more
- Volunteers
- 405 people
- Sponsor
- Boehringer Ingelheim
Systemic Lupus Erythematosus
Phase IIb Study of IFN-K in Systemic Lupus Erythematosus
The safety and immunogenicity of the IFNα-Kinoid (IFN-K) have been evaluated in a phase I clinical study conducted in subjects with Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT02665364
- Testing
- IFNα-Kinoid, ISA 51 VG
- Where
- 101 sites in United States, Argentina and 19 more
- Volunteers
- 185 people
- Sponsor
- Neovacs
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
Lupus Erythematosus
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)
To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.
- Trial name
- NCT01686555
- Testing
- ABT-199
- Where
- 15 sites in United States, Germany and 2 more
- Volunteers
- 97 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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 (SLE)
Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients
This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 (ianalumab) or CFZ533 (iscalimab) in patients with systemic lupus erythematosus (SLE) to…
- Trial name
- NCT03656562
- Testing
- VAY736, CFZ533
- Where
- 31 sites in Argentina, Australia and 13 more
- Volunteers
- 107 people
- Sponsor
- Novartis Pharmaceuticals
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
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