Clinical Trials for Sjogren's Syndrome

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Sjogren’s Syndrome from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 21
• Active, not recruiting: 6
• Completed: 13
• Other: 10

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT01425892 — The Pathogenesis and Natural History of Sjogren’s Disease

Background:

-Sjogren s Disease (formerly: Sjogrens Syndrome, Sj(SqrRoot)(Delta)gren s syndrome) is a disease that affects about 1-4 million Americans. It is more common in women. It mainly affects the glands that produce saliva and tears, leading to dry eyes and dry mouth. The cause of Sjogren s Disease is unknown, but inflammation plays an important role. The purpose of this study is to learn…

NCT02327884 — Characterization of Diseases With Salivary Gland Involvement

Background:

- Salivary glands in and around the mouth and throat make saliva. Salivary gland disorders can affect a person s quality of life. Studying people who have a disease that affects their salivary gland(s) may teach researchers about the disorders and their genetics.

Objectives:

- To study salivary gland diseases and disorders. To collect data and samples from people with salivary …

NCT03003572 — Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen’s Syndrome’s Disease Activity

Primary Sjögren’s syndrome (pSS) can affect various organs, sometimes leads to life-threatening conditions and is always responsible for a decreased quality of life. Its evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be carried out routinely is major in patients’ follow-up. Because of the existence of autoreactive immunoglobulins E (IgE) in autoimmune di…

NCT03816345 — Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO

This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body …

NCT04931160 — B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome

The objectif is to study the diagnosis performance of the different classification criteria in reference to the gold standard consisting of the diagnosis made by expert doctors after standardized assessment, of pSS (primary Sjogren syndrome)

NCT06548607 — Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases

This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV, IIM and pSS.

NCT06392711 — Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia

The goal of this clinical trial is to evaluate the safety and tolerability of injecting certain cells produced in bone marrow called mesenchymal stromal cells (MSCs) into salivary glands. The main question it aims to answer is whether injection of MSCs into salivary glands results in any improvement in dry mouth.

Participants will:

• have bone marrow collected using a needle
• undergo a saliv…

NCT06747949 — A Long-term Extension Study of Dazodalibep in Participants With Sjögren’s Syndrome (SS)

The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.

NCT06979531 — Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren’s Disease With Moderate to Severe Systemic Disease Activity

This is a Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of IMVT-1402 in adult participants with moderate to severe systemic primary Sjogren’s disease (SjD).

NCT06991114 — AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases.

A Basket Trial of Refractory Rheumatoid Arthritis (RA), Sjögren’s Disease (SjD), Idiopathic Inflammatory Myopathies (IIMs) and Systemic Sclerosis (SSc) subjects to evaluate the safety and efficacy of AlloNK, a non-genetically modified allogeneic NK cell, in combination with rituximab.

NCT06977724 — A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions of ABBV-319 in Adult Participants With Systemic Lupus Erythematosus (SLE) and Sjogren’s Disease (SjD)

Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity and Sjorgren’s disease (SjD) is a chronic, multisystem autoimmune disease characterized by lacrimal and salivary gland inflammation, with resultant dryness of the eyes and mouth and occasional glandular enlargement. ABBV-319 exhibits potential B cell depletion in SLE and SjD which …

NCT07118241 — A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN’S RELATED DRY EYE DISEASE

rhPRG4-Sjögren’s-002 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with Sjögren’s related Dry Eye Disease.

NCT07041099 — A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren’s Disease

A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren’s Disease.

NCT07236762 — An Exploratory Clinical Study of YTS109 Cell for R/R Autoimmune Diseases

This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren’s Syndrome, etc. Aproximately 18 patients aged 18-65 will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3×10⁶ STAR -T cells/kg, employing a 3+3 escalation principle f…

NCT07281456 — Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease

Background:

Sjogren disease is an autoimmune disease - that is, a disease that causes the body’s immune system to attack its own organs and tissues. Sjogren disease can affect the kidneys, lungs, or other organs. It can also cause dry mouth and eyes, fever, joint pain, rashes, and other symptoms. Researchers want to know if a drug approved to treat rheumatoid arthritis and other autoimmune dis…

NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

This is a 2-part study of GSK5926371 in participants with autoimmune rheumatic diseases (ARD). In part 1, participants will receive different doses of GSK5926371 to find a suitable priming dose. In part 2, participants will receive GSK5926371 at doses based on data from part 1. The study is aimed at testing if GSK5926371 is safe, well-tolerated, how the body processes the study drug, how it wor…

NCT07284797 — A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases

The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.

