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60 Autoimmune Diseases Trials
Power is an online platform that helps thousands of Autoimmune Diseases 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.
Nerandomilast for Interstitial Lung Disease
Cleveland, OhioAdults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease.
Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for 26 weeks. Participants continue immunosuppressant treatment for their underlying rheumatic disease.
Participants are in the study for about 7.5 months. During this time, they visit the study site 8 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Pivotal Trial
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
400 Participants Needed
Fostamatinib for Immune Thrombocytopenia (ITP)
Bethesda, MarylandBackground:
People who have a blood stem cell transplant can sometimes develop cytopenia. This means that their levels of one or more types of blood cell, such as the red cells or platelets, are lower than they should be. This can occur because a person s immune system might attack these cells after a stem cell transplant. Up to 20% of people who have blood stem cell transplants develop cytopenias, which can lead to anemia, severe bleeding, infections, and other problems. Treatments are needed to help keep blood cell levels stable after blood stem cell transplant.
Objective:
To evaluate the long-term effects of a study drug (fostamatinib) in people with cytopenia after a blood stem cell transplant.
Eligibility:
People who responded well to fostamatinib in an earlier study.
Design:
Participants will be screened. They will have a physical exam and blood tests.
Fostamatinib is an oral tablet taken by mouth. Participants will take the pills at the same dose and frequency as they did during the previous study. They will take the pills for up to 21 months. The dosage of the drug may be reduced over time if their blood cell levels are stable.
Participants will have a medical assessment every month. This can be with their local doctor or at the NIH clinic.
Participants will have blood tests every 3 months.
Participants will have a follow-up visit after they stop taking the drug. Their vital signs will be taken, and they will have blood drawn. They will answer questions about their health.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Age:18 - 75
Sex:All
20 Participants Needed
CB-010 for Lupus
Cincinnati, OhioThis is a Phase 1 study to evaluate the safety and efficacy of a single infusion of CB-010 in patients with refractory Systemic Lupus Erythematosus (SLE) with cohorts for lupus nephritis (LN) and extrarenal lupus (ERL).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
20 Participants Needed
CNTY-101 for Lupus
Chicago, IllinoisCALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic lupus erythematosus (SLE) with or without lupus nephritis (LN), idiopathic inflammatory myopathies (IIM), and diffuse cutaneous systemic sclerosis (DcSSc).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:17+
Sex:All
Key Eligibility Criteria
Disqualifiers:Hemodialysis, CNS Disease, Transplant, Others
48 Participants Needed
TRX103 for Crohn's Disease
Cleveland, OhioThis research study is testing an investigational research product called TRX103 as a possible treatment for individuals suffering from Crohn's Disease (CD). The primary purpose of this study is to learn how safe and effective different doses of TRX103 are when administered to individuals with CD.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Organ Transplant, HIV, Hepatitis B, Others
Must Be Taking:Corticosteroids
22 Participants Needed
Azer-cel for Autoimmune Disease
Lexington, KentuckyThe main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 60
Sex:All
Key Eligibility Criteria
Disqualifiers:Cancer, Hepatitis B, HIV, Transplant, Others
32 Participants Needed
IMVT-1402 for Rheumatoid Arthritis
Saint Clair Shores, MichiganThis Phase 2b, multicenter, double-blind, placebo-controlled, randomized withdrawal study is designed to assess the efficacy and safety of IMVT-1402 in adult participants with active, difficult-to-treat, anti-citrullinated protein autoantibody (ACPA) positive rheumatoid arthritis (RA). The primary objective is to evaluate the effects of IMVT-1402 compared to placebo, as measured by the American College of Rheumatology 20% (ACR20) response.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Active Malignancy, Immunodeficiency, Others
Must Not Be Taking:Rituximab, Anti-FcRn
120 Participants Needed
IMVT-1402 for Graves' Disease
Farmington Hills, MichiganThis is a study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.
The primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine \[T3\] or free triiodothyronine \[FT3\]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Radioactive Iodine, Thyroidectomy, Autoimmune Disease, Others
Must Be Taking:Antithyroid Drugs
240 Participants Needed
CABA-201 for Myasthenia Gravis
Chicago, IllinoisRESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Infections, Cardiac Impairment, Others
12 Participants Needed
CAR T-Cell Therapy for Myasthenia Gravis
Pittsburgh, PennsylvaniaA Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Subjects with Myasthenia Gravis
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Cardiac Disease, Infections, Dementia, Others
Must Be Taking:Glucocorticoids, Immunotherapies
20 Participants Needed
Molgramostim for Pulmonary Alveolar Proteinosis
Cincinnati, OhioThe goal of this open-label study is to study molgramostim as a treatment for autoimmune pulmonary alveolar proteinosis (aPAP) in pediatric patients between age 6 and 18. The main questions it aims to answer are:
The effect of molgramostim on breathing tests and activity in pediatric patients with aPAP and the safety of molgramostim in pediatric patients with aPAP.
This is an open-label study: all participants will receive treatment with molgramostim.
Patients will:
* Take molgramostim once daily via nebulizer every day for 12 months.
* Visit the clinic approximately every 12 weeks for checkups and tests.
* Keep a diary of any oxygen use.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:6 - 18
Sex:All
5 Participants Needed
The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 111 weeks including screening, treatment phases, and follow-up.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Serious Infections, SLE, Others
Must Be Taking:Immunosuppressants, Corticosteroids
140 Participants Needed
Ianalumab for Autoimmune Diseases
Middleburg Heights, OhioThe 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
CABA-201 for Scleroderma
Ann Arbor, MichiganRESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Infections, Organ Transplant, Others
12 Participants Needed
Mavorixafor for Neutropenia
Ann Arbor, MichiganThe purpose of this study is to demonstrate the efficacy and evaluate the safety, and tolerability of mavorixafor in participants with congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders who are experiencing recurrent and/or serious infections as assessed by demonstrating its clinical benefit and increasing levels of circulating neutrophils.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12+
Sex:All
Key Eligibility Criteria
Disqualifiers:Secondary Neutropenia, Aplastic Anemia, WHIM Syndrome, Others
Must Be Taking:G-CSF
150 Participants Needed
Belimumab for Lupus
Detroit, MichiganThis is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable initial SLE therapy.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Malignancy, Uncontrolled Diseases, Infections, Others
Must Not Be Taking:Belimumab, Anifrolumab, Rituximab, Others
350 Participants Needed
HZN-1116 for Sjogren's Syndrome
Duncansville, PennsylvaniaThe 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
HMPL-523 for Low Platelet Count
Cleveland, OhioThis is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Secondary ITP, Active Malignancy, Others
48 Participants Needed
SBT777101 for Rheumatoid Arthritis
Chicago, IllinoisThis study will test the safety and effects of SBT777101 when given as a single dose to subjects with rheumatoid arthritis. It is the first study of this treatment being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Uncontrolled Disease, Infections, Immunodeficiency, Others
Must Be Taking:RA Medications
24 Participants Needed
CABA-201 for Lupus
Chicago, IllinoisThis trial tests a new cell therapy called CABA-201 for patients with active lupus. It aims to help those whose disease is not well-controlled by current treatments. Patients first get standard medications to prepare their bodies, then receive CABA-201 to help manage their immune system.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Infections, Organ Transplant, Others
12 Participants Needed
CABA-201 for Inflammatory Myopathies
Chicago, IllinoisRESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:6 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Infections, Organ Transplant, Others
24 Participants Needed
IVIG for Small Fiber Neuropathy
