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Clinical Trial Results:
A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet’s Disease uveitis EYEGUARD TM -B

Summary
EudraCT number	2012-001125-27
Trial protocol	GB DE GR PT IT ES
Global end of trial date	29 Sep 2015

Results information
Results version number	v1(current)
This version publication date	18 Sep 2016
First version publication date	18 Sep 2016
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

Top of page

Sponsor protocol code

CL3-78989-002

ISRCTN number

-

US NCT number

NCT01965145

WHO universal trial number (UTN)

-

Sponsor organisation name

Institut de Recherches Internationales Servier

Sponsor organisation address

50 rue Carnot, Suresnes, France,

Public contact

Clinical Studies Department, Institut de Recherches Internationales Servier, +33 155 72 43 66, clinicaltrials@servier.com

Scientific contact

Clinical Studies Department, Institut de Recherches Internationales Servier, +33 155 72 43 66, clinicaltrials@servier.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

29 Sep 2015

Is this the analysis of the primary completion data?

Yes

Primary completion date

29 Sep 2015

Global end of trial reached?

Yes

Global end of trial date

29 Sep 2015

Was the trial ended prematurely?

Yes

Main objective of the trial

The objective of this study is to demonstrate the superiority of gevokizumab as compared to placebo on top of current standard of care in reducing the risk of Behçet’s disease uveitis exacerbations

Protection of trial subjects

The study was conducted in accordance with Good Clinical Practice standards, ethical principles stated in the declaration of Helsinki and applicable regulatory requirements. After the subject has ended his/her participation in the trial, the investigator provided appropriate medication and/or arranged access to appropriate care for the patient.

Background therapy

Standard of care including oral corticosteroids and immunosuppressive therapy (azathioprine, mycophenolate mofetil / mycophenolate sodium, cyclosporine-A and/or methotrexate alone or in any combination)

Evidence for comparator

-

Actual start date of recruitment

14 Nov 2012

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 6

Country: Number of subjects enrolled

Greece: 7

Country: Number of subjects enrolled

Italy: 7

Country: Number of subjects enrolled

Portugal: 2

Country: Number of subjects enrolled

United Kingdom: 2

Country: Number of subjects enrolled

Armenia: 6

Country: Number of subjects enrolled

Brazil: 2

Country: Number of subjects enrolled

Hong Kong: 1

Country: Number of subjects enrolled

Israel: 3

Country: Number of subjects enrolled

Russian Federation: 2

Country: Number of subjects enrolled

Korea, Republic of: 21

Country: Number of subjects enrolled

Tunisia: 1

Country: Number of subjects enrolled

Turkey: 24

Worldwide total number of subjects

84

EEA total number of subjects

24

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

83

From 65 to 84 years

1

85 years and over

0

Subject disposition

Top of page

Recruitment details

-

Screening details

Patients with a history of Behçet’s disease with ocular involvement of the posterior segment, and having experienced at least 2 ocular exacerbations within the 18 months prior to selection, with the most recent having occurred within the last 4 months and having been treated successfully with high dose corticosteroids

Period 1 title

Part 1 (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Gevokizumab

Arm description

-

Arm type

Experimental

Investigational medicinal product name

Gevokizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous dose of 60 mg gevokizumab beginning on Day 0 and administered every 4 weeks

Placebo

Arm description

-

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous dose of placebo beginning on Day 0 and administered every 4 weeks

Number of subjects in period 1	Gevokizumab	Placebo
Started	41	43
Completed	0	0
Not completed	41	43
non-medical reason	6	4
Adverse event, non-fatal	1	3
study discontinuation	34	34
Protocol deviation	-	2

Baseline characteristics

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Reporting group title

Gevokizumab

Reporting group description

-

Reporting group title

Placebo

Reporting group description

-

Reporting group values	Gevokizumab	Placebo	Total
Number of subjects	41	43	84
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	41	42	83
From 65-84 years	0	1	1
85 years and over	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	34.3 ( 9.6 )	35.1 ( 9.5 )	-
Gender categorical
Units: Subjects
Female	12	12	24
Male	29	31	60

End points

Top of page

Reporting group title

Gevokizumab

Reporting group description

-

Reporting group title

Placebo

Reporting group description

-

Primary: Time to first acute ocular exacerbation over the Core study period

Top of page

End point title

Time to first acute ocular exacerbation over the Core study period

End point description

End point type

Primary

End point timeframe

Duration of the core study period (event-driven), i.e. until the occurence of the 29th ocular exacerbation

