Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis

NCT07293871 | Recruiting Phase 2 FDA Device

• 1 other identifier: SURF-CLN-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Rheumatoid Arthritis (RA

Keywords

rheumatoid arthritis; RA; noninvasive; autoimmune

Outcome Measures

Primary Outcomes (2)

• Change in high sensitivity CRP (hsCRP)

  The primary endpoint is the change in hsCRP from baseline to weeks 2, 4, 6 and 8. The baseline value will be calculated as the average of the screening and baseline visits, both of which must be ≥ 10 mg/L.

  8 weeks

• Incidence of Adverse Events

  All adverse events (AEs) regardless of treatment group that occur over the 12 week enrollment period will be coded and summarized by frequency, severity, and relatedness using the latest MedDRA version (v28.1).

  12 weeks

Secondary Outcomes (5)

• American College of Rheumatology (ACR) 20, 50 and 70 response rates

  Week 8

• Change in Disease Activity Score-28 for Rheumatoid Arthritis with CRP (DAS28-CRP).

  Week 8

• Change in Heath Assessment Questionnaire Disability Index (HAQ-DI)

  Week 8

• Change in Clinical Disease Activity Index (CDAI) score for Rheumatoid Arthritis

  Week 8

• Change in Simplified Disease Activity Index (SDAI) for Rheumatoid Arthritis (RA)

  Week 8

Study Arms (2)

Treatment

EXPERIMENTAL

Daily active stimulation for 8 weeks

Device: Active treatment

Control

SHAM COMPARATOR

Daily sham stimulation, for 8 weeks, which will look and feel the same as active stimulation, but with no ultrasound energy entering the body

Device: Sham (No Treatment)

Interventions

Active treatment DEVICE

Daily active ultrasound stimulation

Treatment

Sham (No Treatment) DEVICE

Daily sham ultrasound stimulation

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Surf Therapeutics: lead

Study Sites (2)

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, 75034, United States

RECRUITING

Precision Comprehensive Clinical Research Solutions

Irving, Texas, 75061, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In addition the laboratory personnel analyzing the blood samples, and the statistician analyzing the trial data will be blinded to treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Stage 1 is a single group and open-label. Stage 2 is randomized, double-blind, sham-controlled with 2 treatment arms, active and sham, that are allocated 2:1.

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 19, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)