Phase III Study in Refractory Behcet's Disease | NCT00995709

ID	Type	Description	Link
2009-011237-27	EudraCT Number

Label	Type	Description	Intervention Names
AIN457C 300 mg every 2 week dosage regimen	Experimental	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each. every 2 weeks	Drug: AIN457
AIN457C 300 mg monthly dosage regimen	Experimental	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg e	Drug: AIN457
Placebo	Placebo Comparator	Placebo was administered in 2 s.c. injections every 2 weeks	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AIN457	Drug		AIN457C 300 mg every 2 week dosage regimen
AIN457

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment		Baseline to week 24
Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment	Patients number of occurences during a 24 week period.	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set)	For each corticosteroid medication, dose of the corticosteroid was first converted to a prednisone-equivalent dose. To determine the prednisone equivalent dose, the corticosteroid dose was multiplied by a conversion factor. . The total prednisone equivalent dose was calculated as the sum of the prednisone equivalent doses of all corticosteroids. Consequently, the total converted prednisone equivalent dose was used to obtain the immunosuppressive score. The key secondary efficacy variable was the change in total post-baseline immunosuppressive medication score from baseline.The score is actually the prednisoone equivalents taken by patient as calculated by conversion table. A reduction in prenisone or prenisone equivalents is a positive outcome. An increase in the number of prednisone equivalents suggests that the treatment is not efficacious or that there is disease progression. A score of 0 would be the lowest ( no steriods taken) and the upper limit is indeterminate.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Behçet's disease and with a history of recurrent uveitis in a least one eye.
Documented evidence of >2 recurrent exacerbations of either intermediate uveitis, posterior uveitis or panuveitis in the study eye within the past 6 months (this could include the current exacerbation for patients having an acute exacerbation at screening). Exacerbations fulfilling the study inclusion criteria must have one or more of the following recorded in the patients patients medical record for each recurrent exacerbation:
- >2+ vitreous haze with <2+ anterior chamber cell grade (intermediate or posterior uveitis) or >2+ vitreous haze with >2+ anterior chamber cell grade (panuveitis)
- presence of retinal infiltrates or vasculitis or hemorrhages
- documented >10 ETDRS letter or 2 line Snellen decrease in visual acuity attributed to ocular inflammation secondary to the recurrent exacerbation of Behçet's disease.
Requirement for either of the following immunosuppressive therapies for at least 3 of the past 6 months for the treatment of or to prevent an exacerbation of ocular inflammation related to Behçet's disease:
- Prednisone or equivalent >10 mg daily
- The need for at least >1 periocular injection or >1 intravitreal corticosteroid injection in the study eye within the past 6 months (the last injection must have not been given within 6 weeks of screening)
- Treatment with cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate either as monotherapy or in combination with or without steroids. (Patients treated at any time with chlorambucil or cyclophosphamide are not eligible for the study.)
Patients not meeting the above specified criteria for immunomodulatory therapies are eligible for enrollment if they are intolerant to systemic immunomodulatory therapy as determined by the study investigator.

Exclusion Criteria:

Subjects with infectious uveitis, uveitis due to other causes than Behçet's disease, or uveitis of unknown etiology.
Less severe (i.e. anterior) uveitis associated with Behçet's disease.

Ocular treatments

Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to study screening.
Treatment with any injected or implantable corticosteroid releasing device (i.e., flucinolone acetonide implant, Retisert®) in the study eye within the last 3 years.
Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle.

Systemic conditions or treatments

Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster virus or measles) within 2 months prior to screening.
Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening and no prior treatment with AIN457.
Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil).

Other protocol-defined inclusion/exclusion criteria may apply

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Baltimore	Maryland	21205-2005	United States
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
23290985	Derived	Dick AD, Tugal-Tutkun I, Foster S, Zierhut M, Melissa Liew SH, Bezlyak V, Androudi S. Secukinumab in the treatment of noninfectious uveitis: results of three randomized, controlled clinical trials. Ophthalmology. 2013 Apr;120(4):777-87. doi: 10.1016/j.ophtha.2012.09.040. Epub 2013 Jan 3.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	AIN457C 300 mg Every 2 Week Dosage Regimen	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
FG001	AIN457C 300 mg Monthly Dosage Regimen	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each. One patient in the AIN457 300 mg monthly group (PID 0161/00002) was randomized; however, this patient did not meet eligibility criteria and never received study medication

