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| Completed | 2b | 350 | Europe, Canada, Japan, US, RoW | Placebo, PF-06700841 15 mg, PF-06700841 30 mg, PF-06700841 45 mg | Pfizer | Systemic Lupus Erythematosus | 10/23 | 10/23 | | |
NCT05688696: Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus |
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| Recruiting | 2b | 186 | RoW | Orelabrutinib (Low Dose), Orelabrutinib (High Dose), Orelabrutinib Placebo | Beijing InnoCare Pharma Tech Co., Ltd. | Systemic Lupus Erythematosus, SLE | 05/24 | 05/25 | | |
NCT05967520: JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus |
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| Recruiting | 2a | 48 | RoW | JMKX000189, Placebo | Jemincare | Lupus Erythematosus, Systemic | 05/25 | 12/25 | | |
ACTRN12605000692639: Protocol IM101042: A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. |
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| Recruiting | 2 | 180 | | | Bristol-Myers Squibb Australia, Bristol-Myers Squibb Australia | Systemic Lupus Erythematosus (SLE). | | | | |
ACTRN12623000397617: Temporary Withholding of Immunosuppressant in Rheumatic diseases and Lupus (TWIRL) Study |
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| Recruiting | 2 | 80 | | | Monash Health, Monash University, Arthritis Australia | Systemic lupus erythematosus | | | | |
2011-005392-16: Stydy to evaluate the efficacy and security of anakinra for the treatment of unresponsiveness arthritis to conventional treatment in systemic lupus erythematosus |
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| Ongoing | 2 | 20 | Europe | KINERET, KINERET, Solution for injection in pre-filled syringe, KINERET | Dr Josep Ordi Ros, health department | Systemic lupus erythematosus Lupus eritematoso sistémico, Systemic lupus erythematosus Lupus eritematoso sistémico, Diseases [C] - Immune System Diseases [C20] | | | | |
2005-003070-19: A randomized, multicenter, parallel-group, open-label study to assess the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS, myfortic®) versus continuation of previous therapy in patients with proliferative lupus nephritis on standard maintenance therapy |
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| Ongoing | 2 | 16 | Europe | Myfortic, ERL080A, Myfortic, Myfortic | Novartis Pharma Services AG | lupus nephritis ( as part of the disease \"Systemic Lupus Erythematosus\") | | | | |
2006-001062-17: Efficacy and safety of ASF-1096 cream 0.5% in the treatment of patients with newly developed discoid lupus erythymatosus (DLE) lesions. A multi centre clinical phase 2, placebo controlled and double blind proof of concept study. |
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| | 2 | 20 | Europe | ASF-1096 cream 0.5%, | Astion Danmark A/S | Male or female patients with a clinical diagnosis of either Discoid Lupus Erythmatosus or Systemic Lupus Erythmatosus and at least one newly developed, sharply demarcated DLE lesion. | | 07/07 | | |
2006-004892-36: An open randomized and comparative study on the efficacy and safety of additional treatment of subcutaneous immunoglobulin (Subcuvia) during cessation of Prednisolon in patients with active systemic lupus erythematosus (SLE) |
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| Ongoing | 2 | 20 | Europe | Subcuvia, Subcuvia | Department of Rheumatology,University hospital,Lund | Systemic Lupus Erythematosus (SLE) | | | | |
2009-016804-21: Intérêt de la Tomographie par Émission de Positons avec la 3’-désoxy-3’-[18F]-fluoro-thymidine (18F-FLT) pour l’obtention d’une cartographie de l’activité mitotique myéloïde corps entier dans les syndromes myélofibroses. |
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| Ongoing | 2 | 15 | Europe | 3’-désoxy-3’-[18F]-fluoro-thymidine, 3’-désoxy-3’-[18F]-fluoro-thymidine, | Accelerator Advanced Application | démontrer la faisabilité de cette méthode d’imagerie en pathologie médullaire et analyser les paramètres optimaux d’acquisition d’image.caractériser des cartographies médullaires spécifiques, pré-requis pour analyser les valeurs diagnostiques de la 18F-FLT dans les syndromes myelo prolifératifs et le suivi par la 18F-FLT, de la réponse thérapeutique de ces affections. | | | | |
2012-002345-38: Comparison of rivaroxaban (Xarelto®; Bayer HealthCare), fixed-dose oral anticoagulant (blood thinner), versus warfarin in patients with antiphospholipid syndrome (called APS), with or without \'lupus\' (systemic lupus erythematosus) |
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| Ongoing | 2 | 156 | Europe | Rivaroxaban, Warfarin, Xarelto, The generic name is warfarin and many producers will be involved, Xarelto, The generic name is warfarin and many producers will be involved | University College London, Arthritis Research UK, Bayer plc | Patients with antiphospholipid syndrome (APS), with or without systemic lupus erythematosus (SLE). | | | | |
