Safety of Splenic Stimulation for RA

Galvani Bioelectronics

Status

Enrolling

Conditions

Rheumatoid Arthritis

Treatments

Device: Active Stimulation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04955899

GAL1039

Details and patient eligibility

About

This study will evaluate the safety and tolerability of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. 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). Five participants will be implanted with the device and receive neurostimulation for 12 weeks.

Full description

The study will be an open-label single-arm study to evaluate the safety and tolerability of Galvani's neuromodulation system. Participants with active rheumatoid arthritis (RA) will be implanted with the Galvani system and receive active stimulation for 12 weeks. The total study duration in the study for each participant is approximately 5 months, with a 4-week screening period, 4 weeks recovery from surgery and a 12-week 'treatment' period. The participants will return to the clinic on pre-defined days for follow-up visits during the trial period. At Days 42 and/or Day 56, if study participants are not responding to stimulation, stimulation parameters might be adapted. At the end of the study (Day-84), participants will enroll in a long-term follow-up study up to 5-years after enrollment in this study.

Enrollment

5 estimated patients

Sex

All

Ages

22 to 75 years old

Volunteers

No Healthy Volunteers

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)
Have an appropriate washout from previously used biological DMARDs or JAKi
A female participant should have no child-bearing potential

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.
Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators).
Previous splenectomy
Any investigational small molecule drug or biological within 2 weeks or 2 half-lives whichever is longer, before surgery.
Uncontrolled other inflammatory diseases
Current/recurrent infections that in the opinion of the PI risk>benefit.
History of cancer within the past 5 years, except non-malignant skin cancer.
Chronic use of morphine or oxicodone