Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis

NCT07293871 | Recruiting FDA Device

• 1 other identifier: SURF-CLN-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

This two-stage, multicenter clinical trial is designed to evaluate the feasibility, safety, and preliminary efficacy of splenic ultrasound stimulation to activate immune-neuromodulation (SUSTAIN) in patients with rheumatoid arthritis (RA) and at least moderate disease activity. 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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; RA; noninvasive; autoimmune; cholinergic anti-inflammatory pathway; neuroimmune modulation; spleen

Outcome Measures

Primary Outcomes (2)

• 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

• Adherence to Therapy

  Proportion of patients adherent to treatment, defined by completing ≥70% of the 56 scheduled ultrasound treatments

  8 weeks

Secondary Outcomes (6)

• 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
• At least moderate disease activity, defined as ≥4 tender joints (28-joint count) and ≥4 swollen joints (28-joint count) and a DAS28-CRP \>3.2 at the baseline visit
• hsCRP \> 0.3 mg/dL at the last qualifying visit, baseline or retest

You may not qualify if:

• Able and willing to comply with all study-related procedures, including daily treatment sessions in the study vehicle, research site visits, and assessments
• Unable to provide informed consent
• Current or planned participation in another interventional clinical trial
• Inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis. Current diagnosis of secondary Sjogren's Syndrome is permitted.
• Prior use of \>2 biologic or targeted synthetic DMARDs for RA where the primary reason for discontinuation was efficacy
• Conventional synthetic DMARDs:
• Initiation within 12 weeks prior to enrollment
• Dose adjustment or discontinuation within 4 weeks prior to enrollment
• If on a stable dose, inability to maintain the stable dose during the study period
• Biologic DMARDs:
• Initiation or dose adjustment within 12 weeks prior to enrollment
• Discontinuation within 4 weeks prior to enrollment
• If on a stable dose, inability to maintain the stable dose during the study period
• JAK inhibitors:
• Initiation, dose adjustment, or discontinuation within 4 weeks prior to enrollment

Sponsors & Collaborators

• Surf Therapeutics: lead

Study Sites (3)

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, 75034, United States

RECRUITING

Rheumatology Associates

Dallas, Texas, 75231, 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

Central Study Contacts

Alexander Sackeim, MD

CONTACT

9145237345; alex@surftherapeutics.com

Usman Asaf

CONTACT

9296027717; uasaf@surftherapeutics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• 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 an open-label pilot of 6-10 participants divided into two groups (experimental treatment 1 or experimental treatment 2). Stage 2 is randomized, double-blind, sham-controlled trial of 30-40 participants with 2 arms, active treatment and sham, that are allocated 1:1.

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 19, 2025
• Study Start: March 20, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)