| Sjogren's Syndrome |
ChiCTR-TRC-12002325: Multi-center, randomized, double blind, placebo controlled study of the efficacy and safety of TGP in the treatment of pSS |
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| Completed | 4 | 330 | | TGP capsules (TGP) ;Placebo | China-Japan friendship Hospital Department of Rheumatism; Ningbo Lihua Pharmaceutical Company Limited, Ningbo Lihua Pharmaceutical Company Limited | Primary Sj?gren's Syndrome, pSS | | | | |
2006-000991-34: A randomized, double-blind, monocentric phase IV clinical study on the ocular tolerability of a topical ophthalmic product containing Retinolpalmitat 1000 I.U. in comparison to a reference product containing Carbomer 0.2 % with repeated ocular applications over 12 months in 120 patients with keratoconjunctivitis sicca |
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| Ongoing | 4 | 120 | Europe | Vitagel, Liposic, Vitagel, Liposic | Dr. Gerhard Mann, Chem-pharm. Fabrik GmbH | Patients suffering from keratoconjunctivitis sicca (dry eye) and break-up-time (BUT) values < 10 sec | | | | |
2006-003391-35: Evaluation of the efficacy and safety of unpreserved dexamethasone phosphate 0.1% eye drops (T1910) versus placebo in patients with bilateral treated severe keratoconjunctivitis sicca due to Sjögrens\' syndrome |
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| Ongoing | 4 | 65 | Europe | Monofree Dexamethason 1mg/ml, Monofree Dexamethason 1mg/ml | Laboratoires THEA | keratoconjunctivitis sicca | | | | |
ChiCTR-OIB-16007789: 0.1%Tacrolimus (FK506) in the treatment of sjogren's syndrome clinical efficacy evaluation |
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| Recruiting | 4 | 30 | | 0.1% FK506 + 0.1% sodium hyaluronate eye drops Twice a day for 30 days | Eye Institute of Xiamen University; Eye Institute of Xiamen University, Senju Pharmaceutical Co., Ltd. | Sjogren's syndrome | | | | |
CTRIPS, ChiCTR-IPR-15005990: Cyclosporine A in the Treatment of Interstitial Pneumonitis associated with Sjogren’s syndrome(): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial |
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| Not yet recruiting | 4 | 240 | | glucocorticoid+CsA ;glucocorticoid+placebo | Peking University People's Hospital; Level of the institution：, Hangzhou China-US East China pharmaceutical Co., Ltd. | Sjogren's syndrome | | | | |
PromiseSS, ChiCTR-IPR-15005757: Prospective, Randomized, placebo-cOntrolled, double-blind, MultIcenter, parallel group Study to assess the Efficacy and safety of hydroxychloroquine in chinese patients with primary Sjogren's Syndrome |
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| Not yet recruiting | 4 | 400 | | Taking HCQ ;Nil | Peking Union Medical College Hospital; Peking Union Medical College Hospital, Shanghai Zhongxi Pharmaceutical Co., Ltd. | primary Sjogren's Syndrome | | | | |
ChiCTR-IPR-17013772: A Clinical Multi-center Study of Safety and Efficacy of Tacrolimus Eye Drops in Sjogren's Syndrome Dry Eye |
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| Not yet recruiting | 4 | 60 | | tacrolimus eye drops ;flurometholone eye drops | The Eye Hospital of Wenzhou Medical University; The Eye Hospital of Wenzhou Medical University, Supporting funds of the National Natural Science Foundation of China | Sjogren's Syndrome Dry Eye | | | | |
ChiCTR1900022781: Follow-up study at four years after the end of clinical trial on the efficacy and safety of total glucosides of peony in the treatment of primary sjogren’s syndrome |
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| Recruiting | 4 | 180 | | TGP capsules | Department of Rheumatology and Immunology, Anhui Provincial Hospital; Ningbo Liwah Pharmaceutical Co., Ltd., Ningbo Liwah Pharmaceutical Co., Ltd. | Sjogren's Syndrome | | | | |
ChiCTR1800019784: The metagenomic analysis of oral microflora in patients with primary Sjogren's syndrome before and after caries treatment and topical fluoridation |
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| Recruiting | 4 | 20 | | topical fluoridation; caries treatment ;topical fluoridation | Peking University School and Hospital of Stomatology; Peking University School and Hospital of Stomatology, Scientific research co-ordination fund | primary Sjogren's syndrome, dental caries | | | | |
2021-001414-10: Response to corona vaccination in patients with primary Sjögren's syndrome |
