Clinical trials: Systemic Lupus, Skin Lupus
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
Systemic Lupus Erythematosus
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus…
- Trial name
- NCT05540327
- Testing
- M5049 low dose, M5049 medium dose, M5049 high dose
- Where
- 122 sites in United States, Argentina and 20 more
- Volunteers
- 381 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Systemic Lupus Erythematosus
Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients
Primary Objective: Assess in systemic lupus erythematosus (SLE) patients the effect of SAR113244 on B-cell subsets compared to placebo.
- Trial name
- NCT02331810
- Testing
- SAR113244
- Sponsor
- Sanofi
Systemic Lupus Erythematosus
Belimumab (BENLYSTA®) Pregnancy Registry
This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab…
- Trial name
- NCT01532310
- Testing
- belimumab
- Where
- 15 sites in United States, Austria and 10 more
- Volunteers
- 77 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and Quality of Life (QoL) of Participants With Lupus Nephritis
This is a multicenter prospective study to assess clinical characteristics, demographics, treatment and health-related quality of life (HRQoL) of lupus nephritis (LN) participants across 5 Gulf countries (United Arab Emirates…
- Trial name
- NCT04971590
- Testing
- Participant completed survey, Medical chart review
- Where
- 6 sites in Kuwait, Oman and 2 more
- Volunteers
- 193 people
- Sponsor
- GlaxoSmithKline
Neuropsychiatric Systemic Lupus Erythematosus, Systemic Lupus Erythematosus (SLE)
EG-501 for Cognitive Impairment in Neuropsychiatric SLE (NPSLE): Efficacy and Safety Study
Neuropsychiatric systemic lupus erythematosus with cognitive impairment (NPSLE-CI) is a serious, disabling, and potentially life-threatening manifestation of SLE, affecting up to 80% of patients with cognitive impairments ("brain…
- Conditions
- Neuropsychiatric Systemic Lupus Erythematosus, Systemic Lupus Erythematosus (SLE), Cognitive Impairment
- Trial name
- NCT07281105
- Testing
- EG-501
- Where
- 3 sites in United States
- Volunteers
- 131 people
- Sponsor
- Evergreen Therapeutics, Inc.
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
Systemic Lupus Erythematosus
Study of CM313(SC) Injection in Systemic Lupus Erythematosus(SLE)
To evaluate the efficacy and safety of CM313(SC) injection in systemic lupus erythematosus(SLE)
- Trial name
- NCT06791772
- Testing
- CM313 injection
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Keymed Biosciences Co.Ltd
Lupus Nephritis
Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.
- Trial name
- NCT00429377
- Testing
- tacrolimus
- Where
- 7 sites in Japan
- Volunteers
- 64 people
- Sponsor
- Astellas Pharma Inc
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of IMPT-514 in Active Refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE)
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-514, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with active…
- Trial name
- NCT06153095
- Testing
- IMPT-514
- Where
- 4 sites in United States, Australia
- Sponsor
- Lyell Immunopharma, Inc.
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
Lupus Nephritis
A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis
The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).
- Trial name
- NCT04883619
- Testing
- Nipocalimab, Standard-of-care treatment
- Sponsor
- Janssen Research & Development, LLC
Systemic Lupus Erythematosus
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus (SLE) over a 52 week period.
- Trial name
- NCT01345253
- Testing
- Belimumab
- Where
- 47 sites in China, Japan and 1 more
- Volunteers
- 709 people
- Sponsor
- GlaxoSmithKline
Lupus Erythematosus, Discoid
A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies
Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients with Higher Disease Activity (anti-dsDNA positive and low complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and…
- Trial name
- NCT01858792
- Testing
- Belimumab 1 mg/kg, Belimumab 10 mg/kg
- Volunteers
- 1 people
- Sponsor
- Human Genome Sciences Inc., a GSK Company
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID.
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjogren's Syndrome
- Trial name
- NCT06417398
- Testing
- T cell injection targeting CD19 chimeric antigen receptor
- Volunteers
- 10 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Systemic Lupus Erythematosus
Exploratory Study of DHA in Systemic Lupus Erythematosus Patients
The primary objective of the study is to assess the efficacy of DHA in patients with SLE.
- Trial name
- NCT03396393
- Testing
- Dihydroartemisinin tablet
- Volunteers
- 120 people
- Sponsor
- Kunming Pharmaceuticals, Inc.
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.
Systemic Lupus Erythematosus
Clinical and Demographic Features of Patients With Moderate to Severe Active Systemic Lupus Erythematosus in Russia
This is a multicenter observational retrospective-prospective study consisting of retrospective and prospective phases. Trial will include 2 visits for obtaining the patient's demographic and clinical data: the 1st is…
- Trial name
- SEVERUS (NCT06759519)
- Where
- 32 sites in Russia
- Volunteers
- 637 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)
The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants…
- Trial name
- SIRIUS-SLE 1 (NCT05639114)
- Testing
- Ianalumab
- Where
- 135 sites in United States, Argentina and 17 more
- Volunteers
- 436 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Nephritis
Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.
- Trial name
- NCT05268289
- Testing
- Iptacopan (part 1), Iptacopan (part 2)
- Where
- 74 sites in United States, Argentina and 17 more
- Volunteers
- 81 people
- Sponsor
- Novartis Pharmaceuticals