2005-002207-16: A randomised controlled trial of Myfortic versus Mycophenolate Mofetil in the treatment of multi-system autoimmune disease. |
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| Ongoing | 2 | 40 | Europe | Myfortic, Cellcept, Myfortic, Cellcept | Cambridge University Hospitals NHS Foundation Trust | Multi-system autoimmune diseases including vasculitis and systemic lupus erythematosus (SLE) | | | | |
| Ongoing | 2 | 15 | Europe | Rituximab, Belimumab, rituximab, Benlysta, rituximab, Benlysta | Leiden University Medical Center, Leiden University Medical Center | Systemic lupus erythematosus | | | | |
2015-005543-14: Safety and efficacy of Belimumab After B cell depletion therapy in systemic LUPUS erythematosus – BEAT LUPUS |
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| Ongoing | 2 | 50 | Europe | Belimumab, Powder for concentrate for solution for infusion, Belimumab | University College London, Research Costs Arthritis Research UK, BRC Funding Costs | Systemic Lupus Erythematosus, Lupus, Diseases [C] - Immune System Diseases [C20] | | | | |
2014-003733-25: Pilot Study related to the effect of clopidogrel on plasmatic soluble CD40 ligand during systemic lupus erythematous Essai pilote de phase I/II testant l’effet du clopidogrel sur les taux plasmatiques de CD40 ligand soluble chez des patients affectés de lupus érythémateux systémique |
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| Not yet recruiting | 2 | 30 | Europe | CLOPIDOGREL, Tablet, PLAVIX, clopidogrel, 75mg | CHU de BORDEAUX, Ministère de la Santé | systemic lupus erythematous lupus érythémateux systémique, lupus lupus, Body processes [G] - Immune system processes [G12] | | | | |
| Active, not recruiting | 2 | 93 | Europe, Canada, Japan, US, RoW | belimumab 10mg/kg, placebo, Normal Saline | GlaxoSmithKline, Human Genome Sciences Inc., a GSK Company | Systemic Lupus Erythematosus | 01/18 | 04/28 | | |
2018-003473-94: Tau and Amyloid PET imaging in normal aging, early Alzheimer's disease and related syndroms. Imagerie des protéines tau et amyloide dans le vieillissement normal, la maladie d'Alzheimer débutante, et les syndromes apparentés. |
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| Not yet recruiting | 2 | 150 | Europe | F18-MK6240, Solution for injection/infusion | Cliniques Universitaires Saint-Luc - UCLouvain, FNRS | Alzheimer’s disease (AD), Alzheimer is defined pathologically by the presence of tau tangles and amyloid senile plaques in the neocortex. To quantify pTAU in vivo, p-tau PET tracers have now been developed, like F18-MK6240., Diseases [C] - Nervous System Diseases [C10] | | | | |
NCT03260166: Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus Erythematosus |
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| Active, not recruiting | 2 | 40 | RoW | nicotinamide, Niacinamide | Second Xiangya Hospital of Central South University, National Natural Science Foundation of China, Hunan Provincial Natural Science Foundation of China, National Key Clinical Specialty Construction Project of China | Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus Rash | 01/20 | 07/21 | | |
2020-000473-25: ESKETamine for FIBromyalgia treatment Traitement de la fibromyalgie par S-Ketamine |
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| Not yet recruiting | 2 | 210 | Europe | Vesierra, Solution for infusion, Vesierra | Grand Hôpital de Charleroi, Grand Hôpital de Charleroi | Patients diagnosed with a fibromyalgia syndrome as established by the 2016 ACR criteria and presenting criteria of central sensitization syndrome (based of the CSI (CSI>40))., Patients diagnosed with a fibromyalgia syndrome, Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] | | | | |
2020-001177-78: Certolizumab to Prevent Pregnancy Complications in High-Risk Patients with Antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE) Certolizumab en prévention de complications de la grossesse chez les patientes à haut risque atteintes d’un Syndrome des Antiphospholipides (SAPL) et/ou d’un Lupus Erythémateux Systémique et porteuse de l’anticorps Anticoagulant circulant (ACC) de type lupique |
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| Not yet recruiting | 2 | 50 | Europe | Certolizumab, Solution for injection in pre-filled syringe, CIMZIA | University of Utah, University of Utah | Pregnant women with Antiphospholipid Syndrom (APS) and Lupus Antocoagulant (LAC) Patientes enceintes atteintes d’un Syndrome des Antiphospholipides (SAPL) et/ou d’un Lupus Erythémateux Systémique et porteuse de l’anticorps Anticoagulant circulant (ACC) de type lupique, Pregnant women with Antiphospholipid Syndrom (APS) and Lupus Antocoagulant (LAC) Patientes enceintes atteintes d’un Syndrome des Antiphospholipides (SAPL) et/ou d’un Lupus Erythémateux Systémique et porteuse de l’anticorps Anticoagulant circulant (ACC) de type lupique, Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | | | | |
