ROC-101 for Pulmonary Hypertension
(ROCSTAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests ROC-101, a new potential drug, to determine its effectiveness for certain types of pulmonary hypertension (high blood pressure in the lungs). The research aims to discover if adding ROC-101 to standard treatments can improve symptoms for those with pulmonary arterial hypertension or hypertension linked to interstitial lung disease. Participants will receive ROC-101 alongside their usual care for 24 weeks, with an opportunity to continue afterward. This trial suits individuals diagnosed with pulmonary hypertension who experience symptoms like breathlessness or fatigue. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially benefit from an innovative therapy.
Do I have to stop taking my current medications for the trial?
The trial requires participants to be on stable background therapy for their condition, so you likely won't need to stop your current medications. However, you cannot start or stop any general supportive therapy for pulmonary hypertension within 30 days before the trial starts.
Is there any evidence suggesting that ROC-101 is likely to be safe for humans?
Why do researchers think this study treatment might be promising?
ROC-101 is unique because it offers a new approach to treating pulmonary hypertension by potentially targeting pathways that current treatments don't address. Unlike standard therapies like endothelin receptor antagonists, phosphodiesterase-5 inhibitors, and prostacyclins, ROC-101 may work through a novel mechanism that could provide additional benefits or improve effectiveness. Researchers are excited about ROC-101 because it might offer improved outcomes for patients who don't respond well to existing options, making it a promising candidate in the fight against pulmonary hypertension.
What evidence suggests that ROC-101 might be an effective treatment for pulmonary hypertension?
Research shows that ROC-101 targets a pathway in the body that influences blood vessel constriction and inflammation. Studies on similar pathways have demonstrated their potential to alleviate these issues. Early results from human trials indicate that ROC-101, which participants in this trial will receive, is safe and well-tolerated, without causing low blood pressure. Although complete data on its effectiveness for pulmonary hypertension is not yet available, its mechanism suggests potential efficacy. This makes ROC-101 a promising option for treating pulmonary hypertension.13456
Are You a Good Fit for This Trial?
Adults with Pulmonary Arterial Hypertension (PAH) or PH due to Interstitial Lung Disease (ILD-PH), who have specific heart and lung function measurements, are on stable treatments, can swallow tablets, and agree to use effective contraception. Excludes those not meeting lung function criteria or other protocol specifics.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard of care plus ROC-101, starting at 10 mg and escalating to 40 mg daily for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term extension
Participants may continue receiving ROC-101 until the end of the program or marketing approval
What Are the Treatments Tested in This Trial?
Interventions
- ROC-101
Find a Clinic Near You
Who Is Running the Clinical Trial?
AllRock Bio, Inc.
Lead Sponsor