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Clinical Trial Results:
A three-part multi-center study, with a randomized, double-blind, placebo controlled, withdrawal design in Part II to assess efficacy, safety and tolerability of ACZ885 (antiinterleukin-1β monoclonal antibody) in patients with Muckle-Wells Syndrome

Summary
EudraCT number	2006-005455-15
Trial protocol	DE ES FR GB Outside EU/EEA
Global end of trial date	29 Oct 2008

Results information
Results version number	v1(current)
This version publication date	13 Jul 2016
First version publication date	06 Aug 2015
Other versions

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

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Trial information

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Sponsor protocol code

CACZ885D2304

ISRCTN number

US NCT number

NCT00465985

WHO universal trial number (UTN)

Sponsor organisation name

Novartis Pharma AG

Sponsor organisation address

CH-4002, Basel, Switzerland,

Public contact

Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,

Scientific contact

Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,

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

Yes

EMA paediatric investigation plan number(s)

EMEA-000060-PIP01-07

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

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

Yes

Analysis stage

Final

Date of interim/final analysis

29 Oct 2008

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

29 Oct 2008

Was the trial ended prematurely?

Main objective of the trial

The main objective of the study was to assess efficacy of canakinumab (percentage of subjects who experienced disease flare) compared with placebo as determined by the Physician’s global assessment of auto-inflammatory disease activity, assessment of skin disease and inflammation markers (C-reactive protein (CRP) and/or serum amyloid A (SAA).

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.

Background therapy

Evidence for comparator

Actual start date of recruitment

04 Jun 2007

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 9

Country: Number of subjects enrolled

France: 16

Country: Number of subjects enrolled

Germany: 4

Country: Number of subjects enrolled

United States: 5

Country: Number of subjects enrolled

India: 1

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study was conducted at 11 centres in 5 countries.

Screening details

A total of 41 subjects were screened and 35 entered the study. Remaining 6 subjects were screening failures.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Data analyst, Assessor

Blinding implementation details

The study was conducted in 3 parts, Part 1 (Open-label treatment period 1), Part 2 (double-blind treatment period) and Part 3 (open-label treatment period 2). In Part 2 of the study, randomization data were kept strictly confidential until the time of unblinding, and was accessible only to an independent, unblinded qualified study person at the investigator’s site who prepared the study medication. During Part 1 and Part 3, blinding was not performed.

Are arms mutually exclusive

Canakinumab - Part I

Arm description

Subjects received body-weight stratified dose of canakinumab (150 milligrams (mg) or 2 mg/kilograms[kg]) subcutaneous (s.c.) injection. Subjects with body weight more than (>) 40 kg received one injection of canakinumab 150 mg s.c. while subjects with a body weight between 15 kg to 40 kg received an equivalent of 2 mg/kg s.c. every 8 weeks.

Arm type

Experimental

Investigational medicinal product name

Canakinumab

Investigational medicinal product code

ACZ885

Other name

Pharmaceutical forms

Powder for cutaneous solution

Routes of administration

Subcutaneous use

Dosage and administration details

Body-weight stratified dose of canakinumab (150 mg or 2 mg/kg) s.c. injection was administered every 8 weeks.

Canakinumab - Part II

Arm description

Subjects received body-weight stratified dose of canakinumab (150 mg or 2 mg/kg) s.c injection. Subjects with body weight > 40 kg received one injection of canakinumab 150 mg s.c. while subjects with a body weight between 15 kg to 40 kg received an equivalent of 2 mg/kg s.c. every 8 weeks. The maximum duration of Part II was 24 weeks.

Arm type

Experimental

Investigational medicinal product name

Canakinumab

Investigational medicinal product code

ACZ885

Other name

Pharmaceutical forms

Powder for cutaneous solution

Routes of administration

Subcutaneous use

Dosage and administration details

Body-weight stratified dose of canakinumab (150 mg or 2 mg/kg) s.c. injection was administered every 8 weeks.

Placebo - Part II

Arm description

Placebo s.c. injection was administered every 8 weeks. The maximum duration of Part II was 24 weeks.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for cutaneous solution

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo s.c. injection was administered every 8 weeks.

Canakinumab - Part III

Arm description

Subjects received body weight stratified dose of canakinumab (150 mg or 2 mg/kg) s.c. injection. Subjects with body weight > 40 kg received one injection of canakinumab 150 mg s.c. while subjects with a body weight between 15 kg to 40 kg received an equivalent of 2 mg/kg s.c. every 8 weeks. The maximum duration of Part III was 16 weeks.

