Clinical Trials Register

Summary
EudraCT Number:	2013-005615-27
Sponsor's Protocol Code Number:	D2210C00008
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-01-09
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

Czechia - SUKL

A.2

EudraCT number

2013-005615-27

A.3

Full title of the trial

A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo
Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab
in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled
Corticosteroid Plus Long-Acting β2-Agonist

Multicentrická, randomizovaná, dvojitě zaslepená, placebem kontrolovaná, 52 týdenní studie fáze III s paralelními skupinami, hodnotící účinnost a bezpečnost tralokinumabu u dospělých a dospívajících pacientů, kteří nemají astma plně pod kontrolou při užívání inhalačního kortikosteroidu s dlouhodobě působícím ß2 agonistou

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A Phase 3 study to evaluate the Efficacy and Safety of Tralokinumab in Adults
and Adolescents with asthma that is not controlled.

Studie fáze 3, hodnotící účinnost a bezpečnost tralokinumabu u dospělých a dospívajících pacientů, kteří nemají astma plně pod kontrolou.

A.4.1

Sponsor's protocol code number

D2210C00008

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1158-7974

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/280/2011

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AstraZeneca AB
B.1.3.4	Country	Sweden
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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca AB
B.5.2	Functional name of contact point	Eva Augurell
B.5.3	Address:
B.5.3.1	Street Address	151 85
B.5.3.2	Town/ city	Sodertalje
B.5.3.4	Country	Sweden
B.5.4	Telephone number	46317761315
B.5.6	E-mail	eva.augurell@astrazeneca.com

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	Tralokinumab
D.3.2	Product code	CAT-354
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	Yes
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	No

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 in pre-filled syringe
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

E.1.1.1

Medical condition in easily understood language

Asthma

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10003553
E.1.2	Term	Asthma
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

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 evaluate the effect of tralokinumab compared with placebo on the
annualised asthma exacerbation rate in adult and adolescent subjects with
asthma that is inadequately controlled with inhaled corticosteroid plus longacting
β2-agonist.

E.2.2

Secondary objectives of the trial

To assess the effect of tralokinumab with regards to lung function.
To assess the effect of tralokinumab with regards to asthma symptoms.
To assess the effect of tralokinumab with regards to asthma specific health-related quality of life.
To assess the effect of tralokinumab with regards to ACQ-6 defined asthma control.
To assess the effect of tralokinumab with regards to ER and urgent care visits and hospitalizations due to asthma.
To assess the effect of tralokinumab with regards to health care resource utilization and productivity loss due to asthma.
To assess the effect of tralokinumab with regards to health related quality of life.
To assess the effect of tralokinumab with regards to asthma symptoms and asthma control.
To evaluate the PK and immunogenicity of tralokinumab.
To evaluate the safety and tolerability of tralokinumab.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age 12 -75 years
2. Documented physician-diagnosed asthma at least 12 months prior to enrollment.
3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone
propionate dry powder formulation equivalents and a LABA for at least 3 months.
4. Morning pre-BD FEV1 value of ≥40 and <80% value (<90% for patients 12 to 17 years of
age) of their PNV
5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1
6. ACQ-6 score ≥1.5
7. At least 2 documented asthma exacerbations in the 12 months prior to the date of informed consent.

E.4

Principal exclusion criteria

1. Clinically important pulmonary disease other than asthma
2. History of anaphylaxis following any biologic therapy
3. Hepatitis B, C or HIV
4. Pregnant or breastfeeding
5. History of cancer
6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years
7. Previous receipt of tralokinumab

E.5 End points

E.5.1

Primary end point(s)

Annual asthma exacerbation rate

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 0 to Week 52

E.5.2

Secondary end point(s)

1. Percent change from baseline to Week 52 in pre-dose/pre-bronchodilator forced expiratory volume in 1 second.
2. Change from baseline to Week 52 in daily asthma symptom score.
3. Change from baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older total score.
4. Change from baseline to Week 52 in Asthma Control Questionnaire-6 defined asthma control.
5. Time to first asthma exacerbation and proportion of subjects with ≥1 asthma exacerbation.
6. Annualised asthma exacerbation rate that is associated with an ER or urgent care visit, or a hospitalization.
7. Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questionnaire and European Quality of Life -5 Dimensions - 5 Levels Daily Living Quesitonnaire.
8. Rescue medication use, Home peak expiratory flow (morning and evening).
9. Night-time awakening due to asthma.
10. Pharmacokinetic parameters and Anti-Drug Antibodies.
11. Safety and Tolerability of tralokinumab assessed by the reporting of adverse events/serious adverse events and assessments for physical examination, electocardiogram, laboratory values and vital signs.

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 0 to Week 52 (except PK and ADA, 0 to Week 72 weeks)

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

Yes

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

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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.8.2.4

Number of treatment arms in the trial

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

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

Canada

Chile

Czech Republic

Hong Kong

Italy

Japan

Mexico

Philippines

Russian Federation

South Africa

Ukraine

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

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

LVLS

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

653

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

245

F.4.2.2

In the whole clinical trial

770

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

2015-03-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-01-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-09-21

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