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

NCT07175038 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ROC-101-201
• Study Type: interventional
• Target: 40
• Locations: 7 countries
• Sites: 17

Brief 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.

Conditions

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

Keywords

Rho kinase inhibitor; ROCK inhibitor; Pan ROCK Inhibitor; ROCK-1 and ROCK-2 Inhibitor; ROC-101; PVR; Pulmonary Arterial Hypertension (PAH); Pulmonary Hypertension, Interstitial Lung Disease

Outcome Measures

Primary Outcomes (2)

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

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

  Baseline and 24 weeks

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

  Number of Participants Who Experienced an Adverse Event (AE)

  24 Weeks

Secondary Outcomes (12)

• Change in 6-minute Walk Distance (6MWD) from Baseline versus at 24 weeks

  Baseline and 24 Weeks

• Change in NT-proBNP from Baseline versus at 24 weeks

  Baseline and 24 Weeks

• Change in World Health Organization (WHO) Functional Classification

  Baseline and 24 weeks

• Change in Right Atrial Pressure (RAP) measured by Right Heart Catheterization (RHC)

  Baseline and 24 weeks

• Change in Mean Pulmonary Artery Pressure (mPAP) measured by Right Heart Catheterization (RHC)

  Baseline and 24 Weeks

Study Arms (1)

ROC-101 Oral Dose

EXPERIMENTAL

Drug: ROC-101

Interventions

ROC-101 DRUG

Oral, daily administered Rho kinase inhibitor

ROC-101 Oral Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be age 18 or older at the time of signing the informed consent form (ICF). The participant must understand and voluntarily sign an ICF prior to any study-related procedures
• Documented findings on a right heart catheterization (RHC) consistent with a diagnosis World Health Organization (WHO) Group 1 PAH or WHO GROUP 3 PAH
• Symptomatic Pulmonary Hypertension (PH) classified as WHO Functional Class II or III symptoms
• PAH participants: Pulmonary Vascular Resistance (PVR) of ≥ 5 Wood units, Pulmonary Capillary Wedge Pressure (PCWP) ≤ 15 mmHg and Mean Pulmonary Arterial Pressure (mPAP) \> 20 mm Hg and ILD-PH participants: PVR of ≥ 3 Wood units, PCWP ≤ 15 mmHg and mPAP \> 20 mm Hg
• Participants on stable background therapy for PAH or ILD-PH.
• Females of childbearing potential (as defined in protocol) must agree to use highly effective contraception (as defined in the protocol)
• Male participants must follow protocol-specified contraception guidance.
• Participants must be able to communicate well with Investigators, understand the study procedures in the ICF and are agreeable to complete the study in accordance with the protocol.
• Must be able to swallow tablets.
• Pulmonary function tests (PFT):
• PAH participants at Screening as follows:
• Forced Vital Capacity (FVC) \> 70% predicted; or if between 60% to 70% predicted, or if not possible to be determined, confirmatory High-Resolution Computed Tomography (HRCT) indicating no more than mild (\<10% fibrosis) ILD; and
• The ratio of FEV1 (first second)/FVC \> 0.70 of predicted.
• ILD-PH participants at Screening as follows:
• PFTs consistent with their ILD diagnosis and showing FEV1/ FVC ratio \> 65% and HRCT \> 10% fibrosis, based on the proportion of lung parenchyma affected by fibrotic changes.

You may not qualify if:

• Diagnosis of PH WHO Groups 2, 4, or 5
• Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease and/or pulmonary capillary hemangiomatosis
• Positive blood test for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody (HCVAb) (unless participants have had treatment for HCV and have a negative HCV ribonucleic acid \[RNA\] polymerase chain reaction \[PCR\]) or HIV antibody
• Participants with known hypersensitivity to ROC-101 or any components of its formulations
• History of malignancy within the last 5 years, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas of the skin
• History of clinically significant (as determined by the Investigator) non-PAH related cardiac, endocrine, hematologic, hepatic, immune, metabolic, urologic, pulmonary, neurologic, neuromuscular, dermatologic, psychiatric, renal, and/or other diseases that may limit participation in the study
• Participation in another clinical trial involving intervention with another investigational drug, approved therapy for investigational use, or investigational device within 4 weeks prior to Baseline Visit (unless it is in the follow-up period of an interventional study), or if the half-life of the previous product is known, within 5× the half-life prior to Baseline Visit (Day 1), whichever is longer
• Major surgery within 8 weeks prior to Baseline Visit (Day 1) or major surgery scheduled or planned in the main study. Participants must have completely recovered from any previous surgery prior to the Screening Visit
• Prior heart or heart-lung transplants, or a participant listed for heart and/or lung transplantation or prior pneumonectomy
• Pregnant or breastfeeding females
• Males who do not agree to protocol contraception guidelines
• Uncontrolled systemic hypertension as evidenced by sitting SBP \> 160 mm Hg or sitting diastolic BP \> 100 mm Hg during Screening Visit and Baseline Visit (Day 1) after a period of rest
• Systolic BP \< 90 mm Hg during Screening Visit or at Baseline Visit (Day 1)
• History of known pericardial constriction or a clinically significant (more than trace or trivial \[i.e., ≥10 mm\]) pericardial effusion seen in diastole or in both systole and diastole on echocardiogram (ECHO) historically and confirmed on screening ECHO
• RHC contraindicated during the study per Investigator

Sponsors & Collaborators

• AllRock Bio, Inc.: lead

Study Sites (17)

Arizona Pulmonary Specialists

Phoenix, Arizona, 85012, United States

RECRUITING

University of California Davis Health

Rancho Cordova, California, 95670, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

George Washington University Medical

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Mayo Clinic of Florida

Jacksonville, Florida, 32224, United States

RECRUITING

The University of Kansas Medical Center Research Institute

Kansas City, Kansas, 66160, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Bend Memorial Clinic

Bend, Oregon, 97701, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

RECRUITING

Peter Lougheed Centre

Calgary, Alberta, T1Y 6J4, Canada

RECRUITING

London Health Ontario

London, Ontario, N6A 5W9, Canada

RECRUITING

CHU de BICETRE SERVICE PNEUMOLOGIE

Le Kremlin-Bicêtre, Val-de-Marne, 94275, France

RECRUITING

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Lung Diseases, Interstitial; Hereditary Sensory and Autonomic Neuropathies

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); LA (1); FR (1); DE (1); ES (1); US (10); AU (1)