NCT06779123 Treatment With Auricular Vagus Nerve Stimulation in Rheumatoid Arthritis - the TRAVAGA Study
| NCT ID | NCT06779123 |
| Status | Recruiting |
| Phase | — |
| Sponsor | taVNS AB |
| Condition | Rheumatoid Arthritis (RA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2026-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 128 participants in total. It began in 2025-03-21 with a primary completion date of 2026-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Purpose and aim The overall aim is to investigate efficacy and safety of a newly developed non-invasive auricular investigational device that electrically stimulates the auricular branch of the vagus nerve to activate the cholinergic anti-inflammatory mechanism to treat rheumatoid arthritis patients not responding to standard therapy. The mode of treatment is termed transcutaneous auricular vagus nerve stimulation (taVNS). Specifically, the investigators will address the following research questions: The investigation is a multicenter, placebo-controlled, randomized, double-blinded, superiority, clinical study to evaluate the safety and efficacy of a novel transcutaneous auricular vagus nerve stimulator system, termed TRAVAGUS, in patients with moderate-to-severe rheu-matoid arthritis (RA) who are incomplete responders or are intolerant to biologic or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs). The primary efficacy endpoint is the proportion of patients achieving an ACR20 response (a composite measure of the effectiveness of arthritis treatments set forth by the American College of Rheumatology) in the treatment group compared to sham group at 12 weeks. Electrical vagus nerve stimulation is an investigational anti-inflammatory therapy targeting the nervous system to modulate immune activity. RA is a global disease associated with significant reduced quality of life and very high health care costs substantially driven by therapeutics. While many with RA have benefited from modern era biologic and small molecule therapies, unresolved chronic inflammation is common despite treatment. Therefore, non-toxic, lower cost anti-inflammatory, non-pharmacologic therapy is needed. Note: This study relates to a FDA-nonregulated Drug and FDA-nonregulated Device. There are no U.S. Locations for the study. The study was approved by EMA.
Eligibility Criteria
Inclusion Criteria: * \> 18 years of age on day of signing informed consent * Active RA, DAS28\>3.2, at least 4/28 tender and 4/28 swollen joints * Demonstrated an inadequate response, loss of response, or intolerance to one or more approved for rheumatoid arthritis biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), including Janus kinase inhibitors. * Stable dose of glucocorticoids or conventional disease-modifying agents in RA (csDMARDs) at least 2 and 4 weeks, respectively, before screening Exclusion Criteria: * History of vagotomy * Partial or complete splenectomy * Recurrent vasovagal syncope episodes * Untreated or poorly controlled psychiatric illness * Significant immunodeficiency due to underlying illness * History of cerebrovascular insult * Clinically significant cardiovascular disease * Uncontrolled fibromyalgia * Pregnancy (if sexually active, using reliable form of birth control or being at least 2 yrs post-menopausal)
Contact & Investigator
Ulf Andersson, Professor
STUDY DIRECTOR
taVNS AB
Frequently Asked Questions
Who can join the NCT06779123 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rheumatoid Arthritis (RA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06779123 currently recruiting?
Yes, NCT06779123 is actively recruiting participants. Contact the research team at jon.lampa@ki.se for enrollment information.
Where is the NCT06779123 trial being conducted?
This trial is being conducted at Lund, Sweden, Malmö, Sweden, Örebro, Sweden, Stockholm, Sweden and 2 additional locations.
Who is sponsoring the NCT06779123 clinical trial?
NCT06779123 is sponsored by taVNS AB. The principal investigator is Ulf Andersson, Professor at taVNS AB. The trial plans to enroll 128 participants.
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