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17 Sjögren's Syndrome Trials
Power is an online platform that helps thousands of Sjögren's Syndrome patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Nivolumab for Cancer
Salina, KansasThis phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Chemotherapy, Radiotherapy, Allogeneic Transplant, Others
Must Not Be Taking:Anticancer Investigational Agents
300 Participants Needed
Ianalumab for Sjogren's Syndrome
Oklahoma City, OklahomaThe purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjogrens syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 \[NCT05350072\] or CVAY736A2302 \[NCT05349214\]).
* The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe (PFS) or in a 2 mL autoinjector (AI) for injection. All participants will receive ianalumab either monthly or every 3 months.
* The treatment duration will be 3 years with an additional up to 2-year safety follow-up. The total duration of this extension study will be up to 5 years.
* The visit frequency will be monthly during both the treatment period and mandatory follow-up, and then less frequently during the subsequent conditional follow-up.
Treatment of interest: The randomized treatment (ianalumab) will be received monthly or every 3 months. Participants assigned to treatment every 3 months will receive placebo every month between the ianalumab doses to maintain blinding.
Number of Participants: Approximately 600 participants from the NEPTUNUS core studies will be rolled over into the extension study.
Treatment Groups:There will be no screening period in this trial. From Week 48 of the NEPTUNUS core study, participants will be given the opportunity to consent to this extension study. From Week 52 of the NEPTUNUS core studies (i.e., Day 1 in the extension study), eligible participants will be assigned to either one of the treatment regimens:
* ianalumab 300 mg monthly or
* ianalumab 300 mg once every 3 months
Participants receiving placebo in either of the NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or every 3 months starting from Week 60 and participants receiving ianalumab in either of the NEPTUNUS core studies will continue the same treatment in the extension study.
Ianalumab will be given as a subcutaneous injection from a 2 mL pre-filled syringe or a 2 mL autoinjector. Participants will be given the opportunity to self-inject at home on some visits after receiving training.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Live Vaccines, Others
600 Participants Needed
Ianalumab for Autoimmune Diseases
Oklahoma City, OklahomaThe purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).
A second optional cohort may be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Infections, Live Vaccines, Pregnancy, Others
140 Participants Needed
Deucravacitinib for Sjögren's Syndrome
Kansas City, KansasThe purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Rheumatoid Arthritis, SLE, Systemic Sclerosis, Others
Must Not Be Taking:Tyrosine Kinase 2 Inhibitors
756 Participants Needed
Dazodalibep for Sjögren's Syndrome
Kansas City, KansasPrimary Objective:
To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state
Secondary Objectives:
1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS.
2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS
3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Thrombosis, Polymyositis, Malignancy, Pregnancy, Others
435 Participants Needed
Dazodalibep for Sjögren's Syndrome
Kansas City, KansasThis trial is testing dazodalibep, a medication, to see if it can help people with moderate-to-severe Sjögren's Syndrome. The goal is to reduce their symptoms and improve their quality of life. Researchers will also check if the medication is safe and well-tolerated by patients.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Cancer, Cardiovascular, HIV, Others
Must Not Be Taking:Biologics, B-cell Therapies
621 Participants Needed
ADX-629 for Sjogren-Larsson Syndrome
Omaha, NebraskaThis trial tests if ADX-629, a medicine taken by mouth, is safe and effective for people with Sjögren-Larsson syndrome (SLS). SLS is a rare genetic disorder that causes harmful fats to build up in the body. ADX-629 helps remove these harmful fats, which may reduce symptoms in the skin, brain, and eyes.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:5 - 50
Sex:All
Key Eligibility Criteria
Disqualifiers:Malignancy, HIV, Cardiovascular, Renal, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids, Others
8 Participants Needed
RSLV-132 for Sjögren's Syndrome
McKinney, TexasThe goal of this clinical study is to learn if RSLV-132 improves the symptoms of SS in adults. It will also learn about the safety of RSLV-132. The main questions it aims to answer are:
* Does RSLV-132 improve the cardinal symptoms of Sjogren's including fatigue, dryness and pain?
