What side effects are associated with this type of intervention?

Common treatments for Pulmonary Arterial Hypertension (PAH) include prostacyclin analogs, endothelin receptor antagonists (ERAs), phosphodiesterase-5 inhibitors (PDE5Is), and soluble guanylate cyclase stimulators. Side effects of prostacyclin analogs like epoprostenol and treprostinil can include headache, nausea, diarrhea, flushing, and jaw pain. ERAs such as bosentan and ambrisentan may cause liver enzyme elevation, fluid retention, and anemia. PDE5Is like sildenafil and tadalafil often result in headache, flushing, dyspepsia, and visual disturbances. Soluble guanylate cyclase stimulators like riociguat can lead to hypotension, dizziness, and gastrointestinal symptoms. These side effects are important considerations when evaluating treatment options with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Pulmonary Arterial Hypertension (PAH), targeting pathways involved in vascular remodeling and pulmonary pressure. These include prostacyclin analogues like epoprostenol, treprostinil, and iloprost, which help dilate blood vessels and inhibit platelet aggregation. Endothelin receptor antagonists such as bosentan, ambrisentan, and macitentan block the effects of endothelin-1, a potent vasoconstrictor. Phosphodiesterase type 5 inhibitors, including sildenafil and tadalafil, enhance nitric oxide signaling, leading to vasodilation and reduced pulmonary pressure. These treatments aim to improve exercise capacity, hemodynamics, and overall quality of life in PAH patients.

What other types of research exist?

Promising novel alternatives to KER-012 for PAH treatment include: 1) Macitentan, an endothelin receptor antagonist, which has shown benefits in slowing disease progression and improving exercise tolerance. 2) Ambrisentan, another endothelin receptor antagonist, which has demonstrated efficacy in delaying disease progression and improving quality of life. 3) Oral treprostinil, a prostacyclin analog, which has shown improvements in dyspnea and exercise capacity. 4) BI 1015550, a PDE4B inhibitor, currently being investigated for its potential benefits in PAH. These alternatives offer different mechanisms of action and have shown promise in clinical trials.

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KER-012 for Pulmonary Arterial Hypertension

Phase 2

Waitlist Available

Research Sponsored by Keros Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Idiopathic pulmonary arterial hypertension (IPAH);

Has WHO/New York Heart Association (NYHA) Functional Class (FC) II or III symptoms as assessed by the Investigator Must be on a stable PAH background therapy with either an endothelin-receptor antagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE5-I) or soluble guanylate cyclase (sGC) stimulator and/or prostacyclin analogue or receptor agonist (oral/inhaled/SC/intravenous)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 24 (primary treatment period) and up to week 96 (extension period)

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of KER-012 aren't specified here, but common risks may include reactions at injection sites, headaches, dizziness, nausea, and potential impact on liver function. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with IPAH.

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

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I have a connective tissue disease.

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I have inherited pulmonary arterial hypertension.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 24 (primary treatment period) and up to week 96 (extension period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 24 (primary treatment period) and up to week 96 (extension period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 24 (primary treatment period) and up to week 96 (extension period) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in PVR (Pulmonary Vascular Resistance)

Secondary study objectives

Change from Baseline in the 6MWD

Change from baseline in QTcF intervals

Change from baseline in Systolic and Diastolic Blood Pressure

+13 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 3 (N=20)Experimental Treatment1 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 (N=20)Experimental Treatment1 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 (N=20)Experimental Treatment1 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 (N=30)Placebo Group2 Interventions

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Pulmonary Arterial Hypertension (PAH) include phosphodiesterase-5 inhibitors (PDE5Is), endothelin receptor antagonists (ERAs), and prostacyclin analogs. PDE5Is, such as sildenafil and tadalafil, enhance nitric oxide signaling to promote vasodilation and reduce pulmonary pressure. ERAs, like bosentan and ambrisentan, block endothelin-1, a vasoconstrictor, reducing vascular remodeling and pressure. Prostacyclin analogs, including epoprostenol and treprostinil, mimic prostacyclin to promote vasodilation and inhibit platelet aggregation. These treatments are vital for PAH patients as they address the underlying vascular changes, improving symptoms and potentially slowing disease progression. KER-012, under study, likely targets similar pathways, offering a novel approach to modulate vascular remodeling or pulmonary pressure.