Clinical trials: SLE
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
A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus
This study will evaluate the efficacy and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus.
- Trial name
- NCT07405970
- Testing
- MIL62
- Where
- China
- Volunteers
- 316 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Healthy Volunteers, Rheumatoid Arthritis
A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)
The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.
- Conditions
- Healthy Volunteers, Rheumatoid Arthritis, Systemic Lupus Erythematosus
- Trial name
- NCT06917742
- Testing
- CPTX2309
- Where
- 3 sites in Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Capstan Therapeutics
Lupus Erythematosus, Systemic, Lupus Erythematosus
A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE
To compare the effect of RAYOS® versus immediate-release (IR) prednisone on fatigue as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
- Conditions
- Lupus Erythematosus, Systemic, Lupus Erythematosus, Fatigue
- Trial name
- RIFLE (NCT03098823)
- Testing
- RAYOS, Prednisone
- Where
- 21 sites in United States
- Volunteers
- 62 people
- Sponsor
- Ampel BioSolutions, LLC
Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN)
A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
This Phase 1, open label, dose escalation study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of HB2198, a tetravalent bispecific anti CD19/CD20 antibody, in adults with…
- Conditions
- Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN), Extra-renal Lupus (ERL)
- Trial name
- NCT07491900
- Testing
- HB2198
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- Hinge Bio
Systemic Lupus Erythematosus
ELEVATE - (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation)
To explore the potential for use of DxTerity's AIP IFN-1 test as personalized guided care and monitoring module in patients with Systemic lupus erythematosus(SLE) using consented patient health information
- Trial name
- ELEVATE (NCT05347992)
- Where
- United States
- Volunteers
- 423 people
- Sponsor
- DxTerity Diagnostics
SLE, SLE (Systemic Lupus)
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT06613360
- Testing
- CLN-978
- Where
- 24 sites in United States, Australia and 7 more
- Volunteers
- 24 people
- Sponsor
- Cullinan Therapeutics Inc.
Lupus Erythematosus, Systemic
Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).
- Trial name
- ADDRESS II (NCT01972568)
- Testing
- Atacicept 75 milligram (mg), Atacicept 150 mg
- Where
- 138 sites in United States, Argentina and 16 more
- Volunteers
- 306 people
- Sponsor
- EMD Serono
Systemic Lupus Erythematosus
A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
- Trial name
- NCT07011043
- Testing
- Budoprutug
- Where
- 18 sites in United States, Bulgaria and 6 more
- Volunteers
- 30 people
- Sponsor
- Climb Bio, Inc.
Systemic Lupus Erythematosus, Scleroderma
Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）
This is an open lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease（AID）
- Conditions
- Systemic Lupus Erythematosus, Scleroderma, Rheumatoid Arthritis
- Trial name
- SLE，SSc，RA (NCT06801119)
- Testing
- HN2301 injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shenzhen MagicRNA Biotechnology Co., Ltd
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
- 32 sites in Australia, Belgium and 8 more
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
Observational Study Investigating Demographic and Clinical Characteristics of SLE Patients in Egypt
Systemic lupus erythematosus (SLE) is an autoimmune condition characterized by a complicated, unclear etiology that involves various complex factors.
- Trial name
- ROSE (NCT07144514)
- Volunteers
- 276 people
- Sponsor
- AstraZeneca
Lupus Arthritis
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis
The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules (0.5 milligrams [mg] and 1 mg) in participants with active lupus arthritis.
- Trial name
- NCT01085084
- Testing
- Laquinimod
- Where
- 22 sites in United States, Canada
- Volunteers
- 82 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Lupus
Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE)
The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients with SLE and who are…
- Trial name
- NCT00299819
- Testing
- MEDI-545, MEDI 545
- Where
- 21 sites in United States, Canada
- Volunteers
- 45 people
- Sponsor
- MedImmune LLC
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
Sjogren Disease, Systemic Lupus Erythematosus
Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases
The purpose of this pharmacokinetic (PK) study is to describe the PK profile of ianalumab following s.c. administration in Chinese participants with systemic lupus erythematosus (SLE) and/or Sjögren's disease (SjD).
- Trial name
- NCT06411639
- Testing
- ianalumab
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus
A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE
The purpose of this study is to assess whether co-administration of belimumab and a single cycle of rituximab will optimize treatment with belimumab, which will result in improvements of clinical status with a favorable safety…
- Trial name
- NCT03312907
- Testing
- Belimumab, Rituximab, Standard therapy (Including Immunosuppressants)
- Where
- 79 sites in United States, Argentina and 9 more
- Volunteers
- 292 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76
This pooled analysis will assess data from the Phase 3 belimumab registration studies BLISS-52 (aka BEL110752) and BLISS-76 (aka BEL110751). The analysis was pre-planned and agreed prior to the unblinding of either study.
- Trial name
- NCT01914770
- Testing
- Belimumab 1 mg/kg, Belimumab 10 mg/kg
- Volunteers
- 1,016 people
- Sponsor
- GlaxoSmithKline
Chronic Inflammatory Diseases, Type 2 Diabetes Mellitus
NOX-E36 First-in-Human (FIH) Study
This is the first time NOX-E36 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-E36 is administered by single intravenous (IV) and subcutaneous (SC) doses to healthy…
- Conditions
- Chronic Inflammatory Diseases, Type 2 Diabetes Mellitus, Systemic Lupus Erythematosus
- Trial name
- NCT00976729
- Testing
- NOX-E36
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- TME Pharma AG
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