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Autoimmune & Inflammatory

Behçet Disease Clinical Trials and Treatments

Also called Behcet's Disease, Behçet's Syndrome

Behçet Disease is a chronic, recurrent systemic vasculitis affecting small, medium, and large vessels of multiple organ systems. The pathophysiology involves abnormal T cell activation, increased Th1/Th17 responses, and immune complex deposition leading to vessel inflammation. Recurrent mouth ulcers occur in nearly all patients, and most also have genital ulcers.

In plain words, Behçet disease is a rare long-term condition where blood vessels become swollen and irritated again and again. Painful sores in the mouth and genitals are common, along with eye, skin and other organ problems.

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Behçet Disease

Where treatments stand, from ClinicalTrials.gov and FDA labels

Also 4 studies with no phase, like observational studies.

FDA review0

No decision pending. FDA calendar

FDA-approved medicines1

Otezla

Behçet Disease has 1 FDA-approved medicine, 5 open or active clinical trials (3 recruiting), and no pending FDA decision.

Labels checked October 21, 2026. Corticosteroids and immune globulins count once each.Download the data

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More about Behçet Disease

Recurrent painful oral ulcers are the hallmark feature, typically appearing as well-demarcated shallow ulcers with erythematous borders. Genital ulcers occur in 75% of patients and can be more painful and scarring than oral ulcers. Ocular involvement (uveitis) occurs in 50-90% of patients, ranging from mild anterior uveitis to severe posterior uveitis with retinal vasculitis, optic neuritis, and vision-threatening complications.

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Skin manifestations include erythema nodosum, pseudofolliculitis, papulopustules, and acne-like lesions. Vascular involvement includes superficial and deep venous thrombosis (thrombophlebitis), arterial aneurysms, and large vessel vasculitis. Neurologic manifestations (neuro-Behçet) occur in 5-30% and include meningoencephalitis, optic neuritis, and myelitis. Gastrointestinal involvement with ulceration occurs in 5-10%.

What are the symptoms of Behçet Disease?

These are common symptoms of Behçet Disease, and how strong they are varies from person to person.

  • Recurrent painful oral ulcers (aphthous stomatitis)
  • Recurrent genital ulcers
  • Ocular involvement with eye pain, redness, and vision loss (uveitis)
  • Skin lesions including erythema nodosum and pseudofolliculitis
  • Vascular complications including thrombosis
  • Neurologic symptoms from central nervous system involvement

Who gets Behçet Disease?

NORD reports that Behçet Disease usually begins between ages 30 and 40, though it can start at any age. In the United States it is more common in women, whose symptoms tend to be milder, while in Middle Eastern countries men may be affected more often and usually have more severe disease, according to NORD.

The disease predominantly affects people from Turkey, Iran, Japan, Korea, China, Middle East, and Mediterranean regions. It is rare in Northern European and North American populations. HLA-B51 positive patients tend to have more severe disease.

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Which medicines are FDA-approved for Behçet Disease?

There is currently 1 FDA-approved medication for Behçet Disease.

apremilast
Amgen
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Source: openFDA drug labeling data. This list may not include all treatments. Always consult your doctor.

Which new Behçet Disease medicines are in trials?

Investigational medicines Trial Friend tracks for Behçet Disease, with trial results, safety findings and where each one stands.

How to get help paying for Behçet Disease treatment

Charity funds and drugmaker programs for Behçet Disease, checked at the source.

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Side effects people have reported to the FDA

Side effects people have reported to the FDA

Real-world side effect reports from the FDA Adverse Event Reporting System (FAERS). Includes both FDA-approved drugs and investigational therapies from active clinical trials. Click any drug to see what patients reported.

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Diagnosis and genetic testing

Genetic testing for Behçet Disease

Genetic testing can confirm a diagnosis, guide treatment decisions, and identify family members who may be at risk.

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Trusted Behçet Disease resources

Reputable organizations and medical references for learning more about Behçet Disease, including disease registries, foundation resources, and clinical guidelines.

Active clinical trials for Behçet Disease

Use this Behçet Disease clinical trial finder to see the 3 studies recruiting patients and 2 not yet recruiting in the United States and worldwide, with eligibility criteria in plain English. Of these, 3 test a treatment and 2 are observational studies or registries; each card says which. Every trial comes from ClinicalTrials.gov.

Jump to the trial list, the site map or the pipeline timeline.

Note: Trial recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator before making plans.

5 active trials worldwide
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Not yet recruitingObservational study, no treatment givenRecently updatedNCT07737470

Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research

Sponsor: Assistance Publique - Hôpitaux de Paris

INFLAME-BANK is a French multicenter prospective observational ancillary study of the international EACVI-INFLAME project. It aims to establish a biobank and perform immunophenotyping and proteomic analyses in patients with suspected inflammatory cardiovascular diseases and autoimmune rheumatic diseases (ICARDs).

Ages 18 Years+
Expected to start Dec 2026Updated todayEst. Oct 2028 (~1y 10m)
Not yet recruitingObservational study, no treatment givenRecently updatedNCT07845162

Serum EBI-3 Protein Levels in Behçet's Disease

Sponsor: Assiut University

This cross-sectional study aims to evaluate serum Epstein-Barr virus-induced gene 3 (EBI-3) protein levels in patients with Behçet's disease compared with healthy controls.

Ages 18 Years+
Expected to start Sep 2026Updated 1 month agoEst. Sep 2027 (~10 months)
RecruitingTreatment trialPhase 3Updated a few months agoNCT04528082

Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease

Intervention: Apremilast, Placebo

Sponsor: Amgen

The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to < 18 years of age with oral ulcers associated with Behçet's disease (BD) through week 12.

Ages 2 Years to 17 Years
Started Sep 2021Updated 3 months agoEst. Feb 2030 (~3y 2m)
RecruitingTreatment trialNo updates in a whileNCT04334031

Deployment o the Multidisciplinary Prospective Cohort Imminent

Intervention: Biobanking with genetic analysis, SF-12 questionnaire

Sponsor: University Hospital, Lille

Immune-mediated inflammatory diseases (IMIDs) most often affect young patients and have high impact on morbidity and mortality with a significant alteration in the quality of life of patients with professional, social and emotional repercussions.

Ages 18 Years+1 location
Started Jul 2020Updated 6 months agoEst. Jul 2031 (~4y 8m)
RecruitingTreatment trialNo updates in a whileNCT07375940

Clinical, Biochemical and Epigenetic Profile of Pediatric Behçet Disease

Intervention: Biomarker analysis of blood samples, Biomarker analysis of blood samples, Biomarker analysis of blood samples

Sponsor: Meyer Children's Hospital IRCCS

Behçet disease (BD) is a chronic multisystem inflammatory disorder with a relapsing-remitting course. Pediatric-onset BD is rare and characterized by marked clinical heterogeneity, frequent incomplete presentation at disease onset, and limited availability of pediatric-specific outcome measures and biomarkers.

Ages 6 Months to 70 Years2 locations
Started Jan 2026Updated 9 months agoEst. Jan 2036 (~9y 2m)
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Active trial locations25 cities
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Trial Pipeline

Jan 2021 to Nov 2031
2021
2023
2025
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2029
2031
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Phase 3
Observational
Observational
RecruitingNot yet recruitingDelayed startTodayHover a bar for trial details

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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
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Behçet Disease patient communities

Facebook groups, Reddit communities and YouTube channels where Behçet Disease patients, caregivers and advocacy groups talk.

Companies developing Behçet Disease treatments

Drugmakers that list Behçet Disease in their rare disease portfolio, 2 in all.

Questions people ask about Behçet Disease