Activating the Cholinergic Anti-Inflammatory Pathway in Healthy Volunteers and People With Inflammatory Arthritis

Not Applicable

Recruiting

• Conditions: Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

• Registration Number: NCT06555562
• Lead Sponsor: Surf Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-3
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Healthy Volunteer Population<br><br>Inclusion Criteria:<br><br> - 22-75 years of age<br><br> - Weigh at least 40 kg<br><br>Exclusion Criteria:<br><br> - Any physical disabilities, conditions, or diseases that limit the capacity to<br> participate in study procedures or increase the risk of harm as determined by the<br> study PI<br><br> - Unable to provide informed consent<br><br> - Active bacterial or viral infection<br><br> - Class II obesity with a BMI of 35 or higher<br><br> - Pregnant women or those trying to become pregnant<br><br> - Active use of tobacco/nicotine products<br><br> - History of substance use disorder or active regular use of substances (nicotine,<br> marijuana, cocaine, psychedelics, stimulants, etc.)<br><br> - Splenomegaly, asplenia, or splenectomy<br><br>Inflammatory Arthritis Population<br><br>Inclusion Criteria:<br><br> - 22-75 years of age<br><br> - Weigh at least 40 kg<br><br> - Diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Axial Spondyloarthritis<br> of at least 6 months duration as defined by ACR guidelines<br><br> - Able to continue the same stable dose of immunomodulatory medication(s) while<br> participating in the study<br><br>Exclusion Criteria:<br><br> - Unable to provide informed consent<br><br> - Took a JAK inhibitor within the last 4 weeks, or likely to start one while<br> participating in this study<br><br> - Started a conventional synthetic DMARD (csDMARD) within the last 8 weeks or had a<br> change in prescription within the last 4 week<br><br> - Started a Tumor Necrosis Factor (TNF) inhibitor within the last 5 months or had a<br> change in prescription within the last 3 months<br><br> - Started any other biologic or targeted synthetic DMARD within the last 3 months, or<br> likely to start one while participating in the study<br><br> - Started a corticosteroid, had a change in prescription, or on a stable dose = or ><br> 10 mg of prednisone daily within the last 4 weeks<br><br> - Regular use of epinephrine like medications (cold, cough, congestion, or sinus<br> medications, bronchodilators, appetite suppressants)<br><br> - Active use of tobacco/nicotine products<br><br> - History of substance use disorder or likely use of substances during the study<br> period (marijuana, opioids/heroin, cocaine, psychedelics, methamphetamine, etc.)<br><br> - Active bacterial or viral infection<br><br> - Receiving chemotherapy or immunotherapy to treat malignancy<br><br> - Significant immunodeficiency due to underlying illness<br><br> - Class II obesity with a BMI of 35 or higher<br><br> - Pregnant women or those trying to become pregnant<br><br> - Wound, rash, infection, or traumatic injury over the target area<br><br> - Vagal nerve injury or vagotomy<br><br> - Surgery or major traumatic injury in the past 90 days<br><br> - Chronically-implanted medical devices (i.e. pacemaker, AICD, vagus nerve stimulator,<br> spinal cord stimulator)<br><br> - Clinically significant cardiovascular disease<br><br> - CKD Stage 3 or higher<br><br> - Uncontrolled fibromyalgia or other diffuse pain syndromes

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor Necrosis Factor Alpha Concentration Differences

Secondary Outcome Measures

Name	Time	Method
Interleuken 1b Concentration Difference;Interleuken 6 Concentration Difference