Trials / Recruiting
RecruitingNCT07175038
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).
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- AllRock Bio, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a Phase 2a, open-label, single-arm, multicenter, exploratory study to evaluate the safety, tolerability, and efficacy of oral doses of ROC-101 for the treatment of participants with either World Health Organization (WHO) Group I PAH or WHO Group III ILD-PH. All eligible PAH/ILD-PH participants will receive SOC therapy plus ROC-101 at a starting dose level of 10 mg orally (PO) daily (QD) and escalating to 40 mg PO QD for the remainder of the main study period of 24 weeks. Evaluations include hemodynamic measures collected during right heart catheterization (RHC) and adverse events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ROC-101 | Oral, daily administered Rho kinase inhibitor |
Timeline
- Start date
- 2025-10-01
- Primary completion
- 2027-03-01
- Completion
- 2029-03-01
- First posted
- 2025-09-16
- Last updated
- 2026-04-16
Locations
16 sites across 7 countries: United States, Australia, Canada, France, Germany, Latvia, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07175038. Inclusion in this directory is not an endorsement.