Arm type

Experimental

Investigational medicinal product name

Canakinumab

Investigational medicinal product code

ACZ885

Other name

Pharmaceutical forms

Powder for cutaneous solution

Routes of administration

Subcutaneous use

Dosage and administration details

Body-weight stratified dose of canakinumab (150 mg or 2 mg/kg) s.c. injection was administered every 8 weeks.

Number of subjects in period 1	Canakinumab - Part I	Canakinumab - Part II	Placebo - Part II	Canakinumab - Part III
Started	35	15	16	31
Completed	31	15	4	29
Not completed	4	0	12	2
Adverse event, non-fatal	-	-	-	1
Unsatisfactory therapeutic effect	4	-	12	1

Baseline characteristics

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Reporting group title

Overall Study

Reporting group description

All subjects who received at least one dose of study drug in open-label treatment period (Part I).

Reporting group values	Overall Study	Total
Number of subjects	35	35
Age categorical
Units: Subjects
≥4 - <17	4	4
≥17 - <41	17	17
≥41 - <75	14	14
Age continuous
Units: years
arithmetic mean (standard deviation)	34 ( 14.89 )	-
Gender categorical
Units: Subjects
Female	25	25
Male	10	10

End points

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Reporting group title

Canakinumab - Part I

Reporting group description

Reporting group title

Canakinumab - Part II

Reporting group description

Reporting group title

Placebo - Part II

Reporting group description

Placebo s.c. injection was administered every 8 weeks. The maximum duration of Part II was 24 weeks.

Reporting group title

Canakinumab - Part III

Reporting group description

Subject analysis set title

Canakinumab (Part I and Part II)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects who received at least one dose of canakinumab in Part I and Part II were evaluated for pharmacokinetic parameters.

Primary: Percentage of subjects with disease flare at Week 32 (Part II)

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End point title

Percentage of subjects with disease flare at Week 32 (Part II) ^[1]

End point description

Disease relapse in subjects was defined as a CRP and/or SAA value >30 mg/L and either a Physician’s global assessment of autoinflammatory disease activity greater than minimal on a 5-point scale (0: absent to 5: severe), or a Physician’s global assessment of autoinflammatory disease activity equal to minimal in conjunction with an assessment of skin disease greater than minimal using a 5-point scale (0: absent to 5: severe), or discontinued prematurely in Part II due to any reason. The analysis was performed in Intent to treat (ITT) population, defined as all subjects who received at least one dose of study drug in double-blind treatment period (Part II).

End point type

Primary

End point timeframe

Week 32

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The evaluation was planned for selected arm (Part II) only.

End point values	Canakinumab - Part II	Placebo - Part II
Number of subjects analysed	15	16
Units: Percentage of subjects
number (not applicable)	0	0.81

Odds ratio of treatment responders

Statistical analysis description

Common odds ratio was used for test statistics and corresponding 95% confidence intervals. Null hypothesis suggested that common odds ratio was 1, i.e. the probability of having disease flare was same for both groups. Common odds ratio < 1 favored canakinumab.

Comparison groups

Canakinumab - Part II v Placebo - Part II

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Fisher exact

Parameter type

Odds ratio (OR)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

0.14

Secondary: Number of subjects with treatment response at Week 8 (Part I)

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End point title

Number of subjects with treatment response at Week 8 (Part I) ^[2]

End point description

Treatment response was graded as complete response (CR), partial response (PR), disease flare based on Physician's global assessment of auto-inflammatory disease activity, assessment of skin disease and serum values of CRP and/or SAA. CR was defined as physician global assessment and skin disease to be minimal (≤1) using a 5-point scale (0: absent to 5: severe) and normal CRP and/or SAA. PR was defined as reduction of CRP and/or SAA from baseline by >30% but not reaching normal values and physician global assessment score improvement from baseline by at least one category. Disease flare was characterized by CRP and/or SAA > 30 mg/L and either physician global assessment score > minimal or physician global assessment score = minimal and skin disease > minimal. Non-responders were determined as subjects without PR by Day 8 or no CR by Day 15. The analysis was performed in ITT population, defined as all subjects who received at least one dose of study drug in open-label period (Part I).

End point type

Secondary

End point timeframe

Week 8

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The evaluation was planned for selected arm (Part I) only.