* Does RSLV-132 improve the tiredness/fatigue caused by Sjogren's?
* What are the blood levels of RSLV-132 over time?
* What is the immune (antibody) response in the body to RSLV-132?
* What is the safety profile of RSLV-132?
Researchers will compare RSLV-132 to a placebo (a look-alike substance that contains no drug) to see if RSLV-132 improves the symptoms of pSS.
Participants will:
Take RSLV-132 or a placebo 13 times over 22 weeks Visit the clinic once every week for the first 2 weeks, then every 2 weeks until the end of treatment and then for a final time 4 weeks later (Day 211) for check-ups, tests and to answer questionnaires about their symptoms Record their symptoms every day on an electronic device
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:Female
Key Eligibility Criteria
Disqualifiers:Active Autoimmune, Fibromyalgia, HIV, Others
106 Participants Needed
Abiprubart for Sjögren's Syndrome
Allen, TexasPrimary objective of the study is to evaluate the effect of abiprubart on an established systemic disease activity measure for Sjögren's Disease.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Fibromyalgia, Immunodeficiency, Thromboembolic, Others
Must Not Be Taking:Injectable Corticosteroids
200 Participants Needed
Ianalumab for Sjögren's Syndrome
Colleyville, TexasA 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)
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18 - 100
Sex:All
276 Participants Needed
Nipocalimab for Sjogren's Syndrome
Denver, ColoradoThe purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Uncontrolled Autoimmune, Cardiovascular, Hepatic, Others
600 Participants Needed
HZN-1116 for Sjogren's Syndrome
Jackson, TennesseeThe purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:System Sclerosis, Active Malignancy, Pregnancy, Others
Must Not Be Taking:Biologics, B Cell Therapies
262 Participants Needed
Sibeprenlimab for Sjögren's Syndrome
Austin, TexasThis is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (SC) every 4 (Q4) weeks as an add-on to background treatment in participants with Sjögren's disease.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
80 Participants Needed
Efgartigimod for Sjogren's Syndrome
Houston, TexasThe main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. The maximum study duration for participants in both study parts is approximately 105 weeks.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Secondary Sjögren's, Active Fibromyalgia, Others
Must Not Be Taking:Cyclophosphamide, Anti-CD20, Anti-CD19
580 Participants Needed
Mesenchymal Stromal Cells for Dry Mouth
Madison, WisconsinThe 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 salivary gland ultrasound
* complete questionnaires
* receive an injection of the bone marrow cells into a salivary gland
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 90
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Malignancy, Transfusion Dependency, Others
Must Not Be Taking:Diuretics, Investigational Drugs
36 Participants Needed
Levocarnitine for Dry Eye in Sjogren's Syndrome
Nashville, TennesseeThis trial tests levocarnitine, a supplement that helps transport carnitine into cells, in adults with Sjogren's syndrome who have dry eyes. Sjogren's syndrome causes dryness in the eyes and mouth. Levocarnitine may help by increasing carnitine levels in tears, potentially reducing eye dryness and improving comfort. Levocarnitine is a molecule required in mammalian energy metabolism, facilitating the transport of long-chain fatty acids across the mitochondrial membrane for energy production.
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Age:18 - 75
Sex:All
15 Participants Needed
Dazodalibep for Sjögren's Syndrome
Saint Clair Shores, MichiganThe primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
844 Participants Needed
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Frequently Asked Questions
How much do Sjögren's Syndrome clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Sjögren's Syndrome clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Sjögren's Syndrome trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Sjögren's Syndrome is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Sjögren's Syndrome medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Sjögren's Syndrome clinical trials ?
Most recently, we added Sibeprenlimab for Sjögren's Syndrome, Dazodalibep for Sjögren's Syndrome and Nipocalimab for Sjogren's Syndrome to the Power online platform.