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| Ongoing | 4 | 180 | Europe | Dispersion for injection, Suspension for injection, Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified), COVID-19 Vaccine AstraZeneca suspension for injection COVID-19 Vaccine (ChAdOx1-S [recombinant]), COVID-19 Vaccine Janssen suspension for injection COVID-19 vaccine (Ad26.COV2-S [recombinant]) | University Medical Center Groningen, Dutch Association of Sjögren patients (NVSP) | Primary Sjögren's syndrome, Primary Sjögren's syndrome, Diseases [C] - Immune System Diseases [C20] | | | | |
ChiCTR1900022696: A prospective, controlled, randomized, open-label, single-center study for eramyd in the treatment of active sjogren's syndrome |
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| Not yet recruiting | 4 | 120 | | Iguratimod 25mg bid po ;hydroxychloroquine 0.2-0.4g/d+prednison0.2-0.5mg/kg.d | Shanghai Tongji Hospital; Shanghai Tongji Hospital, scientific research funds | Sjogren syndrome | | | | |
ChiCTR2100052314: Effect of triamcinolone acetonide for parotid gland lavage on the salivary secretion of patients with Sjogren's syndrome |
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| Not yet recruiting | 4 | 54 | | Perfusing parotid gland with triamcinolone acetonide injection through parotid duct ;The parotid gland was perfused with normal saline through parotid duct | Affiliated Stomatological Hospital of Nanjing Medical University; Affiliated Stomatological Hospital of Nanjing Medical University, the National Natural Science Foundation of China (No. 81600908 and 81701491), the Nature Science Foundation of Jiangsu Province (No. BK2018040793 and BK20170152) | Sjogren syndrome | | | | |
NCT04909255: Beta-3 Agonist and Anti-muscarinic Agent for Sjogren's Syndrome With Overactive Bladder |
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| Recruiting | 4 | 50 | RoW | mirabegron, Betmiga, oxybutynin, tolterodine, solifenacin, Ditropan, tartrate, vesicare | China Medical University Hospital | Sjogren's Syndrome, Overactive Bladder Syndrome | 08/22 | 08/22 | | |
NCT04981145: The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome |
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| Recruiting | 4 | 78 | RoW | Iguratimod Tablets, Hydroxychloroquine Sulfate Tablets | Second Affiliated Hospital, School of Medicine, Zhejiang University | Primary Sjögren's Syndrome | 12/24 | 07/25 | | |
NCT05918406: Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya |
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| Completed | 4 | 30 | US | Nasal Guide | Oyster Point Pharma, Inc. | Dry Eye, Keratoconjunctivitis Sicca | 08/23 | 08/23 | | |
| Completed | 4 | 39 | US | Varenicline Nasal Spray | University of Pennsylvania, Oyster Point Pharma, Inc. | Sjogren's Syndrome, Dry Eye | 08/23 | 08/23 | | |
| Recruiting | 4 | 15 | RoW | Rituximab, Belimumab | Peking Union Medical College Hospital, Children's Hospital of Chongqing Medical University, Central South University, Shenzhen Children's Hospital, The First Hospital of Jilin University, Children's Hospital of The Capital Institute of Pediatrics, The Affiliated Hospital of Qingdao University, Children's Hospital of Nanjing Medical University, Children's Hospital of Fudan University, Shengjing Hospital, Shanghai Children's Hospital, Tianjin Children's Hospital | Sjogren's Syndrome, Pediatric ALL | 12/25 | 12/26 | | |
| Completed | 4 | 50 | US | Cyclosporine 0.09% Ophthalmic Solution, Cequa Ophthalmic Product | Center for Ophthalmic and Vision Research, LLC, Sun Pharmaceutical Industries Limited | Dry Eye, Dry Eye Syndromes, Sjogren's Syndrome | 03/24 | 03/24 | | |
| Recruiting | 4 | 2005 | RoW | Recombinant Herpes Zoster Vaccine (RZV), Shingrix®, MTX Discontinuation, MMF Discontinuation, Placebo, MTX maintain, MMF maintain | University of Sao Paulo General Hospital, GlaxoSmithKline | Rheumatoid Arthritis, Spondylitis, Ankylosing, Spondyloarthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Vasculitis, Systemic, Juvenile Idiopathic Arthritis, Dermatomyositis, Juvenile, Behçet Disease | 05/25 | 05/27 | | |
ChiCTR2200057578: Tofacitinib treatment in patients with primary Sjogren syndrome: a prospective pilot trial |
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| Not yet recruiting | 4 | 120 | | Same dose of hydroxychloroquine sulfate as before ;Tofacitinib 5mg bid po+the same dose of hydroxychloroquine sulfate as before | Ningbo Medical Center Lihuili Hospital; Ningbo Medical Center Lihuili Hospital, Hisun biopharmaceutical.CO.,Ltd | Sjogren Syndrome | | | | |
ChiCTR2300071950: Effect of acetylcysteine solution for salivary gland lavage on the salivary secretion of patients with Sjogren's syndrome |
