Scientists hunt for hidden triggers of autoimmune diseases
NCT ID NCT06587828
First seen Jun 24, 2026 · Last updated Sep 16, 2026 · Updated 3 times
Summary
This study collects tissue and blood samples from 300 people with autoimmune diseases like Crohn's, multiple sclerosis, and celiac disease. Researchers aim to identify the specific targets of immune cells (T cells) that cause inflammation. The goal is to discover new targets for future therapies that could calm the immune system without shutting it down completely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could identify new targets for therapies that calm the immune system in autoimmune diseases like Crohn's or multiple sclerosis.
- What could go wrong
- This is an early-stage sample collection study, not a treatment trial. It may not lead to any new therapies, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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238 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Sep 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with a known or suspected autoimmune disease will be enrolled into the study. Additionally, patients who have an apparent evolving autoimmune disease may be eligible. Patients with autoimmune disease who had excess materials cryopreserved in a manner that is expected to yield sufficient T cells for this research study, and where biologic samples were ethically obtained, will be utilized for this study. Both men and women and members of all races and ethnic groups are eligible for this protocol. It is expected that the mix of patients entering this study will reflect the demographics of the clinic population seen in hospitals and associated clinics in the region from which the biologic materials are collected.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Cohort Legend: Cohort 1: Inflammatory Bowel Diseases - Crohn's Disease or Ulcerative Colitis, Cohort 2: Celiac Disease, Cohort 3: Ankylosing spondylitis or non-radiographic axial spondyloarthritis (nr-axSpA), Cohort 4: Multiple Sclerosis, Cohort 5: Scleroderma, Cohort 6: Systemic Sclerosis with pulmonary involvement, Cohort 7: Other Autoimmune Disease, Cohort 8: Apparent Evolving Autoimmune Disease, Cohort 9: Frozen Cryopreserved Inclusion Criteria: * Study cohorts 1,2,3,4,5,6,7,8.9: Known or suspected diagnosis, with subsequent diagnostic confirmation, of one of the following cohorts associated with the following autoimmune diseases: * Inflammatory Bowel Diseases - Crohn's Disease or ulcerative colitis * Celiac disease * Ankylosing spondylitis or Non radiographic axial spondyloarthritis (nr-axSpA) * Multiple sclerosis * Scleroderma * Systemic sclerosis with pulmonary involvement * Other autoimmune disease (as agreed between Investigator and Sponsor) * Apparent evolving autoimmune disease * Frozen cryopreserved * Age equal or greater than 18 years at time of informed consent. * Ability to understand and willingness to sign an informed consent document when informed consent is required by an ethical review board. * On disease-modifying treatments that are not known to be directly T cell toxic. Such treatments are allowed and include: * Non-steroidal anti-inflammatory drugs including aspirin, ibuprofen, acetaminophen, celecoxib, indomethacin, diclofenac, etodolac, naproxen, meloxicam, sulindac, nabumetone amongst others. * Tumor necrosis factor alpha (TNF-alpha) antagonists including infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi) and biosimilar drugs with the same generic name. * Interleukin-12/23 antagonists including ustekinumab (Stelara) and risankizumab-rzaa (Skyrizi) * Alpha-4-integrin antagonists including vedolizumab (Entyvio), natalizumab (Tysabri) * Interleukin-17 inhibitors including secukinumab (Cosentyx), ixekizumab (Taltz) * Recombinant interferon beta * CD20 antagonists including rituximab (Rituxan), ocrelizumab (Ocrevus), ofatumumab (Kesimpta) * Oral fumarates including dimethyl fumarate (Tecfidera), diroximel fumarate (Vumerity), monomethyl fumarate (Bafiertam) * Oral sphingosine 1-phosphate receptor (S1PR) modulators including fingolimod (Gilenya), siponimod (Mayzent), ozanimod (Zeposia), ponesimod (Ponvory) * Oral glatiramer acetate (copolymer 1; Copaxone) * Patient is an appropriate candidate for a procedure to obtain a biopsy, tissue samples or biologic materials during a clinically indicated procedure where it is expected that excess materials could be used for research OR * In the opinion of the clinical investigator, a patient is an appropriate, low-risk candidate for a research only procedure to obtain a biopsy, tissue samples or biologic materials. Exclusion Criteria: * On treatment with drugs that are known to be T cell toxic and cannot be held for at least 4 weeks or longer. The following treatments are not allowed except in designated cohorts when approved by Sponsor: * Glucocorticoids including prednisone, methylprednisolone (Solu-medrol), budesonide (Entocort), hydrocortisone (Solu-cortef), dexamethasone (Decadron), betamethasone (Betaject) * Sulfasalazine (Azulfidine) * Aminosalicylates including mesalamine/ mesalazine (Asacol, Pentasa). * Thiopurines including azathioprine (Imuran) and 6-mercaptopurine (Purixan) * Systemic JAK inhibitors including tofacitinib (Xeljanz), abrocitinib (Cibinqo), baricitinib (Olumiant), upadacitinib (Rinvoq) * CD52 inhibitors including alemtuzumab (Campath) * Methotrexate * Cladribine * Teriflunomide (Aubagio) * Concurrent disease or condition that would make the patient inappropriate for study participation, or any serious medical or psychiatric disorder that would interfere with the subject's safety. * Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. * Patients receiving research biopsy procedures will not have a history of serious or life-threatening allergic reaction to local anesthetics (i.e., lidocaine, xylocaine), if local anesthetic is required for the procedure or to medications used for sedation during a procedure. * Pregnant or nursing women are excluded because there may be unanticipated adverse events and increased risk to both mother and fetus in the setting of local anesthetic or study procedures. * Any other medical or psychiatric condition, which in the opinion of the patient's treating clinician, would make participation in this protocol unreasonably hazardous for the patient.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Arnold Arthritis & Rheumatology
Skokie, Illinois, 60076, United States
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Cura Clinical Research
Sherman Oaks, California, 91403, United States
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Knowledge Research Center
Orange, California, 92868, United States
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Massachusetts Eye Research and Surgery Institution (MERSI)
Waltham, Massachusetts, 02451, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Nexus Research
Cranston, Rhode Island, 02920, United States
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Novel Research
Bellaire, Texas, 77401, United States
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Palmetto Gastroenterology Clinical Research, LLC
Summerville, South Carolina, 29486, United States
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RI Rheumatology
Cranston, Rhode Island, 02920, United States
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Susquehanna Research Group
Harrisburg, Pennsylvania, 17110, United States
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University of Kentucky Research Foundation
Lexington, Kentucky, 40536, United States
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