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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-04-27
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
Interventions
- DRUG
-
ROC-101
Oral, daily administered Rho kinase inhibitor
Sponsors & Collaborators
-
AllRock Bio, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2027-03-31
- Completion
- 2029-03-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- France
- Germany
- Latvia
- Spain
Study Locations
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