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| Not yet recruiting | 4 | 51 | | Salivary gland irrigation with physiological saline through the opening of the salivary duct ;Salivary gland irrigation with acetylcysteine solution through the opening of the salivary duct ;N/A | The Fourth Affiliated Hospital of Nanjing Medical University ; The Fourth Affiliated Hospital of Nanjing Medical University, self-funding | Sjögren's syndrome | | | | |
2014-003140-12: Leflunomide and Hydroxychloroquine combination therapy for primary Sjogren's Syndrome Leflunomide en Hydroxychloroquine combinatie therapie voor het primaire Syndroom van Sjogren |
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| Ongoing | 3 | 30 | Europe | Leflunomide mylan, Plaquenil, Capsule, Leflunomide Mylan, Plaquenil | UMC Utrecht, ZonMw | Sjogren's Syndrome Syndroom van Sjogren, Sjogren's Syndrome Syndroom van Sjogren, Diseases [C] - Immune System Diseases [C20] | | | | |
2017-001371-24: Intravenous immunoglobulins for the treatment of primary Sjögren's syndrome associated painful sensory neuropathies Immunoglobulines administrées par voie intraveineuse pour le traitement d’une neuropathie sensitive douloureuse compliquant un syndrome de Gougerot Sjögren primaire |
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| Not yet recruiting | 3 | 24 | Europe | Solution for infusion, Privigen 100 mg/ml, solution pour perfusion | Hôpitaux Universitaires de Strasbourg, Hôpitaux universitaires de Strasbourg, CSL Behring | Primary Sjögren's syndrome associated painful sensory neuropathies Neuropathie sensitive douloureuse compliquant un syndrome de Gougerot Sjögren primaire, Primary Sjögren's syndrome associated painful sensory neuropathies Neuropathie sensitive douloureuse compliquant un syndrome de Gougerot Sjögren primaire, Diseases [C] - Nervous System Diseases [C10] | | | | |
2021-005687-22: A clinical study to investigate ianalumab is effective and safe in the treatment of active Sjögren`s syndrome |
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| Ongoing | 3 | 489 | Europe | ianalumab, VAY736, Solution for injection in pre-filled syringe | Novartis Pharma AG, Novartis Pharma AG | Active Sjögren’s syndrome, Sjögren’s syndrome, Diseases [C] - Immune System Diseases [C20] | | | | |
2020-005661-14: A clinical study to investigate if ianalumab is effective and safe in the treatment of active Sjögren`s syndrome |
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| Ongoing | 3 | 268 | Europe | ianalumab, VAY736, Solution for injection in pre-filled syringe | Novartis Pharma AG, Novartis Farmacéutica, S.A., Novartis Pharma AG | Active Sjögren's syndrome, Sjögren's syndrome, Diseases [C] - Immune System Diseases [C20] | | | | |
2022-002158-15: Treatment with tivanisiran for the dry eye in patients witht Sjögren Syndrome Tratamiento con tivanisirán para el ojo seco en pacientes con Síndrome de Sjögren |
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| Not yet recruiting | 3 | 200 | Europe | Tivanisiran, SYL1001, Eye drops, solution | Sylentis SAU, Sylentis SAU | Dry Eye Disease Enfermedad de Ojo Seco, Ocular dryness Sequedad ocular, Diseases [C] - Eye Diseases [C11] | | | | |
NCT04252209: the Effect of Mixture of Natural Products As Salivary Substitutes in Treatment Of Xerostomia |
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| Completed | 3 | 24 | RoW | natural herbs of coconut, aloe vera, and pepperint, natural products, carboxy methyl cellulose, CMC | Cairo University | Sjogren's Syndrome, Xerostomia | 11/22 | 03/23 | | |
NCT04819269: Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome |
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| Completed | 3 | 203 | Europe, US | Tivanisiran sodium ophthalmic solution, Vehicle ophthalmic solution | Sylentis, S.A. | Dry Eye Disease, Sjögren Syndrome | 12/23 | 12/23 | | |
HZNP-DAZ-303, NCT06245408: A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State |
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| Recruiting | 3 | 435 | Europe, Canada, Japan, US, RoW | Dazodalibep, VIB 4920, MEDI4920, Placebo | Amgen | Sjögren's Syndrome (SS) | 05/26 | 05/26 | | |
| Active, not recruiting | 3 | 505 | Europe, Canada, Japan, US, RoW | VAY736, Placebo | Novartis Pharmaceuticals, Novartis Pharma AG | Sjogren Syndrome | 05/25 | 05/27 | | |
TINISS, NCT03700138: Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies |
