Clinical trials: System Lupus Erythematosus
Systemic Lupus Erythematosus
A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus
This is a Phase I, randomized, placebo-controlled, double-blind, dose-escalation study of single and repeat doses of rhuMAb IFNalpha, administered through the SC or IV route, in adults with Systemic Lupus Erythematosus.
- Trial name
- NCT00541749
- Testing
- rhuMAb IFNalpha
- Volunteers
- 60 people
- Sponsor
- Genentech, Inc.
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
The primary objective of this multicenter observational registry is to characterize the clinical, epidemiological, and biological profiles of individuals of Middle Eastern, North African, and Levantine ancestry, including…
- Conditions
- Antiphospholipid (aPL)-Positive, Rheumatic Arthritis, Celiac Disease, Focal Segmental Glomerulosclerosis (FSGS)
- Trial name
- MERIT (NCT07892651)
- Where
- Jordan
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Axiom Bioregistry
Systemic Lupus Erythematosus
A Phase Ib Study of QLS4131 in Subjects With Systemic Lupus Erythematosus
The goal of this open label, dose escalation phase 1b clinical trial is to investigate the safety, tolerability, pharmacokinetic, pharmacodynamics, immunogenicity and preliminary clinical efficacy of QLS4131 in subjects with…
- Trial name
- NCT07001839
- Testing
- QLS4131 for Injection.
- Volunteers
- 108 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Systemic Lupus Erythematosus, Active Cutaneous Lupus Erythematosus
Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)
The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) in reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement…
- Trial name
- LILAC (NCT02847598)
- Testing
- BIIB059 (litifilimab)
- Where
- 128 sites in United States, Argentina and 10 more
- Volunteers
- 264 people
- Sponsor
- Biogen
Lupus Nephritis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with…
- Trial name
- POSTERITY (NCT05039619)
- Testing
- Obinutuzumab, Mycophenolate Mofetil, Acetaminophen/paracetamol
- Where
- 44 sites in United States, Brazil and 10 more
- Volunteers
- 40 people
- Sponsor
- Hoffmann-La Roche
Systemic Lupus Erythematosus
Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus
A one month multi-dose study will evaluate the safety and tolerability of 3 intravenous infusions of RSLV-132 in subjects with inactive to mild SLE.
- Trial name
- NCT02194400
- Testing
- RSLV-132
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- Resolve Therapeutics
Systemic Lupus Erythematosus
The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study
The goal of this study is to enable the study sponsor to develop a new blood test method for clinicians to accurately predict which individuals with lupus will flare, when the flare will occur, and flare severity.
- Trial name
- SAGE (NCT00671047)
- Testing
- non-interventional
- Where
- 12 sites in United States, Canada
- Volunteers
- 1,000 people
- Sponsor
- XDx
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 of Obexelimab in Patients With Systemic Lupus Erythematosus
This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).
- Trial name
- SunStone (NCT06559163)
- Testing
- Obexelimab
- Where
- 110 sites in United States, Belgium and 16 more
- Volunteers
- 190 people
- Sponsor
- Zenas BioPharma (USA), LLC
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLE
The primary objective of this phase Ib study is to evaluate the safety and tolerability of multiple-ascending, subcutaneous (SC) doses of HC022 in SLE/CLE subjects.
- Trial name
- NCT07306585
- Testing
- HC022
- Where
- China
- Volunteers
- 32 people
- Sponsor
- HC Biopharma Inc.
SLE - Systemic Lupus Erythematosus
MB-CART19.1 in Refractory SLE
This is a phase l/ll open-label, multicentre, interventional single-arm trial of MB-CART19.1 in patients with refractory SLE systemic lupus erythematosus.
- Trial name
- NCT06189157
- Testing
- MB-CART19.1
- Where
- 3 sites in Germany
- Volunteers
- 29 people
- Sponsor
- Miltenyi Biomedicine GmbH
Systemic Lupus Erythematosus
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.
- Trial name
- POETYK SLE-1 (NCT05617677)
- Testing
- Deucravacitinib
- Where
- 197 sites in United States, Argentina and 20 more
- Volunteers
- 516 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus
A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of GSK4527363 in healthy participants (Part A), participants with active SLE (Part B), healthy participants of Chinese and…
- Trial name
- NCT06576271
- Testing
- GSK4527363, Belimumab
- Where
- 28 sites in United States, Argentina and 4 more
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus, Arthritic Psoriasis
The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients
The purpose of this study is to investigate the effect of BMS-986165 in combination with an oral contraceptive in healthy female patients.
- Conditions
- Systemic Lupus Erythematosus, Arthritic Psoriasis, Psoriasis, Inflammatory Bowel Diseases
- Trial name
- NCT03262727
- Testing
- BMS-986165, Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Lupus Nephritis, Lupus Nephritis - WHO Class III
KYSA-3: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis
- Conditions
- Lupus Nephritis, Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV
- Trial name
- NCT06342960
- Testing
- KYV-101 anti-CD19 CAR-T cell therapy, Standard lymphodepletion regimen
- Where
- 6 sites in Germany
- Volunteers
- 2 people
- Sponsor
- Kyverna Therapeutics
Systemic Lupus Erythematosus
Study to Characterise Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Anifrolumab Administered Subcutaneously (SC) or Intravenously (IV)
The purpose of this study is to assess the PK, PD, and safety of anifrolumab as SC administration or IV infusion in adult participants with systemic lupus erythematosus (SLE).
- Trial name
- NCT07688980
- Testing
- Anifrolumab: SC formulation via AI, Anifrolumab: IV formulation, Anifrolumab: SC formulation via aPFS
- Volunteers
- 92 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus (SLE)
A Study to Evaluate the Safety, Tolerability, and PK Profile of Single and Multiple Doses TJ202 in Patient With Systemic Lupus Erythematosus
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of TJ202 in Patients with Systemic Lupus…
- Trial name
- NCT05140824
- Testing
- TJ202 injection
- Where
- 2 sites in China
- Volunteers
- 1 people
- Sponsor
- TJ Biopharma Co., Ltd.
Lupus Nephritis
A Study of Telitacicept in Lupus Nephritis
The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis.
- Trial name
- NCT05680480
- Testing
- Telitacicept 240 mg, Telitacicept 160 mg
- Where
- 45 sites in China
- Volunteers
- 120 people
- Sponsor
- RemeGen Co., Ltd.
Systemic Lupus Erythematosus
Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.
The primary objective of this phase Ia study is to evaluate the safety and tolerability of single-ascending, subcutaneous (SC) doses of HC022 in healthy subjects.
- Trial name
- NCT06657703
- Testing
- HC022
- Where
- 3 sites in China
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- HC Biopharma Inc.
Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
A Study to Assess the Mass Balance Recovery (Absorption, Distribution, Metabolism and Excretion) of [14C]CCX168 in Healthy Participants
The primary objective of this study is to perform mass balance following a single oral dose of [14C]CCX168 in healthy adult male participants.
- Trial name
- NCT06004960
- Testing
- [14C]CCX168
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Amgen