2021-000962-14: A drug trial to evaluate the safety and efficacy of daratumumab, an agent already approved for other diseases, in combination with standard background anti-rheumatic therapy in patients with moderate-to-severe systemic lupus erythematosus Eine Medikamentenstudie zur Untersuchung der Sicherheit und Wirksamkeit des bereits für andere Erkrankungen zugelassenen Wirkstoffs Daratumumab in Kombination mit einer anti-rheumatischen Standard-Begleittherapie bei Patienten mit mittelschwerem bis schwerem systemischen Lupus erythematodes |
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| Not yet recruiting | 2 | 10 | Europe | Daratumumab, JNJ-54767414, Solution for injection, Darzalex | Charité - Universitätsmedizin Berlin, JANSSEN-CILAG GmbH | Systemic Lupus Erythematosus Systemischer Lupus Erythematodes (SLE), Systemic Lupus Erythematosus Systemischer Lupus Erythematodes (SLE), Diseases [C] - Immune System Diseases [C20] | | | | |
2020-005569-14: A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus |
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| Ongoing | 2 | 225 | Europe | Nipocalimab, JNJ-80202135, Solution for infusion | Janssen-Cilag International NV, Janssen Research & Development, LLC | Active Systemic Lupus Erythematosus, Active Systemic Lupus Erythematosus, Diseases [C] - Immune System Diseases [C20] | | | | |
2021-000097-29: A Phase II Randomized Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients with Active Class III or IV Lupus Nephritis Estudio fase II, aleatorizado y controlado paraevaluar la eficacia, seguridad y farmacocinética de obinutuzumab en pacientes adolescentes con nefritis lúpica de casle III o IV activa |
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| Not yet recruiting | 2 | 30 | Europe | Obinutuzumab, mycophenolate mofetil, RO5072759, Concentrate for solution for infusion, Tablet, Gazyvaro, Myfenax | Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd, F. Hoffman-La Roche Ltd., F. HOFFMANN - LA ROCHE LTD., F. Hoffman-La Roche Ltd. | Lupus Nephritis (LN) Nefritis lúpica (NL), Lupus nephritis is inflammation of the kidney that is caused by systemic lupus erythematous (SLE). SLE is an autoimmune disease, in which the body’s immune system attacks its own healthy body tissue. La nefritis lúpica es una inflamación del riñón causada por el lupus eritematoso sistémico(LES).LES es una enfermedad autoinmune,en la que el sistema inmune del cuerpo ataca sus propios tejidos sanos, Diseases [C] - Immune System Diseases [C20] | | | | |
2019-004021-25: A Study Evaluating the Efficacy and Safety of BMS-986256 Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) |
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| Ongoing | 2 | 600 | Europe | TLR7/8 Antagonist (2.5mg), TLR7/8 Antagonist (10mg), BMS-986256, Capsule, hard | Bristol-Myers Squibb International Corporation, Bristol-Myers Squibb International Corporation | Active Systemic Lupus Erythematosus., SLE is a chronic autoimmune disease in which the immune system attacks its own tissues, causing inflammation and tissue damage in the affected organs (skin, joints, kidneys, heart and other organs)., Diseases [C] - Immune System Diseases [C20] | | | | |
| Recruiting | 2 | 146 | RoW | Sirolimus, rapamycin, Placebo | Chinese SLE Treatment And Research Group, Beijing Municipal Science & Technology Commission, North China Pharmaceutical Group Corporation | Systemic Lupus Erythematosus | 10/24 | 05/25 | | |
NCT04835883: Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients |
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| Recruiting | 2 | 10 | RoW | CS20AT04 (allogenic bone marrow derived mesenchymal stem cell) | Hanyang University Seoul Hospital, Corestem, Inc., Ministry of Health & Welfare, Korea | Systemic Lupus Erythematosus | 11/21 | 01/26 | | |
NCT03396393: Exploratory Study of DHA in Systemic Lupus Erythematosus Patients |
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| Not yet recruiting | 2 | 120 | NA | Dihydroartemisinin tablet, No other names, Placebo tablet | Kunming Pharmaceuticals, Inc. | Systemic Lupus Erythematosus | 12/21 | 12/22 | | |
2021-001406-30: A study investigating the treatment of Systemic Lupus Erythematosus with LY3361237 |
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| Not yet recruiting | 2 | 90 | Europe | LY3361237, Solution for injection | Eli Lilly and Company, Eli Lilly and Company | Systemic Lupus Erythematosus (SLE), Systemic Lupus Erythematosus, Diseases [C] - Immune System Diseases [C20] | | | | |
2021-004648-27: A Study of Enpatoran in Patients With Systemic Lupus Erythematosus andCutaneous Lupus Erythematosus Un estudio de enpatoran en pacientes con lupus eritematoso sistémico y lupus eritematoso cutáneo |