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| Recruiting | 3 | 24 | Europe | Privigen® 100mg/ml at the dose of 2g/kg of body weight, NaCl 0,9% | University Hospital, Strasbourg, France | Primary Sjögren's Syndrome Painful Sensory Neuropathies | 12/25 | 07/26 | | |
NCT06104124: A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity |
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| Recruiting | 3 | 510 | Europe, Canada, Japan, US, RoW | Dazodalibep, VIB 4920, MEDI 4920, Placebo | Amgen | Sjogren's Syndrome | 07/26 | 07/26 | | |
| Active, not recruiting | 3 | 276 | Europe, US, RoW | VAY736, Placebo | Novartis Pharmaceuticals, Novartis Pharma AG | Sjogren Syndrome | 05/25 | 05/27 | | |
POETYK SjS-1, NCT05946941: A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome |
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| Recruiting | 3 | 756 | Europe, Canada, Japan, US, RoW | Deucravacitinib, BMS-986165, Placebo | Bristol-Myers Squibb | Sjögren's Syndrome | 11/26 | 11/28 | | |
NCT05673993: A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome |
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| Active, not recruiting | 3 | 381 | RoW | Telitacicept 80 mg, RC 18 80 mg, Telitacicept 160 mg, RC 18 160 mg, Placebo | RemeGen Co., Ltd. | Primary Sjogren's Syndrome | 12/27 | 06/28 | | |
NEPTUNUS-Ext, NCT05985915: A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome. |
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| Recruiting | 3 | 600 | Europe, Canada, Japan, US, RoW | Ianalumab (VAY736), Placebo | Novartis Pharmaceuticals | Sjogrens Syndrome | 08/28 | 07/30 | | |
| Completed | 2/3 | 100 | RoW | Omega 3 fatty acid, Placebo | Hawler Medical University | Sjogren's Syndrome | 02/23 | 02/23 | | |
| Not yet recruiting | 2/3 | 54 | NA | Hydroxychloroquine, Tacrolimus | Peking Union Medical College Hospital | Sjogren Syndrome With Other Organ Involvement | 12/23 | 03/24 | | |
NCT05694130: Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS |
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| Not yet recruiting | 2/3 | 110 | NA | Prednisolone, Tacrolimus | Peking Union Medical College Hospital | Sjogren Syndrome With Other Organ Involvement | 09/24 | 12/24 | | |
| Recruiting | 2 | 10 | | | St Vincent's Hospital / University of New South Wales, Roche Product, St Vincent's Hospital | Sjogrens Syndrome | | | | |
2016-001586-87: A Phase 2 Study of RSLV-132 in Subjects with Sjogren’s Syndrome |
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| Ongoing | 2 | 28 | Europe | RSLV-132, Concentrate for solution for infusion | Resolve Therapeutics, LLC, Resolve Therapeutics, LLC | Primary Sjogrens Syndrome, Sjogrens Syndrome, Body processes [G] - Immune system processes [G12] | | | | |
NCT02679612: Safety, Pharmacokinetics and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome |
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| Not yet recruiting | 2 | 27 | Europe | CDZ173, Placebo | Novartis Pharmaceuticals | Primary Sjögren's Syndrome | 12/17 | 12/17 | | |
2019-003131-31: Ravagalimab Vs Placebo in Subjects with Moderately to Severely Active Primary Sjogren's Syndrome |
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| Not yet recruiting | 2 | 45 | Europe | Ravagalimab, ABBV-323, Powder for concentrate for solution for injection/infusion | AbbVie Deutschland GmbH & Co. KG, AbbVie Inc. | Moderately to Severely Active Primary Sjogren's Syndrome, An autoimmune disease affecting the entire body; symptoms include dry mouth, and serious complications such as profound fatigue, chronic pain, major organ involvement, neuropathies and lymphomas., Diseases [C] - Immune System Diseases [C20] | | | | |
| Active, not recruiting | 2 | 20 | US | Orencia, Abatacept, Placebo, Saline | Arthritis & Rheumatism Associates, P.C., Bristol-Myers Squibb | Sjogren's Syndrome | 05/21 | 12/21 | | |
2020-001933-11: Leflunomide and Hydroxychloroquine combination therapy for primary Sjögren’s Syndrome |
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| Ongoing | 2 | 52 | Europe | Leflunomide, Hydroxychloroquine, Film-coated tablet, Tablet, Leflunomide, Plaquenil | University Medical Center Utrecht, ZonMw | Primary Sjogren Syndrome, Primary Sjogren Syndrome, Diseases [C] - Immune System Diseases [C20] | | | | |
2020-004937-19: A study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD) |
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| Ongoing | 2 | 60 | Europe | MHV370, MHV370, Capsule, hard | Novartis Pharma AG, Novartis Pharma AG | Sjögren’s syndrome Mixed connective tissue disease, Sjögren’s syndrome Mixed connective tissue disease, Diseases [C] - Immune System Diseases [C20] | | | | |
