Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05781451
Status:
WITHDRAWN
Last Update Posted:
2024-04-17
First Post:
2023-02-23
Brief Title:
Anti-BTLA Agonist Therapy in Subjects With Primary Sjogrens Syndrome
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
A Phase 2 Open Label Study of Anti-BTLA Agonist Therapy in Subjects With Primary Sjogrens 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WITHDRAWN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 Sjogrens 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 Sjogrens syndrome
The primary objective is to evaluate the efficacy of LY3361237 in patients with primary Sjogrens syndrome by assessing changes in the Sjogrens 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 PETMRI
The primary objective is to evaluate the efficacy of LY3361237 in patients with primary Sjogrens syndrome by assessing changes in the Sjogrens 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 PETMRI
Detailed Description:
This study is a single-site open-label study in subjects with primary Sjogrens 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 proteincreatinine 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 Sjogrens 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 PETMRI 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 proteincreatinine 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 Sjogrens 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 PETMRI 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:
None
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?:
None