Autoimmune Disease Studies Enrolling at Yale

If you or your child are 2 years or older and have symptoms and/or a diagnosis of neurologic damage or dysfunction, you may be eligible for a Yale University study for establishing a biological specimen repository to investigate rare and undiagnosed neurologic autoimmune diseases.

This study aims to uncover the underlying causes and mechanisms of unexplained neurologic diseases using tools that look at autoimmunity in the blood, spinal fluid, and tissues. Participants may provide blood, cerebrospinal fluid, or tissue samples to help advance future discoveries. All samples and data are de-identified—join us in pushing the boundaries of neurologic research.

Study procedures include (compensation provided):

• Blood draw
• Lumbar puncture (optional)
• Collection of leftover tissue (if available)

To learn more email us at neuroautostudy@yale.edu or call 475-375-6808.

Sponsored by National Institute of Neurological Disorders and Stroke (NINDS); HIC# 2000039436

Most people with MS start immune suppressing medications immediately after their diagnosis and remain on these medications indefinitely. However, emerging data suggests that at least some patients may not require lifelong immune suppression to control their MS. The AMS05 clinical trial is testing the highly effective MS medication, ocrelizumab, in people with early relapsing MS, to see if a short-term treatment can lead to lasting remission. The study will provide study drug (ocrelizumab) for all participants and frequent MRI scans throughout the study. Blood and stool biospecimens will be collected, and study participation will last 4 years.

Are you eligible?

• Age 18-55
• Your first symptoms of MS were within the last 2 years
• Not yet started a treatment for your MS
• Not currently pregnant or planning pregnancy within the next 4 years

Please reach out to MSResearch@yale.edu and reference the AMS05 clinical trial.

Sponsored by University of Pennsylvania; HIC# 2000034445

There are few effective treatment options available for people with non-relapsing, secondary progressive MS. Frexalimab is a monoclonal antibody that binds to and disrupts a protein called CD40L, which is found on certain white blood cells and is necessary for them to function. Frexalimab is being studied as a treatment for people with secondary progressive MS in a randomized, placebo controlled clinical trial (Freviva).

This is a Phase 3 trial, designed to see whether the investigational medicine works in this group of patients and whether it is safe. Participants will be randomly selected to receive placebo or the study drug; each participant has a 2 out of 3 chance of getting the active medication. Neither you nor your doctor will know which treatment you received until after the study is over. The study will provide study drug (a monthly infusion), blood testing and MRIs throughout the entire study, and study participation will last approximately 4.5 years.

For more information about this study, including how to volunteer, contact Dimitri Duvilaire at 203.287.6100 or email: msresearch@yale.edu.

Sponsored by Sanofi, HIC# 2000036443

DREAM study (Detection Research on Early Asymptomatic MS)

Yale researchers are looking for participants in an ongoing research study. Participation includes one in-person visit with a blood draw, and questionnaires, which can be completed online. Additional blood draws and procedures are optional.

You may be eligible to participate if you:

• Have a close family member (parent, sibling, or child) with multiple sclerosis
• Are age 13 or older

Prescreening survey link is here: https://redcap.link/r057eydl

Sponsored by Hoffmann (F) - La Roche, Ltd; Yale University School of Medicine; HIC# 2000032952

Lupus Studies at Yale

If you are 18 years of age or older and have been diagnosed with Lupus, you may be eligible to participate in treatment studies. There are very few treatment options available to patients with Lupus. Dr. Koumpouras at Yale University is currently conducting several clinical research studies that examine investigational new treatments for Lupus symptoms. Compensation is offered, but varies by study.

To learn more about our clinical trial programs or to see if you are eligible to participate, call 203-785-6631 or email lupus@yale.edu.

Current Lupus Trials:

• Regency CA41705 (HIC 2000028219): A Phase 3 Randomized, Double Blinded, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Lupus Nephritis - The purpose of this study is to ovulate the effect of Obinutuzumab against placebo on patients with lupus nephritis. This study will help determine if using Obinutuzumab to reduce B cells will improve the signs and symptoms of lupus nephritis. If you meet the study requirements and are enrolled, you will be in this study for about 76 weeks.
• BioRepository (HIC 2000017276): Yale Lupus and Connective Tissue Disease Bio-Repository / Yale Rheumatology Bio-Repository - The purpose of this study is to create a Yale School of Medicine Section of Rheumatology patient registry and bio-repository of blood samples that will be used for current and future research projects involving the study of systemic lupus erythematosus and other connective tissue diseases and related medical issues. This study may help researchers in the future learn more about how to prevent, find and treat lupus, rheumatoid arthritis, and other rheumatologic diseases.
• Naïve (HIC 2000030285): Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in patients with moderately to severely active Systemic Lupus Erythematosus: A Multi-Centre Open Label Parallel Group Trial: The NAÏVE study - The purpose of this study is to compare the vaccine response to influenza vaccine in people who have active systemic lupus when being treated with approved therapies for SLE.
• Vibrant (HIC 2000031663): Trial of VIB4920 for Active Lupus Nephritis - The purpose of this study is to find out if study treatment with Mycophenolate Mofetil (MMF), prednisone and the study drug VIB4920 is safe to use in combination than standard treatment with MMF and prednisone for lupus nephritis.
• BMS 246 (HIC 2000033879): A Phase 3, Randomized, Double-blind, Placebo-controlled study and the purpose is to evaluate the efficacy and safety of Deucravacitinib in participants with Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1) while receiving stable background standard of care treatment. If you meet the study requirements and are enrolled, you will be in this study for a little over 1 year.

SPIN Study

If you are an individual diagnosed with scleroderma (systemic sclerosis) who is at least 18 years of age and willing to answer questionnaires every 3 months about your quality of life and well-being, you may be eligible to participate in a free and confidential study. Dr. Monique Hinchcliff and the Scleroderma Patient-Centered Intervention Network (SPIN) are conducting this study to better understand problems identified by patients as important to them, determine the best way to measure outcomes related to these problems, and to plan for interventions to address these problems.

To learn more or see if you are eligible to participate, please contact Yale Rheumatology Research at scleroderma@yale.edu.

Funded by the Canadian Institutes of Health Research (CIHR); HIC# 2000027461

The purpose of this research study is to better understand the development of systemic sclerosis (SSc)/scleroderma-related lung fibrosis (scarring)/ interstitial lung disease (ILD) and how certain molecular and cellular characteristics of scleroderma lung disease might be linked to clinical outcomes. Study procedures will include screening forms, health questionnaires, blood collection, possible skin biopsy collection, and possible high-resolution CT imaging.

Three visits are required and will take 3-5 hours total. Taking part in this study may help scientists to better understand scleroderma lung and skin disease, which may lead to better management and treatments in the future.

You will receive $100 for each visit and an additional $50 if you donate skin biopsies.

To learn more or see if you are eligible to participate, please contact Yale Rheumatology Research at scleroderma@yale.edu.

Sponsored by Boehringer Ingelheim Pharmaceuticals, Inc.; HIC# 2000032581

The purpose of this research study is to better understand the development of systemic sclerosis (SSc)/scleroderma-related lung fibrosis (scarring)/interstitial lung disease (ILD) and how the development of scleroderma lung disease might be associated with scleroderma skin and esophageal disease. Study procedures will include: screening form, health questionnaires, blood collection, skin biopsy collection, suture removal, saliva collection, bronchoscopy, and possible esophageal biopsy.

Two to three visits are required. These visits will take 6-7 hours total.

Taking part in this study may help scientists to better understand scleroderma lung, skin and esophageal disease, which may lead to better management and treatments in the future.

You will receive a $100 for the completion of the first visit and $300 for the completion of the second visit.

To learn more or see if you are eligible to participate, please contact Yale Rheumatology Research at scleroderma@yale.edu.

Sponsored by National Institute of Arthritis & Musculoskeletal & Skin Diseases (NIAMS); HIC #2000024862