End point values	Gevokizumab	Placebo
Number of subjects analysed	40	43
Units: number of pts with a 1st exacerbation	14	15

Cox's proportional hazard model adjusted

Comparison groups

Placebo v Gevokizumab

Number of subjects included in analysis

83

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.661

Method

Cox model

Parameter type

Hazard ratio (HR)

Point estimate

0.85

Confidence interval

level

95%

sides

2-sided

lower limit

0.41

upper limit

1.77

Adverse events

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Timeframe for reporting adverse events

EAEs reported during the Part 1 (i.e. the core study and the double masked extension period)

Adverse event reporting additional description

Emergent adverse events are presented (EAEs) . EAEs on treatment were defined as all adverse events which occurred between the first injection date (included) and the last study drug injection date + 25 days (included), or which worsened or became serious.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

17

Reporting group title

Gevokizumab

Reporting group description

-

Reporting group title

Placebo

Reporting group description

-

Serious adverse events	Gevokizumab	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	13 / 41 (31.71%)	14 / 43 (32.56%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Investigations
Weight decreased
subjects affected / exposed	1 / 41 (2.44%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Ankle fracture
subjects affected / exposed	1 / 41 (2.44%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	0 / 41 (0.00%)	1 / 43 (2.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Behcet's syndrome
subjects affected / exposed	5 / 41 (12.20%)	5 / 43 (11.63%)
occurrences causally related to treatment / all	0 / 8	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	1 / 41 (2.44%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	0 / 41 (0.00%)	1 / 43 (2.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 41 (2.44%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Malaise
subjects affected / exposed	1 / 41 (2.44%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	1 / 41 (2.44%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Cataract
subjects affected / exposed	1 / 41 (2.44%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glaucoma
subjects affected / exposed	0 / 41 (0.00%)	2 / 43 (4.65%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Macular ischaemia
subjects affected / exposed	0 / 41 (0.00%)	1 / 43 (2.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Macular oedema
subjects affected / exposed	0 / 41 (0.00%)	2 / 43 (4.65%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal haemorrhage
subjects affected / exposed	0 / 41 (0.00%)	1 / 43 (2.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal vein occlusion
subjects affected / exposed	0 / 41 (0.00%)	1 / 43 (2.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uveitic glaucoma
subjects affected / exposed	0 / 41 (0.00%)	1 / 43 (2.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vitreous haemorrhage
subjects affected / exposed	0 / 41 (0.00%)	1 / 43 (2.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Ascites
subjects affected / exposed	1 / 41 (2.44%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	1 / 41 (2.44%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enterocolitis
subjects affected / exposed	0 / 41 (0.00%)	1 / 43 (2.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal ulcer haemorrhage
subjects affected / exposed	2 / 41 (4.88%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematochezia
subjects affected / exposed	1 / 41 (2.44%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal ulcer haemorrhage
subjects affected / exposed	1 / 41 (2.44%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	0 / 41 (0.00%)	1 / 43 (2.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	0 / 41 (0.00%)	1 / 43 (2.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	0 / 41 (0.00%)	1 / 43 (2.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Major depression
subjects affected / exposed	0 / 41 (0.00%)	1 / 43 (2.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sleep disorder
subjects affected / exposed	0 / 41 (0.00%)	1 / 43 (2.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	0 / 41 (0.00%)	1 / 43 (2.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Renal failure acute
subjects affected / exposed	1 / 41 (2.44%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	0 / 41 (0.00%)	1 / 43 (2.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	1 / 41 (2.44%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	2 / 41 (4.88%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	1 / 41 (2.44%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Gevokizumab	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	37 / 41 (90.24%)	40 / 43 (93.02%)
