Actively Recruiting
A Study of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH) (ROCSTAR STUDY)
Led by AllRock Bio, Inc. · Updated on 2026-04-27
40
Participants Needed
17
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH) (ROCSTAR STUDY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be age 18 or older and able to voluntarily sign informed consent
- Diagnosed with WHO Group 1 PAH or WHO Group 3 ILD-PH confirmed by right heart catheterization
- Symptomatic Pulmonary Hypertension classified as WHO Functional Class II or III
- PAH participants: Pulmonary Vascular Resistance (PVR) 6 5 Wood units, Pulmonary Capillary Wedge Pressure (PCWP) 6 15 mmHg, Mean Pulmonary Arterial Pressure (mPAP) > 20 mm Hg; ILD-PH participants: PVR 6 3 Wood units, PCWP 6 15 mmHg, mPAP > 20 mm Hg
- On stable background therapy for PAH or ILD-PH
- Females of childbearing potential must agree to use highly effective contraception
- Male participants must follow contraception guidance
- Able to communicate with investigators and complete the study
- Able to swallow tablets
- PAH participants: Forced Vital Capacity (FVC) > 70% predicted or 60-70% with confirmatory HRCT showing mild ILD; FEV1/FVC ratio > 0.70
- ILD-PH participants: PFTs consistent with ILD diagnosis, FEV1/FVC ratio > 65%, HRCT showing > 10% fibrosis, minimum FVC 50%, DLCO > 25%
- PAH participants must have normal or low probability ventilation-perfusion scan
- Acceptable ECG findings including normal sinus rhythm and QTcF intervals
- Body weight > 50.0 kg and BMI between 19.00 and 36.00 kg/m2
- 6-minute walk distance (6MWD) between 100 and 550 meters, consistent on repeat tests
You will not qualify if you...
- Diagnosis of Pulmonary Hypertension Groups 2, 4, or 5
- Certain PAH Group 1 subtypes including HIV-associated, portal hypertension-associated, schistosomiasis-associated PAH, pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis
- Positive tests for hepatitis B, hepatitis C (unless treated), or HIV
- Known allergy to ROC-101 or its components
- History of recent malignancy except certain treated skin or cervical cancers
- Significant non-PAH related health conditions limiting study participation
- Participation in another investigational drug or device trial recently
- Recent major surgery or planned surgery during the study
- Prior heart or heart-lung transplants or planned transplant
- Pregnancy or breastfeeding
- Uncontrolled hypertension or low blood pressure
- Certain heart conditions including pericardial constriction or significant valvular disease
- Contraindications for right heart catheterization
- Recent stroke or severe cardiomyopathies
- Recent symptomatic coronary disease or heart failure
- Changes in supportive therapy for PH within 30 days
- High oxygen supplementation needs
- Recent use of intravenous inotropes
- History of portal hypertension or severe liver disease
- Untreated severe obstructive sleep apnea
- Current daily use of cannabis or tobacco
- Current alcohol or illicit drug abuse
- Severe lung disease with specific pulmonary function test thresholds
- Lab abnormalities at screening
- Severe kidney disease or recent acute renal failure
- Recent or planned initiation of cardiopulmonary rehabilitation exercise
- Use of certain medications sensitive to cytochrome enzymes
- Plans to donate blood during the study and 28 days after last dose
- History or presence of impaired cardiac function
- Withdrawal from main study due to adverse event related to study drug (extension period)
- Pregnancy, breastfeeding, or intention to conceive during extension (extension period)
- Failure to follow contraception guidelines (extension period)
- Any condition posing risk or interfering with participation or assessments (extension period)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Arizona Pulmonary Specialists
Phoenix, Arizona, United States, 85012
Actively Recruiting
2
University of California Davis Health
Rancho Cordova, California, United States, 95670
Actively Recruiting
3
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
4
George Washington University Medical
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
5
Mayo Clinic of Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
6
The University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States, 66160
Actively Recruiting
7
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
8
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
9
Bend Memorial Clinic
Bend, Oregon, United States, 97701
Actively Recruiting
10
Temple University
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
11
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
12
Peter Lougheed Centre
Calgary, Alberta, Canada, T1Y 6J4
Actively Recruiting
13
London Health Ontario
London, Ontario, Canada, N6A 5W9
Actively Recruiting
14
CHU de BICETRE SERVICE PNEUMOLOGIE
Le Kremlin-Bicêtre, Val-de-Marne, France, 94275
Actively Recruiting
15
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
16
Pauls Stradins Clinical University Hospital
Riga, Latvia, LV-1002
Actively Recruiting
17
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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