Clinical trials: Systemic Lupus, Skin Lupus
Nephritis, Lupus, Lupus Erythematosus, Systemic
A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment
The goal of this clinical trial is to learn if cenerimod, on top of regular treatment, works to treat active lupus nephritis in adults with systemic lupus erythematosus and active lupus nephritis.
- Trial name
- LUMIOS (NCT07201129)
- Testing
- Cenerimod
- Where
- 14 sites in United States
- Volunteers
- 300 people
- Sponsor
- Viatris Innovation GmbH
Refractory Lupus Nephritis, Refractory Systemic Sclerosis
A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN) or Refractory Systemic Sclerosis (SSc)
The main aim of the trial is to learn how well adults with refractory lupus nephritis (LN) or refractory systemic sclerosis (SSc) tolerate TAK-007 and to check for side effects (adverse events).
- Trial name
- NCT06377228
- Testing
- TAK-007, Chemotherapy Agents
- Where
- United States
- Sponsor
- Takeda
Systemic Lupus Erythematosus
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core…
- Trial name
- SIRIUS-SLE LTE (NCT06133972)
- Testing
- Ianalumab
- Where
- 164 sites in United States, Argentina and 27 more
- Volunteers
- 550 people
- Sponsor
- Novartis Pharmaceuticals
Autoimmune Thrombocytopenia
Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia
This is a single-arm, open-label，phase I clinical study to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection in treatment of refractory systemic lupus erythematosus-related immune thrombocytopenia.
- Trial name
- NCT06826430
- Testing
- Inaticabtagene autoleucel Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Juventas Cell Therapy Ltd.
Systemic Lupus Erythematosus
A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers
The intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of CUG252 in healthy adult subjects.
- Trial name
- NCT05328557
- Testing
- CUG252
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cugene Inc.
Systemic Lupus Erythematosus
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus…
- Trial name
- NCT05162586
- Testing
- Enpatoran low dose, Enpatoran medium dose, Enpatoran high dose
- Where
- 153 sites in United States, Argentina and 20 more
- Volunteers
- 456 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus
A Study to Assess the Safety and PK/PD of LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus
A Double-blind, Randomized, Placebo-controlled, Dose-escalation Phase I Study to Assess the Safety and PK/PD of LBL-047 Subcutaneous Injection in Healthy Adults and Patients with Systemic Lupus Erythematosus.
- Trial name
- NCT07323173
- Testing
- LBL-047 for Injection
- Where
- 12 sites in China
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Nanjing Leads Biolabs Co.,Ltd
Systemic Lupus Erythematosus
Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus
In China, Belimumab (GSK1550188) will be developed for a dosing regimen of once-monthly intravenous (IV) infusion for the treatment of SLE.
- Trial name
- NCT02880852
- Testing
- Belimumab
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
Anifrolumab PK Study for Systemic Lupus Erythematosus (SLE)
To assess the pharmacokinetic parameters of anifrolumab in Chinese participants with active systemic lupus erythematosus(SLE).
- Trial name
- NCT05001698
- Testing
- Anifrolumab
- Where
- 3 sites in China
- Volunteers
- 15 people
- Sponsor
- AstraZeneca
Lupus Nephritis, Primary Membranous Nephropathy
A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)
This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in…
- Trial name
- NCT06557265
- Testing
- NKX019, Fludarabine, Cyclophosphamide
- Where
- 19 sites in United States, Australia and 1 more
- Volunteers
- 120 people
- Sponsor
- Nkarta, Inc.
Lupus Erythematosus, Systemic
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematosus in adult patients with moderate to severe symptoms.
- Trial name
- OPUS-1 (NCT05648500)
- Testing
- Cenerimod
- Where
- 198 sites in United States, Argentina and 15 more
- Volunteers
- 470 people
- Sponsor
- Viatris Innovation GmbH
Systemic Lupus Erythematosus
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are…
- Trial name
- ALLEGORY (NCT04963296)
- Testing
- Obinutuzumab, Acetaminophen/Paracetamol, Diphenhydramine hydrochloride
- Where
- 64 sites in United States, Argentina and 12 more
- Volunteers
- 303 people
- Sponsor
- Hoffmann-La Roche
Lupus Nephritis
An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
The main objectives of this trial are to evaluate the long term efficacy and safety of different doses of BI 655064 versus placebo as add-on therapy to Standard of Care (SOC) during maintenance therapy for lupus nephritis.
- Trial name
- NCT03385564
- Testing
- BI 655064
- Where
- 36 sites in United States, Australia and 14 more
- Volunteers
- 69 people
- Sponsor
- Boehringer Ingelheim
Proteinuria
Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria
The primary objective of this study is to assess the impact of proteinuria on the pharmacokinetic (PK) of a single dose of ALXN1720 in participants with proteinuria.
- Trial name
- NCT05314231
- Testing
- ALXN1720
- Where
- 2 sites in South Korea
- Volunteers
- 13 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
This is a Phase 1 single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with seropositive SLE or RA.
- Trial name
- NCT03334851
- Testing
- PF-06835375
- Where
- 17 sites in United States
- Volunteers
- 74 people
- Sponsor
- Pfizer
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
A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis
The objective of this study is to assess the safety and tolerability of sifalimumab in adult participants with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who participated in the…
- Trial name
- NCT00979654
- Testing
- Sifalimumab
- Where
- 28 sites in United States, Brazil and 2 more
- Volunteers
- 118 people
- Sponsor
- MedImmune LLC
Systemic Lupus Erythematosus
Study of CD19 CAR-T Therapy for Refractory SLE
This is an investigator-initiated trial aimed at assessing the safety and efficacy of PTOC1 cells Injection in the treatment of refractory systemic lupus erythematosus.
- Trial name
- NCT07403097
- Testing
- PTOC1
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Systemic Lupus Erythematosus
Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)
- Trial name
- EMBODY4 (NCT01408576)
- Testing
- Epratuzumab
- Where
- 228 sites in United States, Australia and 23 more
- Volunteers
- 1,250 people
- Sponsor
- UCB Pharma
Systemic Lupus Erythematosus
Study of LJP 394 (Abetimus Sodium) in Lupus Patients
The primary purpose of this study is to assess the safety and pharmacodynamic effect of LJP 394 at doses of 100 mg, 300 mg and 900 mg on anti-dsDNA antibody levels in patients with SLE.
- Trial name
- NCT00390091
- Testing
- abetimus sodium (LJP 394)
- Where
- 2 sites in United States
- Sponsor
- La Jolla Pharmaceutical Company