KER-012 for Pulmonary Arterial Hypertension

Recruiting at 63 trial locations

Overseen By Keros Therapeutics, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Keros Therapeutics, Inc.

Must be taking: Endothelin-receptor antagonists, PDE5 inhibitors

Disqualifiers: Left ventricular dysfunction, Lung disease, Thromboembolic disease, Uncontrolled hypertension, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 24

Duration: 24 weeks

113 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing KER-012, a new injectable medication, in adults with a specific type of high blood pressure in the lungs. The goal is to see if it can lower lung blood pressure and help patients walk better.

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.

What data supports the effectiveness of the drug KER-012 for treating pulmonary arterial hypertension?

Research suggests that targeting the bone morphogenetic protein type-2 receptor (BMPR2) pathway, which KER-012 may influence, is a promising approach for treating pulmonary arterial hypertension. This pathway is crucial in the disease's cellular mechanisms, and therapies focusing on it are being explored in clinical trials. ^{1 2 3 4 5}

Eligibility Criteria

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

I have been diagnosed with IPAH.

I have moderate heart symptoms and am on stable heart medication.

My condition is related to drug or toxin exposure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KER-012 or placebo by subcutaneous injection every 4 weeks for 24 weeks while on stable background PAH therapy

24 weeks

6 visits (in-person, every 4 weeks)

Extension

Participants who complete the treatment period continue to receive KER-012 every 4 weeks for an additional 72 weeks

72 weeks

18 visits (in-person, every 4 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• KER-012

Trial Overview The TROPOS Study is testing different doses of KER-012 against a placebo in people with PAH. Participants will be randomly assigned to receive either the drug or placebo alongside their current PAH treatments for 24 weeks, followed by an extension period where all get Dose B KER-012.

Participant Groups

Group I: Arm 3 Experimental Treatment 1 Intervention

KER-012 (Dose C) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks

Group II: Arm 2 Experimental Treatment 1 Intervention

KER-012 (Dose B) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks

Group III: Arm 1 Experimental Treatment 1 Intervention

KER-012 (Dose A) subcutaneously (SC) (every 4 weeks \[Q4W\]) Treatment Period: Dose A for 24 weeks; Extension Period: Dose A for another 72 weeks

Group IV: Arm 4 Placebo Group 2 Interventions

Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks

Who Is Running the Clinical Trial?

Keros Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

600+

Findings from Research

In a study of 11 children and young adults with pulmonary arterial hypertension, selexipag showed significant improvements in key hemodynamic parameters, such as mean pulmonary arterial pressure and cardiac index, indicating its potential efficacy as a treatment.

The treatment was generally well-tolerated, with no clinical worsening observed in patients, although one young adult discontinued due to severe headache, highlighting the need to monitor for side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy and safety of selexipag in children and young adults with idiopathic and heritable pulmonary arterial hypertension. Takatsuki, S., Nakayama, T., Shimizu, Y., et al.[2023]

Selexipag significantly reduced the risk of disease progression in patients with pulmonary arterial hypertension (PAH) compared to placebo, as shown in the GRIPHON trial, and has a long-term safety profile consistent with earlier findings.

In the ongoing GRIPHON OL study, 953 patients treated with selexipag showed promising survival rates over a median exposure of 31.7 months, with 1-year survival at 92% and 5-year survival at 71.2%, indicating its potential effectiveness in long-term management of PAH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Survival, Safety and Tolerability with Selexipag in Patients with Pulmonary Arterial Hypertension: Results from GRIPHON and its Open-Label Extension. Galiè, N., Gaine, S., Channick, R., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Real-Life Experience with Selexipag as an Add-On Therapy to Oral Combination Therapy in Patients with Pulmonary Arterial or Distal Chronic Thromboembolic Pulmonary Hypertension: A Retrospective Analysis. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Clinical efficacy and safety of selexipag in children and young adults with idiopathic and heritable pulmonary arterial hypertension. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Approaches to treat pulmonary arterial hypertension by targeting BMPR2: from cell membrane to nucleus. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Long-Term Survival, Safety and Tolerability with Selexipag in Patients with Pulmonary Arterial Hypertension: Results from GRIPHON and its Open-Label Extension. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Relationship Between Time From Diagnosis and Morbidity/Mortality in Pulmonary Arterial Hypertension: Results From the Phase III GRIPHON Study. [2021]