KER-012 for Pulmonary Arterial Hypertension
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of a new treatment called KER-012 for individuals with pulmonary arterial hypertension (PAH), a type of high blood pressure affecting the lungs. The trial will compare various doses of KER-012 to a placebo (a treatment with no active medicine) to determine which dose is safest and most effective. Individuals with PAH who are already on stable treatment might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
The trial requires participants to be on stable PAH therapy with specific medications, so you will not need to stop your current PAH medications if they are part of the allowed therapies.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that KER-012 is being tested for safety in treating pulmonary arterial hypertension (PAH). Earlier studies examined its interaction with proteins involved in cell growth and inflammation, which may help manage PAH symptoms. So far, patients have generally tolerated KER-012 well, with no major safety issues reported.
Current studies closely monitor for any unwanted side effects to ensure the treatment's safety. Since this trial is in the middle stages, KER-012 has already passed initial safety checks in earlier studies, suggesting it is reasonably safe for further testing in humans.
However, as with any new treatment, unknown risks may still exist. Trial participants are carefully monitored for any problems, allowing for quick action if safety concerns arise.12345Why are researchers excited about this trial's treatments?
Researchers are excited about KER-012 for pulmonary arterial hypertension (PAH) because it works differently from most treatments currently available. Standard PAH treatments often include endothelin receptor antagonists, phosphodiesterase-5 inhibitors, or prostacyclin analogs, which primarily focus on dilating blood vessels to reduce pressure. KER-012, however, targets the TGF-beta superfamily signaling pathway, which is involved in controlling blood vessel remodeling and inflammation. This new mechanism of action could offer a novel approach to managing PAH, potentially improving outcomes for patients by addressing underlying disease processes rather than just symptoms. Additionally, KER-012 is administered subcutaneously every four weeks, which might offer a more convenient treatment option compared to some existing therapies.
What evidence suggests that this trial's treatments could be effective for pulmonary arterial hypertension?
Research has shown that KER-012, also known as cibotercept, is being studied for its potential to help people with pulmonary arterial hypertension (PAH). In this trial, participants will receive different doses of KER-012 or a placebo. One study found that KER-012 might improve blood flow through the lungs compared to a placebo, potentially lowering lung pressure, which benefits people with PAH. Early studies also showed that KER-012 did not increase red blood cell counts, indicating good safety. These initial findings suggest that KER-012 could be a promising treatment option for PAH.13567
Are You a Good Fit for This Trial?
Adults over 18 with Pulmonary Arterial Hypertension (PAH) who are already on stable PAH medication can join. They should have symptoms classified as WHO/NYHA Functional Class II or III and a specific type of high blood pressure in the lungs, but not heart-related issues that could cause similar symptoms.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive KER-012 or placebo by subcutaneous injection every 4 weeks for 24 weeks while on stable background PAH therapy
Extension
Participants who complete the treatment period continue to receive KER-012 every 4 weeks for an additional 72 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KER-012
Find a Clinic Near You
Who Is Running the Clinical Trial?
Keros Therapeutics, Inc.
Lead Sponsor