Clinical Trials Register

Summary
EudraCT Number:	2008-007844-33
Sponsor's Protocol Code Number:	CAT-354-MI-CP199
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:	2009-05-22
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

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2008-007844-33

A.3

Full title of the trial

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Fully Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults with Uncontrolled, Moderate-to-severe, Persistent Asthma

A.4.1

Sponsor's protocol code number

CAT-354-MI-CP199

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	MedImmune Limited
B.1.3.4	Country	United Kingdom
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	CAT-354
D.3.2	Product code	CAT-354
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	1044515-88-9
D.3.9.2	Current sponsor code	CAT-354
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	150
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	IgG4 Engineered Human Monoclonal Antibody

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	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Asthma

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	8.1
E.1.2	Level	PT
E.1.2	Classification code	10003553
E.1.2	Term	Asthma

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to evaluate the effect of three SC treatment regimens of CAT-354 on asthma control at Study Day 92 versus placebo in adults with uncontrolled, moderate-to-severe, persistent asthma.

E.2.2

Secondary objectives of the trial

1) Evaluate the effect on the safety profile in this subject population;
2) Evaluate the effect on the time to asthma control through Study Days 92 and 169;
3) Evaluate the effect on the proportion of subjects achieving a change from baseline in ACQ score consistent with well controlled and partly controlled asthma
4) Evaluate the effect on the time to first asthma exacerbation
5) Evaluate the effect on asthma exacerbation rates and severity (hospitalizations)
6) Evaluate the effect on the variability of airflow obstruction using the parameters of forced expiratory volume within 1 second (FEV1) and peak expiratory flow (PEF)
7) Evaluate the effect on a subject’s requirement for concomitant controller or rescue medications and daily asthma symptoms
8) Evaluate the effect on the patient reported outcomes including health-related quality of life using the AQLQ(S) and the patient global impression of change
9) PK and immunogenicity of SC CAT-354.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Male or female subjects.
2) Age 18 to 65 years at the time of screening.
3) Subjects must have a body mass index (BMI) between 18 and 40 kg/m2.
4) Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
5) Physician-diagnosed moderate-to-severe, persistent asthma requiring treatment with appropriate asthma controller medication
6) Shows FEV1 reversibility postbronchodilator of ≥ 12% and ≥ 200 mL or have shown such values in a previous test within the last year, or have a positive AHR test result in the last year.
7) Pre-bronchodilator FEV1 value ≥ 40% of individual predicted value at Visits 1 and 3
8) Uncontrolled, moderate-to-severe, persistent asthma consistent with Expert Panel Report (EPR)-3. In the 2 to 4 weeks preceding the screening visit, subjects should have a history of one or more of the following: i) Daytime asthma symptoms ≥ 2 days/week ii)Nighttime awakening ≥ 1 night/week iii)Salbutamol use ≥ 2 days/week.
9) An ACQ score ≥ 1.5 at Visits 1 and 3
10) At least one occurrence of asthma exacerbation in the past year that required an unscheduled medical encounter.
11) Women of child-bearing potential, unless surgically sterile (including tubal ligation) and/or at least 2 years postmenopausal must have a negative pregnancy test prior to the first dose of investigational product, and must agree to use 2 effective methods of avoiding pregnancy (including oral, injectable, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, use of condom by male sexual partner); or abstinence or sterile sexual partner from screening through Study Day 169. Women of childbearing potential must continue to practice birth control during the study and for at least 2 months after completing the study.
12) Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide) and must use such precautions from Study Day 1 through Study Day 169.
13) Otherwise healthy by medical history and physical examination for that age group.
14) A chest x-ray or CT scan within the previous 12 months before entering the study with no findings suggestive of acute or chronic respiratory pathology other than asthma.
15) Ability and willingness to complete the follow-up period until Study Day 169 as required by the protocol.

E.4

Principal exclusion criteria

1) Known history of allergy or reaction to any component of the investigational product formulation.
2) Acute illness other than asthma at the start of the study.
3) History of an active infection within 4 weeks prior to screening, or evidence of clinically significant active infection, including ongoing chronic infection.
4) History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; or a diagnosis of parasitic infection within 6 months prior to screening.
5) Use of immunosuppressive medication (except oral prednisone up to 10 mg/day and inhaled and topical corticosteroids) within 30 days before randomization into the study.
6) Receipt of immunoglobulin or blood products within 30 days before randomization into the study.
7) Receipt of any investigational drug therapy or use of any biologicals including omalizumab within 6 months before the first dose of investigational product in this study or within 5 half-lives of an investigational agent or biologic, whichever is longer.
8) History of any known immunodeficiency disorder.
9) A positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or subject’s verbal report.
10) A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject’s verbal report.
11) A live or attenuated vaccination received within 4 weeks prior to screening
12) Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study.
13) History of clinically significant abnormality on electrocardiogram (ECG) in the opinion of the investigator.
14) Lactation (women)
15) History of treatment for alcohol or drug abuse within the past year.
16) History suggestive of chronic obstructive pulmonary disease (COPD) and of cigarette smoking ≥ 10 pack-years.
17) Evidence of any systemic disease on physical examination.
18) History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≤ 1 year prior to Study Day 1 or other malignancies treated with apparent success with curative therapy ≤ 5 years prior to entry.
19) Known exposure to inhaled occupational agents or fumes.
20) Any condition (eg, cystic fibrosis [CF] or COPD) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results.
21) Individuals who are legally institutionalized
22) Employees of the clinical study site or any other individuals involved with the conduct of the study, or family members of such individuals.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the change from baseline in the mean ACQ score at Study Day 92.

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

Last subject last visit

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 years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	40
F.4.2	For a multinational trial
F.4.2.1	In the EEA	192
F.4.2.2	In the whole clinical trial	192

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

2009-01-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-04-01

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-08-03

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