Clinical trials: Systemic Lupus
Healthy Volunteers, Systemic Lupus Erythematosus (SLE)
A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Part 1 : To evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KK4277 in healthy Japanese or non-Asian adult males.
- Conditions
- Healthy Volunteers, Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
- Trial name
- NCT05411016
- Testing
- KK4277
- Where
- 23 sites in Japan, South Korea
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin Co., Ltd.
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, Lupus Nephritis
A Study of KITE-363 in Participants With Refractory Autoimmune Diseases
This study will have two Phases: Phase 1a and Phase 1b. The goal of this clinical study is to learn more about the study drug KITE-363, to establish dosing, tolerability, safety, and preliminary efficacy of KITE-363 in…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathy
- Trial name
- NCT07038447
- Testing
- KITE-363, Fludarabine, Cyclophosphamide
- Where
- 10 sites in United States, Australia and 2 more
- Volunteers
- 52 people
- Sponsor
- Kite, A Gilead Company
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 (SLE), Cutaneous Lupus Erythematosus (CLE)
A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]
The purpose of this study is to evaluate the long-term safety and efficacy of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908_0001)…
- Trial name
- NCT07840287
- Testing
- Enpatoran
- Where
- 2 sites in United States, Germany
- Volunteers
- 404 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus
A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice.
Anifrolumab Study of Treatment Effectiveness in the Real World (ASTER) study will collect real world data to obtain a good understanding of the (sustained) clinical effect and patient quality of life outcomes among diagnosed SLE…
- Trial name
- ASTER (NCT05637112)
- Testing
- None (Observational study)
- Where
- 74 sites in Austria, Belgium and 7 more
- Volunteers
- 551 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344 in comparison with placebo in the treatment of participants aged 18…
- Trial name
- APATURA (NCT05039840)
- Testing
- SAR441344 IV, SAR441344 SC
- Where
- 73 sites in United States, Argentina and 14 more
- Volunteers
- 109 people
- Sponsor
- Sanofi
Lupus Erythematosus, Systemic
Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.
This is an observational, multicenter, prospective study on patients with systemic lupus erythematosus treated with anifrolumab in Italy aimed at evaluating the achievement of LLDAS5
- Trial name
- DAHLIA (NCT07330245)
- Testing
- Anifrolumab
- Where
- 22 sites in Italy
- Volunteers
- 218 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus (SLE)
F182112 Phase Ib Clinical Study for the Treatment of Patients With Systemic Lupus Erythematosus
The investigational drug is an injectable recombinant humanized anti-BCMA/CD3 bispecific antibody (code: F182112) that can simultaneously target the immune effector cell antigen CD3 and the antigen BCMA.
- Trial name
- NCT07829614
- Testing
- F182112
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Lupus Erythematosus, Systemic
Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus
The Polish multicentre observational (non-interventional) study aiming to collect data on the characteristic of patients with systemic lupus erythematosus and clinical outcomes of anifrolumab administered in the scope of routine…
- Trial name
- SLE-ARTEMIS (NCT06673043)
- Testing
- Anifrolumab
- Where
- 11 sites in Poland
- Volunteers
- 105 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
Anifrolumab Pregnancy Study
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
- Trial name
- ROSE (NCT07049653)
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis
This Phase IIa, open-label, single-arm study includes an initial Safety Run-In followed by dose expansion to evaluate the safety, tolerability, cellular kinetics, pharmacodynamics, and preliminary clinical activity of a single…
- Trial name
- NCT07328581
- Testing
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- iCell Gene Therapeutics
Systemic Lupus Erythematosus (SLE)
To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus Erythematosus
This was a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study. The primary objective was to evaluate the efficacy of SG301 SC injection in participants with Systemic Lupus Erythematosus (SLE) based…
- Trial name
- NCT07447986
- Testing
- SG301 SC Injection
- Where
- 40 sites in China
- Volunteers
- 120 people
- Sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
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
Anifrolumab Malignancy and Serious Infections Study
This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate/severe SLE patients who receive anifrolumab compared with a comparable population…
- Trial name
- SIMA (NCT07000110)
- Testing
- Anifrolumab
- Where
- 4 sites in Denmark, France and 2 more
- Volunteers
- 3,506 people
- Sponsor
- AstraZeneca
Lupus Nephritis, Systemic Lupus Erythematosus
A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis
The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory…
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, SLE - Systemic Lupus Erythematosus, Lupus Nephritis - WHO Class III
- Trial name
- RECLAIM-LN (NCT07570862)
- Testing
- FT819
- Where
- 12 sites in United States
- Volunteers
- 53 people
- Sponsor
- Fate Therapeutics
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
Systemic Lupus Erythematosus
The Anifrolumab PRIM Program
Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program
- Trial name
- PRIM (NCT06795893)
- Testing
- Anifrolumab
- Where
- Sweden
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Lupus Erythematosus, Systemic
A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
This is a Phase 1b/2, single-arm, open-label, multi-center, clinical study of AZD0120, a CD19/BCMA dual CAR T cell therapy, to evaluate the safety, tolerability, and efficacy in adult participants with refractory Systemic Lupus…
- Trial name
- NCT06897930
- Testing
- AZD0120, Cyclophosphamide, Fludarabine
- Where
- 20 sites in United States, Australia and 2 more
- Volunteers
- 150 people
- Sponsor
- AstraZeneca
Refractory Systemic Lupus Erythematosus
A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus
This is a single-arm, open-label, multicenter, phase 1/2 clinical study to assess the safety and efficacy of GC012F Injection in subjects with refractory Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT06530849
- Testing
- GC012F Injection
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- Gracell Biotechnologies (Shanghai) Co., Ltd.