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| Not yet recruiting | 2 | 532 | Europe, RoW | Enpatoran 25mg, M5049, Film-coated tablet | Merck Healthcare KGaA, Merck Healthcare KGaA | Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) Lupus eritematoso sistémico (LES) y Lupus eritematoso cutáneo (LEC), Systemic lupus erythematosus (SLE) and cutaneous lupuserythematosus (CLE) Lupus eritematoso sistémico (LES) y Lupus eritematoso cutáneo (LEC), Diseases [C] - Immune System Diseases [C20] | | | | |
2021-001567-25: Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus Eficacia y seguridad de SAR441344 para el tratamiento del Lupus Eritematoso Sistémico. |
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| Not yet recruiting | 2 | 166 | Europe | SAR441344, SAR441344, Solution for injection | Sanofi-Aventis Recherche et Développement, SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT, Sanofi-Aventis Recherche et Développement, Sanofi-aventis Recherche & Développement | Systemic lupus erythematosus Lupus Eritematoso Sistémico, Systemic lupus erythematosus Lupus Eritematoso Sistémico, Diseases [C] - Musculoskeletal Diseases [C05] | | | | |
2019-002205-22: "Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment." |
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| Not yet recruiting | 2 | 185 | Europe | Branebrutinib, Abatacept, BMS-986195, BMS-188667, Capsule, hard, Solution for injection in pre-filled syringe, ORENCIA 125 mg solution for injection in pre-filled syringe | Bristol-Myers Squibb International Corporation, Bristol-Myers Squibb Research and Development, Bristol-Myers Squibb Company | SLE Sub-protocol: Systemic Lupus Erythematosus pSS Sub-protocol: Primary Sjögren’s Syndrome RA Sub-protocol: Rheumatoid Arthritis, Lupus, Sjögren’s Syndrome and Arthritis are autoimmune diseases that develops when body's immune system overreacts to unknown stimulus making antibodies/proteins directed against own's body tissues., Diseases [C] - Immune System Diseases [C20] | | | | |
| Completed | 2 | 291 | Europe, Canada, Japan, US, RoW | LY3471851, Rezpegaldesleukin, REZPEG, NKTR-358, Placebo | Nektar Therapeutics, Eli Lilly and Company | Systemic Lupus Erythematosus | 01/23 | 02/23 | | |
| Active, not recruiting | 2 | 25 | Europe, Japan, US, RoW | Belimumab | GlaxoSmithKline | Systemic Lupus Erythematosus | 01/23 | 04/27 | | |
DARALUP, NCT04810754: An Open Label Study to Evaluate Daratumumab in Participants With Moderate to Severe Systemic Lupus Erythematosus |
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| Not yet recruiting | 2 | 10 | NA | Daratumumab Injection, DARZALEX (trade name) | Charite University, Berlin, Germany, Janssen-Cilag G.m.b.H, Labor Berlin-Charité Vivantes G.m.b.H, Deutsches Rheuma-Forschungszentrum Berlin (DRFZ), Charité Clinical Trial Office (CTO) | Systemic Lupus Erythematosus | 03/23 | 12/23 | | |
| Completed | 2 | 214 | Europe, US, RoW | VIB7734, Daxdilimab, HZN-7734, Placebo | Amgen | Lupus Erythematosus, Systemic | 05/23 | 06/23 | | |
| Terminated | 2 | 168 | Europe, Canada, Japan, US, RoW | Efavaleukin Alfa, AMG 592, Placebo, Standard of Care | Amgen | Active Systemic Lupus Erythematosus | 05/23 | 05/23 | | |
| Completed | 2 | 244 | Europe, Canada, Japan, US, RoW | Rozibafusp Alfa, Placebo for Rozibafusp Alfa | Amgen | Systemic Lupus Erythematosus (SLE) | 07/23 | 07/23 | | |
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| Recruiting | 2 | 40 | RoW | Lacteol forte capsules, lactobacillus delbruekii and lactobacillus fermentum | Ain Shams University | Systemic Lupus Erythematosus | 10/23 | 12/23 | | |
2022-000855-35: An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Daxdilimab (HZN-7734) in Subjects with Systemic Lupus Erythematosus |
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| Not yet recruiting | 2 | 156 | Europe | Daxdilimab, HZN-7734, VIB7734, Solution for injection | Horizon Therapeutics Ireland DAC, Horizon Therapeutics Ireland DAC | Systemic Lupus Erythematosus (SLE), Systemic Lupus Erythematosus, Diseases [C] - Immune System Diseases [C20] | | | | |
| Active, not recruiting | 2 | 187 | US | Hydroxychloroquine, Plaquenil, Placebo Oral Capsule, Placebo | Milton S. Hershey Medical Center, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Systemic Lupus Erythematosus | 09/24 | 01/25 | | |
MEASURE, NCT03355482: MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE |
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| Terminated | 2 | 9 | US | Methylprednisolone, Placebos | Oklahoma Medical Research Foundation, Bristol-Myers Squibb | Systemic Lupus Erythematosus Arthritis | 02/22 | 12/22 | | |
NCT05000216: COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders |
