NCT02720081

Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)

Completed Phase 2 Results posted Last updated 27 September 2018

What this trial tests

Phase 2 trial testing MK-1029 150 mg in Asthma in 142 participants. Completed in 6 September 2017.

Timeline

11 May 2016

Primary endpoint
16 August 2017

6 September 2017

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	142
Start date	11 May 2016
Primary completion	16 August 2017
Estimated completion	6 September 2017

Drugs / interventions tested

• MK-1029 150 mg — full drug profile →
• MK-1029 Matching-image Placebo — full drug profile →
• Montelukast 10 mg
• Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 65, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1) Primary · Before the first dose of study investigational product (Baseline)

FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second.

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	2.264	± 0.566
MK-1029 Placebo + Montelukast 10 mg	2.234	± 0.612

Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6 Secondary · Up to 4 weeks

A day with worsening asthma was defined as any day during which any of the following occurred: a decrease from baseline in morning (AM) peak expiratory flow (PEF) of more than 20%; AM PEF less than 180 liters/minute (L/min); an increase in β-agonist use of more than 70% (and a minimum increase of at least 2 puffs); an increase from baseline in daytime asthma symptom score of more than 50%; overnight asthma symptom of: Awake "all night"; an asthma attack, as defined by any day when one or more of the following events due to asthma has occurred: corticosteroid use (systemic); unscheduled visit t

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	16.970	10.115 – 23.826
MK-1029 Placebo + Montelukast 10 mg	21.746	14.291 – 29.201

Percentage of Participants Who Experienced an Adverse Event (AE) Secondary · Up to 8 weeks

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	25.7
MK-1029 Placebo + Montelukast 10 mg	26.1

Percentage of Participants Who Discontinued Study Drug Due to an AE Secondary · Up to 6 weeks

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	0.0
MK-1029 Placebo + Montelukast 10 mg	4.3

Change From Baseline in Alkaline Phosphatase (ALP) at Week 6 Secondary · Baseline and Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Baseline

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	61.16	± 19.05
MK-1029 Placebo + Montelukast 10 mg	67.96	± 21.17

Change at Week 6

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	-0.83	± 7.68
MK-1029 Placebo + Montelukast 10 mg	0.44	± 9.98

Change From Baseline in Alanine Aminotransferase (ALT) at Week 6 Secondary · Baseline and Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Baseline

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	22.33	± 12.75
MK-1029 Placebo + Montelukast 10 mg	19.35	± 9.77

Change at Week 6

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	-0.99	± 9.84
MK-1029 Placebo + Montelukast 10 mg	0.34	± 6.31

Change From Baseline in Aspartate Aminotransferase (AST) at Week 6 Secondary · Baseline and Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Baseline

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	23.53	± 10.28
MK-1029 Placebo + Montelukast 10 mg	20.64	± 7.62

Change at Week 6

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	-0.09	± 12.52
MK-1029 Placebo + Montelukast 10 mg	0.76	± 7.67

Change From Baseline in Bilirubin at Week 6 Secondary · Baseline and Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Baseline

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	0.62	± 0.25
MK-1029 Placebo + Montelukast 10 mg	0.54	± 0.21

Change at Week 6

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	-0.00	± 0.25
MK-1029 Placebo + Montelukast 10 mg	-0.01	± 0.20

Change From Baseline in Eosinophil (Percent [%]) at Week 6 Secondary · Baseline and Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Baseline

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	4.40	± 4.54
MK-1029 Placebo + Montelukast 10 mg	3.58	± 2.65

Change at Week 6

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	0.11	± 4.29
MK-1029 Placebo + Montelukast 10 mg	0.51	± 1.96

Change From Baseline in Neutrophil (%) at Week 6 Secondary · Baseline and Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Baseline

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	59.13	± 10.30
MK-1029 Placebo + Montelukast 10 mg	57.86	± 10.48

Change at Week 6

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	-1.32	± 10.53
MK-1029 Placebo + Montelukast 10 mg	0.12	± 9.11

Change From Baseline in Platelet Count at Week 6 Secondary · Baseline and Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Baseline

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	256.85	± 60.83
MK-1029 Placebo + Montelukast 10 mg	258.44	± 70.23

Change at Week 6

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	-4.97	± 30.93
MK-1029 Placebo + Montelukast 10 mg	2.65	± 29.44

Change From Baseline in White Blood Cell Count at Week 6 Secondary · Baseline and Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Baseline

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	6.76	± 2.55
MK-1029 Placebo + Montelukast 10 mg	6.53	± 1.88

Change at Week 6

Group	Value	95% CI
MK-1029 150 mg + Montelukast 10 mg	-0.08	± 2.00
MK-1029 Placebo + Montelukast 10 mg	0.09	± 1.51

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 8 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MK-1029 150 mg + Montelukast 10 mg

Serious: 0/70 (0%)

Deaths: 0/70

MK-1029 Placebo + Montelukast 10 mg

Serious: 1/69 (1%)

Deaths: 0/69

Serious adverse events (1 terms)

Reaction	System	MK-1029 150 mg + Monteluka…	MK-1029 Placebo + Monteluk…
Asthma	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	MK-1029 150 mg + Monteluka…	MK-1029 Placebo + Monteluk…
Asthma	Respiratory, thoracic and mediastinal disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—

Most-reported serious reactions: Asthma.

Data from ClinicalTrials.gov NCT02720081 adverse events section.

Sponsor's own description

The purpose of this trial is to compare the safety, tolerability, and efficacy of adding MK-1029 to montelukast in adults with persistent asthma that is uncontrolled while receiving montelukast alone. Participants will have a specific genetic marker for clinical efficacy of MK-1029. The primary hypothesis is that when added to montelukast, treatment with MK-1029 is superior to placebo, as demonstrated by an increase in forced expiratory volume in one second (FEV1), measured as the average change from baseline at the end of Week 4 and Week 6 of treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Role of Biologics in Asthma.
   McGregor MC, Krings JG, Nair P, Castro M. · · 2019 · cited 319× · PMID 30525902 · DOI 10.1164/rccm.201810-1944ci