Clinical trials: System Lupus Erythematosus
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
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants
This open-label, Phase I study will assess the safety and tolerability of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.
- Trial name
- ASSURO (NCT07201558)
- Testing
- Surovatamig
- Where
- 35 sites in United States, Australia and 8 more
- Volunteers
- 48 people
- Sponsor
- AstraZeneca
Lupus Erythematosus, Systemic
Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.
- Trial name
- NCT00071487
- Testing
- Belimumab 1 mg/kg, Belimumab 4 mg/kg, Belimumab 10 mg/kg
- Where
- 62 sites in United States, Canada
- Volunteers
- 449 people
- Sponsor
- Human Genome Sciences Inc.
Active Systemic Lupus Erythematosus
Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus
The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.
- Trial name
- NCT04680637
- Testing
- Efavaleukin Alfa, Standard of Care
- Where
- 150 sites in United States, Austria and 17 more
- Volunteers
- 168 people
- Sponsor
- Amgen
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
Systemic Lupus Erythematosus
A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184
This study is a Phase I, two-part, open-label study designed to evaluate the effect of repeated doses of GSK2586184 on the pharmacokinetics (PK) of Simvastatin and Rosuvastatin in healthy volunteers (Cohort A), and to evaluate…
- Trial name
- NCT01953835
- Testing
- GSK2586184 standard formulation, Simvastatin, Rosuvastatin
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study
A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.
- Trial name
- RECAST SLE OLE (NCT05430854)
- Testing
- Daxdilimab
- Where
- 52 sites in United States, Argentina and 7 more
- Volunteers
- 155 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus
Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard treatments for patients with SLE.
- Trial name
- NCT00383214
- Testing
- Epratuzumab
- Where
- 60 sites in United States, Belgium and 9 more
- Volunteers
- 54 people
- Sponsor
- UCB Pharma
Healthy Volunteers, Systemic Lupus Erythematosus (SLE)
A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Part 1 : To evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KK4277 in healthy Japanese or non-Asian adult males.
- Conditions
- Healthy Volunteers, Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
- Trial name
- NCT05411016
- Testing
- KK4277
- Where
- 23 sites in Japan, South Korea
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin Co., Ltd.
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
Main purpose: To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID).
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, IgG4 Related Disease
- Trial name
- NCT06361745
- Testing
- T cell injection targeting CD19 chimeric antigen receptor
- Where
- China
- Volunteers
- 10 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
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
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts
- Trial name
- NCT02391259
- Testing
- AMG 557
- Where
- 13 sites in United States, United Kingdom
- Volunteers
- 57 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetic of TQB3702 Tablets in Healthy Adult Subjects
This is a phase I, randomized, double-blind, placebo-controlled, dose-escalating clinical study aimed at evaluating the safety of TQB3702 tablets following single and multiple doses administered to healthy subjects
- Trial name
- NCT06448273
- Testing
- TQB3702 tablets
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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.
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
Lupus Nephritis (LN)
Study to Assess Efficacy and Safety of HSK39297 Tablets in Patients With LN
A double-blind,placebo controlled,randomized Phase 2 study to evaluate the safety and tolerability of once-daily, oral administration of 200 or 300 mg HSK39297 tablets versus placebo in Patients With Lupus Nephritis
- Trial name
- NCT07363460
- Testing
- HSK39297 200mgQD, HSK39297 300mgQD
- Where
- China
- Volunteers
- 105 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Systemic Lupus Erthematosus
A Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity.
- Trial name
- NCT07564596
- Testing
- Budoprutug
- Where
- 10 sites in China
- Volunteers
- 30 people
- Sponsor
- Climb Bio, Inc.
Systemic Lupus Erythematosus
CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have autoantibody positive, clinically-active…
- Trial name
- NCT02074020
- Testing
- Blisibimod
- Sponsor
- Anthera Pharmaceuticals
Systemic Lupus Erythematosus, Systemic Sclerosis
Clinical Study on Targeted CD19CAR-T Therapy for Autoimmune Diseases
This is an open-label, investigator-initiated clinical trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with active SLE, SSc, AAV, IIM, and pSS
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06549296
- Testing
- RD06-04 CART Cell Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Systemic Lupus Erythematosus
A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus
This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. The study consists of a 21 day screening period followed by administration of the investigational product and up to 70 day follow up…
- Trial name
- NCT02443506
- Testing
- AMG 623
- Volunteers
- 56 people
- Sponsor
- Amgen