Clinical trials: Systemic Lupus, Skin Lupus
Systemic Lupus Erythematosus
Anifrolumab Early Access Program
To provide early access (ie, before marketing authorisation) to anifrolumab 300 mg IV Q4W while receiving standard therapy in adult patients with moderate-to-severe active SLE
- Trial name
- AMANA (NCT04750057)
- Testing
- Anifrolumab
- 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.
Systemic Lupus Erythematosus (SLE)
A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Systemic Lupus Erythematosus
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of ESG206 in participants with Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT07760155
- Testing
- ESG206
- Where
- 20 sites in China
- Volunteers
- 40 people
- Sponsor
- Shanghai Escugen Biotechnology 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
Lupus Nephritis
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis
- Trial name
- IRIS (NCT05138133)
- Testing
- Anifrolumab
- Where
- 164 sites in United States, Argentina and 22 more
- Volunteers
- 363 people
- Sponsor
- AstraZeneca
Nephritis, Systemic Lupus Erythematosus
Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis
This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, multiple dose escalation study, enrolling approximately 48 subjects.
- Trial name
- NCT00818948
- Testing
- AMG 811
- Where
- 12 sites in United States, France and 3 more
- Volunteers
- 56 people
- Sponsor
- Amgen
Active Systemic Lupus Erythematosus
Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.
- Trial name
- TULIP SLE LTE (NCT02794285)
- Testing
- Anifrolumab
- Where
- 175 sites in United States, Argentina and 22 more
- Volunteers
- 559 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus
The purpose of this study is to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while…
- Trial name
- NCT07630714
- Testing
- Anifrolumab + APFS
- Where
- 39 sites in Australia, Belgium and 8 more
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
The purpose of this study is to evaluate the safety and efficacy of repeated intravenous infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE) compared with people who receive a placebo.
- Trial name
- BT063 in SLE (NCT02554019)
- Testing
- BT063
- Where
- 14 sites in Belarus, Georgia and 2 more
- Volunteers
- 36 people
- Sponsor
- Biotest
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Ascension® Post- Approval Study; PyroCarbon Metacarpophalangeal Total Joint Prosthesis
This study is a non-randomized, consecutive enrollment, one-year post-approval study of patients who are treated with the Ascension® MCP.
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Osteoarthritis, Post-traumatic Arthritis
- Trial name
- MCP (NCT02408471)
- Testing
- Ascension® MCP Finger Implant
- Where
- 9 sites in United States
- Volunteers
- 97 people
- Sponsor
- Smith & Nephew, Inc.
Systemic Lupus Erythematosus
A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects
This will be the first-in-human study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of DS-7011a in healthy participants.
- Trial name
- NCT05203692
- Testing
- DS-7011a
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Systemic Lupus Erythematosus, SLE
Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus
This is a phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of orelabrutinib in adult subjects with SLE who are receiving standard of care (SOC) therapy.
- Trial name
- NCT05688696
- Testing
- Orelabrutinib (Low Dose), Orelabrutinib (High Dose)
- Where
- 41 sites in China
- Volunteers
- 186 people
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
Immunologic Diseases, Autoimmune Diseases
Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
The purpose of this study is to determine whether LJP 394 (abetimus sodium) is safe and effective in delaying and reducing renal flares in patients with lupus nephritis.
- Conditions
- Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, Lupus Nephritis
- Trial name
- NCT00035308
- Testing
- Abetimus sodium (LJP 394)
- Where
- 82 sites in United States, Austria and 8 more
- Volunteers
- 330 people
- Sponsor
- La Jolla Pharmaceutical Company
Lupus Nephritis
Evaluation of the Tolerance, Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of MIL62 Injection for Treating Lupus Nephritis
This study is composed of two stages: Part A is a randomized, double-blind, placebo-controlled dose-escalation study (i.e., Phase 1b study).
- Trial name
- NCT07044115
- Testing
- Recombinant Humanized Monoclonal Antibody MIL62 Injection
- Where
- China
- Volunteers
- 41 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Systemic Lupus Erythematosus, Rheumatoid Arthritis
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA). The main goal of the study is to learn about the safety of MK-1045 and if people tolerate it when they receive it at…
- Trial name
- NCT07363590
- Testing
- MK-1045
- Where
- 21 sites in Australia, Belgium and 9 more
- Volunteers
- 21 people
- Sponsor
- Merck Sharp & Dohme LLC
Systemic Lupus Erythematosus
A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations
This study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and tolerability of anifrolumab given via the subcutaneous (SC) route of administration in adult Systemic Lupus Erythematosus (SLE) subjects…
- Trial name
- NCT02962960
- Testing
- Anifrolumab
- Where
- 14 sites in United States, Hungary and 2 more
- Volunteers
- 36 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus Nephritis
The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.
- Trial name
- NCT01541670
- Testing
- Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
- Where
- 24 sites in United States, Australia and 3 more
- Volunteers
- 4 people
- Sponsor
- Baxalta now part of Shire
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic…
- Trial name
- NCT07355218
- Testing
- Enpatoran, Standard of care (SoC)
- Where
- 70 sites in United States, Australia and 18 more
- Volunteers
- 202 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus
This Project Aims to Understand the Needs of Rheumatologists and Other Specialties in the Care of Patients With SLE
The project will be conducted in four distinct stages. Firstly, evidence synthesis will be carried out to gather and analyze available data on the topic.
- Trial name
- LESBRA (NCT06698900)
- Where
- Brazil
- Volunteers
- 1,000 people
- Sponsor
- AstraZeneca
Autoimmune Diseases
A Study to Investigate the Safety and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Male and Female Participants Aged 18 to 75 With Autoimmune Disease
The goal of this clinical trial is to assess the safety and tolerability profile of belantamab. The study will also assess how the levels of belantamab change over time and body's reaction to it in participants with stable but…
- Trial name
- NCT06413511
- Testing
- Belantamab
- Sponsor
- GlaxoSmithKline