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment

Full Analysis Set

Posted

Mean

Standard Deviation

Ocular Exacerbations

Baseline to week 24

ID	Title	Description
OG000	AIN457C 300 mg Every 2 Week Dosage Regimen	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
OG001	AIN457C 300 mg Monthly Dosage Regimen (a)	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
OG002	Placebo to AIN457C	Placebo was administered in 2 s.c. injections

Units	Counts
Participants	OG00039 OG00139 OG00239

Title

Denominators

Categories

Title	Measurements
	OG0007.7± 22.40 OG00111.5± 28.19 OG0027.7± 22.35

Secondary

Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set)

For each corticosteroid medication, dose of the corticosteroid was first converted to a prednisone-equivalent dose. To determine the prednisone equivalent dose, the corticosteroid dose was multiplied by a conversion factor. . The total prednisone equivalent dose was calculated as the sum of the prednisone equivalent doses of all corticosteroids. Consequently, the total converted prednisone equivalent dose was used to obtain the immunosuppressive score. The key secondary efficacy variable was the change in total post-baseline immunosuppressive medication score from baseline.The score is actually the prednisoone equivalents taken by patient as calculated by conversion table. A reduction in prenisone or prenisone equivalents is a positive outcome. An increase in the number of prednisone equivalents suggests that the treatment is not efficacious or that there is disease progression. A score of 0 would be the lowest ( no steriods taken) and the upper limit is indeterminate.

Full Analysis Set

Posted

Mean

Standard Deviation

immunosuppressive medication score

24 weeks

ID	Title	Description
OG000	AIN457C 300 mg Every 2 Week Dosage Regimen	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
OG001	AIN457C 300 mg Monthly Dosage Regimen (a)	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each

Secondary

To Determine the Effect of AIN457 on Macular Edema and Visual Acuity in Patients With Posterior Segment Uveitis Secondary to Behçet's Disease as Determined by Optical Coherence Tomography.

Optical coherence tomography (OCT) is amedical imaging technique that uses light to capture micrometer-resolution, three-dimensional images from within optical scattering media (e.g., biological tissue). OCT is based on low-coherence interferometry, typically employing near-infrared light. The use of relatively long wavelength light allows it to penetrate into the scattering medium. OCT is a noninvasive procedure that uses optical interferometry to visualize the structures within the retina. Following dilation of the pupil, a light source operating at 850nm provides probe illumination which is split and detected with and without the refraction of the retinal tissues. Cross-sectional imaging is accomplished in 1.3 second by acquiring a sequence of interferometric A-scans. A false color tomogram of optical reflectivity is produced by the computer. Central foveal thickness will be the primary variable derived from OCT. A increase in thickness could translate to disease progression.

(Full Analysis Set)

Posted

Mean

Standard Deviation

change from baseline : micrometers

baseline, and wk 24 (end of study)

ID	Title	Description
OG000	AIN457C 300 mg Every 2 Week Dosage Regimen	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
OG001	AIN457C 300 mg Monthly Dosage Regimen (a)

Secondary

To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet's Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol.

The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration. Scores range from 0 to 100, with higher scores indicating better visual function.

Full Analysis Set

Posted

Mean

Standard Deviation

Score

screening, and wk 24 (end of study)

ID	Title	Description
OG000	AIN457C 300 mg Every 2 Week Dosage Regimen	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
OG001	AIN457C 300 mg Monthly Dosage Regimen (a)	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
OG002	Placebo to AIN457C	Placebo was administered in 2 s.c. injections

Secondary

To Observe the Effect of AIN457 on the Systemic Non-ocular Manifestations of Behçet's Disease in Patients With Posterior Segment Uveitis Requiring Systemic Immunosuppression as Measured by the Bechet's Disease Current Activity Form.

The BDCAF scores oral and genital ulceration, skin, joint and gastrointestinal involvement, presence of fatigue and headache according to the duration of symptoms. The presence and type of large-vessel and central nervous system (CNS) involvement are documented. Eye activity was deemed present if there was a history of blurring of vision or if the eye was painful or red. . The BDCAF score was calculated by adding the score of each index and ranged between 0 and 12 A reduction in score signifies a lessening of the disease.

