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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05612035




Registration number
NCT05612035
Ethics application status
Date submitted
3/11/2022
Date registered
10/11/2022
Date last updated
6/05/2024

Titles & IDs
Public title
MK-5475-013 INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of MK-5475 (an Inhaled sGC Stimulator) in Adults With PH-COPD
Scientific title
A Phase 2a Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Secondary ID [1] 0 0
MK-5475-013
Secondary ID [2] 0 0
5475-013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 0 0
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MK-5475
Treatment: Drugs - Placebo

Experimental: MK-5475 - Participants with PH-COPD will receive 380 µg of MK-5475 as an oral inhalation once daily for 24 weeks (base period) and thereafter for 18 months (optional extension period).

Placebo Comparator: Placebo - Participants with PH-COPD will receive matching placebo as an oral inhalation once daily for 24 weeks (base period) and then 380 µg of MK-5475 as an oral inhalation once daily for 18 months (optional extension period).


Treatment: Drugs: MK-5475
MK-5475 380 µg administered as dry powder inhalation once daily.

Treatment: Drugs: Placebo
Placebo administered as dry powder inhalation once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [1] 0 0
Mean Change From Baseline in 6MWD at Week 12
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Mean Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) at Week 12
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
Mean Change From Baseline in NT-ProBNP at Week 24
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
Percentage of Participants Whose World Health Organization-Functional Class (WHO-FC) Does not Worsen Relative to Baseline at Week 12
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [5] 0 0
Percentage of Participants Whose WHO-FC Does not Worsen Relative to Baseline at Week 24
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
Percentage of Participants With One or More Adverse Events (AEs)
Timepoint [6] 0 0
Up to Week 104
Secondary outcome [7] 0 0
Percentage of Participants who Discontinued Study Treatment due to an AE
Timepoint [7] 0 0
Up to Week 102

Eligibility
Key inclusion criteria
The key inclusion and exclusion criteria include but are not limited to the following:



- Has Group 3.1 pulmonary hypertension chronic obstructive pulmonary disease (PH-COPD)
as defined by the Clinical Classification of Pulmonary Hypertension.

- Has a right heart catheterization (RHC) at screening or historical RHC within 12
months before screening that meets hemodynamic criteria.

- Has a physician diagnosis of obstructive lung disease on pulmonary function testing
(PFT) performed at screening.

- Has a WHO Functional Class assessment of Class II to IV.

- If on supplemental oxygen, the regimen must be stable.

- Has stable and optimized chronic, baseline COPD-specific therapy.

- If on PDE5 inhibitor, has stable concomitant use (initiated at least 3 months prior to
randomization and no change in drug or dosage for at least 3 months prior to
randomization) and changes to PDE5 inhibitor dosing is not anticipated during the 24
week Base Period.

- If on antihypertensives and/or a diuretic regimen has stable concomitant use.

- If on anticoagulants has stable concomitant use.

- Is of any sex/gender from 40 to 85 years of age inclusive.

- Female is not pregnant or breastfeeding, and is not of childbearing potential or uses
acceptable contraceptive method or abstains from sexual intercourse, or has a negative
highly sensitive pregnancy test within 24 hours before the first dose of study
intervention, or whose history and sexual activity has been reviewed by the
investigator.
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Has Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary
hypertension (PH).

- Has non-COPD related Group 3 PH.

- Has evidence of untreated more than mild obstructive sleep apnea.

- Has significant left heart disease.

- Expects to receive a lung and/or heart transplant from screening through the end of
the 24 week Base Period.

- Has evidence of a resting oxygen saturation (SpO2) < 88%.

- Has experienced a moderate or severe COPD exacerbation within 2 months before
randomization.

- Has experienced right heart failure within 2 months before randomization.

- Has uncontrolled tachyarrhythmia.

- Has acute coronary syndrome, undergone coronary artery bypass graft, or percutaneous
coronary intervention within 2 months before randomization.

