A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren’s Disease

The Purpose of the Study

Sjogren’s Disease (SjD) is an autoimmune disease that causes symptoms like dry eyes and dry mouth. This study evaluates a new investigational treatment called CLN-978 to see how safe it is and how well it works for individuals with active, moderate to severe forms of the condition.

What is CLN-978?

CLN-978 is a CD19-directed T-cell engager designed to be administered as a subcutaneous injection. In many autoimmune diseases, B-cells begin producing autoantibodies that mistakenly attack the body’s healthy tissues. CLN-978 acts like a matchmaker by physically bringing your body’s T-cells into contact with these problematic B-cells so the immune system can eliminate them. The goal of selectively removing these rogue cells is to allow the immune system to “start fresh” and reset, potentially providing a lasting reduction in autoimmune activity.

Who Can Participate?

You may be eligible to participate if you:

  • Have been diagnosed with Sjogren’s Disease for at least 24 weeks prior to the screening visit and meet the 2016 EULAR / ACR Classification Criteria.
  • Have an active, moderate to severe case of the disease, defined by an ESSDAI score of 5 or more at screening.
  • Meet specific laboratory requirements, including designated levels for your absolute lymphocyte count, absolute neutrophil count, and hemoglobin.
  • Do not have a concomitant rheumatological autoimmune disease or a high risk of thrombosis.
  • Have not received a live or attenuated vaccine within 28 days prior to the screening visit.

What to Expect During the Trial

  • Study Design: This is a Phase 1b open-label study, meaning all participants in the trial will receive the investigational drug. The trial is broken into two parts: a Part A dose escalation phase and a Part B further dose evaluation phase.
  • Dosing: Participants will receive the CLN-978 medication subcutaneously on specified days.
  • Monitoring: The treatment period will run for approximately 48 weeks, followed by an additional 4 to 8-week monitoring period to continually evaluate safety, effectiveness, and check for the detection of anti-drug antibodies.

Why Participate?

By participating in this Phase 1 trial, you will help researchers determine the safest and most optimal dose of CLN-978 for human patients. While there is no guarantee of direct personal benefit, your participation provides vital information that contributes to the development of this potential new targeted therapy for Sjogren’s Disease.

https://clinicaltrials.gov/study/NCT07041099