Investigations
Blood triglycerides increased
subjects affected / exposed	1 / 41 (2.44%)	3 / 43 (6.98%)
occurrences all number	1	4
C-reactive protein increased
subjects affected / exposed	2 / 41 (4.88%)	3 / 43 (6.98%)
occurrences all number	2	4
Intraocular pressure increased
subjects affected / exposed	5 / 41 (12.20%)	4 / 43 (9.30%)
occurrences all number	9	6
Mycobacterium tuberculosis complex test positive
subjects affected / exposed	2 / 41 (4.88%)	3 / 43 (6.98%)
occurrences all number	2	3
Vascular disorders
Behcet's syndrome
subjects affected / exposed	23 / 41 (56.10%)	25 / 43 (58.14%)
occurrences all number	56	67
Hypertension
subjects affected / exposed	3 / 41 (7.32%)	2 / 43 (4.65%)
occurrences all number	3	2
Nervous system disorders
Dizziness
subjects affected / exposed	3 / 41 (7.32%)	2 / 43 (4.65%)
occurrences all number	3	3
Headache
subjects affected / exposed	8 / 41 (19.51%)	6 / 43 (13.95%)
occurrences all number	13	7
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 41 (0.00%)	3 / 43 (6.98%)
occurrences all number	0	3
Fatigue
subjects affected / exposed	0 / 41 (0.00%)	6 / 43 (13.95%)
occurrences all number	0	16
Eye disorders
Cataract
subjects affected / exposed	2 / 41 (4.88%)	6 / 43 (13.95%)
occurrences all number	2	8
Eye pain
subjects affected / exposed	3 / 41 (7.32%)	3 / 43 (6.98%)
occurrences all number	4	3
Macular oedema
subjects affected / exposed	4 / 41 (9.76%)	14 / 43 (32.56%)
occurrences all number	11	33
Vision blurred
subjects affected / exposed	5 / 41 (12.20%)	0 / 43 (0.00%)
occurrences all number	11	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	4 / 41 (9.76%)	1 / 43 (2.33%)
occurrences all number	4	1
Abdominal pain upper
subjects affected / exposed	3 / 41 (7.32%)	0 / 43 (0.00%)
occurrences all number	3	0
Constipation
subjects affected / exposed	1 / 41 (2.44%)	3 / 43 (6.98%)
occurrences all number	1	3
Diarrhoea
subjects affected / exposed	4 / 41 (9.76%)	4 / 43 (9.30%)
occurrences all number	5	5
Nausea
subjects affected / exposed	4 / 41 (9.76%)	3 / 43 (6.98%)
occurrences all number	5	3
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	1 / 41 (2.44%)	3 / 43 (6.98%)
occurrences all number	1	3
Skin and subcutaneous tissue disorders
Swelling face
subjects affected / exposed	0 / 41 (0.00%)	3 / 43 (6.98%)
occurrences all number	0	3
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	5 / 41 (12.20%)	2 / 43 (4.65%)
occurrences all number	5	2
Back pain
subjects affected / exposed	0 / 41 (0.00%)	4 / 43 (9.30%)
occurrences all number	0	4
Myalgia
subjects affected / exposed	3 / 41 (7.32%)	3 / 43 (6.98%)
occurrences all number	5	3
Pain in extremity
subjects affected / exposed	3 / 41 (7.32%)	1 / 43 (2.33%)
occurrences all number	3	1
Infections and infestations
Conjunctivitis
subjects affected / exposed	1 / 41 (2.44%)	3 / 43 (6.98%)
occurrences all number	1	3
Nasopharyngitis
subjects affected / exposed	6 / 41 (14.63%)	6 / 43 (13.95%)
occurrences all number	7	7
Upper respiratory tract infection
subjects affected / exposed	4 / 41 (9.76%)	3 / 43 (6.98%)
occurrences all number	6	3

More information

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Were there any global substantial amendments to the protocol? Yes

30 Aug 2012

− Precision in contraception methods; − Introduction of 6 months wash out period for subtenonian triamcinolone acetonide; − Introduction of macular oedema as a rescue criterion; − Introduction of OCT at each visit with ophthalmologic exam − Additional tests for HIV, HCV, hepatitis B and IGRA

07 Nov 2013

- Increase the statistical power from 80% to 90% while maintaining the same hazard ratio and type one error rate planned in the protocol for the determination of the number of events. - Eliminate the upper weight limit of 120 kg in the selection criteria. - Extend the delay between selection (ASSE) and inclusion (D0) from 7 to 10 days.

28 Jan 2015

- Update of the study completion date. - Postponment of immune competence assessment - Cessation of laboratory sampling for cytokines, vascular markers, genomics / other omics after the end of the Core study

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
23 Jul 2015	At the end of the Core study period, the study discontinuation was decided owing to Sponsor’s decision, (primary endpoint not achieved). Consequently the 1-year double masked extension period had been prematurely stopped and the open long-term safety follow-up period was not carried on.	-

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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