Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT05781451
Status:
WITHDRAWN
Last Update Posted:
2024-04-17
First Post:
2023-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-BTLA Agonist Therapy in Subjects With Primary Sjogren's Syndrome
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
A Phase 2, Open Label Study of Anti-BTLA Agonist Therapy in Subjects With Primary Sjogren's Syndrome
Status:
WITHDRAWN
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug unavailable
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: