Clinical trials: System Lupus Erythematosus
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
A Study of Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Mod-severe Systemic Lupus Erythematosus
This study aims to describe clinical outcomes, with focus on remission, achieved with use of anifrolumab participants with SLE on standard-of-care (as recommended by 2025 China SLE guidelines).
- Trial name
- LOTUS (NCT07751848)
- Testing
- Anifrolumab
- Where
- 74 sites in China
- Volunteers
- 417 people
- Sponsor
- AstraZeneca
Lupus Nephritis
A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Lupus Nephritis
To demonstrate that the treatment effect in lupus nephritis of MZR is non-inferior to that of standard therapy CTX through analyzing overall remission rate after treatment.
- Trial name
- NCT02256150
- Testing
- Mizoribine (MZR), Cyclophosphamide (CTX)
- Where
- 26 sites in China
- Volunteers
- 250 people
- Sponsor
- Asahi Kasei Therapeutics Corporation
Systemic Lupus Erythematosus
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).
- Trial name
- NCT03252587
- Testing
- BMS-986165
- Where
- 192 sites in United States, Argentina and 15 more
- Volunteers
- 363 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus
Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients
This study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (SLE) disease…
- Trial name
- NCT02119156
- Testing
- Belimumab
- Where
- 20 sites in United States, China and 2 more
- Volunteers
- 80 people
- Sponsor
- GlaxoSmithKline
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
Systemic Lupus Erythematosus
Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood
To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to when given as an intravenous (iv) infusion in…
- Trial name
- NCT02306629
- Testing
- Epratuzumab sc, Epratuzumab iv
- Where
- United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
Lupus Erythematosus, Systemic, Lupus Erythematosus
Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals
OASIS: A mobile study to measure and predict lupus (SLE) disease activity using digital signals The OASIS study is exploring how patient reported data and digital biomarkers, like activity level and heart rate variability, can be…
- Trial name
- OASIS (NCT04449653)
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Progentec Diagnostics, Inc.
Lupus Arthritis, Systemic Lupus Erythematosus
Safety Study of AMG 557 in Subjects With Lupus Arthritis
This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.
- Trial name
- NCT01683695
- Testing
- AMG 557
- Where
- 13 sites in United States, Australia and 6 more
- Volunteers
- 20 people
- Sponsor
- Amgen
Autoimmune Thrombocytopenia
Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia
This is a single-arm, open-label，phase I clinical study to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection in treatment of refractory systemic lupus erythematosus-related immune thrombocytopenia.
- Trial name
- NCT06826430
- Testing
- Inaticabtagene autoleucel Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Juventas Cell Therapy Ltd.
Systemic Lupus Erythematosus
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of SHR-2173 in Patients With Systemic Lupus Erythematosus
To investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple subcutaneous injections of SHR-2173 in patients with systemic lupus erythematosus (SLE).
- Trial name
- NCT06955598
- Testing
- SHR-2173
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
Lupus Nephritis
Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN).
- Trial name
- TULIP-LN1 (NCT02547922)
- Testing
- Anifrolumab
- Where
- 80 sites in United States, Argentina and 15 more
- Volunteers
- 147 people
- Sponsor
- AstraZeneca
Lupus Nephritis
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN
- Trial name
- SIRIUS-LN (NCT05126277)
- Testing
- ianalumab s.c. q4w, ianalumab s.c. q12w
- Where
- 145 sites in United States, Argentina and 25 more
- Volunteers
- 452 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus (SLE)
AZAHAR Study To Describe Anifrolumab in a Real-World Setting
AZAHAR is an observational retrospective and longitudinal study with adults patients with SLE who initiated treatment with anifrolumab from June 1, 2023 to May 31, 2024.
- Trial name
- AZAHAR (NCT06626945)
- Where
- 13 sites in Spain
- Volunteers
- 152 people
- Sponsor
- AstraZeneca
Lupus Nephritis
RY_SW01 Cell Injection Therapy in Active Lupus Nephritis
RY_SW01 Cell Injection's preclinical research results have shown that the injection significantly improved urine biochemical indicators and tissue damage in two lupus nephritis animal models after MSC administration, with no…
- Trial name
- NCT06058078
- Testing
- RY_SW01 cell injection, Basic treatment
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Renocell Biotech Company
Systemic Lupus Erythematosus
Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients
The purpose of this study is to evaluate the safety/tolerability and to explore the efficacy of MT-1303 in subjects with systemic lupus erythematosus
- Trial name
- NCT02307643
- Testing
- MT-1303 Low dose, MT-1303 High dose
- Where
- 14 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Tanabe Pharma Corporation
Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)
A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc.
- Conditions
- Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06978647
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 12 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Lupus Nephritis
Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis.
- Trial name
- NCT02949349
- Testing
- Mycophenolate mofetil, Azathioprine, Prednisolone
- Volunteers
- 32 people
- Sponsor
- Genovate Biotechnology Co., Ltd.,
Crohn Disease, Ulcerative Colitis
Expanded Access to Upadacitinib
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility.
- Conditions
- Crohn Disease, Ulcerative Colitis, Idiopathic Arthritis (Including sJIA, pJIA, or JPsA), Atopic Dermatitis
- Trial name
- NCT04159597
- Testing
- Upadacitinib
- Sponsor
- AbbVie
Systemic Lupus Erythematosus
A Study of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus
This is a multi-center, open-label, phase 1 study.
- Trial name
- NCT05687526
- Testing
- Telitacicept
- Where
- 12 sites in China
- Volunteers
- 16 people
- Sponsor
- RemeGen Co., Ltd.