Pulmonary Arterial Hypertension (PAH)Phase 2ROCSTARNCT07175038
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 2 study testing ROC-101 in people with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension, Interstitial Lung Disease, run by AllRock Bio, Inc. at 24 sites in 9 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension, Interstitial Lung Disease
- What is being tested?
- ROC-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 24 sitesin 9 countries
- Study dates
- 1 Oct 2025to Mar 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (≥ 400 dynes/sec/cm-5) and, 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 (≥ 240 dynes/sec/cm-5) with a maximum enrollment of 5 participants with PVR between 3 and 4 Wood units inclusive (240-320 dynes/sec/cm-5 inclusive) and the remaining 5 participants must have PVR >4 Wood units (> 320 dynes/sec/cm-5) and, 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)
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- 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 emphysema (less than 10%); 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 having more than 10% fibrosis and less than 10% emphysema, based on the proportion of lung parenchyma affected by fibrotic and emphysema changes.
- and,
- Minimum FVC of 50% and diffusing capacity for carbon monoxide (DLCO) (corrected for Hb g/dl) >25%
- In PAH participants, i.e., Cohorts 1 and 2 only, ventilation-perfusion (VQ) scan (or, if unavailable, a negative Computed tomography pulmonary angiogram [CTPA] or pulmonary angiography result), any time prior to Screening or conducted during the Screening Period, with a normal or low probability result that is not clinically significant
- Acceptable Electrocardiogram (ECG) findings as assessed by the Investigator or qualified designee at the Screening Visit and at the Baseline Visit (Day 1), including each criterion as listed below:
- Normal sinus rhythm (HR) between 40 and 100 beats per minute, inclusive);
- Corrected QT Interval (QTcF) interval ≤ 450 msec (males) and ≤ 460 msec (females);
- QRS interval ≤ 120 msec; if > 120 msec, result will be confirmed by a manual overread
- Body weight at the Screening visit and at Baseline (Day 1) is greater than 50.0 kg and the body mass index (BMI) is in the range of 19.00 to 36.00 kg/m2, inclusive
- 6MWD ≥ 100 and ≤ 550 meters repeated twice, once during Screening Period and once at the Baseline Visit (Day 1) and both values within 15% of each other, allowing for a third repeat if > 15% difference, calculated from the higher/highest value
- Participants must complete the main study period (defined as completion of assessments through the Week 24 visit)
- Women of child-bearing potential (WOCBP) must have negative pregnancy test
- All participants must comply with contraceptive guidance until 28 days after last dose of study drug for WOCBP and 90 days after the last dose of study drug for males
Who cannot join
- 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
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- 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) or, if during screening, orthostatic systolic BP decreases by more than 20 mm Hg and the participant is symptomatic.
- 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
- Cerebrovascular accident within 3 months (120 days) of start of Screening
- History of restrictive or constrictive or congestive cardiomyopathy
- Left ventricular ejection fraction (LVEF) < 50% on historical echocardiogram (ECHO) performed within 6 months prior to start of Screening period (and confirmed during the Screening ECHO) or grade 2 or higher diastolic dysfunction
- Any current symptomatic coronary disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain in the past 6 months (180 days) prior to start of Screening)
- History of acutely decompensated left heart failure or right heart failure within 90 days prior to Baseline, as per Investigator assessment
- Significant (≥ 2+ [or > mild] regurgitation) mitral regurgitation or aortic regurgitation valvular disease, or more than mild mitral stenosis or aortic stenosis valvular disease as seen on Screening ECHO
- Started or stopped receiving any general supportive therapy for PH (e.g., oxygen, anticoagulants, digoxin) within 30 days prior to start of Screening
- Use of supplemental oxygen > 10 liters/minute or and SpO2 < 90% while receiving typical oxygen supplementation, unless living at > 1000 meters altitude above sea level in which SpO2 cannot be lower than 85% while receiving typical oxygen supplementation