NCT07404865 — Phase 3 Study of Telitacicept in Active Primary Sjögren’s Disease

Phase 3 Study of Telitacicept in Active Primary Sjögren’s Disease (UPSTREAM SjD)

NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases

This is the first-in-human trial of MTS109 (mRNA-LNP). The goal of this clinical trial is to evaluate the safety, tolerability of intravenous injection of MTS109 in moderate to severe autoimmune diseases.

NCT06875102 — Fatigue in Sjögren’s Syndrome: 3 Therapeutic Strategies

Unexplained fatigue is a frequent (60-70%) chronic complaint in Sjögren’s syndrome (SjS) with a clear unmet therapeutic need, despite the recommendation of adapted physical activity (APA) programs, which are effective and feasible, but only to some extent. Hence, other therapeutic approaches, such as Acupuncture (ACU) or transcutaneous vagal nerve stimulation (tVNS), have been evaluated during …

NCT07544394 — Explanatory Factors and Predictors of Fatigue in Patients With Sjögren’s Disease: A 3-month Longitudinal Study

This prospective longitudinal study will be conducted in patients diagnosed with Sjögren’s disease who are followed at the rheumatology outpatient clinic of Kahramanmaras Sutcu Imam University Medical Faculty Hospital. Demographic and clinical data will be collected from routine clinical assessments and medical records, including laboratory results obtained during standard care.

Participants w…

Active, Not Recruiting

NCT03711214 — Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome

Primary Sjögren’s syndrome (pSS) is a chronic systemic inflammatory disease, which mainly affects the lacrimal and salivary glands, leading to sicca syndrome. pSS has a probable autoimmune etiology, with the production of several autoantibodies such as antinuclear antibodies (ANA), anti-Ro/SS-A, anti-La/SS-B, rheumatoid factor (RF) and cryoglobulins. Recently, our group described a high frequen…

NCT05349214 — Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren’s Syndrome

A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren’s syndrome (NEPTUNUS-2)

NCT05879419 — Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases

Introduction: Patients with autoimmune rheumatic diseases (ARDs), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PAs), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), primary Sjögren’s syndrome (pSS) , systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM) and primary vasculitides, have a high risk of herpes zoster (HZ) infectio…

NCT05946941 — A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren’s Syndrome

The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren’s Syndrome.

NCT05985915 — A Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjögren’s syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 [NCT05350072] or CVAY736A2302 [NCT05349214]).

NCT06741969 — Nipocalimab in Moderate to Severe Sjogren’s Disease

The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren’s disease (SjD).

Not Yet Recruiting

NCT07596680 — CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases

This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune diseases. The enrolled population consists of patients with active autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), ANCA-associa…

NCT07642843 — CM336 for Active Sjogren’s Syndrome Study

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CM336 in adult participants with active primary Sjogren’s Syndrome.

NCT07621809 — Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren’s Disease With High Symptom Burden

The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren’s disease who have high symptom burden.

NCT07649265 — A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body

This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020. The study will enroll healthy participants at low doses, followed by participants with moderate to severe autoimmune diseases with predominant B-cell involvement. Eligible participants include patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc),…

NCT07671222 — Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease

Sjögren’s syndrome is a condition in which the immune system attacks the body’s moisture-producing glands. This often causes severe dry eye, leading to discomfort, irritation, blurred vision, and damage to the eye surface. Inflammation plays an important role in this process, and a protein called TNF-alpha is one of the key drivers.

This study will test a new eye drop containing infliximab, a …

Completed Trials

NCT01208792 — Auto-immunity and Pulmonary Arterial Hypertension

The investigators have recently evidenced the presence of antibodies to endothelial cells and fibroblasts in patients with idiopathic or SSc-associated PAH. The investigators also have identified several target antigens of anti-fibroblasts antibodies.

The objective of this study is to further investigate for the presence of antibodies to endothelial cells and fibroblasts in patients and charac…

NCT02370225 — Aerobic Exercise in Primary Sjögren’s Syndrome

The purpose of this sudy is to investigate the effects of a regular aerobic exercise on aerobic capacity, fatigue, depression, quality of life, perception of symptoms and disease activity in women with pSS.

NCT03157011 — Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome

the investigators propose to carry out a prospective study consisting of a systematic research of digestive symptoms in patients with SGSp with the validated Global symptom score (GSS) questionnaire, which allowed to grades severity of 10 digestive symptoms (absent, mild, moderate, or severe), asthenia and fever.

NCT03905525 — Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren’s Syndrome

This study was to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren’s Syndrome (SjS).

NCT03841318 — Involvement of Immune Cells Derived From the Intestine in Sjogren’s Syndrome

The study aims at defining the role of immune cells derived from the intestine in the pathogenesis of Sjogren’s disease. This research might open new therapeutic approaches for the treatment of autoimmune diseases.

