Clinical trials: Lupus
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.
Cutaneous Lupus Erythematosus
Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants
The goal of this study is to investigate the safety and tolerability of the topical application of SOF-SKN in healthy volunteers. The study will be divided into part 1 and part 2.
- Trial name
- HERACLES (NCT07072611)
- Testing
- SOF-SKN 0.25%, SOF-SKN 0.5%, SOF-SKN 1%
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Noxopharm Limited
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
Lupus Nephritis
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Lupus Nephritis Previously Enrolled in Study U2970g
This is a Phase III, multicenter, extension study to evaluate the safety of rituximab administered on a scheduled basis approximately every 6 months.
- Trial name
- NCT00404157
- Testing
- Rituximab
- Sponsor
- Genentech, Inc.
Cutaneous Lupus Erythematosus(CLE)
A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults
A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults
- Trial name
- NCT07749651
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
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
Cutaneous Lupus Erythematosus
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
Primary Objective: Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE) Secondary Objectives: Assess the effect of SAR443122 on the physician's global assessment of disease activity (PhysGA - disease activity)…
- Trial name
- CLEan (NCT04781816)
- Testing
- SAR443122
- Where
- 50 sites in United States, Argentina and 13 more
- Volunteers
- 78 people
- Sponsor
- Sanofi
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
Systemic Lupus Erythematosus, Lupus
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Refractory Systemic Lupus Erythematosus (GALLOP)
This is a Phase 1 study to evaluate the safety and efficacy of a single infusion of CB-010 in patients with refractory Systemic Lupus Erythematosus (SLE) with cohorts for lupus nephritis (LN) and extrarenal lupus (ERL).
- Conditions
- Systemic Lupus Erythematosus, Lupus, Lupus Erythematosus, Lupus Nephritis
- Trial name
- GALLOP (NCT06752876)
- Testing
- CB-010
- Sponsor
- Caribou Biosciences, Inc.
Systemic Lupus Erythematosus
Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and pharmacodynamics (PD) of repeat doses of 200 milligrams per milliliter (mg/mL) belimumab administered via SC injection in pediatric participants 5 to…
- Trial name
- NCT04179032
- Testing
- Belimumab
- Where
- 11 sites in United States, Argentina and 5 more
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Nephritis, Lupus, Lupus Erythematosus, Systemic
A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment
The goal of this clinical trial is to learn if cenerimod, on top of regular treatment, works to treat active lupus nephritis in adults with systemic lupus erythematosus and active lupus nephritis.
- Trial name
- LUMIOS (NCT07201129)
- Testing
- Cenerimod
- Where
- 14 sites in United States
- Volunteers
- 300 people
- Sponsor
- Viatris Innovation GmbH
Systemic Lupus Erythematosus
Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.
- Trial name
- NCT02472795
- Testing
- Cenerimod
- Where
- 18 sites in United States, Belarus and 4 more
- Volunteers
- 105 people
- Sponsor
- Viatris Innovation GmbH
Lupus Erythematosus, Systemic
Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
this study extension objective is to evaluate the safety and tolerability of a 200-mcg dose every 4 weeks for 24 weeks of IPP-201101 in patients with active systemic lupus erythematosus (SLE) who had participated in the main…
- Trial name
- IP-006 (NCT03427151)
- Testing
- IPP-201101
- Where
- 14 sites in United States, Czechia and 5 more
- Volunteers
- 62 people
- Sponsor
- ImmuPharma
Systemic Lupus Erythematosus
CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have autoantibody positive, clinically-active…
- Trial name
- NCT02074020
- Testing
- Blisibimod
- Sponsor
- Anthera Pharmaceuticals
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.