Clinical Trials Register

Summary
EudraCT Number:	2015-005054-36
Sponsor's Protocol Code Number:	MK-1029-015
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-07-11
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

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A. Protocol Information

A.1

Member State Concerned

Poland - Office for Medicinal Products

A.2

EudraCT number

2015-005054-36

A.3

Full title of the trial

A Phase-II, Randomized, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Safety of MK-1029 in Adult Subjects with Persistent Asthma That is Uncontrolled While Receiving Montelukast.

A.3.1

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

Phase-II Study of MK-1029 added to Montelukast in Adults with Uncontrolled Asthma.

A.3.2

Name or abbreviated title of the trial where available

Phase-II Study of MK-1029 added to Montelukast in Adults with Uncontrolled Asthma

A.4.1

Sponsor's protocol code number

MK-1029-015

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	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
B.1.3.4	Country	United States
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	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
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
B.5.2	Functional name of contact point	Global Clinical Trials Operations

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	MK-1029
D.3.2	Product code	MK-1029
D.3.4	Pharmaceutical form	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	MK-1029 Free Acid Form III
D.3.9.2	Current sponsor code	MK-1029
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
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.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	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	MONTELUKAST
D.3.2	Product code	MK-0476
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	MONTELUKAST SODIUM
D.3.9.2	Current sponsor code	MK-0476
D.3.9.4	EV Substance Code	SUB03324MIG
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	10
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	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

Persistent 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.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate that MK-1029, compared with placebo, increases lung function when added to montelukast.

E.2.2

Secondary objectives of the trial

1)Key Secondary Objective: To demonstrate that MK-1029, compared with placebo, improves control of asthma when added to montelukast.

2)Objective: To characterize the safety and tolerability of MK-1029, when added to montelukast, during 6 weeks of treatment.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.

E.3

Principal inclusion criteria

•Male/Female subjects between the ages of 18 and 65
•Have a consistent clinical history, for at least one year, of symptoms of persistent asthma that may include, but are not limited to, dyspnea, wheezing, chest tightness, cough, and/or sputum production.
•Must have documented SNP+ test result prior to Visit 2
•Have acceptable lung function at Visit 2 and Visit 4:
FEV1 ≥55% and ≤85% of the predicted value (or, ≥60% and ≤90% of the predicted value if subject is receiving controllers) at Visit 2, after withholding inhaled beta-agonist bronchodilators prior to spirometry (see section 5.5.1);
AND FEV1 ≥50% and ≤85% of the predicted value at Visit 4
•Have evidence of reversibility of airway obstruction, defined as an increase in FEV1 of at least 12% and at least 200mL when measured 10 to 30 minutes following short-acting beta-agonist (SABA)
•Have a history of asthma treatment, prior to Visit 1, that is in one of two categories (see section 4.2.1.3):
Controllers: Receiving stable doses of low- or medium-dose ICS, combination ICS/LABA, and/or other asthma controller medications; and (based on investigator’s judgment) can tolerate tapering of these controllers (e.g., ICS) or discontinuing these controllers (i.e., non-ICS) while receiving montelukast 10mg once daily (QD) starting at Visit 3; OR
Non-controllers: Not receiving asthma controller medications, and using only “as-needed” inhaled SABAs, for ≥4 weeks prior to Visit 1.
•Agree at Visit 3 to discontinue controllers (e.g., leukotriene antagonists other than montelukast), or taper them (e.g., ICS) over 2-4 weeks (as described in Appendix 12.10). Also, agree at Visit 3 to begin montelukast 10 mg QD.
•Have a daytime and nocturnal SABA administration average ≥1 puff per day, as recorded on the subject’s e-Diary for the last 7 days prior to Visit 4.
•Have an ACQ-6 score meeting the following requirements.
Non-controllers: At Visit 2, must have an ACQ-6 score ≥1.5 and a score between 1 and 6 for Question #6. At Visit 4, must have an ACQ-6 score ≥1.5.
Controllers: Visit 4 must have an ACQ-6 score ≥1.5.
•Not be pregnant

Refer to protocol for complete list

E.4

Principal exclusion criteria

•Is unable to perform acceptable, repeatable spirometry.
•Has evidence of another clinically significant, active pulmonary disorder, such as bronchiectasis or COPD, documented by history, physical examination, or chest x-ray.
•Has been treated in an emergency room for asthma within 4 weeks of Visit 1 or has been hospitalized for asthma or respiratory condition within 2 months prior to Visit 1.
•Has had an upper respiratory tract infection (viral or bacterial) within 1 month prior to Visit 1.
•Has evidence of active, clinically significant sinus disease within 2 weeks prior to Visit 1.
•Experiences a clinically significant deterioration of asthma between Visit 2 and Visit 4. A significant deterioration of asthma is defined as one or more of the following:

Decrease in absolute FEV1 (in L) by 20% or more from the FEV1 at Visit 2;
Decrease in %-predicted FEV1 to less than 50% of the predicted value;
Clinical asthma exacerbation requiring emergency treatment, hospital admission (serious AE), or treatment with additional asthma medication (other than SABAs).

Refer to protocol for complete list

E.5 End points

E.5.1

Primary end point(s)

Average change from baseline in FEV1 as measured at the end of Week 4 and Week 6 of treatment.

E.5.1.1

Timepoint(s) of evaluation of this end point

The end of Week 4 and Week 6 of treatment.

E.5.2

Secondary end point(s)

•Percent of days with worsening asthma (%d-WA) as measured daily during Week 3 to Week 6 (inclusive) of treatment

Safety Analysis
•Percentage of subjects with adverse experience
•Clinical and laboratory adverse experiences reported during the treatment period
•Change from baseline in vital signs parameters and change or percent change (as appropriate) from baseline in laboratory safety parameters at the end of the trial

E.5.2.1

Timepoint(s) of evaluation of this end point

Percent of days with worsening asthma (%d-WA) as measured daily during Week 3 to Week 6 (inclusive) of treatment
-Timepoint of evaluation: measured daily during Week 3 to Week 6 (inclusive) of treatment
Percentage of subjects with adverse experience
-Timepoint of evaluation: during each period of the trial
Clinical and laboratory adverse experiences reported during the treatment period
-Timepoint of evaluation: during each period of the trial
Change from baseline in vital signs parameters and change or percent change (as appropriate) from baseline in laboratory safety parameters at the end of the trial
-Timepoint of evaluation: At the end of the treatment

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

tolerability

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)

Yes

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

Information not present in EudraCT

E.8.4

The trial involves multiple sites in the Member State concerned

Information not present in EudraCT

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

Guatemala

Japan

Malaysia

Poland

South Africa

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

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

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:

110

F.1.3

Elderly (>=65 years)

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

100

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)

Standard of care

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

2016-08-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-06-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-09-06

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