A Study to Evaluate the Efficacy and Safety of Ustekinumab in patients with Behçet disease
- Conditions
- Behçet diseaseSTELABEC-1: patients with oral ulcersSTELABEC-2 : patients with active posterior uveitis or panuveitisMedDRA version: 18.1Level: LLTClassification code 10004212Term: Behcet's diseaseSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-002190-37-FR
- Lead Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
1. Are at least 18 years of age.
2. 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).
3. 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 :
i. Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
ii. >=2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria)
iii. >=2+ vitreous haze (National Eye Institute [NEI]/SUN criteria)
Patients presenting with both muco-cutaneous and ocular manifestations will be included in the STELABEC-1 or STELABEC-2 trial according to the severity of each manifestation, based on the decision of the physician in charge of the patients. Patients with predominant muco-cutaneous manifestations will be included in STELABEC-1, whereas those with predominant ocular manifestations will be included in STELABEC-2.
4. 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)
5. Are on a stable BD 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 (ie, day of 1st dose of study agent)
- 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 (ie, day of 1st dose of study agent)
- Thalidomide for a period of at least 60 days prior to Day 0
6. 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 ag
1. 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)
2. Have received intravenous (IV) or oral cyclophosphamide within 180 days of Day 0.
3. 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).
4. Have received any of the following within 60 days of Day 0:
- A non-biologic investigational agent.
- Any new immunosuppressive/immunomodulatory agent.
Note: New inhaled steroids and new topical immunosuppressive agents (eg, eye drops, topical creams) are allowed. Any NSAID use for < 1 week is allowed.
- Any steroid injection (intramuscular, intraarticular or intravenous).
5. 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.
6. 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.
7. Have a history of a major organ transplant (eg, heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
8. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to BD (ie, cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk.
9. Have a planned surgical procedure or a history of any other medical disease (eg, cardiopulmonary), laboratory abnormality, or condition (eg, poor venous access) that, in the opinion of the principal investigator, makes the subject unsuitable for the study.
10. Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
11. Have required management of acute or chronic infections, as follows:
- 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.
12. 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.
13. Have a historically positive test or test positive at screening for HIV-1 antibody, hepatitis C virus antibodies, hepatitis B surface antigen (HbsAg) (with or without positive serum HBV DNA), or antiHBcAg positivity (without HbsAg positivity), or positive for Hepatitis C antibody (confirmed on the same sample with a Hepatitis C RIBA® immunoblot assay). .
14. Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale e
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method