- Received intravenous (IV) inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to start of Screening
- History of atrial septostomy within 180 days prior to start of Screening
- History of portal hypertension or chronic liver disease, defined as mild to severe hepatic impairment (Child-Pugh Classes A to C)
- Untreated, severe (defined as apnea hypoxia index of > 30) obstructive sleep apnea
- Active daily smoker of cannabis or tobacco
- Current alcohol abuse or current illicit drug use
- WHO Group 3 due to severe chronic obstructive pulmonary disease (COPD) or chronic pulmonary fibrosis and emphysema (CPFE) or PFT with FVC < 50% or FEV1/FVC < 65% or DLCO < 25% (corrected for Hb g/dl)
- Presence of lab abnormalities at Screening
- History of greater than severe renal disease, including any episode of acute renal failure, with or without a prior history of renal disease in which acute dialysis (e.g., intermittent hemodialysis or continuous veno-venous hemofiltration) was required
- Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to Baseline or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible)
- Participants who plan to continue, or start during the study, medications which are sensitive cytochrome (CYP) 2D6 substrates with a narrow therapeutic index, such as nortriptyline, venlafaxine, and amitriptyline or CYP1A2 substrates with a narrow therapeutic index
- History or presence of impaired cardiac function
- Participants who plan to donate blood after signing consent for the study and for 28 days after their last dose of study drug
- Participant withdrew from main study period due to an AE related to study drug
- Female participant who is pregnant, breastfeeding, or intends to conceive during the long-term extension period
- Males who do not agree to follow protocol contraception guidelines
- Any condition that in the opinion of the investigator may pose a risk to the participant, interferes with the participant's participation or confounds assessments of the participant
Trial locations and contacts
24 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
24 sites in 9 countries
United States11 sites, 11 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
University of Michigan, 857-239-1966, info@allrockbio.com
- Recruiting
University of Colorado
Aurora, Colorado, 80045
University of Colorado, 857-239-1966, info@allrockbio.com
- Recruiting
Bend Memorial Clinic
Bend, Oregon, 97701
Bend Memorial Clinic, 857-239-1966, info@allrockbio.com
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Ohio State University, 857-239-1966, info@allrockbio.com
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Houston Methodist Hospital, 857-239-1966, info@allrockbio.com
- Recruiting
Mayo Clinic of Florida
Jacksonville, Florida, 32224
Mayo Clinic of Florida, 857-239-1966, info@allrockbio.com
- Recruiting
The University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
The University of Kansas Medical Center Research Institute, 857-239-1966, info@allrockbio.com
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Temple University, 857-239-1966, info@allrockbio.com
- Recruiting
Arizona Pulmonary Specialists
Phoenix, Arizona, 85012
Arizona Pulmonary Specialist, 857-239-1966, info@allrockbio.com
- Recruiting
University of California Davis Health
Rancho Cordova, California, 95670
University of California Davis Health, 857-239-1966, info@allrockbio.com
- Recruiting
George Washington University Medical
Washington D.C., District of Columbia, 20037
George Washington University Medical, 857-239-1966, info@allrockbio.com
Italy3 sites, 3 recruiting
- Recruiting
Policlinico Riuniti di Foggia
Foggia, Apulia, 71122
Policlinico Riuniti di Foggia, 857-239-1966, info@allrockbio.com
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100
Fondazione IRCCS Policlinico San Matteo, 857-239-1966, info@allrockbio.com
- Recruiting
Aou Policlinico Umberto I - Uoc Malattie Cardiovascolari (Padiglione Viii)
Rome, Rome, 00161
AOU POLICLINICO UMBERTO I - UOC MALATTIE CARDIOVASCOLARI (PADI, 857-239-1966, info@allrockbio.com
Australia2 sites, 2 recruiting
- Recruiting
Pulmonary Hypertension Research Queensland
Auchenflower, Queensland, 4066
Pulmonary Hypertension Research Queensland, 857-239-1966, info@allrockbio.com
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Royal Prince Alfred Hospital, 857-239-1966, info@allrockbio.com