End point values	Canakinumab - Part I
Number of subjects analysed	35
Units: Number of subjects
number (not applicable)
Complete Response	34
Partial Response	0
Disease flare	1
Non-responders	0

No statistical analyses for this end point

Secondary: Change from Week 8 in serum concentrations of C-reactive protein and Serum Amyloid A protein at Week 32 (Part II)

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End point title

Change from Week 8 in serum concentrations of C-reactive protein and Serum Amyloid A protein at Week 32 (Part II) ^[3]

End point description

The CRP and SAA were used as inflammatory markers. The normal level concentration was < 10 mg/L. Reduced change in concentration of CRP or SAA indicated improvement. The analysis was performed on ITT population in double-blind treatment period (Part II). Missing values were imputed using last observation carried forward (LOCF) technique.

End point type

Secondary

End point timeframe

Week 8 to Week 32

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The evaluation was planned for selected arm (Part II) only.

End point values	Canakinumab - Part II	Placebo - Part II
Number of subjects analysed	15	16
Units: mg/L
arithmetic mean (standard deviation)
CRP	1.1 ( 3.086 )	19.93 ( 24.175 )
SAA	2.27 ( 8.064 )	71.09 ( 136.637 )

No statistical analyses for this end point

Secondary: Percentage of subjects with defined grades of physician global assessment of autoinflammatory disease activity at Week 32 (Part II)

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End point title

Percentage of subjects with defined grades of physician global assessment of autoinflammatory disease activity at Week 32 (Part II) ^[4]

End point description

Physician global assessment of autoinflammatory disease activity grades were based on a 5-point scale: 0=absent, 1= minimal, 2= mild, 3= moderate and 4: severe. The physician performed the assessment of following disease activities or symptoms: skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, and other symptoms related or not related to autoinflammatory syndrome. Lower scores indicated improvement. The analysis was performed on ITT population in double-blind treatment period (Part II). Missing values were imputed using LOCF technique.

End point type

Secondary

End point timeframe

Week 32

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The evaluation was planned for selected arm (Part II) only.

End point values	Canakinumab - Part II	Placebo - Part II
Number of subjects analysed	15	16
Units: percentage of subjects
number (not applicable)
Absent	53.3	0
Minimal	46.7	25
Mild	0	50
Moderate	0	25
Severe	0	0

No statistical analyses for this end point

Secondary: Percentage of subjects with defined grades of Subject's global assessment of symptoms total score at Week 32 (Part II)

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End point title

Percentage of subjects with defined grades of Subject's global assessment of symptoms total score at Week 32 (Part II) ^[5]

End point description

Subject’s or parent’s rated the disease symptoms on a 5-point scale for assessing disease symptoms as 0=absent, 1= minimal, 2= mild, 3= moderate and 4: severe. The total score was sum of scores of 7-items like fever or chills, skin rash, joint or muscle pain, eye discomfort or redness, fatigue, headaches, and other symptoms. Lower scores indicated improvement. The analysis was performed on ITT population in double-blind treatment period (Part II). Missing values were imputed using LOCF technique.

End point type

Secondary

End point timeframe

Week 32

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The evaluation was planned for selected arm (Part II) only.

End point values	Canakinumab - Part II	Placebo - Part II
Number of subjects analysed	15	16
Units: percentage of subjects
number (not applicable)
Absent	40	0
Minimal	26.7	31.3
Mild	6.7	25
Moderate	0	37.5
Severe	26.7	0

No statistical analyses for this end point

Secondary: Clearance of canakinumab (Part I and Part II)

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End point title

Clearance of canakinumab (Part I and Part II)

End point description

Clearance from serum of canakinumab was obtained using NONMEM software for population pharmacokinetic modeling. The serum concentration data was obtained from subjects who received at least one dose of canakinumab from Day 1 to Day 225.

End point type

Secondary

End point timeframe

Day 1 (pre-dose), 8 hours post-dose, Days 8, 29, 57, 85, Day 113 (pre-dose), Day 141, Day 169 (pre-dose), Day 197, 225

End point values	Canakinumab (Part I and Part II)
Number of subjects analysed	35
Units: Litres/day
arithmetic mean (standard deviation)	0.177 ( 0.085 )

No statistical analyses for this end point

Secondary: Serum concentration of total interleukin-1beta antibody (IL-1β) (Part I, Part II and Part III)

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End point title

Serum concentration of total interleukin-1beta antibody (IL-1β) (Part I, Part II and Part III)

End point description

Pharmacodynamics of canakinumab was assessed by total IL-1β (sum of free and bound canakinumab) concentration, determined in serum by means of competitive enzyme linked immunosorbent assay (ELISA) with limit of detection at 0.25 picograms/millilitre (pg/mL). The analysis was performed in ITT population in respective parts of the study (Part I, II and III).

