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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06664801




Registration number
NCT06664801
Ethics application status
Date submitted
28/10/2024
Date registered
30/10/2024

Titles & IDs
Public title
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024)
Scientific title
A Phase 2, Multicenter, Single-blinded, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care
Secondary ID [1] 0 0
2024-512278-92
Secondary ID [2] 0 0
7962-024
Universal Trial Number (UTN)
Trial acronym
LIGHTRAY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Sotatercept
Treatment: Other - Background PAH Therapy

Experimental: Weight-based sotatercept dosing - Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of 0.3 mg/kg and then at a maintenance dose of 0.7 mg/kg using a weight-based method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study.

Experimental: Weight-banded sotatercept dosing - Participants will receive sotatercept via SC injection every 3 weeks at an initial dose of up to 45 mg and then at a maintenance dose of up to 90 mg using a weight-banded method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study.


Treatment: Other: Sotatercept
SC administered every 3 weeks.

Treatment: Other: Background PAH Therapy
Background PAH therapy may consist of the following drug classes: single, double, or triple combination of therapy with endothelin-receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogs or receptor antagonists
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Steady-State Average Serum Concentrations of Sotatercept (Cavg)
Timepoint [1] 0 0
Predose and at designated time points post-dose (up to 24 weeks)
Primary outcome [2] 0 0
Number of Participants Who Experience One or More Adverse Events (AEs)
Timepoint [2] 0 0
Up to 37 weeks
Primary outcome [3] 0 0
Number of Participants who Discontinue Study Treatment due to an Adverse Event
Timepoint [3] 0 0
Up to 21 weeks
Secondary outcome [1] 0 0
Initial Dose Average Serum Concentrations of Sotatercept (Cavg)
Timepoint [1] 0 0
Predose and at designated time points post-dose (up to 3 weeks)

Eligibility
Key inclusion criteria
* Has documented diagnostic Right Heart Catheterization, with the diagnosis of World Health Organization (WHO) Pulmonary Atrial Hypertension (PAH) Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
* Has symptomatic PAH classified as WHO Functional Class II or III
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a weight of <35 kg
* Has a diagnosis of PH WHO Groups 2, 3, 4, or 5
* Has a diagnosis of the following PAH Group 1 subtypes: HIV-associated PAH, PAH associated with portal hypertension, Exclusion in PAH Group 1 should also include schistosomiasis-associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis
* Has uncontrolled systemic hypertension
* Has a history of pneumonectomy
* Has a history of known pericardial constriction
* Has a history of restrictive cardiomyopathy
* Has history of atrial septostomy (within 180 days prior to study start)
* Has personal or family history of long QT syndrome
* Has history of coronary artery disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass, graft surgery, or cardiac anginal chest pain) (within 6 months prior to study start)
* Has a cerebrovascular accident (within 3 months prior to study start)
* Has significant (>2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
* Has untreated more than mild obstructive sleep apnea
* Has known malignancy that is progressing or has required active treatment within the past 5 years
* Has recently started (within 12 months prior to study start) or has plans to start weight loss medication or enter a weight loss program during the study period
* Has a previous (within 3 years) or planned (during the study) obesity treatment with surgery or a weight-loss device

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


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
14/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/07/2026
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Westmead Hospital ( Site 0100) - Westmead
Recruitment hospital [2] 0 0
Wesley Research Institute ( Site 0101) - Auchenflower
Recruitment hospital [3] 0 0
The Alfred Hospital ( Site 0102) - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
New Mexico
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Argentina
State/province [6] 0 0
Buenos Aires
Country [7] 0 0
Argentina
State/province [7] 0 0
Cordoba
Country [8] 0 0
Argentina
State/province [8] 0 0
Caba
Country [9] 0 0
Argentina
State/province [9] 0 0
Corrientes
Country [10] 0 0
Argentina
State/province [10] 0 0
Santa Fe
Country [11] 0 0
China
State/province [11] 0 0
Guangdong
Country [12] 0 0
China
State/province [12] 0 0
Hunan
Country [13] 0 0
China
State/province [13] 0 0
Yunnan
Country [14] 0 0
France
State/province [14] 0 0
Puy-de-Dome
Country [15] 0 0
Germany
State/province [15] 0 0
Nordrhein-Westfalen
Country [16] 0 0
Germany
State/province [16] 0 0
Berlin
Country [17] 0 0
Hungary
State/province [17] 0 0
Csongrad
Country [18] 0 0
Israel
State/province [18] 0 0
Haifa
Country [19] 0 0
Israel
State/province [19] 0 0
Petah-Tikva
Country [20] 0 0
Israel
State/province [20] 0 0
Ramat Gan
Country [21] 0 0
Japan
State/province [21] 0 0
Osaka
Country [22] 0 0
Japan
State/province [22] 0 0
Tokyo
Country [23] 0 0
Japan
State/province [23] 0 0
Okayama
Country [24] 0 0
Netherlands
State/province [24] 0 0
Gelderland
Country [25] 0 0
Singapore
State/province [25] 0 0
Central Singapore
Country [26] 0 0
Spain
State/province [26] 0 0
Baleares
Country [27] 0 0
Spain
State/province [27] 0 0
Cantabria
Country [28] 0 0
Spain
State/province [28] 0 0
Cataluna
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Spain
State/province [31] 0 0
Sevilla
Country [32] 0 0
Spain
State/province [32] 0 0
Toledo
Country [33] 0 0
Taiwan
State/province [33] 0 0
Kaohsiung
Country [34] 0 0
Taiwan
State/province [34] 0 0
Tainan
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taipei
Country [36] 0 0
Thailand
State/province [36] 0 0
Krung Thep Maha Nakhon
Country [37] 0 0
Thailand
State/province [37] 0 0
Chiang Mai
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Cambridgeshire
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London, City Of
Country [40] 0 0
United Kingdom
State/province [40] 0 0
West Dunbartonshire

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06664801