Clinical trial for Pulmonary Arterial Hypertension
Official title A Study of HS235 for Treatment of Pulmonary Arterial Hypertension (PAH) in Adults
ClinicalTrials.gov ID: NCT07143448
What this study is testing
What is HS235?
HS235 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for pulmonary arterial hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants are eligible to be included in the study only if they meet all of the following criteria:
- Male and female participants, 18 years of age and older.
- Body Mass Index (BMI) 18.5 and 40 kg/m2 and body weight at or below 120 kg.
- Baseline RHC performed during the Screening Period documenting:
- A minimum PVR of ≥ 5 Wood units (WU) or ≥ 400 dyn sec cm-5 and,
You likely can't join if
- PH WHO Groups 2, 3, 4 or 5.
- Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.
- Any symptomatic coronary disease events.
- History of heart transplant or on heart transplant list.
- Uncontrolled systemic hypertension.
- History of restrictive, constrictive or congestive cardiomyopathy.
See the full eligibility criteria
- Participants are eligible to be included in the study only if they meet all of the following criteria:
- Male and female participants, 18 years of age and older.
- Body Mass Index (BMI) 18.5 and 40 kg/m2 and body weight at or below 120 kg.
- Baseline RHC performed during the Screening Period documenting:
- A minimum PVR of ≥ 5 Wood units (WU) or ≥ 400 dyn sec cm-5 and,
- A pulmonary artery wedge pressure (PAWP) of ≤ 15 mm Hg.
- Diagnosis of WHO pulmonary arterial hypertension (PAH) Group 1.
- Symptomatic PAH classified as WHO Functional class II to IV.
- On stable doses of at least 2 approved background PAH therapies and diuretics.
- 6-Minute Walk Distance (6MWD) ≥ 150 m and ≤ 500 m repeated twice during screening.
- Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
- PH WHO Groups 2, 3, 4 or 5.
- Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.
- Any symptomatic coronary disease events.
- History of heart transplant or on heart transplant list.
- Uncontrolled systemic hypertension.
- History of restrictive, constrictive or congestive cardiomyopathy.
- History of significant mitral regurgitation or aortic regurgitation valvular disease.
- Untreated or poorly controlled moderate or severe obstructive sleep apnea.
- A diagnosis of worse than moderate COPD or worse than mild ILD.
- Cerebrovascular event within 90 days prior to screening
- A pneumonectomy or lobectomy
- Having received an activin signaling inhibitor such as sotatercept at any time prior to screening
- A Hgb \> sex-specific ULN
- Platelets count \< 100,000/mm3
- Severe (stage ≥4) renal failure with eGFR \< 30 mL/min/m2
- Abnormally elevated liver function enzymes (ALT or AST \> 3X ULN, or total bilirubin \> 1.5X ULN).
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Providence, Rhode Island, United States
- Barcelona, Spain
- London, London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Providence, Rhode Island, United States; Barcelona, Spain; London, London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.