End point type

Secondary

End point timeframe

Day 1 (pre-dose), 8 hours post-dose, Days 8, 29, 57, 85, Day 113 (pre-dose), Day 141, Day 169 (pre-dose), Day 197, 225, 253, Day 281 (pre-dose), Day 309, 337

End point values	Canakinumab - Part I	Canakinumab - Part II	Placebo - Part II	Canakinumab - Part III
Number of subjects analysed	34 ^[6]	15 ^[7]	5 ^[8]	31 ^[9]
Units: pg/mL
arithmetic mean (standard deviation)	19.047 ( 17.6609 )	21.943 ( 10.3698 )	0.596 ( 0.7289 )	23.018 ( 16.5193 )

Notes
[6] - Evaluable subjects in Part I for this measure at Day 57
[7] - Evaluable subjects in Part II at Day 169
[8] - Evaluable subjects in Part II at Day 169
[9] - Evaluable subjects in Part III at Day 337

No statistical analyses for this end point

Secondary: Percentage of subjects with skin disease at Week 32 (Part II)

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End point title

Percentage of subjects with skin disease at Week 32 (Part II) ^[10]

End point description

Physician assessed the skin disease (urticarial skin rash) in subjects based on 5-point scale: 0=absent, 1= minimal, 2= mild, 3= moderate and 4: severe. Lower scores indicated improvement. The analysis was performed in ITT population of double blind treatment period (Part II), imputed using LOCF technique.

End point type

Secondary

End point timeframe

Week 8, Week 32

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The evaluation was planned for selected arm (Part II) only.

End point values	Canakinumab - Part II	Placebo - Part II
Number of subjects analysed	15	16
Units: percentage of subjects
number (not applicable)
Absent	93.3	31.3
Minimal	6.7	18.8
Mild	0	31.3
Moderate	0	18.8
Severe	0	0

No statistical analyses for this end point

Secondary: Number of subjects with clinically significant findings in audiogram, neurological and opthalmological assessments at Week 32 (Part II)

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End point title

Number of subjects with clinically significant findings in audiogram, neurological and opthalmological assessments at Week 32 (Part II) ^[11]

End point description

Audiologic examination evaluated the status of hearing in subjects and included air-conduction thresholds for pure tone frequencies, bone conduction thresholds when indicated and possible, tympanometry, and distortion product otoacoustic emissions. A structured neurological assessment was conducted on each subject, with attention to signs of chronic meningitis, chronic headaches, fever, and vomiting. A standardized ophthalmologic evaluation was performed by an ophthalmology consultant focusing on visual changes that are sensitive in documenting optic nerve function. The overall interpretation of these assessments was categorized as normal, clinically insignificant abnormality, clinically significant abnormality when compared to baseline. The analysis was performed in safety population, defined as subjects who received at least one dose of study drug and had at least one post-baseline safety assessment.

End point type

Secondary

End point timeframe

Week 32

Notes
[11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The evaluation was planned for selected arm (Part II) only.

End point values	Canakinumab - Part II	Placebo - Part II
Number of subjects analysed	15	16
Units: number of subjects
number (not applicable)
Clinically significant audiogram assessment	7	11
Clinically significant neurological assessment	6	1
Clinically significant opthalmological assessment	2	1

No statistical analyses for this end point

Secondary: Number of subjects with anti-canakinumab antibodies (Part I, Part II and Part III)

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End point title

Number of subjects with anti-canakinumab antibodies (Part I, Part II and Part III)

End point description

Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples when canakinumab was administered through subcutaneous route into the body. The immune response (presence of antibodies) was detected using BIAcore system based on a validated surface plasmon resonance spectroscopy assay method. The analysis was performed in safety population, defined as subjects who received at least one dose of study drug and had at least one post-baseline immunogenicity assessment.

End point type

Secondary

End point timeframe

Baseline, Day 1, 57, 113, 169, 225, 281, 337

End point values	Canakinumab - Part I	Canakinumab - Part II	Placebo - Part II	Canakinumab - Part III
Number of subjects analysed	35	15	16	31
Units: Number of subjects
number (not applicable)	0	0	0	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

11.1

Reporting group title

Canakinumab - Part II

Reporting group description

Reporting group title

Canakinumab - Part I

Reporting group description

Reporting group title

Placebo - Part II

Reporting group description

Subjects received placebo s.c. injection matching to canakinumab every 8 weeks.

