Clinical trials: SLE
Lupus Nephritis, Lupus Erythematosus
Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) obtained from bone marrow for the treatment of adults with active proliferative lupus nephritis.
- Trial name
- MSV_LE (NCT03673748)
- Testing
- Mesenchymal stem cells (MSC)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Red de Terapia Celular
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.
Systemic Lupus Erythematosus
Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE
This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.
- Trial name
- NCT07331467
- Testing
- CD19 CAR-T cells
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Systemic Lupus Erythematosus
A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Systemic Lupus Erythematosus
This study is a randomized, controlled, phase I clinical study with safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics in patients with systemic lupus erythematosus.
- Trial name
- NCT06857214
- Testing
- GNC-038, Belimumab
- Where
- China
- Volunteers
- 84 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Cutaneous Lupus, Discoid Lupus
Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus
This is a multi-center, randomized, double-blind, placebo-controlled, two-period, crossover study in which approximately 20 subjects with Discoid Lupus Erythematosus will be enrolled to receive AMG 811 and placebo in one of two…
- Conditions
- Cutaneous Lupus, Discoid Lupus, Lupus, Systemic Lupus Erythematosus
- Trial name
- NCT01164917
- Testing
- AMG811
- Where
- 8 sites in United States
- Volunteers
- 16 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus
Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
The trial will evaluate efficacy, safety and tolerability of ianalumab compared to placebo, given as monthly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus…
- Trial name
- SIRIUS-SLE 2 (NCT05624749)
- Testing
- ianalumab
- Where
- 90 sites in United States, Argentina and 13 more
- Volunteers
- 288 people
- Sponsor
- Novartis Pharmaceuticals
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, Lupus Nephritis
A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease
This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis
- Trial name
- NCT06544330
- Testing
- SYNCAR-001, STK-009
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Synthekine
SLE - Systemic Lupus Erythematosus
MB-CART19.1 in Refractory SLE
This is a phase l/ll open-label, multicentre, interventional single-arm trial of MB-CART19.1 in patients with refractory SLE systemic lupus erythematosus.
- Trial name
- NCT06189157
- Testing
- MB-CART19.1
- Where
- 3 sites in Germany
- Volunteers
- 29 people
- Sponsor
- Miltenyi Biomedicine GmbH
SLE (Systemic Lupus), Systemic Sclerosis
Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV…
- Conditions
- SLE (Systemic Lupus), Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06548607
- Testing
- CD19 or CD19-BCMA CAR-T
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Active Systemic Lupus Erythematosus
Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in Asian participants with active systemic lupus erythematosus (SLE).
- Trial name
- NCT04931563
- Testing
- Anifrolumab
- Where
- 65 sites in China, Hong Kong and 4 more
- Volunteers
- 277 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT01283139
- Testing
- Sifalimumab 200 mg, Sifalimumab 600 mg, Sifalimumab 1,200 mg
- Where
- 107 sites in United States, Argentina and 20 more
- Volunteers
- 834 people
- Sponsor
- MedImmune LLC
Systemic Lupus Erythematosus, Arthritic Psoriasis
A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation
The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165 capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie meal and increased gastric pH on the BMS-986165…
- Conditions
- Systemic Lupus Erythematosus, Arthritic Psoriasis, Psoriasis, Inflammatory Bowel Diseases
- Trial name
- NCT03254784
- Testing
- BMS-986165 Capsule, BMS-986165 Tablet
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Refractory Active Systemic Lupus Erythematosus
A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus
This study aimed to observe the safety and tolerability of SYS6020 in adult participants with refractory active systemic lupus erythematosus, determine the recommended dose (RD) that may be explored for subsequent studies, and…
- Trial name
- NCT06694298
- Testing
- SYS6020
- Volunteers
- 50 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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
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
Systemic Lupus Erythematosus, Lupus
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Refractory Systemic Lupus Erythematosus (GALLOP)
This is a Phase 1 study to evaluate the safety and efficacy of a single infusion of CB-010 in patients with refractory Systemic Lupus Erythematosus (SLE) with cohorts for lupus nephritis (LN) and extrarenal lupus (ERL).
- Conditions
- Systemic Lupus Erythematosus, Lupus, Lupus Erythematosus, Lupus Nephritis
- Trial name
- GALLOP (NCT06752876)
- Testing
- CB-010
- Sponsor
- Caribou Biosciences, Inc.
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
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, Cutaneous Lupus Erythematosus
A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis
The purpose of this study is to evaluate the safety and tolerability of escalating, multiple subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)…
- Conditions
- Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis
- Trial name
- NCT03817424
- Testing
- VIB7734
- Where
- 30 sites in United States, Poland and 1 more
- Volunteers
- 31 people
- Sponsor
- Amgen