Splenic Stimulation for RA

• Status: Recruiting
• Trial end date: 2029-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, and effects of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. The study will consist of 4 study periods, including a Randomized Control Trial period (Period 1), an Open Label period (Period 2), a Treat-to-target period (Period 3), and a Long-term Follow-up period (Period 4). Participants eligible for implant will have active rheumatoid arthritis (RA) and have an inadequate response or intolerance to at least two biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) or JAK inhibitors (JAKis). A sufficient number of participants will be enrolled so that approximately 28 participants will undergo device implantation.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galvani Bioelectronics
• Collaborators: NAMSA; Q2 Solutions

Criteria

Inclusion Criteria:

• Adult-onset RA of at least six months duration

• Male or female participants, 22-75 years of age

• Active RA

• Inadequate Response to at least 2 biologic DMARDs and/or JAK-inhibitors (JAKis) including at least one TNF inhibitor.

• Have an appropriate washout from previously used biological DMARDs or JAKi

• Receiving treatment with standard dose(s) of conventional synthetic DMARD(s)

Exclusion Criteria:

• Inability to provide informed consent

• Significant psychiatric disease or substance abuse

• History of unilateral or bilateral vagotomy

• Active or latent tuberculosis

• Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B

• Positive SARS COV 2 PCR screening test for COVID-19 infection (at the point of screening for this study)

• Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators)

• Previous splenectomy