Reporting group title

Canakinumab - Part III

Reporting group description

Reporting group title

Canakinumab Treated (Total)

Reporting group description

Subjects who received body-weight stratified dose of canakinumab (150 mg or 2 mg/kg) s.c injection during the study (Part I, II and III).

Serious adverse events	Canakinumab - Part II	Canakinumab - Part I	Placebo - Part II	Canakinumab - Part III	Canakinumab Treated (Total)
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	0 / 16 (0.00%)	2 / 31 (6.45%)	2 / 35 (5.71%)
number of deaths (all causes)	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0
Investigations
Intraocular pressure increased
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	0 / 16 (0.00%)	1 / 31 (3.23%)	1 / 35 (2.86%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	0 / 16 (0.00%)	1 / 31 (3.23%)	1 / 35 (2.86%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	0 / 16 (0.00%)	1 / 31 (3.23%)	1 / 35 (2.86%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	0 / 16 (0.00%)	1 / 31 (3.23%)	1 / 35 (2.86%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Blindness unilateral
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	0 / 16 (0.00%)	1 / 31 (3.23%)	1 / 35 (2.86%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Sepsis
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	0 / 16 (0.00%)	1 / 31 (3.23%)	1 / 35 (2.86%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Canakinumab - Part II	Canakinumab - Part I	Placebo - Part II	Canakinumab - Part III	Canakinumab Treated (Total)
Total subjects affected by non serious adverse events
subjects affected / exposed	15 / 15 (100.00%)	27 / 35 (77.14%)	14 / 16 (87.50%)	24 / 31 (77.42%)	35 / 35 (100.00%)
Vascular disorders
Haematoma
subjects affected / exposed	0 / 15 (0.00%)	1 / 35 (2.86%)	1 / 16 (6.25%)	0 / 31 (0.00%)	2 / 35 (5.71%)
occurrences all number	0	1	1	0	2
Hot flush
subjects affected / exposed	1 / 15 (6.67%)	1 / 35 (2.86%)	0 / 16 (0.00%)	0 / 31 (0.00%)	2 / 35 (5.71%)
occurrences all number	1	1	0	0	2
Hypertension
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Orthostatic hypotension
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
General disorders and administration site conditions
Asthenia
subjects affected / exposed	1 / 15 (6.67%)	2 / 35 (5.71%)	0 / 16 (0.00%)	0 / 31 (0.00%)	2 / 35 (5.71%)
occurrences all number	1	2	0	0	3
Fatigue
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Chest pain
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Hangover
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Influenza like illness
subjects affected / exposed	0 / 15 (0.00%)	1 / 35 (2.86%)	0 / 16 (0.00%)	1 / 31 (3.23%)	2 / 35 (5.71%)
occurrences all number	0	1	0	1	2
Non-cardiac chest pain
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Oedema peripheral
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Immune system disorders
Allergy to arthropod bite
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Seasonal allergy
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
House dust allergy
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Respiratory, thoracic and mediastinal disorders
Allergic cough
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Cough
subjects affected / exposed	2 / 15 (13.33%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	2 / 35 (5.71%)
occurrences all number	3	0	0	0	3
Oropharyngeal pain
subjects affected / exposed	1 / 15 (6.67%)	1 / 35 (2.86%)	0 / 16 (0.00%)	1 / 31 (3.23%)	3 / 35 (8.57%)
occurrences all number	3	1	0	1	5
Epistaxis
subjects affected / exposed	0 / 15 (0.00%)	1 / 35 (2.86%)	1 / 16 (6.25%)	1 / 31 (3.23%)	3 / 35 (8.57%)
occurrences all number	0	1	1	1	3
Respiratory tract congestion
subjects affected / exposed	0 / 15 (0.00%)	1 / 35 (2.86%)	0 / 16 (0.00%)	1 / 31 (3.23%)	2 / 35 (5.71%)
occurrences all number	0	1	0	1	2
Rhinitis allergic
subjects affected / exposed	1 / 15 (6.67%)	1 / 35 (2.86%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	1	0	0	2