NCT07469865 — Efficacy and Safety of 20% and 100% Autologous Serum Eye Drops in Patients With Severe Dry Eye Disease (AST)

A prospective, single-blinded, randomized, controlled crossover trial was conducted in patients with severe dry eye syndrome. Topical treatment with autologous serum eye drops (ASED) diluted at 20%, undiluted ASED and conventional preservative-free artificial tears (PFAT) were compared as a treatment for severe dry eye disease. The primary outcome measure was assessment of ocular symptoms using…

NCT05016297 — Efficacy and Safety of Baricitinib in Sjogren’s Syndrome

The investigators had observed that baricitinib was effective and safe in active pSS patients in a pilot study. So the investigators plan to conduct a multi-center, prospective, open-label, randomized study to evaluate the efficacy and safety of baricitinib in active pSS patients. The participants will be randomized (1:2) to receive HCQ (200mg twice a day) or baricitinib (4mg per day) with or w…

NCT05350072 — Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren’s Syndrome

A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren’s syndrome (NEPTUNUS-1)

NCT05644795 — Wheat-free Diet in the Treatment of Sjogren’s Syndrome

Recent data show that some foods can increase intestinal mucosa permeability and immune activation of subjects with gastrointestinal (GI) symptoms. Wheat seems the most frequent food which activates this inflammatory response and can cause both GI and extra-intestinal symptoms. Patients suffering from wheat-related troubles, in absence of celiac disease diagnosis, can suffer from non-celiac whe…

NCT05961267 — Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism

Autoimmune diseases are the consequence of an abnormality of the immune system, leading it to attack components of our own body. They have a wide variety of presentations. They preferentially affect women, and often at a young age. Systemic lupus erythematosus, for example, most often occurs between the ages of 15 and 40.

Inflammatory rheumatism, such as spondyloarthritis or rheumatoid arthrit…

NCT06437652 — An AI Algorithm for Lymphocyte Focus Score of Minor Salivary Gland Biopsy Samples for Diagnosing Sjogren’s Syndrome

The aim of this research is to discover an artificial intelligence (AI) algorithm for lymphocyte focus score in whole slide images of labial minor salivary gland (SG) biopsy samples for diagnosing Sjogren’s Syndrome, in order to enhance the precision of pathological interpretation of labial minor SG biopsy samples in patients with suspected Sjogren’s syndrome and aid clinicians make an accurate…

NCT06410742 — Comprehensive Evaluation of Clinical and Biopsychosocial Characteristics in Primary Sjögren’s Disease

Following the guidance of individuals with primary Sjögren’s Syndrome who receive diagnosis, routine medical care, and treatment management, the evaluations will be performed once by the researchers and will take approximately one hour.

In addition, healthy individuals with a similar average age to the evaluation group without any disease diagnosis will be included in the study as a control gr…

NCT07264517 — Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED).

This is a Phase 2, multi-site, double-masked, randomized, vehicle-controlled, study designed to evaluate the safety, tolerability, and efficacy in adult participants with DED.

Available Studies

NCT07244289 — Managed Access Programs for VAY736, Ianalumab

The purpose of this registration is to list Managed Access Programs (MAPs) related to VAY736, ianalumab

Other (Withdrawn)

NCT02450396 — Pregnancy and Medically Assisted Conception in Rare Diseases

Rare diseases frequently affect women of childbearing age. Pregnancy in these women has become less rare, but remains associated with high levels of complications. One obstacle to their optimal management during pregnancy is that there are no prospective studies of pregnancy during rare diseases and several connective tissue diseases. As a consequence, the management of these pregnancies is non…

Other (Terminated)

NCT06312020 — A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren’s Syndrome

The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren’s syndrome (SS).

NCT06544642 — A Study to Evaluate the Effects of ASP5502 in Healthy Adults and Adults With Primary Sjögren’s Syndrome

Primary Sjögren’s syndrome (pSS) is a condition when the body’s immune system attacks glands that produce fluids, such as the tear and saliva glands. This leads to dry eyes and a dry mouth. However, other symptoms may occur such as fatigue, joint pain, and skin problems. These symptoms can be severe. Symptoms can be treated but there is an unmet need to treat the actual condition.

In this stud…

Other (Suspended)

NCT07527936 — A Study of BEN301 Injection in theTreatment of Autoimmune Diseases

The study aims to investigate the safety, tolerability, and preliminary clinical efficacy of BEN301 Injection in patients with autoimmune diseases. In patients with autoimmune diseases, Treg cells are typically deficient or dysfunctional. CAR-Treg cell therapy represents a promising strategy for the treatment of autoimmune diseases and may be applicable to a broad spectrum of autoimmune conditi…