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| Completed | 2 | 257 | US | Moderna mRNA-1273, mRNA-1273 vaccine (Moderna), Moderna COVID-19 Vaccine, SARS-CoV-2 RNA vaccine, COVID-19 vaccine, BNT162b2, mRNA-1273 vaccine (Pfizer/BioNTech), Pfizer-BioNTech COVID-19 vaccine, Ad26.COV2.S, Janssen COVID-19 Vaccine, JNJ-78436735, Continue IS (MMF or MPA), immunosuppressive medication, mycophenolate mofetil, MMF, CellCept®, mycophenolic acid, MPA, Continue IS (MTX), methotrexate, MTX, Continue IS (B cell depletion therapy), mAbs targeting CD19 or CD20, anti-BAFF mAb, Monovalent [B.1.351] CoV2 preS dTM-AS03, Sanofi-GSK COVID-19 Vaccine, Withhold IS (MMF or MPA), Withhold IS (MTX), Withhold IS (B cell depletion therapy), Moderna mRNA-1273, Bivalent, mRNA-1273 vaccine (Moderna), Bivalent, Moderna COVID-19 Vaccine, Bivalent, SARS-CoV-2 RNA vaccine, Bivalent, COVID-19 vaccine, Bivalent, BNT162b2, Bivalent, mRNA-1273 vaccine (Pfizer/BioNTech), Bivalent, Pfizer-BioNTech COVID-19 vaccine, Bivalent | National Institute of Allergy and Infectious Diseases (NIAID), Autoimmunity Centers of Excellence, Rho Federal Systems Division, Inc. | Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Pemphigus Vulgaris, Multiple Sclerosis (MS), Systemic Sclerosis (SSc), Pediatric SLE, Juvenile Idiopathic Arthritis (JIA), Juvenile Dermatomyositis (JDM), Pediatric-Onset Multiple Sclerosis (POMS) | 06/23 | 03/24 | | |
| Recruiting | 2 | 270 | Europe, Canada, Japan, US, RoW | MK-6194, Placebo | Merck Sharp & Dohme LLC | Systemic Lupus Erythematosus | 01/26 | 07/27 | | |
NCT04451772 / 2020-001690-72: A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State |
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| Completed | 2 | 185 | Europe, Japan, US, RoW | Elsubrutinib, ABBV-105, Placebo for Elsubrutinib, Upadacitinib, ABT-494, RINVOQ, Placebo for Upadacitinib | AbbVie | Systemic Lupus Erythematosus (SLE) | 01/24 | 01/24 | | |
| Recruiting | 2 | 36 | US | Lisinopril Pills, Benazepril Pill | Northwell Health, Lupus Research Alliance | Systemic Lupus Erythematosus | 06/25 | 11/25 | | |
NCT05123586: A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus |
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| Completed | 2 | 85 | Europe, US, RoW | LY3361237, Placebo | Eli Lilly and Company | Systemic Lupus Erythematosus | 12/23 | 12/23 | | |
| Active, not recruiting | 2 | 100 | US, RoW | PRV-3279, Placebo | Provention Bio, a Sanofi Company | Systemic Lupus Erythematosus | 09/25 | 09/25 | | |
NCT06360068: A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus |
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| Not yet recruiting | 2 | 20 | NA | Sulfasalazine Tablets | Qiong Fu | Systemic Lupus Erythematosus | 05/25 | 05/25 | | |
| Terminated | 2 | 155 | Europe, US, RoW | Daxdilimab, HZN-7734 | Amgen, Horizon Therapeutics Ireland DAC | Systemic Lupus Erythematosus | 10/23 | 10/23 | | |
NCT06293365: Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease |
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| Not yet recruiting | 2 | 140 | NA | VAY736 1ml PFS, Ianalumab, VAY736 2 ml PFS, VAY736 2ml AI | Novartis Pharmaceuticals | Sjögrens Disease, Systemic Lupus Erythematosus, Rheumatoid Arthritis | 07/25 | 02/29 | | |
ChiCTR2100052493: Fecal Microbiota Transplantation in the Treatment of Active Systemic Lupus Erythematosus: A Randomized, Double-blind, Placebo-controlled, National Multi-center Clinical Trial |
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| Recruiting | 2 | 170 | | Add fecal microbiota transplantation (FMT) capsules to original treatment ;Add placebo capsules to original treatment | Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College; Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Innovation Fund for Medical Sciences (CIFMS) No.2021-I2M-1-059 | Systemic Lupus Erythematosus | | | | |
NCT05929248: Exploring the Therapeutic Effect of Telitacicept on Lupus Erythematosus Complicated With Thrombocytopenia |
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| Not yet recruiting | 2 | 64 | NA | Telitacicept, RC18, conventional therapy, Placebo | Guanmin Gao | Systemic Lupus Erythematosus | 06/24 | 12/24 | | |
| Active, not recruiting | 2 | 532 | Europe, Japan, US, RoW | Enpatoran low dose, M5049, Enpatoran medium dose, Enpatoran high dose, Placebo | EMD Serono Research & Development Institute, Inc., Merck KGaA, Darmstadt, Germany | Systemic Lupus Erythematosus | 07/24 | 08/24 | | |
NCT05440422: The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD |
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| Recruiting | 2 | 45 | US | anifrolumab, Placebo | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Systemic Lupus Erythematosus, Cardiovascular Disease, Premature Atherosclerosis | 08/24 | 08/24 | | |
NCT04077684: Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial |
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| Recruiting | 2 | 160 | RoW | Interleukin-2, Human recombinant IL-2 | Peking University People's Hospital | Systemic Lupus Erythematosus | 08/24 | 12/24 | | |