Rhinorrhoea
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Psychiatric disorders
Anxiety
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	2 / 35 (5.71%)
occurrences all number	1	0	1	0	2
Depression
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	1 / 31 (3.23%)	2 / 35 (5.71%)
occurrences all number	1	0	0	1	2
Stress
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Investigations
Liver function test abnormal
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Weight increased
subjects affected / exposed	0 / 15 (0.00%)	3 / 35 (8.57%)	0 / 16 (0.00%)	1 / 31 (3.23%)	4 / 35 (11.43%)
occurrences all number	0	3	0	1	4
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	3	0	0	0	3
Face injury
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Joint sprain
subjects affected / exposed	2 / 15 (13.33%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	3 / 35 (8.57%)
occurrences all number	2	0	1	0	3
Traumatic haematoma
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Nervous system disorders
Headache
subjects affected / exposed	2 / 15 (13.33%)	0 / 35 (0.00%)	0 / 16 (0.00%)	3 / 31 (9.68%)	5 / 35 (14.29%)
occurrences all number	3	0	0	3	6
Complex regional pain syndrome
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Hypoaesthesia
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Memory impairment
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	0 / 16 (0.00%)	2 / 31 (6.45%)	2 / 35 (5.71%)
occurrences all number	0	0	0	2	2
Nystagmus
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	0 / 16 (0.00%)	2 / 31 (6.45%)	2 / 35 (5.71%)
occurrences all number	0	0	0	2	2
Sciatica
subjects affected / exposed	1 / 15 (6.67%)	1 / 35 (2.86%)	0 / 16 (0.00%)	2 / 31 (6.45%)	2 / 35 (5.71%)
occurrences all number	1	1	0	2	4
Paraesthesia
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Tension headache
subjects affected / exposed	0 / 15 (0.00%)	1 / 35 (2.86%)	0 / 16 (0.00%)	1 / 31 (3.23%)	2 / 35 (5.71%)
occurrences all number	0	1	0	1	2
Blood and lymphatic system disorders
Lymphocytosis
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Neutropenia
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Ear and labyrinth disorders
Hypoacusis
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Tinnitus
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	1 / 31 (3.23%)	2 / 35 (5.71%)
occurrences all number	1	0	0	1	2
Vertigo
subjects affected / exposed	0 / 15 (0.00%)	1 / 35 (2.86%)	0 / 16 (0.00%)	2 / 31 (6.45%)	3 / 35 (8.57%)
occurrences all number	0	1	0	4	5
Eye disorders
Erythema of eyelid
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Eye pain
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	0 / 16 (0.00%)	2 / 31 (6.45%)	2 / 35 (5.71%)
occurrences all number	0	0	0	3	3
Abdominal discomfort
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Abdominal pain upper
subjects affected / exposed	0 / 15 (0.00%)	2 / 35 (5.71%)	0 / 16 (0.00%)	0 / 31 (0.00%)	2 / 35 (5.71%)
occurrences all number	0	2	0	0	2
Aphthous stomatitis
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	1 / 16 (6.25%)	1 / 31 (3.23%)	3 / 35 (8.57%)
occurrences all number	1	0	1	1	3
Diarrhoea
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	2 / 16 (12.50%)	5 / 31 (16.13%)	7 / 35 (20.00%)
occurrences all number	1	0	2	7	10
Haemorrhoids
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Mouth ulceration
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	1 / 31 (3.23%)	2 / 35 (5.71%)
occurrences all number	1	0	0	1	2
Nausea
subjects affected / exposed	1 / 15 (6.67%)	3 / 35 (8.57%)	1 / 16 (6.25%)	1 / 31 (3.23%)	5 / 35 (14.29%)
occurrences all number	1	3	2	1	7
Stomach discomfort
subjects affected / exposed	1 / 15 (6.67%)	1 / 35 (2.86%)	0 / 16 (0.00%)	0 / 31 (0.00%)	2 / 35 (5.71%)
occurrences all number	1	1	0	0	2
Rectal haemorrhage
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Tooth impacted
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Vomiting