2019-002470-32: Nuovi end-points clinici in pazienti con sindrome di Sjögren primaria (pSS): uno studio interventistico basato sulla stratificazione dei pazienti. NEw Clinical End-points in patients with primary Sjögren's Syndrome (pSS): an Interventional Trial based on stratifYing patients |
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| Ongoing | 2 | 300 | Europe | Leflunomide, mycophenolate mofetil, Hydroxychloroquine, [Leflunomide], [mycophenolate mofetil], [Hydroxychloroquine], Tablet, Arava, Mycophenolate mofetil TEVA, PLAQUENIL | ASSITANCE PUBLIQUE DES HOPITAUX DE PARIS, Innovative Medicines Initiative 2 | Primary Sjögren's syndrome (pSS) sindrome di Sjögren primaria (pSS), Primary Sjögren's syndrome (pSS) sindrome di Sjögren primaria (pSS), Body processes [G] - Immune system processes [G12] | | | | |
2021-000665-32: A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) Un estudio de nipocalimab en adultos con síndrome de Sjögren primario (SSp) |
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| Ongoing | 2 | 150 | Europe | Nipocalimab, M281, Solution for infusion | Janssen-Cilag International NV, Janssen Research & Development, LLC | Primary Sjogren's Syndrome Síndrome de Sjögren primario, Primary Sjogren's Syndrome Síndrome de Sjögren primario, Diseases [C] - Immune System Diseases [C20] | | | | |
NCT04884217: Treatment of Dry Eye Disease Using Pro-ocularâ„¢ - A Proof of Concept, Safety, and Efficacy Study |
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| Enrolling by invitation | 2 | 80 | RoW | Pro-ocularâ„¢ Topical Gel, PG101, Placebo Topical Gel | PharmaDax Inc., Glia, LLC | Dry Eye Syndrome, Keratoconjunctivitis Sicca | 10/21 | 12/21 | | |
NCT04830644: A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome. |
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| Recruiting | 2 | 144 | RoW | Iguratimod, Placebo | Jiangsu Simcere Pharmaceutical Co., Ltd. | Primary Sjögren Syndrome | 04/22 | 06/22 | | |
2020-005055-20: A clinical study with biopsy to investigate how ianalumab works in Sjögren`s and how safe it is Une étude clinique avec biopsie pour étudier comment l'ianalumab agit dans la maladie de Sjögren et à quel point il est sûr |
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| Not yet recruiting | 2 | 24 | Europe | Ianalumab, VAY736, Solution for injection | Novartis Pharma AG, Novartis Pharma AG | Sjögren's syndrome Syndrome de Sjögren, Sjögren's syndrome Syndrome de Sjögren, Diseases [C] - Immune System Diseases [C20] | | | | |
2022-000609-28: Efficacy and safety of anifrolumab treatment for 24 weeks in patients with primary Sjögren’s syndrome compared to placebo |
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| Not yet recruiting | 2 | 30 | Europe | Anifrolumab, Infusion, Saphnelo | University Medical Centre Groningen, AstraZeneca BV | Primary Sjögren's syndrome. Patients will be included if the fulfil the 2016 ACR/EULAR classification criteria for pSS and if they have active disease according to an ESSDAI score of 5 or more and/or an ESSPRI score of 5 or more., Primary Sjögren's syndrome, a systemic, auto-immune disease., Diseases [C] - Immune System Diseases [C20] | | | | |
| Completed | 2 | 183 | Europe, US, RoW | VIB4920, Dazodalibep, Placebo | Amgen | Sjögren's Syndrome | 09/22 | 03/23 | | |
| Completed | 2 | 273 | Europe, Canada, Japan, US, RoW | CFZ533, iscalimab, Placebo | Novartis Pharmaceuticals | Sjögren Syndrome | 09/22 | 06/23 | | |
| Completed | 2 | 40 | Europe | ASCs, Allogeneic adipose-derived mesenchymal stem cells, Cryostor CS10 | Rigshospitalet, Denmark | Keratoconjunctivitis Sicca, in Sjogren's Syndrome | 12/22 | 01/23 | | |
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] | | | | |
2021-005911-30: A Study of the safety and effectiveness of Efgartigimod in Patients with Primary Sjögren’s Syndrome (pSS) |
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| Not yet recruiting | 2 | 30 | Europe | efgartigimod, ARGX-113, Concentrate for solution for infusion | argenx BV, argenx BV | Primary Sjögren’s Syndrome, Primary Sjögren’s Syndrome, Body processes [G] - Immune system processes [G12] | | | | |
NCT05087589: Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome |
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| Recruiting | 2 | 10 | RoW | Tofacitinib | Peking University People's Hospital | Primary Sjögren's Syndrome | 01/23 | 10/23 | | |
NCT04605978: Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients |
