Clinical trials: System Lupus Erythematosus
Systemic Lupus Erythematosus
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements.
- Trial name
- PRIMULA Lac (NCT06594068)
- Testing
- Anifrolumab
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus, Lupus Nephritis
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
- Trial name
- NCT06121297
- Testing
- CABA-201
- Where
- 23 sites in United States, Canada and 1 more
- Volunteers
- 28 people
- Sponsor
- Cabaletta Bio
Refractory Lupus Nephritis, Myasthaenia Gravis
A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101
The purpose of this long-term follow-up (LTFU) study is to collect delayed adverse events (AEs) and understand the persistence of KYV-101 (autologous CAR T cell product; gene-modified product), in participants who have been…
- Conditions
- Refractory Lupus Nephritis, Myasthaenia Gravis, Stiff Person Syndrome, Rheumatoid Arthritis (RA)
- Trial name
- KYSA-4 (NCT07403188)
- Testing
- KYV-101
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Kyverna Therapeutics
Systemic Lupus Erythematosus, Primary Sjögren's Syndrome
A Study of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases
This study consists of a randomized, double-blind, placebo-controlled Phase Ia part and an open-label Phase Ib part. The Phase Ia part is a single ascending-dose study of subcutaneous QLS2404 Injection in healthy participants…
- Trial name
- NCT07751315
- Testing
- Ia:QLS2404 very low dose, Ia:QLS2404 low dose, Ia:QLS2404 middle dose
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Systemic Lupus Erythematosus
Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS)
SPOCS is an international, multicenter, prospective observational cohort study with bi-annual study visits over a 3-year follow-up designed to systematically describe the comprehensive SLE patient-journey regarding clinical…
- Trial name
- SPOCS (NCT03189875)
- Testing
- Standard of Care
- Where
- 135 sites in United States, Australia and 6 more
- Volunteers
- 830 people
- Sponsor
- AstraZeneca
Lupus Erythematosus, Systemic
Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
The goal of this clinical study is to learn about the long-term safety and tolerability of cenerimod in adult patients with moderate to severe symptoms of systemic lupus erythematosus.
- Trial name
- OPUS OLE (NCT06475742)
- Testing
- Cenerimod
- Where
- 122 sites in United States, Argentina and 24 more
- Volunteers
- 680 people
- Sponsor
- Viatris Innovation GmbH
Discoid Lupus Erythematosus
Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus
A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with moderate-to-severe active primary Discoid Lupus Erythematosus (DLE) refractory to…
- Trial name
- NCT05591222
- Testing
- Daxdilimab
- Where
- 68 sites in United States, Argentina and 9 more
- Volunteers
- 72 people
- Sponsor
- Amgen
Lupus Erythematosus, Systemic
Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
this study extension objective is to evaluate the safety and tolerability of a 200-mcg dose every 4 weeks for 24 weeks of IPP-201101 in patients with active systemic lupus erythematosus (SLE) who had participated in the main…
- Trial name
- IP-006 (NCT03427151)
- Testing
- IPP-201101
- Where
- 14 sites in United States, Czechia and 5 more
- Volunteers
- 62 people
- Sponsor
- ImmuPharma
Systemic Lupus Erythematosus (SLE)
A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination…
- Trial name
- NCT04451772
- Testing
- Elsubrutinib, Upadacitinib
- Where
- 87 sites in United States, Argentina and 16 more
- Volunteers
- 185 people
- Sponsor
- AbbVie
Vasculitis, Systemic Lupus Erythematosus (SLE)
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants
The primary objective of this study will be to evaluate the safety and tolerability of single and multiple oral doses of CCX168, over a range of dose levels, in healthy male and female participants.
- Trial name
- NCT05984251
- Testing
- CCX168
- Where
- Switzerland
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Amgen
Lupus Nephritis
A Study of Guselkumab in Participants With Active Lupus Nephritis
The purpose of this study is to evaluate the efficacy of guselkumab in participants with active lupus nephritis (LN).
- Trial name
- ORCHID-LN (NCT04376827)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Standard-of-care treatment
- Where
- 60 sites in United States, Argentina and 7 more
- Volunteers
- 33 people
- Sponsor
- Janssen Research & Development, LLC
Lupus Nephritis
A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis
This study will compare the efficacy of CellCept [0.5-2 grams per day (g/day) orally (p.o.)] and cyclophosphamide [0.5-1 grams per square meter (g/m2) quarterly] as maintenance treatment for patients with lupus nephritis.
- Trial name
- NCT02081183
- Testing
- Mycophenolate mofetil (MMF), Cyclophosphamide, Maintenance Phase, Cyclophosphamide, Induction Phase
- Where
- 2 sites in Venezuela
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
Inflammation, Systemic Lupus Erythematosus (SLE)
An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)
This trial is conducted in North America. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses of AGS-009 in patients with systemic lupus…
- Trial name
- NCT00960362
- Testing
- AGS-009
- Where
- 6 sites in United States
- Volunteers
- 13 people
- Sponsor
- Argos Therapeutics
Lupus Erythematosus, Systemic
Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)
This is an open label study to determine the association of the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical involvement, SLEDAI score…
- Trial name
- ReLATE (NCT05845593)
- Testing
- Decision Support Test
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Ampel BioSolutions, LLC
Systemic Lupus Erythematosus, Lupus Erythematosus, Systemic
A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the safety and tolerability of TAK-079 in comparison with matching placebo, administered once every 3 weeks over a 12-week dosing period in participants with active SLE who are receiving…
- Trial name
- NCT03724916
- Testing
- TAK-079
- Where
- 19 sites in United States
- Volunteers
- 23 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Relapsed/Refractory Autoimmune Diseases
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory autoimmune diseases.
- Trial name
- NCT06866080
- Testing
- LCAR-AIO T cells
- Where
- 4 sites in China
- Sponsor
- Nanjing Legend Biotech Co.
Systemic Lupus Erythematosus
A Study of SHR-2173 in Participants With Systemic Lupus Erythematosus
This study is a randomized, double-blind, multi-center, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in adult participants with active Systemic Lupus Erythematosus (SLE), including a…
- Trial name
- NCT07299422
- Testing
- SHR-2173 Injection
- Where
- 2 sites in China
- Volunteers
- 248 people
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
Systemic Lupus Erythematosus, Active Refractory Rheumatoid Arthritis
A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and…
- Trial name
- NCT06570798
- Testing
- Inebilizumab, Blinatumomab
- Where
- 58 sites in United States, Australia and 8 more
- Volunteers
- 220 people
- Sponsor
- Amgen
Lupus Nephritis
Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.
- Trial name
- NCT00429377
- Testing
- tacrolimus
- Where
- 7 sites in Japan
- Volunteers
- 64 people
- Sponsor
- Astellas Pharma Inc
Lupus Nephritis
The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis
The purpose of this study is to learn whether atacicept treatment leads to improvement in kidney function in subjects with active lupus nephritis in combination with mycophenolate mofetil (MMF) and corticosteroids.
- Trial name
- NCT00573157
- Testing
- Atacicept, Mycophenolate mofetil, Corticosteroids
- Where
- 20 sites in United States, Czechia and 3 more
- Volunteers
- 6 people
- Sponsor
- EMD Serono