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Behçet DiseasePhase 2STELABECNCT02648581

Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients With Behçet Disease

A Phase 2 study testing Subcutaneous Ustekinumab in people with Behçet Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the proof of concept of efficacy of ustekinumab in subjects with Behçet disease, including patients with oral ulcers (STELABEC-1) and patients with active posterior uveitis or panuveitis (STELABEC-2) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Behçet Disease
What is being tested?
Subcutaneous Ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteFrance
Study dates
14 Jun 2017to 19 Nov 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are at least 18 years of age.
  • Have a diagnosis of BD according to the International Classification Criteria (criteria from the International Study Group and/or the 2013 International Criteria for BD).
  • Have an active disease at screening, defined by the presence of :
  • For the STELABEC-1 study : Recurrent oral and/or genital ulcers, defined as ≥2 episodes within 3 months before study entry. Before study entry, patients should have at least 2 oral ulcers within the last 2 weeks before baseline visit.
  • For the STELABEC-2 study : Active posterior uveitis and/or panuveitis and/or retinal vasculitis, defined by the presence of at least 1 or the following parameters in at least one eye :
  • Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
Show all 26Show fewer
  • ≥2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria)
  • ≥2+ vitreous haze (National Eye Institute [NEI]/SUN criteria)
  • Have previously received at least 1 non-biologic therapy :
  • For the STELABEC-1 study : Colchicine ≥1 mg/day for all patients For the STELABEC-2 study : Subjects must have active disease at the baseline visit despite at least 2 weeks of oral prednisone ≥ 10 mg/day to ≤60 mg/day (or oral corticosteroid equivalent) with or without prior high dose corticoid pulse.
  • Are without treatment regimen (due to ineffectiveness / intolerance) or on a stable BC treatment regimen consisting of any of the following medications (alone or in combination) : Corticosteroids for a period of at least 2 weeks prior to Day 0 Colchicine for a period of at least 30 days prior to Day 0 Immunosuppressive or immunomodulatory agents for a period of at least 30 days prior to Day 0 Thalidomide for a period of at least 60 days prior to Day 0
  • A female subject is eligible to enter the study if she is :
  • Not pregnant or breast-feeding
  • Of non-childbearing potential (ie, women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); or
  • Of childbearing potential (ie, women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at screening, and agree to 1 of the following :
  • Complete abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent until 8 weeks after the last dose of study agent; or
  • Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the study agent and 15 weeks after the last dose of study agent :
  • Implants of levonorgestrel;
  • Injectable progesterone;
  • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year;
  • Oral contraceptives (either combined or progesterone only);
  • Double barrier method: Condom, cervical cap or diaphragm with spermicidal agent;
  • Transdermal contraceptive patch;
  • Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subject.
  • Have the ability to understand the requirements of the study provide written informed consent (including consent for the use and disclosure of research-related health information) and comply with the study protocol procedures (including required study visits).
  • Affiliation with a mode of social security (profit or being entitled)

Who cannot join

  • Have required 3 or more courses of systemic corticosteroids for concomitant conditions (eg, asthma, atopic dermatitis) within 90 days of Day 0 (Topical or inhaled steroids are permitted)
  • Have received intravenous (IV) or oral cyclophosphamide within 180 days of Day 0.
  • Have received any of the following within 90 days of Day 0 :
  • Anti-TNF therapy (eg, adalimumab, etanercept, infliximab). Interleukin-1 receptor antagonist (anakinra). Abatacept Interleukin-6 receptor antagonist (tocilizumab) Intravenous immunoglobulin (IVIG) High dose prednisone (> 100 mg/day).
  • Have received any of the following within 60 days of Day 0 :
  • A non-biologic investigational agent. Any new immunosuppressive/immunomodulatory agent. Any steroid injection (intramuscular, intraarticular or intravenous).
Show all 25Show fewer
  • Have received any of the following within 30 days of Day 0 :
  • A live vaccine within 30 days of Day 0. A change in dose of a corticosteroid within 2 weeks days of Day 0. A change in dose of other immunosuppressive/immunomodulatory agent within 30 days of Day 0.
  • Have very severe Behçet disease (defined by current severe complication of BD: digestive, cardiac, pulmonary or central nervous system involvement assessed as very severe by the referring clinician) requiring high dose prednisone (≥1mg/kg) within 30 days of Day 0 (with the exception of high dose prednisone pulse for active uveitis)
  • Have a history of a major organ transplant (eg, heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
  • Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to BD which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk.
  • Have a planned surgical procedure or a history of any other.
  • Medical disease, laboratory abnormality, or condition that, in the opinion of the principal investigator, makes the subject unsuitable for the study.
  • Have a history of malignant neoplasm within the last 5 years, except for treated cancers of the skin or carcinoma in situ of the uterine cervix.
  • Have required management of acute or chronic infections :
  • Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria).
  • Hospitalization for treatment of infection within 60 days of Day 0.
  • Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 60 days of Day 0.
  • Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0.
  • Have a historically positive test or test positive at screening for HIV-1 antibody, hepatitis C virus antibodies, hepatitis B surface antigen (HbsAg), or antiHBcAg positivity (without HbsAg positivity).
  • Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed:
  • Stable Grade 3 prothrombin time (PT) secondary to warfarin treatment.
  • Stable Grade 3/4 proteinuria (≤ 6 g/24 hour equivalent by spot urine protein to creatinine ratio allowed).
  • Stable Grade 3 neutropenia or stable Grade 3 white blood cell count.
  • Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Cochin, Department of Internal Medicine, National Reference Center for Autoimmune and Systemic Diseases

