Back to search results

ROCSTAR Study: ROC-101 for Pulmonary Hypertension

This study is testing ROC-101, an oral medication taken daily, for adults with Pulmonary Arterial Hypertension (PAH) or Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD-PH). You would receive ROC-101 along with your usual care for 24 weeks, followed by a longer study period. Researchers will look at how ROC-101 affects the pressure in your lungs (Pulmonary Vascular Resistance or PVR) after 24 weeks, and also track any side effects. To join, you must be 18 or older and have a confirmed diagnosis of WHO Group 1 PAH or WHO Group 3 ILD-PH. The study is currently unclear on its recruitment status and plans to enroll 40 participants.

Study design
This is a Phase 2a, open-label, single-arm study, meaning all 40 participants will receive ROC-101 and researchers will know who is getting the treatment.
What's involved
You would take ROC-101 daily for 24 weeks, with the dose potentially increasing. You will have evaluations including right heart catheterization (RHC) at the beginning and after 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
After the initial 24-week treatment, there is a long-term extension period through the end of the program or marketing approval/authorization.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07175038

A Study of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH) (ROCSTAR STUDY)

Recruiting
PHASE2Ages 18–80InterventionalTreatment
AllRock Bio, Inc.
~40 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:ROC-101

At a glance

Recruiting sites
23 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pulmonary Vascular Resistance (PVR) from Baseline versus at 24 weeks
Measured over Baseline and 24 weeks
+1 more outcome measured

Conditions

Pulmonary Arterial Hypertension (PAH)
Pulmonary Hypertension, Interstitial Lung Disease

Explore related trials

Interstitial Lung DiseasePulmonary Arterial HypertensionPulmonary Hypertension

Where it's being run

23 sites across 23 states
Arizona1
California1
Colorado1
District of Columbia1
Florida1
Kansas1
Michigan1
Ohio1

Who to contact

Arizona Pulmonary Specialist
[email protected]
857-239-1966
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Normal sinus rhythm (HR) between 40 and 100 beats per minute, inclusive);
Corrected QT Interval (QTcF) interval ≤ 450 msec (males) and ≤ 460 msec (females);
QRS interval ≤ 120 msec; if \> 120 msec, result will be confirmed by a manual overread 13. Body weight at the Screening visit and at Baseline (Day 1) is greater than 50.0 kg and the body mass index (BMI) is in the range of 19.00 to 36.00 kg/m2, inclusive 14. 6MWD ≥ 100 and ≤ 550 meters repeated twice, once during Screening Period and once at the Baseline Visit (Day 1) and both values within 15% of each other, allowing for a third repeat if \> 15% difference, calculated from the higher/highest value

What this trial measures

  • Change in Pulmonary Vascular Resistance (PVR) from Baseline versus at 24 weeksBaseline and 24 weeks

    Each participant's PVR, at resting supine, was measured by Right Heart Catheterization (RHC) at baseline and at 24 weeks.

  • Safety assessments: Number of Participants Who Experienced an Adverse Event (AE)24 Weeks

    Number of Participants Who Experienced an Adverse Event (AE)