Clinical trials: Systemic Lupus
Systemic Lupus Erythematosus, Healthy Volunteers
Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 (Litifilimab) in Healthy Volunteers and Participants With Systemic Lupus Erythematosus
The primary objective of Parts 1 and 2 is to evaluate the safety and tolerability of either single-ascending intravenous (IV) doses or a single subcutaneous (SC) dose of BIIB059 (litifilimab) in healthy volunteers (HV), and a…
- Trial name
- NCT02106897
- Testing
- BIIB059 (litifilimab)
- Where
- 5 sites in United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Biogen
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
A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
The reason for this study is to see if the study drug LY3471851 (NKTR-358) is safe and effective in adults with systemic lupus erythematosus (SLE).
- Trial name
- ISLAND-SLE (NCT04433585)
- Testing
- LY3471851
- Where
- 112 sites in United States, Argentina and 17 more
- Volunteers
- 291 people
- Sponsor
- Nektar Therapeutics
Lupus Nephritis
Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.
- Trial name
- NCT05268289
- Testing
- Iptacopan (part 1), Iptacopan (part 2)
- Where
- 74 sites in United States, Argentina and 17 more
- Volunteers
- 81 people
- Sponsor
- Novartis Pharmaceuticals
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
Lupus Nephritis (LN)
Atacicept in Subjects With Active Lupus Nephritis (COMPASS)
The objective of the study is to evaluate the effect of atacicept compared to placebo on changes to renal response in adult subjects with LN.
- Trial name
- COMPASS (NCT05609812)
- Testing
- Atacicept
- Where
- 33 sites in United States, Puerto Rico and 1 more
- Sponsor
- Vera Therapeutics, Inc.
Lupus Nephritis
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and…
- Trial name
- LUMINA (NCT07053800)
- Testing
- Obecabtagene autoleucel
- Where
- 16 sites in United States, Brazil and 3 more
- Volunteers
- 35 people
- Sponsor
- Autolus Limited
Lupus Nephritis, Immunoglobulin A Nephropathy
Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition…
- Trial name
- SANCTUARY (NCT04564339)
- Testing
- Ravulizumab, Background Therapy
- Where
- 64 sites in United States, Australia and 10 more
- Volunteers
- 123 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Lupus Erythematosus, Systemic
Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE
A Study to Investigate the Tolerability, Safety,Pharmacokinetics and efficacy of GR1603 in subjects with Systemic Lupus Erythematosus ； GR1603 injection is a monoclonal antibody targeting IFNAR1, which can block IFNAR binding to…
- Trial name
- NCT06015230
- Testing
- low dose GR1603 in phase Ⅰb, high dose GR1603 in phaseⅠb, low dose GR1603 in phase Ⅱ
- Where
- China
- Volunteers
- 136 people
- Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Systemic Lupus Erythematosus (SLE)
Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care…
- Trial name
- NCT04058028
- Testing
- Rozibafusp Alfa
- Where
- 147 sites in United States, Argentina and 17 more
- Volunteers
- 244 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus
Phase IIb Study of IFN-K in Systemic Lupus Erythematosus
The safety and immunogenicity of the IFNα-Kinoid (IFN-K) have been evaluated in a phase I clinical study conducted in subjects with Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT02665364
- Testing
- IFNα-Kinoid, ISA 51 VG
- Where
- 101 sites in United States, Argentina and 19 more
- Volunteers
- 185 people
- Sponsor
- Neovacs
Lupus Erythematosus, Systemic
MSC2364447C Phase 1b in Systemic Lupus Erythematosus
The primary purpose of this Phase 1b double-blind, randomized, placebo-controlled trial is to evaluate the safety, tolerability, pharmacokinetic (PK), and biological effect of MSC2364447C administered for 4 weeks in systemic…
- Trial name
- NCT02537028
- Testing
- MSC2364447C
- Where
- 13 sites in United States, Bulgaria
- Volunteers
- 24 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease…
- Trial name
- PHOENYCS GO (NCT04294667)
- Testing
- DZP
- Where
- 177 sites in United States, Argentina and 23 more
- Volunteers
- 321 people
- Sponsor
- UCB Biopharma SRL
Systemic Lupus Erythematosus
A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)
This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE.
- Trial name
- NCT07409181
- Testing
- BI 3000202
- Where
- 139 sites in United States, Argentina and 19 more
- Volunteers
- 405 people
- Sponsor
- Boehringer Ingelheim
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
Lupus Nephritis
PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis
The goal of this clinical study is to assess the efficacy and safety of LUPKYNIS® in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response in patients with lupus nephritis (LN).
- Trial name
- NCT07611214
- Testing
- LUPKYNIS, belimumab, obinutuzumab or anifrolumab, mycophenolic acid analog (MPAA)
- Where
- 27 sites in United States
- Volunteers
- 150 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
Systemic Lupus Erythematosus
Phase I Study of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK1550188 in Japanese subjects with Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT01381536
- Testing
- GSK1550188 1mg/kg or 10mg/kg
- Where
- 2 sites in Japan
- Volunteers
- 12 people
- Sponsor
- GlaxoSmithKline
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.
Systemic Lupus Erythematosus
A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of GSK4527363 in healthy participants (Part A), participants with active SLE (Part B), healthy participants of Chinese and…
- Trial name
- NCT06576271
- Testing
- GSK4527363, Belimumab
- Where
- 28 sites in United States, Argentina and 4 more
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.