Canada2 sites, 2 recruiting
- Recruiting
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4
Peter Lougheed Centre, 857-239-1966, info@allrockbio.com
- Recruiting
London Health Ontario
London, Ontario, N6A 5W9
London Health Ontario, 857-239-1966, info@allrockbio.com
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
HOSPITAL UNIVERSITARIO 12 DE OCTUBRE, +1-857-239-1966, info@allrockbio.com
- Recruiting
Hospital Universitario de Toledo
Toledo, Toledo, 45007
Hospital Universitario de Toledo, 857-239-1966, info@allrockbio.com
France1 site, 1 recruiting
- Recruiting
CHU de BICETRE SERVICE PNEUMOLOGIE
Le Kremlin-Bicêtre, Val-de-Marne, 94275
CHU de BICETRE SERVICE PNEUMOLOGIE, +1-857-239-1966, info@allrockbio.com
Germany1 site, 1 recruiting
- Recruiting
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Medizinische Hochschule Hannover, 857-239-1966, info@allrockbio.com
Latvia1 site, 1 recruiting
- Recruiting
Pauls Stradins Clinical University Hospital
Riga, LV-1002
Pauls Stradins Clinical University Hospital, 857-239-1966, info@allrockbio.com
Poland1 site, 1 recruiting
- Recruiting
Krakowski Szpital Specjalistyczny im. św. Jana Pawla II
Krakow, Poland
Krakowski Szpital Specjalistyczny im. św. Jana Pawla II, 857-239-1966, info@allrockbio.com
About this study
Official title: 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).
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.
Read the 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.
- Being tested
- ROC-101
- 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
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary, Lung Diseases, Interstitial, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROC-101Drug
Oral, daily administered Rho kinase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| ROC-101 Oral Dose | Experimental | Not described Receives: Drug: ROC-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 24 weeks
Safety assessments: Number of Participants Who Experienced an Adverse Event (AE)
Number of Participants Who Experienced an Adverse Event (AE)
Measured: 24 Weeks
Secondary outcomes (12)
Change in 6-minute Walk Distance (6MWD) from Baseline versus at 24 weeks
The 6MWD was the distance walked in 6 minutes as a measure of functional capacity. This was assessed using the 6-minute walk test (6MWT). Per protocol, change from baseline in 6MWD at Week 24 will be measured
Measured: Baseline and 24 Weeks
Change in NT-proBNP from Baseline versus at 24 weeks
NT-proBNP is a circulating biomarker that reflects myocardial stretch and is one of the biomarkers measured. The change from baseline in NT-proBNP level versus at Week 24 will be measured.
Measured: Baseline and 24 Weeks
Change in World Health Organization (WHO) Functional Classification
The severity of participant's pulmonary arterial hypertension (PAH) symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in WHO FC were classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. Percentage of participants who improve in WHO FC at Week 24 from baseline will be reported.
Measured: Baseline and 24 weeks
Change in Right Atrial Pressure (RAP) measured by Right Heart Catheterization (RHC)
Measured: Baseline and 24 weeks
Change in Mean Pulmonary Artery Pressure (mPAP) measured by Right Heart Catheterization (RHC)
Measured: Baseline and 24 Weeks
Change in Cardiac Output (CO) measured by Right Heart Catheterization (RHC)
Measured: Baseline and 24 Weeks
Change in Cardiac Index (CI) measured by Right Heart Catheterization (RHC)
Measured: Baseline and 24 Weeks
Change in Pulmonary Capillary Wedge Pressure (PCWP) measured by Right Heart Catheterization (RHC)
Measured: Baseline and 24 Weeks
Changes in Mixed Venous Oxygen Saturation (SvO2) measured by Right Heart Catheterization (RHC)
Measured: Baseline and 24 Weeks
Changes in Stroke Volume (SV) SV index (SVI) measured by Right Heart Catheterization (RHC)
Measured: Baseline and 24 Weeks
Change in Pulse Pressure (PP) measured by Right Heart Catheterization (RHC)
Measured: Baseline and 24 Weeks
Changes in Pulmonary Artery Compliance (PAC) measured by Right Heart Catheterization (RHC)
Measured: Baseline and 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AllRock Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175038
- Sponsor's protocol ID
- ROC-101-201
- Acronym
- ROCSTAR
- Status last verified
- Apr 2026
- First submitted
- 2 Sep 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No