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	1 / 31 (3.23%)	1 / 35 (2.86%)
occurrences all number	0	0	1	1	2
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	0 / 16 (0.00%)	2 / 31 (6.45%)	2 / 35 (5.71%)
occurrences all number	0	0	0	2	2
Erythema
subjects affected / exposed	0 / 15 (0.00%)	1 / 35 (2.86%)	0 / 16 (0.00%)	2 / 31 (6.45%)	3 / 35 (8.57%)
occurrences all number	0	1	0	2	3
Hyperhidrosis
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	0 / 16 (0.00%)	2 / 31 (6.45%)	2 / 35 (5.71%)
occurrences all number	0	0	0	2	2
Pruritus
subjects affected / exposed	1 / 15 (6.67%)	1 / 35 (2.86%)	0 / 16 (0.00%)	1 / 31 (3.23%)	3 / 35 (8.57%)
occurrences all number	1	1	0	1	3
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	0 / 15 (0.00%)	1 / 35 (2.86%)	0 / 16 (0.00%)	2 / 31 (6.45%)	3 / 35 (8.57%)
occurrences all number	0	1	0	2	3
Arthralgia
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Joint swelling
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Groin pain
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Muscle contracture
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	1 / 31 (3.23%)	2 / 35 (5.71%)
occurrences all number	0	0	1	1	2
Muscle spasms
subjects affected / exposed	0 / 15 (0.00%)	2 / 35 (5.71%)	0 / 16 (0.00%)	0 / 31 (0.00%)	2 / 35 (5.71%)
occurrences all number	0	2	0	0	2
Musculoskeletal chest pain
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	1 / 31 (3.23%)	1 / 35 (2.86%)
occurrences all number	0	0	2	2	4
Pain in extremity
subjects affected / exposed	0 / 15 (0.00%)	1 / 35 (2.86%)	0 / 16 (0.00%)	2 / 31 (6.45%)	3 / 35 (8.57%)
occurrences all number	0	1	0	2	3
Musculoskeletal pain
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	1 / 16 (6.25%)	2 / 31 (6.45%)	4 / 35 (11.43%)
occurrences all number	1	0	1	2	4
Tendonitis
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Infections and infestations
Bronchitis
subjects affected / exposed	1 / 15 (6.67%)	3 / 35 (8.57%)	1 / 16 (6.25%)	0 / 31 (0.00%)	4 / 35 (11.43%)
occurrences all number	1	5	1	0	7
Herpes zoster
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Gastroenteritis
subjects affected / exposed	2 / 15 (13.33%)	0 / 35 (0.00%)	1 / 16 (6.25%)	2 / 31 (6.45%)	4 / 35 (11.43%)
occurrences all number	2	0	1	2	5
Influenza
subjects affected / exposed	2 / 15 (13.33%)	1 / 35 (2.86%)	3 / 16 (18.75%)	0 / 31 (0.00%)	6 / 35 (17.14%)
occurrences all number	2	1	3	0	6
Nasopharyngitis
subjects affected / exposed	4 / 15 (26.67%)	4 / 35 (11.43%)	2 / 16 (12.50%)	4 / 31 (12.90%)	12 / 35 (34.29%)
occurrences all number	4	4	2	4	14
Oral herpes
subjects affected / exposed	0 / 15 (0.00%)	1 / 35 (2.86%)	2 / 16 (12.50%)	0 / 31 (0.00%)	3 / 35 (8.57%)
occurrences all number	0	1	2	0	3
Rhinitis
subjects affected / exposed	1 / 15 (6.67%)	4 / 35 (11.43%)	2 / 16 (12.50%)	0 / 31 (0.00%)	6 / 35 (17.14%)
occurrences all number	1	4	2	0	7
Pharyngitis
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	1 / 16 (6.25%)	2 / 31 (6.45%)	4 / 35 (11.43%)
occurrences all number	1	0	1	2	4
Tinea pedis
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Tooth infection
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Tooth abscess
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	1	0	0	0	1
Upper respiratory tract infection
subjects affected / exposed	1 / 15 (6.67%)	0 / 35 (0.00%)	1 / 16 (6.25%)	1 / 31 (3.23%)	3 / 35 (8.57%)
occurrences all number	1	0	3	1	5
Viral infection
subjects affected / exposed	2 / 15 (13.33%)	0 / 35 (0.00%)	0 / 16 (0.00%)	0 / 31 (0.00%)	2 / 35 (5.71%)
occurrences all number	3	0	0	0	3
Urinary tract infection
subjects affected / exposed	2 / 15 (13.33%)	0 / 35 (0.00%)	0 / 16 (0.00%)	1 / 31 (3.23%)	2 / 35 (5.71%)
occurrences all number	3	0	0	1	4
Metabolism and nutrition disorders
Hypercholesterolaemia
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1
Hypertriglyceridaemia
subjects affected / exposed	0 / 15 (0.00%)	0 / 35 (0.00%)	1 / 16 (6.25%)	0 / 31 (0.00%)	1 / 35 (2.86%)
occurrences all number	0	0	1	0	1

