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Anti-BTLA Agonist Therapy in Subjects With Primary Sjogren's Syndrome

NCT05781451 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-04-17

No results posted yet for this study

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.

Conditions

  • Primary Sjogren's Syndrome

Interventions

DRUG

LY3361237

All patients will receive LY3361237 450mg subcutaneously every 2 weeks for a total of 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Matthew C Baker, MD, MS · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-01-01
Completion
2028-01-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05781451 on ClinicalTrials.gov