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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 belowSelect...
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)
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 moreTrial 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
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.
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Who is running the clinical trial?
Keros Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
475 Total Patients Enrolled