- Has evidence of significant chronic renal insufficiency.

- Has evidence of chronic liver disease, portal hypertension, cirrhosis, or hepatic
abnormalities.

- Initiated a pulmonary rehabilitation program within 2 months before randomization.

- Has impairments that limit the ability to perform 6MWT.

- Has history of cancer.

- Is a user of illicit drugs or has a recent history of drug/alcohol abuse or
dependence.

- Has used PAH-specific therapies within 2 months of randomization.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/03/2028
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Westmead Hospital-Department of Respiratory and Sleep Medicine ( Site 0902) - Westmead
Recruitment hospital [2] 0 0
The Prince Charles Hospital ( Site 0904) - Brisbane
Recruitment hospital [3] 0 0
Mater Misericordiae Limited ( Site 0905) - South Brisbane
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4032 - Brisbane
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Tucuman
Country [16] 0 0
Argentina
State/province [16] 0 0
Cordoba
Country [17] 0 0
Austria
State/province [17] 0 0
Steiermark
Country [18] 0 0
Austria
State/province [18] 0 0
Tirol
Country [19] 0 0
Belgium
State/province [19] 0 0
Bruxelles-Capitale, Region De
Country [20] 0 0
Colombia
State/province [20] 0 0
Antioquia
Country [21] 0 0
Colombia
State/province [21] 0 0
Atlantico
Country [22] 0 0
Colombia
State/province [22] 0 0
Valle Del Cauca
Country [23] 0 0
France
State/province [23] 0 0
Bouches-du-Rhone
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
Vienne
Country [26] 0 0
Germany
State/province [26] 0 0
Baden-Wurttemberg
Country [27] 0 0
Germany
State/province [27] 0 0
Hessen
Country [28] 0 0
Germany
State/province [28] 0 0
Niedersachsen
Country [29] 0 0
Germany
State/province [29] 0 0
Sachsen
Country [30] 0 0
Germany
State/province [30] 0 0
Schleswig-Holstein
Country [31] 0 0
Israel
State/province [31] 0 0
Haifa
Country [32] 0 0
Israel
State/province [32] 0 0
Petah Tikva
Country [33] 0 0
Italy
State/province [33] 0 0
Friuli-Venezia Giulia
Country [34] 0 0
Italy
State/province [34] 0 0
Lombardia
Country [35] 0 0
Italy
State/province [35] 0 0
Palermo
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Incheon
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Seoul
Country [38] 0 0
Mexico
State/province [38] 0 0
Mexico
Country [39] 0 0
Peru
State/province [39] 0 0
Lima
Country [40] 0 0
South Africa
State/province [40] 0 0
Gauteng
Country [41] 0 0
South Africa
State/province [41] 0 0
Kwazulu-Natal
Country [42] 0 0
Spain
State/province [42] 0 0
Cantabria
Country [43] 0 0
Spain
State/province [43] 0 0
Cataluna
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Sevilla
Country [46] 0 0
Switzerland
State/province [46] 0 0
Zurich
Country [47] 0 0
Switzerland
State/province [47] 0 0
Sankt Gallen
Country [48] 0 0
Turkey
State/province [48] 0 0
Ankara
Country [49] 0 0
Turkey
State/province [49] 0 0
Eskisehir
Country [50] 0 0
Turkey
State/province [50] 0 0
Istanbul
Country [51] 0 0
United Kingdom
State/province [51] 0 0
London, City Of
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of once daily oral
inhalation dose of MK-5475 380 µg in participants 40 to 85 years (inclusive) with Pulmonary
Hypertension associated with Chronic Obstructive Pulmonary Disease (PH-COPD).

The primary hypothesis of the study is MK-5475, a soluble Guanylate Cyclase (sGC) stimulator
is superior to placebo in increasing 6 Minute Walking Distance (6MWD) from baseline at Week
24.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05612035
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@merck.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05612035