Clinical Trials Register

Summary
EudraCT Number:	2012-004920-39
Sponsor's Protocol Code Number:	38518168ASH2001
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:	2013-04-02
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

2012-004920-39

A.3

Full title of the trial

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-38518168 in Symptomatic Adult Subjects with Uncontrolled, Persistent Asthma

A.3.1

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

A Study of JNJ-38518168 in Symptomatic Adult Participants with Uncontrolled, Persistent Asthma

A.3.2

Name or abbreviated title of the trial where available

Not Applicable

A.4.1

Sponsor's protocol code number

38518168ASH2001

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Janssen-Cilag International N.V.
B.1.3.4	Country	Belgium
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	Janssen Research & Development, L.L.C.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Janssen Research and Development
B.5.2	Functional name of contact point	Clinical Registry Group
B.5.3	Address:
B.5.3.1	Street Address	Janssen Biologics BV - Clinical Registry Group
B.5.3.2	Town/ city	Archimedesweg 29
B.5.3.3	Post code	2333CM Leiden
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	31 (0)71 524 21 66
B.5.5	Fax number	31 (0)71 524 21 10
B.5.6	E-mail	ClinicalTrialsEU@its.jnj.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	JNJ-38518168-ZBQ - film-coated tablet - 30mg
D.3.2	Product code	JNJ-38518168
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not assigned
D.3.9.2	Current sponsor code	JNJ-38518168-ZBQ
D.3.9.3	Other descriptive name	JNJ-38518168-ZBQ
D.3.9.4	EV Substance Code	SUB92220
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	30
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral 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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10068462
E.1.2	Term	Eosinophilic asthma
E.1.2	System Organ Class	100000004855

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 is to assess the efficacy (as measured by the change from baseline in prebronchodilator percent-predicted forced expiratory volume in 1 second [FEV1]) of JNJ-38518168 compared with placebo in subjects with eosinophilic persistent asthma that is inadequately controlled despite current treatment.

E.2.2

Secondary objectives of the trial

The secondary objectives are to assess the safety, efficacy (as measured by improvement in asthma control), tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in subjects with eosinophilic persistent asthma that is inadequately controlled despite current treatment.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Principal Inclusion Criteria in Lay Language (for a complete list of
inclusion criteria refer to the protocol):

Have a diagnosis of asthma for at least 26 weeks, confirmed by the investigator at Screening Visit 1 -Have been receiving inhaled corticosteroid (ICS) (≤1000 μg/day fluticasone or its equivalent) for at least 12 weeks prior to Screening Visit 1 -At Screening Visit 1, be receiving the same dose of ICS ≤1000 μg/day fluticasone (or equivalent) alone or in conjunction with long-acting β2-agonist
(LABA) and/or montelukast for at least 4 weeks prior to screening with no changes in dose or dosing regimen of any of these therapies during that 4 week period prior to screening -Have an Asthma Control Questionnaire (ACQ) score ≥1.5 at Screening Visit 1 -Have a prebronchodilator forced expiratory volume in
1 second (FEV1) equal to 40% to 80%, inclusive, of predicted value at Screening Visit 1 -Have a ≥12% relative change and ≥200 mL change in FEV1 postbronchodilator at either Screening Visit 1 or 2

E.4

Principal exclusion criteria

Principal Exclusion Criteria in Lay Language (for a complete list of
exclusion criteria refer to the protocol):

Has ever had a life-threatening asthma attack including respiratory arrest, intubation, or intensive care unit (ICU) admission due to asthma -Has a history of any other chronic respiratory condition including, but not limited to, chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic
bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease -Has any use of the following asthma therapies: systemic corticosteroids within 6 weeks of Screening Visit 1; oral beta-agonists within 4 weeks of Screening Visit 1;
cromolyns within 4 weeks of Screening Visit 1; leukotriene inhibitors other than montelukast within 4 weeks
of Screening Visit 1; theophylline within 4 weeks of S reening Visit 1; inhaled anti-cholinergic agents within 4 weeks of Screening Visit 1; or omalizumab within 130 days of Screening Visit 1 -Has initiated or discontinued allergen immunotherapy within 12 weeks of Screening Visit 1 -Has smoked within 3 years of Screening Visit 1 or has a history of smoking ≥ 10 pack years -Body-Mass Index (BMI) >32 kg/m2

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in prebronchodilator forced expiratory
volume in 1 second (preBD FEV1)

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline to Week 16

E.5.2

Secondary end point(s)

1. Change from baseline in Asthma Control Questionnaire (ACQ)
2. Change from baseline in postbronchodilator forced expiratory volume in 1 second (postBD FEV1)
3. Change from baseline in weekly average of daytime asthma diary
symptom scores
4. Change from baseline in weekly average of nighttime asthma diary symptom scores
5. Change from baseline in weekly average of number of puffs in a day that rescue medication is used

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline to Week 16

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

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Biomarker Analysis

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.8.2.4

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

France

Germany

Israel

Italy

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

last visit of the last subject

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

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.1.2.1

Number of subjects for this age range:

128

F.1.3

Elderly (>=65 years)

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

160

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)

Not applicable

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

2013-05-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-08-16

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-07-22

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