Clinical trials: Systemic Lupus
Lupus Nephritis, Immunoglobulin A Nephropathy
Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of ALXN2050 (120 and 180 milligrams [mg]) in addition to background therapy consistent with the standard of care in adult participants (≥ 18 to ≤…
- Conditions
- Lupus Nephritis, Immunoglobulin A Nephropathy, IgAN, LN
- Trial name
- NCT05097989
- Testing
- ALXN2050
- Where
- 71 sites in United States, Argentina and 14 more
- Volunteers
- 100 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Cutaneous Lupus, Discoid Lupus
Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus
This is a multi-center, randomized, double-blind, placebo-controlled, two-period, crossover study in which approximately 20 subjects with Discoid Lupus Erythematosus will be enrolled to receive AMG 811 and placebo in one of two…
- Conditions
- Cutaneous Lupus, Discoid Lupus, Lupus, Systemic Lupus Erythematosus
- Trial name
- NCT01164917
- Testing
- AMG811
- Where
- 8 sites in United States
- Volunteers
- 16 people
- Sponsor
- Amgen
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
SLE (Systemic Lupus), RA - Rheumatoid Arthritis
Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA
The goal of this clinical trial is to inform the safety and tolerability of NTR-1011 in treating adult patients diagnosed with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).
- Trial name
- LIBERATE-I (NCT07237659)
- Testing
- NTR1011
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- Neutrolis
Lupus
To Assess Prevention of Bone Loss in Women With Lupus Receiving Treatment With Glucocorticoids
The purpose of this clinical trial is to study the effects of GL701 on bone mineral density in women with active systemic lupus erythematosus (SLE) who are also receiving treatment with glucocorticoids (e.g., prednisone).
- Trial name
- NCT00053560
- Testing
- Prasterone (GL701)
- Where
- 26 sites in United States, Mexico
- Volunteers
- 155 people
- Sponsor
- Genelabs Technologies
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic
A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus
The main purpose of this study was to evaluate the safety and pharmacokinetics (PK, the action of a drug in the body over a period of time) of multiple intravenous (IV) administrations of CNTO 136 in patients with cutaneous lupus…
- Trial name
- NCT01702740
- Testing
- 1 mg/kg CNTO 136, 4 mg/kg CNTO 136, 10 mg/kg CNTO 136
- Volunteers
- 49 people
- Sponsor
- Centocor Research & Development, Inc.
Systemic Lupus Erythematosus
Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)
- Trial name
- EMBODY4 (NCT01408576)
- Testing
- Epratuzumab
- Where
- 228 sites in United States, Australia and 23 more
- Volunteers
- 1,250 people
- Sponsor
- UCB Pharma
Systemic Lupus Erythematosus
Anifrolumab PK Study for Systemic Lupus Erythematosus (SLE)
To assess the pharmacokinetic parameters of anifrolumab in Chinese participants with active systemic lupus erythematosus(SLE).
- Trial name
- NCT05001698
- Testing
- Anifrolumab
- Where
- 3 sites in China
- Volunteers
- 15 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus
This is a first exploration of GLPG3970 in subjects with active systemic lupus erythematosus (SLE) to evaluate the effect on disease biomarkers and to determine its pharmacokinetics (PK) profile, safety and tolerability, and…
- Trial name
- TAPINOMA (NCT04700267)
- Testing
- GLPG3970 film-coated tablet
- Where
- 14 sites in Bulgaria, Moldova and 3 more
- Volunteers
- 11 people
- Sponsor
- Lakefront Biotherapeutics NV
Systemic Lupus Erythematosus
GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
Open label safety and efficacy follow-up.
- Trial name
- NCT00082511
- Testing
- Prasterone (GL701)
- Where
- 22 sites in United States, Mexico
- Volunteers
- 114 people
- Sponsor
- Genelabs Technologies
Refractory Lupus Nephritis, Refractory Systemic Sclerosis
A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN) or Refractory Systemic Sclerosis (SSc)
The main aim of the trial is to learn how well adults with refractory lupus nephritis (LN) or refractory systemic sclerosis (SSc) tolerate TAK-007 and to check for side effects (adverse events).
- Trial name
- NCT06377228
- Testing
- TAK-007, Chemotherapy Agents
- Where
- United States
- Sponsor
- Takeda
Inflammatory Diseases
Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants
The primary objective of this study is to evaluate the pharmacokinetics (PK) of efavaleukin alfa after single subcutaneous (SC) administration in healthy Chinese, Japanese, and Caucasian participants.
- Trial name
- NCT04987333
- Testing
- Efavaleukin alfa
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amgen
Systemic Lupus Erythematosus, SLE
Phase 1b/2a in SLE With Budoputug
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of budoprutug in participants with SLE
- Conditions
- Systemic Lupus Erythematosus, SLE, B Cells
- Trial name
- NCT06570434
- Testing
- budoprutug
- Sponsor
- Tenet Medicines
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
Lupus Erythematosus, Systemic
SAPHNELO Systemic Lupus Erythematosus Japan Post-Marketing Surveillance (PMS)
To collect information on and evaluate the long-term safety and effectiveness of Anifrolumab in patients with systemic lupus erythematosus in the real-world post-marketing setting.
- Trial name
- NCT05141201
- Where
- 47 sites in Japan
- Volunteers
- 1,620 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects
This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to characterize the pharmacokinetic profile and safety profile of 200 mg single dose of belimumab…
- Trial name
- NCT04136145
- Testing
- Belimumab for IV, Belimumab for SC
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.
- Trial name
- NCT00624351
- Testing
- Epratuzumab
- Where
- 53 sites in United States, Belgium and 9 more
- Volunteers
- 227 people
- Sponsor
- UCB Pharma
Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis
Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE
The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in children and adults with macrophage activation syndrome (sHLH/MAS) in Still's disease (including systemic juvenile idiopathic arthritis…
- Conditions
- Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, Systemic Lupus Erythematosus
- Trial name
- EMERALD (NCT05001737)
- Testing
- Emapalumab
- Where
- 44 sites in United States, Belgium and 11 more
- Volunteers
- 33 people
- Sponsor
- Swedish Orphan Biovitrum
Healthy Subjects (HS), SLE (Systemic Lupus)
First-in-Human Study of ISH0613: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
The goal of this clinical trial is to learn about a study drug called ISH0613 and how it behaves in healthy adults. This study will also evaluate the safety and tolerability of ISH0613 after a single intravenous (IV) dose.
- Trial name
- NCT07516639
- Testing
- ISH0613 for injection
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
Systemic Lupus Erythematosus, Systemic Sclerosis (SSc)
A Study of ATG-201 in Adult Participants With Autoimmune Diseases
This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Sjogren's Disease, Autoimmune Diseases
- Trial name
- ATTRACT (NCT07732309)
- Testing
- ATG-201
- Where
- 22 sites in China
- Volunteers
- 149 people
- Sponsor
- Antengene Biologics Limited