PENCIL, NCT06356740: Efficacy and Tolerance of Abacavir/Lamivudine Treatment in Patients With Systemic Lupus Erythematosus |
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| Not yet recruiting | 2 | 70 | Europe | Blood sample, Treatment :Abacavir 600 mg/lamivudine 300 mg, Lupus Impact Tracker questionnaire | Hospices Civils de Lyon | Systemic Lupus Erythematosus | 11/28 | 06/29 | | |
NCT05029336: Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases |
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| Recruiting | 2 | 20 | US | Depletion of CD3/CD19 in an autologous stem cell transplant, CD3/CD19 depletion using cliniMACs device | Stephan Grupp MD PhD | Systemic Lupus Erythematosus, Systemic Sclerosis | 12/26 | 05/31 | | |
| Active, not recruiting | 2 | 107 | Europe, Japan, RoW | VAY736, Ianalumab, VAY736 Placebo, Ianalumab/Placebo, CFZ533, Iscalimab, CFZ533 Placebo, Iscalimab/Placebo | Novartis Pharmaceuticals | Systemic Lupus Erythematosus (SLE) | 07/22 | 04/26 | | |
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NCT05504187: Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus |
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| Not yet recruiting | 2 | 24 | NA | KP104 | Kira Pharmacenticals (US), LLC. | Systemic Lupus Erythematosus | 10/24 | 10/24 | | |
| Active, not recruiting | 2 | 130 | Europe, US, RoW | ALPN-101, Placebo | Alpine Immune Sciences, Inc. | Systemic Lupus Erythematosus | 11/24 | 01/25 | | |
| Active, not recruiting | 2 | 43 | Europe | Rivaroxaban, Warfarin | University College, London, University College London Hospitals, Barking, Havering and Redbridge University Hospitals NHS Trust, Hammersmith Hospitals NHS Trust, Epsom and St Helier University Hospitals NHS Trust, Barts & The London NHS Trust, King's College Hospital NHS Trust, Versus Arthritis (Funder) | Antiphospholipid Syndrome, Systemic Lupus Erythematosus, Stroke, Ischemic Stroke, Brain Ischemia | 02/25 | 08/25 | | |
| Recruiting | 2 | 116 | Europe, US, RoW | SAR441344 IV, SAR441344 SC, Placebo IV, Placebo SC | Sanofi | Systemic Lupus Erythematosus | 09/25 | 11/26 | | |
NCT02633163: Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE) |
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| Recruiting | 2 | 81 | US | Low Dose Mesenchymal Stem Cells (MSCs), High Dose Mesenchymal Stem Cells (MSCs), Placebo Infusion | Medical University of South Carolina | Systemic Lupus Erythematosus | 12/24 | 06/25 | | |
| Recruiting | 2 | 39 | RoW | MSC treatment, Cellistem ® Lupus, Standard of Care, Standard of Care for Lupus Nephritis, Placebo, Placebo (for MSC) | Universidad de los Andes, Chile | Lupus Erythematosus, Systemic, Lupus Glomerulonephritis | 12/24 | 12/25 | | |
| Active, not recruiting | 2 | 228 | Europe, Japan, US, RoW | Placebo, Nipocalimab, JNJ-80202135, M281, Standard-of-care treatment | Janssen Research & Development, LLC, Janssen Research & Development, LLC | Systemic Lupus Erythematosus | 05/24 | 12/24 | | |
| Active, not recruiting | 2 | 261 | Europe, Canada, Japan, US, RoW | BMS-986165, Deucravacitinib | Bristol-Myers Squibb | Systemic Lupus Erythematosus | 03/25 | 03/25 | | |
| Recruiting | 2 | 532 | Europe, Japan, US, RoW | M5049 low dose, Enpatoran, M5049 medium dose, M5049 high dose, Placebo, M5049 very high dose | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, Merck Healthcare KGaA | Systemic Lupus Erythematosus | 04/25 | 04/25 | | |
LUMUS, NCT05966480: Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus |
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| Recruiting | 2 | 388 | Europe, US, RoW | ESK-001, Placebo | Alumis Inc | SLE | 05/25 | 12/25 | | |
NCT04895696: A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) |
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| Recruiting | 2 | 268 | Europe, Japan, US, RoW | Afimetoran, BMS-986256, Placebo | Bristol-Myers Squibb | Systemic Lupus Erythematosus | 03/26 | 04/29 | | |
ChiCTR2300072438: A phase IIa, randomized, double-blind, placebo-parallel controlled, dose-exploration study of JMKX000189 in the treatment of moderate to severe active systemic lupus erythematosus |
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| Not yet recruiting | 2 | 48 | | oral ;oral ;oral | Peking Union Hospital, Chinese Academy of Medical Sciences; Shanghai Jiyu Pharmaceutical Co., LTD, Completely self-financing | Moderate to severe active systemic lupus erythematosus | | | | |
| Recruiting | 2 | 80 | US | Memantine, Namenda, Placebo | Vanderbilt University Medical Center, Evergreen Therapeutics, Inc., The University of Texas Health Science Center, Houston, The Cleveland Clinic | Lupus Erythematosus, Systemic | 06/26 | 12/26 | | |
DIVERT, NCT05306873: Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus |