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results:
A three-part multi-center study, with a randomized, double-blind, placebo controlled, withdrawal design in Part II to assess efficacy, safety and tolerability of ACZ885 (antiinterleukin-1β monoclonal antibody) in patients with Muckle-Wells Syndrome

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of subjects with disease flare at Week 32 (Part II)

Primary: Percentage of subjects with disease flare at Week 32 (Part II)

Secondary: Number of subjects with treatment response at Week 8 (Part I)

Secondary: Number of subjects with treatment response at Week 8 (Part I)

Secondary: Change from Week 8 in serum concentrations of C-reactive protein and Serum Amyloid A protein at Week 32 (Part II)

Secondary: Change from Week 8 in serum concentrations of C-reactive protein and Serum Amyloid A protein at Week 32 (Part II)

Secondary: Percentage of subjects with defined grades of physician global assessment of autoinflammatory disease activity at Week 32 (Part II)

Secondary: Percentage of subjects with defined grades of physician global assessment of autoinflammatory disease activity at Week 32 (Part II)

Secondary: Percentage of subjects with defined grades of Subject's global assessment of symptoms total score at Week 32 (Part II)

Secondary: Percentage of subjects with defined grades of Subject's global assessment of symptoms total score at Week 32 (Part II)

Secondary: Clearance of canakinumab (Part I and Part II)

Secondary: Clearance of canakinumab (Part I and Part II)

Secondary: Serum concentration of total interleukin-1beta antibody (IL-1β) (Part I, Part II and Part III)

Secondary: Serum concentration of total interleukin-1beta antibody (IL-1β) (Part I, Part II and Part III)

Secondary: Percentage of subjects with skin disease at Week 32 (Part II)

Secondary: Percentage of subjects with skin disease at Week 32 (Part II)

Secondary: Number of subjects with clinically significant findings in audiogram, neurological and opthalmological assessments at Week 32 (Part II)

Secondary: Number of subjects with clinically significant findings in audiogram, neurological and opthalmological assessments at Week 32 (Part II)

Secondary: Number of subjects with anti-canakinumab antibodies (Part I, Part II and Part III)

Secondary: Number of subjects with anti-canakinumab antibodies (Part I, Part II and Part III)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Italy
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Outside EU/EEA

Clinical trials

Clinical Trial Results: A three-part multi-center study, with a randomized, double-blind, placebo controlled, withdrawal design in Part II to assess efficacy, safety and tolerability of ACZ885 (antiinterleukin-1β monoclonal antibody) in patients with Muckle-Wells Syndrome

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of subjects with disease flare at Week 32 (Part II)

Primary: Percentage of subjects with disease flare at Week 32 (Part II)

Secondary: Number of subjects with treatment response at Week 8 (Part I)

Secondary: Number of subjects with treatment response at Week 8 (Part I)

Secondary: Change from Week 8 in serum concentrations of C-reactive protein and Serum Amyloid A protein at Week 32 (Part II)

Secondary: Change from Week 8 in serum concentrations of C-reactive protein and Serum Amyloid A protein at Week 32 (Part II)

Secondary: Percentage of subjects with defined grades of physician global assessment of autoinflammatory disease activity at Week 32 (Part II)

Secondary: Percentage of subjects with defined grades of physician global assessment of autoinflammatory disease activity at Week 32 (Part II)

Secondary: Percentage of subjects with defined grades of Subject's global assessment of symptoms total score at Week 32 (Part II)

Secondary: Percentage of subjects with defined grades of Subject's global assessment of symptoms total score at Week 32 (Part II)

Secondary: Clearance of canakinumab (Part I and Part II)

Secondary: Clearance of canakinumab (Part I and Part II)

Secondary: Serum concentration of total interleukin-1beta antibody (IL-1β) (Part I, Part II and Part III)

Secondary: Serum concentration of total interleukin-1beta antibody (IL-1β) (Part I, Part II and Part III)

Secondary: Percentage of subjects with skin disease at Week 32 (Part II)

Secondary: Percentage of subjects with skin disease at Week 32 (Part II)

Secondary: Number of subjects with clinically significant findings in audiogram, neurological and opthalmological assessments at Week 32 (Part II)

Secondary: Number of subjects with clinically significant findings in audiogram, neurological and opthalmological assessments at Week 32 (Part II)

Secondary: Number of subjects with anti-canakinumab antibodies (Part I, Part II and Part III)

Secondary: Number of subjects with anti-canakinumab antibodies (Part I, Part II and Part III)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A three-part multi-center study, with a randomized, double-blind, placebo controlled, withdrawal design in Part II to assess efficacy, safety and tolerability of ACZ885 (antiinterleukin-1β monoclonal antibody) in patients with Muckle-Wells Syndrome