Recruiting

Ultrasound Stimulation

Sponsor:

Surf Therapeutics

Code:

NCT07293871

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Active treatment

Sham (No Treatment)

Study Details

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

Study ID

NCT07293871

Start date

Mar 20, 2026

Status verified date

Jul, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • If on background DMARD therapy, must be on stable dose (see exclusion criteria)
  • Able and willing to comply with all study-related procedures, including daily treatment sessions in the study vehicle, research site visits, and assessments

Exclusion Criteria:

  • 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
  • If on a stable dose, inability to maintain the stable dose during the study period
  • Corticosteroids:

  • Initiation, dose adjustment, or discontinuation within 4 weeks prior to enrollment
  • Current dose >10 mg/day prednisone (or equivalent)
  • If on a stable dose, inability to maintain the stable dose during the study
  • NSAIDs:

  • Initiation, dose adjustment, or discontinuation of high-dose NSAIDs (≥1200 mg/day ibuprofen) within 14 days of informed consent. Over-the-counter use of NSAIDs is permissible.
  • Pregnant or planning to become pregnant during the study period
  • Known hypersensitivity to ultrasound gel or membrane components
  • History of splenic disorders, including splenectomy, congenital asplenia, or splenomegaly on baseline visit 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
  • Skin to spleen hilum depth >7 cm as measured by ultrasound at the baseline visit
  • Abdominal anatomy or condition precluding adequate ultrasound targeting of the spleen
  • Uncontrolled fibromyalgia or other diffuse pain syndromes that may confound symptom reporting
  • Any condition that, in the investigator's judgment, would preclude safe participation or compliance with study procedures

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Daily active stimulation for 8 weeks

sham comparator: Control

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

Interventions

Active treatment

Daily active ultrasound stimulation

Sham (No Treatment)

Daily sham ultrasound stimulation

Primary outcome measure

  • Incidence of Adverse Events [ Time Frame: 12 weeks ]
  • Adherence to Therapy [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Alexander Sackeim, MD

9145237345alex@surftherapeutics.com

Usman Asaf

9296027717uasaf@surftherapeutics.com

Locations

Precision Comprehensive Clinical Research Solutions

Recruiting

Colleyville, Texas, United States, 75034

Contacts

Sri Lekha Gaddam

469-498-0417info@pccrsolutions.com

Principal Investigator:

Dhiman Basu, MD

Rheumatology Associates

Recruiting

Dallas, Texas, United States, 75231

Contacts

Holly Hoefer

214-550-3029holly.hoefer@heliosclinical.com

Principal Investigator:

Robert Jenkins, MD, PhD

Precision Comprehensive Clinical Research Solutions

Recruiting

Irving, Texas, United States, 75061

Contacts

Akshay Shetty

469-498-0420info@pccrsolutions.com

Principal Investigator:

Renuka Basavaraju, MD

More Information

Sponsor

Surf Therapeutics

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Surf Therapeutics on 2026-07-07.