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| Recruiting | 2 | 120 | US | Mycophenolate Mofetil, CellCept, MMF, Placebo for Mycophenolate Mofetil, Voclosporin, Lupkynis, Lupkynis(TM), Placebo for Voclosporin | National Institute of Allergy and Infectious Diseases (NIAID) | Systemic Lupus Erythematosus | 06/25 | 06/26 | | |
| Recruiting | 2 | 30 | US | Descartes-08 | Cartesian Therapeutics | Systemic Lupus Erythematosus (SLE) | 11/25 | 11/26 | | |
GALACELA, NCT05856448: A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Participants With Active Systemic Lupus Erythematosus |
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| Recruiting | 2 | 180 | Europe, US, RoW | GLPG3667, Placebo | Galapagos NV | Systemic Lupus Erythematosus | 12/25 | 04/26 | | |
NCT05879718: A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms. |
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| Recruiting | 2 | 48 | Europe, Canada, US, RoW | Placebo, PF-06823859 | Pfizer | Lupus Erythematosus, Systemic, Lupus Erythematosus, Cutaneous | 12/25 | 11/26 | | |
NCT00775476: Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine |
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| Recruiting | 2 | 290 | US | N-acetylcysteine, Placebo | State University of New York - Upstate Medical University, Cedars-Sinai Medical Center, University of Rochester, Yale University, Penn State University, Hospital for Special Surgery, New York | Systemic Lupus Erythematosus | 10/26 | 12/27 | | |
| Not yet recruiting | 2 | 220 | NA | Sirolimus, rapamycin, Placebo, Dextrose | State University of New York - Upstate Medical University | Lupus Erythematosus, Systemic | 01/29 | 01/29 | | |
2017-001400-29: Treatment of systemic lupus erythematosus by injection iv of mesenchymal stem cells (MSC-LES) TRAITEMENT DU LUPUS ERYTHEMATEUX SYSTEMIQUE PAR INJECTION IV DE CELLULES SOUCHES MESENCHYMATEUSES ALLOGENIQUES (MSC-LES) |
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| Ongoing | 1/2 | 10 | Europe | ALLOGENEIC MESENCHYMAL STROMAL CELLS DERIVED FROM THE UMBILICAL CORD, Suspension for injection | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP), Fondation du Rein (FdR) sous égide de la FRM, en partenariat avec l’AFM Téléthon et l’AIRG | Treatment of Systemic Lupus Erythematosus refractory to standard treatments. Traitement du Lupus Erythémateux Systémique réfractaire aux traitements standards., Patients with refractory systemic Lupus Erythematosus severe prior conventional treatments (Cyclophosphamide (CY), MMF or corticosteroids with or without corticosteroids) Patients atteints de Lupus Erythémateux Sytémique réfractaire sévère aux traitements classiques préalables (Cyclophosphamide (CY), MMF ou corticoïdes avec ou sans corticoïdes), Diseases [C] - Immune System Diseases [C20] | | | | |
ChiCTR1800018050: A clinical study to evaluate the safety and theraputic effect of regulatory T cells injection in treating systemic lupus erythematosus |
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| Not yet recruiting | 1/2 | 150 | | Regulatory T cells injection | Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine; Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine, Floor 16, Yinhua Building, 3002 Sungang Road West, Futian District ,Shenzhen, Guangdong, China | Systemic Lupus Erythematosus | | | | |
2022-001796-14: An open-label study to assess safety, efficacy and cellular kinetics of YTB323 in severe, refractory systemic lupus erythematosus (srSLE). |
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| Not yet recruiting | 1/2 | 12 | Europe | YTB323, Dispersion for infusion | Novartis Pharma AG, Novartis Farmacéutica, S.A., Novartis Pharma AG | Systemic Lupus ErythematosusLupus Nephritis, Systemic Lupus ErythematosusLupus Nephritis, Diseases [C] - Immune System Diseases [C20] | | | | |
| Not yet recruiting | 1/2 | 30 | Europe | MB-CART19.1, MB-CART19.1, Dispersion for infusion | Miltenyi Biomedicine GmbH, Miltenyi Biomedicine GmbH | Adult patients with refractory active systemic lupus erythematosus (SLE) with organ involvement, Lupus, Diseases [C] - Immune System Diseases [C20] | | | | |
MSC-SLE, NCT03562065: Treatment of Refractory Systemic Lupus Erythematosus by Allogeneic Mesenchymal Stem Cells Derived From the Umbilical Cord |
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| Recruiting | 1/2 | 10 | Europe | mesenchymal stem cells | Assistance Publique - Hôpitaux de Paris | Lupus Erythematosus, Stem Cell Transplant | 06/23 | 06/24 | | |
| Recruiting | 1/2 | 24 | Europe | anti-CD19 CAR T cell therapy | University of Erlangen-Nürnberg Medical School | Systemic Lupus Erythematosus, Systemic Sclerosis, Dermatomyositis, Polymyositis | 05/26 | 05/26 | | |
NCT05278663: A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus Participants |
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| Completed | 1/2 | 26 | Japan | E6742, Placebo | Eisai Co., Ltd. | Lupus Erythematosus, Systemic | 09/23 | 09/23 | | |
NCT04643067: Phase 1b/2a Study to Evaluate Safety and Efficacy of KPG-818 in SLE |
