RecruitingPhase 2NCT07293871

Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis

Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis: Feasibility and Safety in a Multicenter, Randomized, Double-Blind, Sham-Controlled Trial

Sponsor

Surf Therapeutics

Enrollment

40 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis (RA)

Summary

This two-stage, multicenter clinical trial is designed to evaluate the feasibility, safety, and preliminary efficacy of at-home ultrasound stimulation to activate immune-neuromodulation in patients with rheumatoid arthritis (RA) and at least moderate disease activity. The study will enroll up to 40 participants at up to 6 sites across 2 stages. The findings from this trial will directly inform the design and power calculations for a future pivotal trial by identifying an appropriate effect size and confirming protocol feasibility and safety for a daily home-use therapy.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

At least 18 years old
Diagnosis of rheumatoid arthritis as defined by ACR/EULAR 2010 classification criteria
A positive test result for Rheumatoid Factor (RF) \> 14 IU/mL and/or Anti-Citrullinated Protein Antibodies (Anti-CCP) ≥ 20 U/mL
At least moderate disease activity, defined as DAS28-CRP \> 3.8 and at least 4/28 tender and 4/28 swollen joints at the screening and baseline visits
High sensitivity CRP (hsCRP) ≥ 10 mg/L at the screening and baseline visits

Exclusion Criteria25

Able and willing to comply with all study-related procedures, including at-home device use, daily treatment, scheduled visits, and assessments
Unable to provide informed consent
Current or planned participation in another interventional clinical trial
Prior use of \> 2 biologic or targeted synthetic DMARDs for RA where the primary reason for discontinuation was efficacy
Conventional synthetic DMARDs:
Initiated within last 12 weeks or adjusted dose within 4 weeks prior to enrollment
Inability to maintain a stable dose during the study
Biologic DMARDs:
Initiated or dose-adjusted within 12 weeks prior to enrollment
Inability to maintain a stable dose during the study
JAK inhibitors:
Use within 4 weeks prior to enrollment or expected use during study participation
Corticosteroids:
Initiated or dose-adjusted within 4 weeks prior to enrollment
Current dose \> 10 mg/day prednisone (or equivalent)
Current tobacco or nicotine product use
Pregnant or planning to become pregnant during the study period
Known hypersensitivity to ultrasound gel or membrane components
Active bacterial, viral, or fungal infection
Receiving chemotherapy or immunotherapy for malignancy
History of splenic disorders, including splenectomy, congenital asplenia, or splenomegaly on screening ultrasound
Rash, wound, or skin infection overlying the spleen
History of vagal nerve injury, vagotomy, or known autonomic neuropathy
Recent abdominal surgery or trauma within 30 days of screening
Uncontrolled fibromyalgia or other diffuse pain syndromes that may confound symptom reporting