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

NCT02648581 | Completed Phase 2

• 1 other identifier: P140302
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Behçet Disease

Keywords

Behçet; ulcers; uveitis; ustekinumab; biologics

Outcome Measures

Primary Outcomes (2)

• Number of oral ulcers at week 24 compared to baseline

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

  24 weeks

• Number of uveitis or retinal vasculitis remission

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

  24 weeks

Secondary Outcomes (40)

• Number of oral and genital ulcers

  at baseline visit (week 0)

• Number of oral and genital ulcers

  4 weeks

• Number of oral and genital ulcers

  8 weeks

• Number of oral and genital ulcers

  12 weeks

• Number of oral and genital ulcers

  16 weeks

Study Arms (1)

Subcutaneous Ustekinumab

EXPERIMENTAL

Drug: Subcutaneous Ustekinumab

Interventions

Subcutaneous Ustekinumab DRUG

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.

Subcutaneous Ustekinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ≥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 :

You may not qualify if:

• 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).
• 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 :

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

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

Paris, Paris, 75014, France

Location

Related Publications (2)

• 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.

  PMID: 38782788 BACKGROUND

• 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.

  PMID: 34864108 BACKGROUND

MeSH Terms

Conditions

Behcet Syndrome; Ulcer; Uveitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin TERRIER, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: January 7, 2016
• Study Start: June 14, 2017
• Primary Completion: May 7, 2019
• Study Completion: November 19, 2019
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)