Full Analysis set

Posted

Mean

Standard Deviation

change from baseline score

baseline and wk 24 (end of study)

ID	Title	Description
OG000	AIN457C 300 mg Every 2 Week Dosage Regimen	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
OG001	AIN457C 300 mg Monthly Dosage Regimen (a)	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
OG002	Placebo to AIN457C	Placebo was administered in 2 s.c. injections

Primary

Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment

Patients number of occurences during a 24 week period.

Full analysis set

Posted

Number

Participants

24 weeks

ID	Title	Description
OG000	AIN457C 300 mg Every 2 Week Dosage Regimen	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
OG001	AIN457C 300 mg Monthly Dosage Regimen (a)	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
OG002	Placebo to AIN457C	Placebo was administered in 2 s.c. injections

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Cataract cortical (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Cataract nuclear (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Cataract subcapsular (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Choroiditis (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Glaucoma (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Retinal infiltrates (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Retinal infiltrates (Study eye)	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Uveitis (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Uveitis (Study eye)	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0021 affected39 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Haematemesis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Behcet's syndrome	Immune system disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Behcet's syndrome (Fellow eye)	Immune system disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Behcet's syndrome (Study eye)	Immune system disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Folliculitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Hypopyon (Fellow eye)	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Intraocular pressure increased (Fellow eye)	Investigations	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cataract subcapsular (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0003 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Cataract subcapsular (Study eye)	Eye disorders	MedDRA	Systematic Assessment	EG0004 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Eye pain (Study eye)	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0012 affected39 at risk EG0022 affected39 at risk
Retinal vasculitis (Study eye)	Eye disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Vision blurred (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0016 affected39 at risk EG0021 affected39 at risk
Vision blurred (Study eye)	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0023 affected39 at risk
Visual acuity reduced (Study eye)	Eye disorders	MedDRA	Systematic Assessment	EG0004 affected39 at risk EG0012 affected39 at risk EG0021 affected39 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0022 affected39 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0012 affected39 at risk EG0021 affected39 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected39 at risk EG0012 affected39 at risk EG0020 affected39 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0013 affected39 at risk EG0021 affected39 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0022 affected39 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected39 at risk EG0013 affected39 at risk EG0022 affected39 at risk
Toothache	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0010 affected39 at risk EG0023 affected39 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0012 affected39 at risk EG0024 affected39 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0003 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0006 affected39 at risk EG0012 affected39 at risk EG0024 affected39 at risk
Conjunctivitis infective (Study eye)	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0012 affected39 at risk EG0021 affected39 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0014 affected39 at risk EG0021 affected39 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0012 affected39 at risk EG0021 affected39 at risk
Rash pustular	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0012 affected39 at risk EG0021 affected39 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected39 at risk EG0014 affected39 at risk EG0021 affected39 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0022 affected39 at risk
Blood glucose increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0012 affected39 at risk EG0020 affected39 at risk
Intraocular pressure increased (Study eye)	Investigations	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0012 affected39 at risk EG0020 affected39 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected39 at risk EG0013 affected39 at risk EG0023 affected39 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected39 at risk EG0011 affected39 at risk EG0021 affected39 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0013 affected39 at risk EG0020 affected39 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0009 affected39 at risk EG0016 affected39 at risk EG0029 affected39 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0013 affected39 at risk EG0020 affected39 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0011 affected39 at risk EG0022 affected39 at risk
Hirsutism	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0022 affected39 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0012 affected39 at risk EG0020 affected39 at risk

ID	Term
D001528	Behcet Syndrome
D015867	Uveitis, Intermediate
D015864	Panuveitis
D015866	Uveitis, Posterior
D014605	Uveitis

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D014606	Uveitis, Anterior
D014603	Uveal Diseases
D005128	Eye Diseases
D014657	Vasculitis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D056660	Hereditary Autoinflammatory Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012873	Skin Diseases, Genetic
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017445	Skin Diseases, Vascular

ID	Title	Description
BG000	AIN457C 300 mg Every 2 Week Dosage Regimen	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
BG001	AIN457C 300 mg Monthly Dosage Regimen (a)	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
BG002	Placebo to AIN457C	Placebo was administered in 2 s.c. injections
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AIN457 300mg Every 2 Weeks	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.	6	39	28	39
EG001	AIN457 300mg Monthly	AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.	8	39	25	39
EG002	Placebo	Placebo was administered in 2 s.c. injections	5	39	22	39