Safety of Splenic Stimulation for RA

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04955899
• Other study ID #: GAL1039
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: April 2029

Study information

• Verified date: February 2024
• Source: Galvani Bioelectronics
• Contact: Operations Director
• Phone: +44 (0)800 3688514
• Email: clinical[@]galvani.bio
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: April 2029
• Est. primary completion date: April 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Device:
• Active Stimulation
The Galvani System will be implanted in eligible participants, and stimulation will be turned ON

Locations

Country	Name	City	State
Netherlands	Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology	Amsterdam
United Kingdom	Greater Glasgow Health Board	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
Galvani Bioelectronics	NAMSA

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of the Galvani system	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	12 weeks
Secondary	Effect of stimulation on the change in pharmacodynamic and response biomarkers	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	Day 1 to week 12
Secondary	To evaluate the usability of the external Galvani System devices and accessories	Summarize feedback collected on questionnaires pertaining to the use of the external Galvani System devices	12 weeks
Secondary	To evaluate the participants' perception of therapy and sensation	Summarize feedback collected on questionnaires	12 weeks
Secondary	Evaluate device performance	Tabulation of device deficiencies	12 weeks