A Phase 2 interventional study of LY3361237 in Primary Sjogren's Syndrome, sponsored by Stanford University. Withdrawn. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Stanford University · Phase 2, Interventional, and Treatment
This will be a single-site, open-label study in patients with primary Sjogren's syndrome. The aim of this clinical trial is to evaluate the safety and efficacy of anti-BTLA agonist therapy (LY3361237) in treating patients with primary Sjogren's syndrome.
The primary objective is to evaluate the efficacy of LY3361237 in patients with primary Sjogren's syndrome by assessing changes in the Sjogren's Tool for Assessing Response (STAR) after 12 weeks of treatment.
The secondary objective is to determine the effect of LY3361237 on glandular changes measured by PET/MRI.
This study is a single-site, open-label study in subjects with primary Sjogren's syndrome being conducted at the Stanford University rheumatology clinic. All eligible subjects will receive LY3361237 450mg SC Q2W over a period of 12 weeks and will be followed up for an additional 10 weeks after the last dose. Twelve subjects will be included in the study.
After the Screening visit, consenting patients will be seen in clinic on day 1 (Baseline) and return to clinic on Weeks 2, 4, 6, 8, 10, 12, and 22.
At Screening (up to 35 days before baseline), a complete medical history, physical exam, vital signs, clinical laboratory tests [comprehensive metabolic panel, complete blood count, quantitative immunoglobulins, ANA, RF, anti-Ro, anti-La, C3, C4, ESR, CRP, urinalysis, urine protein:creatinine, serum pregnancy test for females, HIV serologies, hepatitis B serologies, hepatitis C serologies, quantiFERON test for tuberculosis, SARS-CoV-2 PCR], chest x-ray, electrocardiogram, and salivary gland ultrasound will be conducted.
At all subsequent visits, at a minimum, a complete physical exam, vital signs, focused history, and clinical laboratory tests (comprehensive metabolic panel, complete blood count, ESR, CRP, and urine pregnancy test for females) will be conducted.
Efficacy will be assessed using the Sjogren's Tool for Assessing Response (STAR) and by measuring changes in unstimulated salivary flow rate, changes in salivary glands by ultrasound, changes in salivary glands by PET/MRI, changes in Schirmer I testing, changes in laboratory values including inflammatory markers (ESR, CRP) complement levels (C3, C4), immunoglobulins (IgG, IgA, IgM), and autoantibodies (ANA, SS-A, SS-B, RF), and changes in patient reported outcomes.
At Screening, Baseline, Week 4, and Week 12, patients will record their global assessment of disease as well as visual analog scales for ocular and salivary symptoms and the ESSPRI. At Baseline, Week 4, and Week 12, patients will record the FACIT-F for fatigue and RAND SF-36, and the physician will calculate the ESSDAI, ClinESSDAI, physician global assessment of disease, and tender and swollen joint count.
In addition, safety will be assessed for all patients.
Stanford University is the lead sponsor of 2,162 studies on the registry; 429 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
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Subjects are eligible for enrollment in the study only if they meet all of the following criteria:
All women (regardless of childbearing potential) must test negative for pregnancy at the time of screening. Women must also agree to use a reliable method of birth control from screening until 12 weeks following last dose of study drug (adequate contraceptive measures include: intrauterine devices, hormonal contraceptives, complete sexual abstinence, or vasectomized partner), unless they are not of child-bearing potential as defined by meeting either of the following:
Exclusion Criteria:
All patients will receive LY3361237 450mg subcutaneously every 2 weeks for a total of 12 weeks.
Drug: LY3361237
All patients will receive LY3361237 450mg subcutaneously every 2 weeks for a total of 12 weeks.
Also known as: Venanprubart
Change in the Sjogren's Tool for Assessing Response (STAR)
Change from Baseline to Week 12 after treatment with LY3361237. STAR is intended to assess treatment efficacy based on improvement of disease activity for primary Sjögren's syndrome. The STAR contains 5 domains: systemic activity, symptoms, lacrimal and glandular gland function, and biomarkers of auto-immune activity. The score consists of five domains (systemic activity worth 3 points, patient-reported outcome worth 3 points, lacrimal gland function worth 1 point, salivary gland function worth 1 point, and biological worth 1 point). A patient is considered a STAR responder if they accrue ≥5 points.
Time frame: Baseline and Week 12
Change in unstimulated salivary flow
Unstimulated salivary flow as assessed by sialometry.
Time frame: Baseline and Week 12
Change in salivary gland ultrasound score
The Hočevar salivary gland ultrasound score (SGUS) will be calculated by assessing Parenchymal echogeneity, Homogeneity, Presence of hypoechogenic areas, Hyperechogenic reflections, and Clearness of salivary gland borders. The Hočevar ultrasound score will be calculated by summation of the grades for the five parameters described above for all four glands, with a range of 0-48 (with a higher score reflecting worse disease activity).
Time frame: Baseline and Week 12
Change in MRI findings on PET/MRI imaging
Imaging of the head and neck will be performed using positron emission magnetic resonance imaging. MRI of the salivary glands in Sjogren's syndrome patient demonstrate inhomogeneity of the parenchyma on both T1- and T2-weighted sequences.
Time frame: Baseline and Week 12
Change in FDG uptake on PET/MRI imaging
Imaging of the head and neck will be performed using positron emission magnetic resonance imaging. FDG-PET may demonstrate areas of uptake signaling active inflammation.
Time frame: Baseline and Week 12
Change in EULAR Sjögren's syndrome (SS) disease activity index
The ESSDAI is a systemic disease activity index that was designed to measure disease activity in patients with primary Sjogren's syndrome. The ESSDAI consists of a composite numerical score of 12 organ specific "domains" contributing to disease activity (constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, peripheral nervous system, central nervous system, muscular, hematological, and biological parameters). Each domain is divided into 3 to 4 levels according to the degree of activity and scored as 0 (no activity), 1 (low activity), 2 (moderate activity), or 3 (high activity). These scores are then multiplied by an assigned weight factor, ranging from 1 to 6, with the total score ranging from 0 to 123 points. A higher score denotes more disease activity.
Time frame: Baseline and Week 12
Change in Schirmer I test
Schirmer's test is used to determine whether the eye produces enough tears to keep it moist.
Time frame: Baseline and Week 12
No study locations are listed for this record.
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This study is withdrawn, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Venanprubart