Detroit, MichiganThis trial will test a treatment called Panzyga on patients with small fiber neuropathy (SFN). SFN patients often suffer from undiagnosed pain, and current treatments have many side effects. Panzyga may help by reducing inflammation and improving nerve function, potentially reducing pain and increasing nerve density in the skin. Panzyga has been shown to be effective in treating various autoimmune neurological disorders and has potential benefits for managing neuropathic pain.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
20 Participants Needed
SSC Transplant + Testicular Tissue Grafting for Male Infertility
Pittsburgh, PennsylvaniaThis trial tests two methods to help men who stored testicular tissue before harmful treatments. It aims to restore their ability to produce sperm by reintroducing essential cells into their testes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:All
Sex:Male
Key Eligibility Criteria
Disqualifiers:Leukemia, Lymphoma, Testicular Cancer, Others
10 Participants Needed
Anifrolumab for Systemic Sclerosis
Cincinnati, OhioThis trial is testing anifrolumab, an injectable medication, in adults with systemic sclerosis. The goal is to see if it can reduce immune system attacks to lessen symptoms and prevent further damage. Anifrolumab is a human monoclonal antibody that targets the type I interferon receptor and has been tested in multiple studies for systemic lupus erythematosus (SLE) and other autoimmune diseases.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Cardiopulmonary, Overlap Syndromes, Malignancy, Others
306 Participants Needed
CC-97540 for Severe Refractory Lupus
Columbus, OhioThis trial is testing a new drug called CC-97540. It aims to help people with severe autoimmune diseases that don't get better with regular treatments. Researchers want to see if the drug is safe, how it moves through the body, and if it can improve patients' health.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Drug-induced SLE, Multiple Sclerosis, Psoriasis, Others
129 Participants Needed
Belimumab for Systemic Sclerosis Interstitial Lung Disease
Cincinnati, OhioThis study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pulmonary Hypertension, SSc Renal Crisis, Others
Must Be Taking:Mycophenolate, Methotrexate, Azathioprine
300 Participants Needed
Povetacicept for Autoimmune Hemolytic Anemia
Hamilton, OntarioThis trial is testing a medication called povetacicept in adults with certain blood disorders where the immune system attacks their own blood cells. The goal is to see if povetacicept is safe and can help improve these conditions. Participants will receive the medication regularly for several months, with an option to extend the treatment for additional months.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Secondary AIHA, CAD, ITP, Others
Must Not Be Taking:Rituximab, IVIg, Sutimlimab, Others
126 Participants Needed
ESK-001 for Lupus
Pittsburgh, PennsylvaniaThis trial is testing a new medication called ESK-001 to see if it can help adults with SLE, a chronic autoimmune disease. The study will check the effectiveness and safety of ESK-001 over several months.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Drug-induced SLE, Lupus Nephritis, Neuropsychiatric SLE, Others
Must Be Taking:Corticosteroids, Antimalarials, DMARDS
388 Participants Needed
Daratumumab for Antiphospholipid Syndrome
Ann Arbor, MichiganThis trial is testing if daratumumab, an IV medication, is safe for people with Anti-Phospholipid Syndrome (APS). APS patients are being studied because they may not respond well to usual treatments. Daratumumab works by helping the immune system target specific cells that might be causing issues.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Systemic Autoimmune Diseases, Active Infection, Others
Must Be Taking:Warfarin, LMWH
22 Participants Needed
Zetomipzomib for Autoimmune Hepatitis
Cleveland, OhioThis trial tests zetomipzomib, a new medication, in patients with autoimmune hepatitis who haven't responded well to standard treatments. The drug is given as an injection to help calm the immune system and reduce liver damage.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
24 Participants Needed
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Frequently Asked Questions
How much do Autoimmune Diseases 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 Autoimmune Diseases 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 Autoimmune Diseases 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 Autoimmune Diseases 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 Autoimmune Diseases 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 Autoimmune Diseases clinical trials ?
Most recently, we added Nerandomilast for Interstitial Lung Disease, Fostamatinib for Immune Thrombocytopenia (ITP) and CB-010 for Lupus to the Power online platform.
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