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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
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522074-37-00
Acronym
ROC-101-201
Enrollment
21
Registered
2025-12-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD-PH)

Brief summary

1. Change in PVR from Baseline versus at 24 weeks, 2. Safety assessments, including adverse events (AEs), vital signs (body temperature, heart rate [HR] and blood pressure [BP], respiratory rate [RR], fraction of inspired oxygen [FiO2] and saturation of peripheral oxygen [SpO2]), 12-lead electrocardiograms (ECG) and safety laboratory tests

Detailed description

1. Change in 6MWD from Baseline versus at 24 weeks, 2. Change in NT-proBNP from Baseline versus at 24 weeks, 3. Change in WHO FC from Baseline versus at 24 weeks, 4. Change in right atrial pressure (RAP), mean pulmonary artery pressure (mPAP), cardiac output (CO), cardiac index (CI), pulmonary capillary wedge pressure (PCWP), mixed venous oxygen saturation (SvO2), stroke volume (SV) SV index (SVI), pulse pressure (PP), and pulmonary artery compliance (PAC) from Screening versus at 24 weeks

Interventions

Sponsors

Allrock Bio Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Change in PVR from Baseline versus at 24 weeks, 2. Safety assessments, including adverse events (AEs), vital signs (body temperature, heart rate [HR] and blood pressure [BP], respiratory rate [RR], fraction of inspired oxygen [FiO2] and saturation of peripheral oxygen [SpO2]), 12-lead electrocardiograms (ECG) and safety laboratory tests

Secondary

MeasureTime frame
1. Change in 6MWD from Baseline versus at 24 weeks, 2. Change in NT-proBNP from Baseline versus at 24 weeks, 3. Change in WHO FC from Baseline versus at 24 weeks, 4. Change in right atrial pressure (RAP), mean pulmonary artery pressure (mPAP), cardiac output (CO), cardiac index (CI), pulmonary capillary wedge pressure (PCWP), mixed venous oxygen saturation (SvO2), stroke volume (SV) SV index (SVI), pulse pressure (PP), and pulmonary artery compliance (PAC) from Screening versus at 24 weeks

Countries

France, Germany, Italy, Latvia, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026