Clinical Trials Register

Summary
EudraCT Number:	2007-003037-17
Sponsor's Protocol Code Number:	CACZ885A2212
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2007-10-11
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2007-003037-17

A.3

Full title of the trial

A randomized, double-blind, double-dummy, active-controlled, parallel group study of single doses of ACZ885 in hospitalized patients with acute gout

A.3.2

Name or abbreviated title of the trial where available

Not available

A.4.1

Sponsor's protocol code number

CACZ885A2212

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

Not available

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Pharma Services
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	ACZ885
D.3.2	Product code	ACZ885
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Canakinumab (WHO approval pending)
D.3.9.1	CAS number	-
D.3.9.2	Current sponsor code	ACZ885
D.3.9.3	Other descriptive name	None
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150 mg
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Human Monoclonal Antibody
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	H02AB02
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dexamethasone
D.3.9.1	CAS number	50-02-2
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	N/A
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	Yes
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Information not present in EudraCT

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Powder for solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Acute gout

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10018628
E.1.2	Term	Gout acute

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the effect of a single dose of ACZ885 on the Likert scale response in patients with acute gout at 72 hours post dose.

E.2.2

Secondary objectives of the trial

To confirm that there is non-inferiority of a single dose of 10mg/kg ACZ885 compared to the active comparator Dexamethasone 12mg i.v.

To assess the safety, tolerability and immunogencitiy following administration of ACZ885 to patients with acute gout.

To assess the use of rescue medication, time to walk independently and time to recurrence of the symptoms of acute gout (if applicable)

To evaluate change in C-reactive protein (CRP) and serum amyloid A protein (SAA) from baseline.

To evaluate the pharmacokinetics (PK) of ACZ885.

To assess any change in pain following ACZ885 administration via a 0-100 mm Visual Analog Scale.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female subjects aged 18 to 80 years (inclusive).

2. Female subjects of childbearing potential must use two acceptable methods of contraception. Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to initial dosing. Menopause will be confirmed by a plasma FSH level of >40 IU/L at screening Female subjects who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing. Periodic adstinence (e.g. calender, ovulation, symptom-termal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

3. Male subjects must use two acceptable methods of contraception , (e.g., spermicidal gel plus condom) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child in the six (6) months following study completion. Periodic adstinence and withdrawal are not accpetable methods of contraception.

4. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2. See Appendix 3 of this protocol for BMI ranges.

5, Patients must score over 40 on the 0-100 VAS pain scale.

6. Patients must be willing to undergo diagnostic arthrocentesis and must have MSU crystals documented by joint aspiration and subsequent microscopy to confirm acute gout if there is no record of a previous aspiration. A repeat aspiration is not required if a history of MSU crystals by microscopic exam documented in the medical record is present. The crystals may have been identified in any joint or from a tophus. Crystals observed in a urinalysis are not acceptable, since this may be a normal finding.

7. Presence of acute gout flare for no longer than 4 days at screening.

8. Able to return to the hospital or Investigator-affiliated clinic for outpatient follow up assessments.

9. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.

E.4

Principal exclusion criteria

1. Smokers whose smoking habits interfere with the conduct of the study.

2. Use of any TNF inhibitor within the past 3 months.

3. Use of any concomitant medication for the treatment of acute gout within the previous 24 hours prior to screening other than a dose of < 10 mg prednisone or the equivalent or no more than 1 single dose of 0.6 mg colchicine (unless this treatment was judged by the Investigator as ineffective). Low dose aspirin (≤325mg once daily) low dose ibuprofen (≤600mg daily), naproxen (≤500mg daily), or dose of any other NSAID or COX-2 inhibitor judged comparable by the investigator, as well as use of chronic, hypouricaemic therapy (e.g. allopurinol, probenrcid) are not exclusion criteria. Concommitant chronic, hypouricaemic therapy (e.g. allopurinol, probenecid, sulfinpyazone or benzbromarone), may initiated during treatment period at the discretion of teh clinical investigator.

4. Class 4 Heart Failure (baseline compensated status prior to hospital admission).

5. Hepatic cirrhosis associated with a prolonged PT.

6. Life expectancy less than 1 year.

7. Participation in any clinical trial for an investigational drug within four weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.

8. Donation or loss of 400ml or more of blood within eight weeks prior to initial dosing, or longer if required by local regulation.

9. Clinical suspicion of an active infection.

10. Pregnant or breastfeeding women.

11. Major surgery with high infection risk (including total joint arthroplasty, open heart, gastrointestinal, diabetes-related surgery) within 1 month of the dose.

12.History of clinically significant atopy (e.g. steroid dependent asthma and urticaria) and /or allergies to the therapeutic /compound class being used in this study.

13. History of immunodeficiency diseases, including a previous, positive HIV (ELISA and Western blot) test result.

14. Known presence of viral hepatitis infection. History or risk (according to the MMWR 2000 guidance) of tuberculosis.

15. History or risk (according to the MMWR 2000 guidance) of tuberculosis.

16. Presence of severe renal function impairment (< 30 mL/min estimated creatinine clearance). History of renal trauma, glomerulonephritis, patients with one kidney, or renal failure requiring regular dialysis treatments.

17. History of malignancy (other than non-melanoma skin carcinoma or adequately treated carcinoma-in-situ of the cervix or prostate carcinoma which has not required treatment)

18. Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg

19. Uncontrolled diabetes (screening blood glucose > 300 mg/dl)

20. History of drug or alcohol abuse which in the opinion of the investigator places a participating patient at increased risk and/or interferes with the conduct of the study.

21. Presence or history of underlying metabolic, endocrine, hematologic, pulmonary, cardiac, blood, renal, hepatic, infectious, psychiatric or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for the participation in a study of an immunomodulatory therapy.

E.5 End points

E.5.1

Primary end point(s)

Positive proof of concept will be determined if at least 13 out of the 22 subjects included in the ACZ885 arm of the study score ‘good’ or ‘excellent’ on the Likerts scale within 72 hours post dose without the requirement for rescue medication.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Double dummy

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Information not present in EudraCT

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LPLV

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2007-11-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-02-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2009-10-23

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials