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ROC-101 HYDROCHLORIDE

Clinical trials are studying ROC-101 HYDROCHLORIDE in people with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. These trials aim to check safety, tolerability, and whether the treatment can improve pulmonary vascular resistance. The study includes adults treated with standard care.

Table of Contents

Trial overview

The main study of ROC-101 HYDROCHLORIDE is titled the ROCSTAR Study and is listed as authorised.[1] It is an interventional trial, which means researchers give the study treatment and then measure the results.[1]

The study plans to enroll 40 participants and is being done in Phase 2.[1] The trial uses oral ROC-101 HYDROCHLORIDE at 40 mg and includes standard of care treatment.[1]

Conditions and population

This trial is studying two lung-related conditions: pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (ILD-PH).[1] Both conditions involve high pressure in the blood vessels of the lungs, which can make it harder for the heart and lungs to work well.[1]

The study summary says the participants are treated with ROC-101 HYDROCHLORIDE plus standard of care.[1] No other eligibility details are provided in the source data.[1]

Study design and phase

This is a Phase 2 study, which usually means the treatment has already been tested enough to move into a larger group and look more closely at possible benefit and safety.[1] The trial is interventional rather than observational, so the research team is actively testing the treatment effect.[1]

The study is authorised, which means it has received permission to move forward.[1]

What the study measures

The main effectiveness measure is the change in pulmonary vascular resistance (PVR) from the start of the study to 24 weeks.[1] PVR is a measure of how hard it is for blood to flow through the lung blood vessels.[1]

The study also checks safety and tolerability, including adverse events, which are unwanted medical problems that happen during the trial.[1] Other safety measures include vital signs, 12-lead ECGs, and safety laboratory tests.[1]

Safety monitoring

The trial lists several safety checks: body temperature, heart rate, blood pressure, respiratory rate, fraction of inspired oxygen, and oxygen saturation.[1] These checks help the study team watch for changes in the body during treatment.[1]

The study also includes 12-lead electrocardiograms (ECG) and safety laboratory tests.[1] An ECG is a heart test that records electrical activity, and laboratory tests can help show whether treatment is affecting the body in unexpected ways.[1]

What this means for patients

For patients, this study is mainly asking whether ROC-101 HYDROCHLORIDE can be used safely in people with PAH or ILD-PH and whether it may help improve blood flow resistance in the lungs.[1] Because it is a Phase 2 study, it is still part of clinical research and is not yet a final answer about how well the treatment works.[1]

The source data does not give a long list of inclusion or exclusion rules, so only the broad target groups can be described from the trial record.[1] The most important details are the condition studied, the 40-person size, the 24-week main endpoint, and the safety monitoring plan.[1]

Trial ID Phase Condition studied Status Enrollment
2025-522074-37-00 Phase 2 Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD-PH) Authorised 40

FAQ

  • What is being studied in ROC-101 HYDROCHLORIDE trials? The trial is studying ROC-101 HYDROCHLORIDE in people with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. It is looking at both safety and whether the treatment may improve pulmonary vascular resistance.
  • Who can take part in these trials? The study is for participants with pulmonary arterial hypertension or pulmonary hypertension associated with interstitial lung disease. The trial summary also says participants are treated with standard of care.
  • What phase is the ROC-101 HYDROCHLORIDE study? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment may work and continue to check safety.
  • What does the trial measure? The main measure is the change in pulmonary vascular resistance from the start of the study to 24 weeks. The trial also checks safety with adverse events, vital signs, ECGs, and safety laboratory tests.
  • How many people are planned for the study? The trial plans to enroll 40 participants. This is a relatively small study, which is common in early phase research.

Ongoing Clinical Trials on ROC-101 HYDROCHLORIDE

  • A Study of ROC-101 Hydrochloride for Patients with Pulmonary Arterial Hypertension and Pulmonary Hypertension Associated with Interstitial Lung Disease

    Recruiting

    2 1 1
    Investigated drugs:
    France Germany Italy Latvia Poland Spain

Glossary

  • Pulmonary arterial hypertension (PAH): A type of high blood pressure in the arteries that carry blood from the heart to the lungs.
  • Pulmonary hypertension associated with interstitial lung disease (ILD-PH): High blood pressure in the lung arteries that happens together with interstitial lung disease, which is a group of lung conditions that can cause scarring.
  • Interstitial lung disease (ILD): A group of diseases that can cause inflammation or scarring in the lungs, making it harder to breathe.
  • Phase 2: A study stage that looks at early signs of benefit and continues safety testing in a larger group than Phase 1.
  • Interventional study: A trial where researchers give a treatment and then measure what happens.
  • Pulmonary vascular resistance (PVR): How hard it is for blood to flow through the blood vessels in the lungs. Lower resistance can mean easier blood flow.
  • Standard of care (SOC): The usual treatment that patients normally receive for their condition.
  • Adverse events (AEs): Unwanted medical problems that happen during a study, whether or not they are caused by the study treatment.
  • Vital signs: Basic body checks such as temperature, heart rate, blood pressure, breathing rate, and oxygen levels.
  • Electrocardiogram (ECG): A test that records the heart’s electrical activity.
  • Safety laboratory tests: Blood or other tests used to check for signs of harm or changes in body function.

References

  1. https://clinicaltrials.gov/study/2025-522074-37-00