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| Completed | 2 | 48 | Europe, US, RoW | S95011 concentrate for solution for infusion, Placebo concentrate for solution for infusion | Institut de Recherches Internationales Servier, ADIR, a Servier Group company | Primary Sjögren's Syndrome | 01/23 | 05/23 | | |
| Not yet recruiting | 2 | 30 | Europe | [89Zr]Zr-Df-crefmirlimab berdoxam, IND 127861, Solution for infusion | radboudumc, Radboudumc, Health Holland Match PPS, ReumaNederland, GSK, Galapagos | Systemic Sclerosis Sjögren's SyndromeCutaneous Lupus Erythematodus Systemische Sclerose Syndroom van SjögrenCutane Lupus Erythematodus, SclerodermaSjögren's SyndromeCLE SclerodermieSyndroom van SjögrenCLE, Diseases [C] - Immune System Diseases [C20] | | | | |
NCT04988087 / 2020-004937-19: A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD) |
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| Terminated | 2 | 30 | Europe, RoW | MHV370, Placebo | Novartis Pharmaceuticals, Novartis Pharma AG | Sjogren Syndrome, Mixed Connective Tissue Disease | 02/23 | 03/23 | | |
NCT05311514: Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host Disease |
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| Recruiting | 2 | 30 | RoW | Allogeneic platelet lysate eye drops | St. Petersburg State Pavlov Medical University | Ocular Graft-versus-host Disease | 04/23 | 04/24 | | |
2020-001526-59: Efficacy and safety of S95011 in primary Sjögren’s Syndrome patients |
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| Not yet recruiting | 2 | 45 | Europe | S95011, S95011, Concentrate for solution for infusion | Institut de Recherches Internationales Servier, Servier Research and Development Ltd, ADIR | Primary Sjögren’s Syndrome, Primary Sjögren’s Syndrome, Diseases [C] - Immune System Diseases [C20] | | | | |
Rho plus, NCT06203457: Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome |
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| Active, not recruiting | 2 | 24 | Europe | Efgartigimod | argenx, Iqvia Pty Ltd | Primary Sjögren's Syndrome | 02/25 | 08/25 | | |
| Completed | 2 | 163 | Europe, Japan, US, RoW | Placebo, Nipocalimab, JNJ-80202135, M281, Standard of Care Treatment | Janssen Research & Development, LLC, Janssen Research & Development, LLC | Sjogren's Syndrome | 10/23 | 11/23 | | |
| Completed | 2 | 84 | Europe, Canada, US, RoW | SAR441344, Placebo | Sanofi | Sjögren's Syndrome, Sjogren's Syndrome | 11/23 | 02/24 | | |
| Recruiting | 2 | 300 | Europe | Hydroxychloroquine 400mg/d, Leflunomide 20mg/d, Mycophenolate mofetil 2000mg/d, Placebo of Hydroxychloroquine 400mg/d, Placebo of Leflunomide 20mg/d, Placebo of Mycophenolate mofetil 2000mg/d | Assistance Publique - Hôpitaux de Paris | Primary Sjögren's Syndrome (pSS) | 02/24 | 04/25 | | |
rho, NCT05817669: A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS) |
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| Completed | 2 | 34 | Europe | Efgartigimod, Placebo | argenx, Iqvia Pty Ltd | Primary Sjögren's Syndrome | 01/24 | 02/24 | | |
| Recruiting | 2 | 30 | Europe | Anifrolumab, Saphnelo, Placebo | University Medical Center Groningen, AstraZeneca | Sjogren's Syndrome | 05/24 | 08/24 | | |
| Completed | 2 | 206 | Europe, Canada, Japan, US, RoW | CFZ533 (iscalimab), iscalimab, CFZ533 Placebo, Placebo | Novartis Pharmaceuticals | Sjogren's Syndrome | 08/24 | 08/24 | | |
NCT06312020: A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome |
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| Recruiting | 2 | 262 | Europe, US, RoW | HZN-1116, VIB1116, Placebo | Amgen | Sjogren's Syndrome | 06/26 | 02/27 | | |
NCT06381986: Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients |
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| Recruiting | 2 | 122 | RoW | SHJ002, Vehicle | Sunhawk Vision Biotech, Inc. | Corneal Erosion | 01/25 | 02/25 | | |
NCT06519617: Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for pSS Glandular Damage |
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| Enrolling by invitation | 2 | 136 | RoW | Yi Qi Yang Yin Decoction, The treatment group, Hydroxychloroquine Sulfate, the control group | Qingwen Tao | Primary Sjögren Syndrome | 12/26 | 12/26 | | |
NCT05016297: Efficacy and Safety of Baricitinib in Sjogren's Syndrome |
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| Active, not recruiting | 2 | 90 | RoW | Baricitinib, Hydroxychloroquine | Peking Union Medical College Hospital, Eli Lilly and Company | Sjogren's Syndrome | 08/24 | 11/24 | | |