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| Completed | 1/2 | 64 | US | KPG-818 low dose, KPG-818 mid dose, KPG-818 high dose, Placebo | Kangpu Biopharmaceuticals, Ltd. | SLE; Drug | 08/23 | 08/23 | | |
NCT05465707: A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus |
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| Not yet recruiting | 1/2 | 40 | NA | CM313 2 mg/kg, CM313 4 mg/kg, CM313 8 mg/kg, CM313 16 mg/kg, Placebo | Keymed Biosciences Co.Ltd | Systemic Lupus Erythematosus | 10/23 | 10/23 | | |
NCT06182969: A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus. |
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| Not yet recruiting | 1/2 | 40 | RoW | APG-2575, Placebo | Ascentage Pharma Group Inc., Suzhou Yasheng Pharmaceutical Co., Ltd. | SLE | 04/26 | 12/26 | | |
ChiCTR2100054011: Randomized, double-blind, placebo-controlled tolerability, safety, pharmacokinetics and preliminary efficacy on Ib/II clinical trail of GR1603 injection in patients with moderate and severe systemic lupus erythematosus |
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| Not yet recruiting | 1/2 | 136 | | GR1603 injection ;Placebo | The Third Xiangya Hospital of Central South University; Genrix (Shanghai) Biopharmaceutical Co., Ltd, self-funded | Systemic lupus erythematosus | | | | |
NCT06153095: A Study of IMPT-514 in Active Refractory Systemic Lupus Erythematosus (SLE) |
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| Recruiting | 1/2 | 30 | US, RoW | IMPT-514 | ImmPACT Bio | Systemic Lupus Erythematosus, Lupus Nephritis | 02/27 | 02/27 | | |
NCT05638802: A Study of DS-7011a in Patients With Systemic Lupus Erythematosus |
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| Recruiting | 1/2 | 24 | US | DS-7011a, Placebo | Daiichi Sankyo | Systemic Lupus Erythematosus | 03/25 | 03/25 | | |
| Not yet recruiting | 1/2 | 29 | Europe | MB-CART19.1, CD19-targeting CAR T cells, Anti-CD19 CAR T cells | Miltenyi Biomedicine GmbH | SLE - Systemic Lupus Erythematosus | 03/25 | 03/27 | | |
BAH247, NCT06428188: Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases |
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| Recruiting | 1/2 | 60 | RoW | BCMA/CD19 CAR-T cells | Essen Biotech | Autoimmune Diseases, Systemic Lupus Erythematosus, Systemic Lupus Erythematosus Acute, Sjogren's Syndrome | 12/25 | 12/26 | | |
BAH242, NCT06350110: Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE) |
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| Not yet recruiting | 1/2 | 75 | RoW | CD19- BCMA CAR-T cells, EB-BH2024-2 | Essen Biotech | Systemic Lupus Erythematosus, Lupus Nephritis, Autoimmune Diseases, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Granulomatous Polyangiitis, Microscopic Polyangiitis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Sjogren's Syndrome | 12/25 | 12/25 | | |
NCT06106893: A Clinical Study of CD19 Universal CAR-γδT Cells in Active Systemic Lupus Erythematosus |
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| Recruiting | 1/2 | 15 | RoW | CD19 Universal CAR-γδ T Cells | Wuhan Union Hospital, China, Guangzhou Bio-gene Technology Co., Ltd | Systemic Lupus Erythematosus | 12/24 | 12/26 | | |
NCT06106906: A Clinical Study of CD19 CAR-T in Active Systemic Lupus Erythematosus |
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| Recruiting | 1/2 | 15 | RoW | CD19 CAR-T cell infusion | Wuhan Union Hospital, China, Guangzhou Bio-gene Technology Co., Ltd | Systemic Lupus Erythematosus | 12/24 | 12/26 | | |
NCT05798117: An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus Erythematosus |
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| Recruiting | 1/2 | 24 | Europe, US, RoW | YTB323 | Novartis Pharmaceuticals | Systemic Lupus Erythematosus, Lupus Nephritis | 10/26 | 10/26 | | |
RESET-SLE, NCT06121297: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus |
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| Recruiting | 1/2 | 12 | US | CABA-201 | Cabaletta Bio | Systemic Lupus Erythematosus, Lupus Nephritis | 12/27 | 12/27 | | |
NCT06015230: Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE |
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| Recruiting | 1/2 | 136 | RoW | low dose GR1603 in phase Ⅰb, high dose GR1603 in phaseⅠb, low dose GR1603 in phase Ⅱ, high dose GR1603 in phase Ⅱ, Placebo in phase Ⅱ | Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Lupus Erythematosus, Systemic | 06/28 | 10/28 | | |
NCT06032923: Double-blind Placebo Controlled Study to Evaluate the Effect of NAD+ Boosting With Nicotinamide Riboside on Immunometabolism and Immunity in Systemic Lupus Erythematosus |
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| Recruiting | 1/2 | 78 | US | Nicotinamide Riboside | National Heart, Lung, and Blood Institute (NHLBI) | Systemic Lupus Erythematosus (Sle) | 08/28 | 08/28 | | |
