Safety of Splenic Stimulation for RA

Sponsor

Galvani Bioelectronics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04955899

Collaborator

NAMSA (Other)

Enrollment

Location

Arm

9.4

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Device: Active Stimulation	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

A Single Arm Pilot Study to Evaluate the Safety and Feasibility of Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis Using an Active Implantable Device

Actual Study Start Date :

Oct 20, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Stimulation Active stimulation for 12 weeks	Device: Active Stimulation The Galvani System will be implanted in eligible participants, and stimulation will be turned ON

Arm

Intervention/Treatment

Experimental: Active Stimulation

Active stimulation for 12 weeks

Device: Active Stimulation

The Galvani System will be implanted in eligible participants, and stimulation will be turned ON

Outcome Measures

Primary Outcome Measures

Safety and tolerability of the Galvani system [12 weeks]
Incidence and relatedness of Adverse Events (AEs), which include clinically significant findings from Laboratory Safety Assessments (clinical chemistry and hematology), vital signs (blood pressure, heart rate, respiratory rate, and body temperature), and 12-Lead ECG

Secondary Outcome Measures

Effect of stimulation on the change in pharmacodynamic and response biomarkers [Day 1 to week 12]
Changes from baseline (Day 1) in the levels of LPS-inducible cytokine/ chemokine release, in whole blood assay at different timepoints after start of stimulation
To evaluate the usability of the external Galvani System devices and accessories [12 weeks]
Summarize feedback collected on questionnaires pertaining to the use of the external Galvani System devices
To evaluate the participants' perception of therapy and sensation [12 weeks]
Summarize feedback collected on questionnaires
Evaluate device performance [12 weeks]
Tabulation of device deficiencies

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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