| Recruiting | 2 | 15 | US | Levocarnitine, Placebo | Vanderbilt University Medical Center | Sjogren's Syndrome, Keratoconjunctivitis Sicca | 03/25 | 03/25 | | |
NCT06440525: A Study of RSLV-132 in Females with Primary Sjögren's Syndrome |
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| Recruiting | 2 | 106 | US | RSLV-132, Placebo | Resolve Therapeutics | Primary Sjögren Syndrome | 05/26 | 07/26 | | |
NCT05781451: Anti-BTLA Agonist Therapy in Subjects With Primary Sjogren's Syndrome |
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| Withdrawn | 2 | 12 | NA | LY3361237, Venanprubart | Stanford University | Primary Sjogren's Syndrome | 01/27 | 01/28 | | |
NCT05124925: Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments. |
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| Active, not recruiting | 2 | 21 | Europe | Ianalumab | Novartis Pharmaceuticals | Sjogren Syndrome | 06/26 | 06/26 | | |
ChiCTR2300078780: Clinical Study on the Efficacy and Safety of CheRe CunJin Gao in the Treatment of primary Sjögren's syndrome |
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| Not yet recruiting | 2 | 220 | | CheRe CunJin Gao: 20g once, three times on one day for 12 weeks; Placebo: 20g once, three times on one day for 12 weeks | Chongqing Hospital of Traditional Chinese Medicine; Chongqing Hospital of Traditional Chinese Medicine, The Science and Health Joint Project of TCM Scientific Research (the significant project) | primary Sjögren's syndrome | | | | |
NCT05605665: Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome |
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| Completed | 1/2 | 30 | RoW | low-dose interleukin-2, Recombinant Human Interleukin-2, rapamycin, sirolimus | Peking University People's Hospital | Sjögren's Syndrome | 12/23 | 03/24 | | |
NCT06049368: 68Ga-P16-093 PET/CT Imaging in the Salivary Gland |
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| Not yet recruiting | 1/2 | 40 | NA | 68Ga-P16-093 | Peking Union Medical College Hospital | Primary Sjögren Syndrome | 12/23 | 03/24 | | |
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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| 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 | | |
NCT06520202: RHPRG4 FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE |
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| Not yet recruiting | 1/2 | 36 | NA | rhPRG4 (450 µg/mL), Vehicle | Lubris Bio Pty Ltd | Sjogren's Syndrome With Dry Eye | 11/24 | 12/24 | | |
NCT04496960: Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome |
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| Recruiting | 1/2 | 76 | US | tofacitinib, Placebo | National Institute of Dental and Craniofacial Research (NIDCR) | Sjogren's Syndrome | 09/25 | 09/25 | | |
ChiCTR-IPR-14005441: A double blind randomized study of Jiedu Tongluo Shengjin Decoction in treatment of primary Sjogren syndrome |
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| Recruiting | 1 | 30 | | hydroxychloroquine+Jiedu Tongluo Shengjin Decoction | Yueyang Hospital of Integrative Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine; Yueyang Hospital of Integrative Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Yueyang Hospital of Integrative Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine | primary Sjogren syndrome | | | | |
ChiCTR-IIR-17013453: Clinical Observation on Effect of Yanghe Decoction inTreating Patients with non-systemic involved Sjogren Syndrome(NSI-SS) |
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| Not yet recruiting | 1 | 80 | | Yanghe Decoction ;HCQs | First Affiliated Hospital, Heilongjiang University of Chinese Medicine; First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China, Self-financing and department sponsorship | Sjogren Syndrome | | | | |
ChiCTR2000034924: Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese |
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| Not yet recruiting | 1 | 158 | | test drug or placebo ;test drug or placebo ;test drug or placebo ;test drug or placebo ;test drug or placebo ;test drug or placebo ;test drug or placebo ;test drug or placebo ;test drug ;test drug ;test drug ;test drug ;test drug ;test drug ;test drug and levofloxacin tablets | The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine; The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, self-raised funds | Rheumatoid arthritis, Sjogren's syndrome | | | | |
NCT04684654: BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome |
