RecruitingPhase 2NCT07175038

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

A Phase 2A, Open-Label Single Arm Multicenter Exploratory Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Doses of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH).


Sponsor

AllRock Bio, Inc.

Enrollment

40 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study evaluates the effect of ROC-101 in adults with either Pulmonary Arterial Hypertension (PAH) or Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD-PH). Each eligible participant will receive standard of care (SOC) plus ROC-101 for a 24-week treatment period, followed by a long-term extension period of the study through the end of the program or marketing approval/authorization.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study — called the ROCSTAR study — is testing a new investigational drug called ROC-101 in people with pulmonary arterial hypertension (PAH) or pulmonary hypertension associated with interstitial lung disease (ILD-PH). Pulmonary hypertension means the blood pressure in the arteries leading to the lungs is dangerously high. **You may be eligible if...** - You are 18 years old or older - You have a confirmed diagnosis of WHO Group 1 (PAH) or WHO Group 3 (pulmonary hypertension with lung disease) based on a right heart catheterization - Your pulmonary hypertension symptoms are classified as moderate (WHO Functional Class II or III) - You have elevated pulmonary vascular resistance and meet specific pressure thresholds on testing **You may NOT be eligible if...** - You have severe pulmonary hypertension symptoms (WHO Functional Class IV) - You have other serious cardiovascular or respiratory conditions that may complicate participation - You do not meet the specific pressure and resistance measurements required Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGROC-101

Oral, daily administered Rho kinase inhibitor


Locations(17)

Arizona Pulmonary Specialists

Phoenix, Arizona, United States

University of California Davis Health

Rancho Cordova, California, United States

University of Colorado

Aurora, Colorado, United States

George Washington University Medical

Washington D.C., District of Columbia, United States

Mayo Clinic of Florida

Jacksonville, Florida, United States

The University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States

University of Michigan

Ann Arbor, Michigan, United States

Ohio State University

Columbus, Ohio, United States

Bend Memorial Clinic

Bend, Oregon, United States

Temple University

Philadelphia, Pennsylvania, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Peter Lougheed Centre

Calgary, Alberta, Canada

London Health Ontario

London, Ontario, Canada

CHU de BICETRE SERVICE PNEUMOLOGIE

Le Kremlin-Bicêtre, Val-de-Marne, France

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Pauls Stradins Clinical University Hospital

Riga, Latvia

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT07175038


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