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Key inclusion & exclusion criteria
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Inclusion Criteria:
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 :
- 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)
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)
with or without prior high dose corticoid pulse.
5. 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
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 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.
7. 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).
8. Affiliation with a mode of social security (profit or being entitled)
Exclusion Criteria:
- 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 Behc¸et 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Secondary Outcome(s)
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Behc¸et Disease Quality of Life Measure : Routine Assessment of Patient Index Data 3 (RAPID3)
[Time Frame: 24 weeks]
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Behc¸et Syndrome Activity Score (BSAS)
[Time Frame: 12 weeks]
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Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze
[Time Frame: 12 weeks]
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Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze
[Time Frame: 24 weeks]
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Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze
[Time Frame: 40 weeks]
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Behc¸et Disease Quality of Life Measure : Routine Assessment of Patient Index Data 3 (RAPID3)
[Time Frame: 52 weeks]
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Number of oral and genital ulcers
[Time Frame: 12 weeks]
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Behc¸et Disease Current Activity Form (BDCAF)
[Time Frame: 24 weeks]
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Behc¸et Disease Quality of Life Measure : Short Form-36 (SF- 36)
[Time Frame: 52 weeks]
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Pain Visual Analog Scales of oral and genital ulcers
[Time Frame: 28 weeks]
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Pain Visual Analog Scales of oral and genital ulcers
[Time Frame: 40 weeks]
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Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze
[Time Frame: 52 weeks]
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Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze
[Time Frame: 8 weeks]
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Behc¸et Disease Current Activity Form (BDCAF)
[Time Frame: 52 weeks]
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Number of oral and genital ulcers
[Time Frame: 16 weeks]
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Pain Visual Analog Scales of oral and genital ulcers
[Time Frame: 4 weeks]
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Behc¸et Disease Current Activity Form (BDCAF)
[Time Frame: 12 weeks]
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Number of oral and genital ulcers
[Time Frame: 8 weeks]
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Number of oral and genital ulcers
[Time Frame: at baseline visit (week 0)]
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Pain Visual Analog Scales of oral and genital ulcers
[Time Frame: 12 weeks]
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Behc¸et Disease Quality of Life Measure : Short Form-36 (SF- 36)
[Time Frame: 12 weeks]
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Behc¸et Disease Quality of Life Measure : Short Form-36 (SF- 36)
[Time Frame: 24 weeks]
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Number of adverse events
[Time Frame: from baseline visit up to 52 weeks]
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Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze
[Time Frame: 4 weeks]
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Pain Visual Analog Scales of oral and genital ulcers
[Time Frame: 8 weeks]
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Behc¸et Syndrome Activity Score (BSAS)
[Time Frame: 24 weeks]
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Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze
[Time Frame: baseline visit (week 0)]
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Pain Visual Analog Scales of oral and genital ulcers
[Time Frame: 24 weeks]
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Number of oral and genital ulcers
[Time Frame: 24 weeks]
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Number of oral and genital ulcers
[Time Frame: 28 weeks]
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Number of oral and genital ulcers
[Time Frame: 40 weeks]
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Pain Visual Analog Scales of oral and genital ulcers
[Time Frame: 52 weeks]
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Pain Visual Analog Scales of oral and genital ulcers
[Time Frame: at baseline visit (week 0)]
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Number of oral and genital ulcers
[Time Frame: 4 weeks]
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Pain Visual Analog Scales of oral and genital ulcers
[Time Frame: 16weeks]
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Behc¸et Disease Quality of Life Measure : Routine Assessment of Patient Index Data 3 (RAPID3)
[Time Frame: 12 weeks]
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Behc¸et Syndrome Activity Score (BSAS)
[Time Frame: 52 weeks]
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Number of chorioretinal and/or inflammatory retinal vascular lesions, inflammation in anterior chamber and in vitreous haze
[Time Frame: 28 weeks]
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Number of oral and genital ulcers
[Time Frame: 52 weeks]
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Visual acuity by Early Treatment Diabetic Retinopathy Study (ETDRS)
[Time Frame: 16 weeks]
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