A Study of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH) (ROCSTAR STUDY)
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- AllRock Bio, Inc.
- Study ID
- NCT07175038
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Pulmonary Arterial Hypertension (PAH)
- Pulmonary Hypertension, Interstitial Lung Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ROC-101 — DRUGOral, daily administered Rho kinase inhibitor
Study Details
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.
Key Dates
- Start date
- Oct 1, 2025
- Status verified
- Apr 2026
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2029
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ROC-101 Oral Dose
Primary Outcome Measure
Change in Pulmonary Vascular Resistance (PVR) from Baseline versus at 24 weeks [ Time Frame: Baseline and 24 weeks ]
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Arizona Pulmonary Specialists | Phoenix | Arizona | 85012 | |
| University of California Davis Health | Rancho Cordova | California | 95670 | |
| University of Colorado | Aurora | Colorado | 80045 | |
| George Washington University Medical | Washington D.C. | District of Columbia | 20037 | |
| Mayo Clinic of Florida | Jacksonville | Florida | 32224 | |
| The University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160 | |
| University of Michigan | Ann Arbor | Michigan | 48109 | |
| Ohio State University | Columbus | Ohio | 43210 | |
| Bend Memorial Clinic | Bend | Oregon | 97701 | |
| Temple University | Philadelphia | Pennsylvania | 19140 |
Find similar trials in Phoenix, AZ
By research site
Arizona Pulmonary Specialists· Phoenix, AZUniversity of California Davis Health· Rancho Cordova, CAUniversity of Colorado· Aurora, COGeorge Washington University Medical· Washington D.C., DCMayo Clinic of Florida· Jacksonville, FLThe University of Kansas Medical Center Research Institute· Kansas City, KS
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