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| Terminated | 1 | 118 | Europe, US | BMS-986325, Placebo for BMS-986325 | Bristol-Myers Squibb | Healthy Participants, Primary Sjögren's Syndrome | 07/23 | 07/23 | | |
NCT05618730: Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B |
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| Active, not recruiting | 1 | 20 | RoW | punctum plug insertion, Eye Drops, Lubricant | Eximore Ltd. | Dry Eye, Keratoconjunctivitis Sicca, Ocular Inflammation | 12/23 | 12/23 | | |
NCT06417398: Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases |
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| Not yet recruiting | 1 | 10 | NA | T cell injection targeting CD19 chimeric antigen receptor | PersonGen BioTherapeutics (Suzhou) Co., Ltd. | Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjogren's Syndrome, Rheumatoid Arthritis, Immune Thrombocytopenia, Primary Biliary Cholangitis | 12/24 | 05/25 | | |
NCT06420154: The Safety and Efficacy of Anti-CD19 CAR-T Cells in Patients With Relapsed/Refractory Autoimmune Diseases |
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| Not yet recruiting | 1 | 9 | RoW | anti-CD19-CAR-T cells | First Affiliated Hospital of Wenzhou Medical University, Shanghai First Song Therapeutics Co., Ltd | Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome, Systemic Sclerosis, Inflammatory Myopathy, ANCA Associated Vasculitis, Antiphospholipid Syndrome | 05/27 | 05/27 | | |
| Not yet recruiting | 1 | 36 | NA | R-2487, Probiotic | Rise Therapeutics LLC | Sjogren's Syndrome, Sjögren, Sjögren Syndrome, Unspecified | 08/26 | 08/26 | | |
NCT06484855: Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome |
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| Recruiting | 1 | 30 | RoW | IBI355, IBI355 placebo | Innovent Biologics (Suzhou) Co. Ltd. | Primary Sjögren's Syndrome | 10/24 | 08/25 | | |
NCT06548607: Clinical Study on Targeted CD19 CAR-T Therapy for Autoimmune Diseases |
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| Recruiting | 1 | 20 | RoW | RD06-04 CART Cell Injection | Nanjing Bioheng Biotech Co., Ltd. | SLE (Systemic Lupus), Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies, Sjogren's Syndrome, Autoimmune Diseases | 07/26 | 07/27 | | |
NCT06544642: A Study to Evaluate the Effects of ASP5502 in Healthy Adults and Adults With Primary Sjögren's Syndrome |
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| Recruiting | 1 | 132 | US | ASP5502, Placebo | Astellas Pharma Global Development, Inc. | Healthy Volunteers, Sjögren's Syndrome | 07/27 | 07/27 | | |
AIM-NIVO, NCT03816345: Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer |
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| Recruiting | 1 | 300 | Canada, US | Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Nivolumab, ABP 206, BCD-263, BMS 936558, BMS-936558, BMS936558, CMAB819, MDX 1106, MDX-1106, MDX1106, NIVO, Nivolumab Biosimilar ABP 206, Nivolumab Biosimilar BCD-263, Nivolumab Biosimilar CMAB819, ONO 4538, ONO-4538, ONO4538, Opdivo | National Cancer Institute (NCI) | Autoimmune Disease, Crohn Disease, Dermatomyositis, Hematopoietic and Lymphoid Cell Neoplasm, Inflammatory Bowel Disease, Malignant Solid Neoplasm, Multiple Sclerosis, Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, Sjogren Syndrome, Systemic Lupus Erythematosus, Systemic Scleroderma, Ulcerative Colitis | 08/26 | 08/26 | | |
NCT06549296: Clinical Study on Targeted CD19CAR-T Therapy for Autoimmune Diseases |
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| Not yet recruiting | 1 | 12 | RoW | RD06-04 CART Cell Injection | Nanjing Bioheng Biotech Co., Ltd. | Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies, Sjogren's Syndrome, Autoimmune Diseases | 08/26 | 08/27 | | |
| Not yet recruiting | 1 | 116 | | Shaoteng granule+ Hydroxychloroquine sulfate tablets placebo; Hydroxychloroquine sulfate tablets+ Shaoteng granule placebo | Guang’anmen Hospital,China Academy of Chinese Medical Sciences; Guang’anmen Hospital,China Academy of Chinese Medical Sciences, Basic research expenses of the central level public welfare research institutes of the China Academy of Chinese Medical Sciences | Sjögren's syndrome | | | | |
NCT06392711: Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia |
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| Recruiting | 1 | 36 | US | Mesenchymal Stromal Cells (MSC) Dose Level 0, Mesenchymal Stromal Cells (MSC) Dose Level 1 | University of Wisconsin, Madison | Xerostomia, Graft-versus-host-disease, Sjogren's Disease | 11/28 | 11/28 | | |
