Pulmonary Arterial Hypertension
Conditions
Brief summary
Phase 1b/2 Study of HS235 Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of the Activin Signaling Inhibitor HS235 Added to Background Treatment in Adults with Pulmonary Arterial Hypertension (PAH)
Detailed description
A Phase 1b/2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of the Activin Signaling Inhibitor HS235 Added to Background Treatment in Adults with Pulmonary Arterial Hypertension (PAH)
Interventions
BIOLOGICALHS235
Subcutaneous Injection
OTHERPlacebo
Subcutaneous Injection
Sponsors
35Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants are eligible to be included in the study only if they meet all of the following criteria: 1. Male and female participants, 18 years of age and older. 2. Body Mass Index (BMI) 18.5 and 40 kg/m2 and body weight at or below 120 kg. 3. Baseline RHC performed during the Screening Period documenting: 1. A minimum PVR of ≥ 5 Wood units (WU) or ≥ 400 dyn·sec·cm-5 and, 2. A pulmonary artery wedge pressure (PAWP) of ≤ 15 mm Hg. 4. Diagnosis of WHO pulmonary arterial hypertension (PAH) Group 1. 5. Symptomatic PAH classified as WHO Functional class II to IV. 6. On stable doses of at least 2 approved background PAH therapies and diuretics. 7. 6-Minute Walk Distance (6MWD) ≥ 150 m and ≤ 500 m repeated twice during screening. 8. Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
Exclusion criteria
1. PH WHO Groups 2, 3, 4 or 5. 2. Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening. 3. Any symptomatic coronary disease events. 4. History of heart transplant or on heart transplant list. 5. Uncontrolled systemic hypertension. 6. History of restrictive, constrictive or congestive cardiomyopathy. 7. History of significant mitral regurgitation or aortic regurgitation valvular disease. 8. Untreated or poorly controlled moderate or severe obstructive sleep apnea. 9. A diagnosis of worse than moderate COPD or worse than mild ILD. 10. Cerebrovascular event within 90 days prior to screening 11. A pneumonectomy or lobectomy 12. Having received an activin signaling inhibitor such as sotatercept at any time prior to screening 13. A Hgb \> sex-specific ULN 14. Platelets count \< 100,000/mm3 15. Severe (stage ≥4) renal failure with eGFR \< 30 mL/min/m2 16. Abnormally elevated liver function enzymes (ALT or AST \> 3X ULN, or total bilirubin \> 1.5X ULN).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Number of Adverse Events (AEs) | up to 29 weeks | An AE is any untoward medical occurrence in a participants or clinical trial participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The incidence and number of participants who experience an AE will be reported. |
Countries
Spain, United Kingdom, United States
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
Outcome results
None listed