    Paris, Paris, 75014

Other trials in France

About this study

Official title: A Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients With Behçet Disease

The purpose of this study is to evaluate the proof of concept of efficacy of ustekinumab in subjects with Behçet disease, including patients with oral ulcers (STELABEC-1) and patients with active posterior uveitis or panuveitis (STELABEC-2)

Read the detailed description

Behçet disease (BD) is a chronic systemic inflammatory disorder at the crossroad between autoimmune and autoinflammatory syndromes. Two recent large genome-wide association studies (GWAS) conducted in Turkey and Japan reported association between single nucleotide polymorphism (SNP) of interleukin (IL)-10 and IL-23R/IL-12RB2 genes and BD. Interleukin-12 and interleukin-23, cytokines that induce naive CD4+ lymphocytes to differentiate into type 1 helper T cells (Th1 cells) and type 17 helper T cells (Th17 cells), respectively, have been identified as key mediators of BD. Promotion of Th1 and Th17 responses and suppression of regulatory T cells correlate with BD activity.

Due to the lack of an etiologic agent, the treatment is symptomatic without consensus. The goals are the functional recovery of a visceral involvement (eye, central nervous system) and prevention of relapse(s). The risks of BD are an increased mortality especially in case of arterial involvement, and a high morbidity due to the cumulative sequelae of ocular and neurological involvement. Steroids are the corner stone of the antiinflammatory agents administered topically or systemically. Relapses are frequently seen after discontinuation of steroids, and corticodependence is frequently observed leading to the use of immunosuppressive drugs.

Biologic agents that selectively block steps in the inflammatory cascade could provide additional therapies for BD.

Conditions
Behçet Disease
Being tested
Subcutaneous Ustekinumab
Keywords
Behçet, ulcers, uveitis, ustekinumab, biologics
Medical subject headings
Behcet Syndrome, Ulcer, Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subcutaneous UstekinumabDrug

    Injections of ustekinumab at 90 mg at week 0, week 4 and week 16. Patients in treatment failure at week 24 will terminate the study. Responder patients at week 24 will receive additional 2 injections of ustekinumab at week 28 and week 40 with a final evaluation at week 52.

Study groups in NCT02648581
Study groupRoleWhat they receive
Subcutaneous UstekinumabExperimentalNot described
Receives: Drug: Subcutaneous Ustekinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of oral ulcers at week 24 compared to baseline

    Treatment efficacy at week 24 for STELABEC-1 study on oral ulcers

    Measured: 24 weeks

  2. Number of uveitis or retinal vasculitis remission

    Treatment efficacy at week 24 for STELABEC-2 study on eye involvement

    Measured: 24 weeks

Secondary outcomes (40)

  1. Number of oral and genital ulcers

    Measured: at baseline visit (week 0)

  2. Number of oral and genital ulcers

    Measured: 4 weeks

  3. Number of oral and genital ulcers

    Measured: 8 weeks

  4. Number of oral and genital ulcers

    Measured: 12 weeks

  5. Number of oral and genital ulcers

    Measured: 16 weeks

  6. Number of oral and genital ulcers

    Measured: 24 weeks

  7. Number of oral and genital ulcers

    Measured: 28 weeks

  8. Number of oral and genital ulcers

    Measured: 40 weeks

  9. Number of oral and genital ulcers

    Measured: 52 weeks

  10. Pain Visual Analog Scales of oral and genital ulcers

    Measured: at baseline visit (week 0)

  11. Pain Visual Analog Scales of oral and genital ulcers

    Measured: 4 weeks

  12. Pain Visual Analog Scales of oral and genital ulcers

    Measured: 8 weeks

  13. Pain Visual Analog Scales of oral and genital ulcers

    Measured: 12 weeks

  14. Pain Visual Analog Scales of oral and genital ulcers

    Measured: 16weeks

  15. Pain Visual Analog Scales of oral and genital ulcers

    Measured: 24 weeks

  16. Pain Visual Analog Scales of oral and genital ulcers

    Measured: 28 weeks

  17. Pain Visual Analog Scales of oral and genital ulcers

    Measured: 40 weeks

  18. Pain Visual Analog Scales of oral and genital ulcers

    Measured: 52 weeks

  19. Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze

    Measured: baseline visit (week 0)

  20. Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze

    Measured: 4 weeks

  21. Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze

    Measured: 8 weeks

  22. Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze

    Measured: 12 weeks

  23. Visual acuity by Early Treatment Diabetic Retinopathy Study (ETDRS)

    Measured: 16 weeks

  24. Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze

    Measured: 24 weeks

  25. Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze

    Measured: 28 weeks

  26. Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze

    Measured: 40 weeks

  27. Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze

    Measured: 52 weeks

  28. Behçet Syndrome Activity Score (BSAS)

    Measured: 12 weeks

  29. Behçet Disease Current Activity Form (BDCAF)

    Measured: 12 weeks

  30. Behçet Syndrome Activity Score (BSAS)

    Measured: 24 weeks

  31. Behçet Disease Current Activity Form (BDCAF)

    Measured: 24 weeks

  32. Behçet Syndrome Activity Score (BSAS)

    Measured: 52 weeks

  33. Behçet Disease Current Activity Form (BDCAF)

    Measured: 52 weeks

  34. Behçet Disease Quality of Life Measure : Short Form-36 (SF- 36)

    Measured: 12 weeks

  35. Behçet Disease Quality of Life Measure : Routine Assessment of Patient Index Data 3 (RAPID3)

    Measured: 12 weeks

  36. Behçet Disease Quality of Life Measure : Short Form-36 (SF- 36)

    Measured: 24 weeks

  37. Behçet Disease Quality of Life Measure : Routine Assessment of Patient Index Data 3 (RAPID3)

    Measured: 24 weeks

  38. Behçet Disease Quality of Life Measure : Short Form-36 (SF- 36)

    Measured: 52 weeks

  39. Behçet Disease Quality of Life Measure : Routine Assessment of Patient Index Data 3 (RAPID3)

    Measured: 52 weeks

  40. Number of adverse events

    adverse events including headache, arthralgia, infection (pneumonia and bronchitis),skin infections, shingles, depression, dizziness, diarrhea, pruritus, myalgia, asthenia

    Measured: from baseline visit up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2016 (estimated)
  2. Study start14 Jun 2017
  3. Primary completion7 May 2019
  4. Study completion19 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02648581
Sponsor's protocol ID
P140302
Acronym
STELABEC
Status last verified
Sep 2025
First submitted
21 Dec 2015
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Revel MP, Chassagnon G, Sanchez O, Ferretti G, Millet I, Rocher L, Maitre S, Lederlin M, Ducou-le-Pointe H, Rousset P, Bennani S, Zins M, Bruneau B, Tissot V, Alison M, Canniff E, Siauve N, Vandeventer S, Le Blanche AF, Planquette B, Tsatsaris V, Coste J. CT venography for the diagnosis of postpartum venous thromboembolism: a prospective multi-center cohort study. Eur Radiol. 2024 Nov;34(11):7419-7428. doi: 10.1007/s00330-024-10791-8. Epub 2024 May 23.

    PubMed 38782788

  • London J, Regent A, Dion J, Jilet L, Jachiet M, Lidove O, Cohen-Aubart F, Aractingi S, Guegan S, Pennaforte JL, Abdoul H, Puechal X, Terrier B. Efficacy and safety of ustekinumab in Behcet disease: Results from the prospective phase 2 STELABEC trial. J Am Acad Dermatol. 2022 Sep;87(3):681-684. doi: 10.1016/j.jaad.2021.11.045. Epub 2021 Dec 2. No abstract available.

    PubMed 34864108

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Subcutaneous Ustekinumab in people with Behçet Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of oral ulcers at week 24 compared to baseline (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02648581, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

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