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KER-012 for Pulmonary Arterial Hypertension

Phase 2

Recruiting

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)

Awards & highlights

Study Summary

This trial tests a new drug to treat Pulmonary Arterial Hypertension in adults. Participants are randomly given drug or placebo to test safety & efficacy.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in PVR (Pulmonary Vascular Resistance)

Secondary outcome measures

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

Find a Location

Who is running the clinical trial?

Keros Therapeutics, Inc.Lead Sponsor

3 Previous Clinical Trials

250 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently recruiting participants for this experiment?

"That is correct. According to clinicaltrials.gov, this scientific research project was initially posted on October 17th 2023 and has been recently updated on December 4th 2023. The trial seeks 90 individuals from 6 sites for participation in the study."

Answered by AI

Has the FDA officially sanctioned Arm 2 (N=20) for public usage?

"Since the trial is in its second phase, and thus lacks evidence for efficacy but has some data showing safety, Arm 2 (N=20) was given a rating of two on our scale."

Answered by AI

How many people are currently participating in this research project?

"Affirmative. According to clinicaltrials.gov, this trial initiated on October 17th 2023 and has been actively seeking participants since then. An estimated 90 individuals need to be enrolled across 6 different sites for the study's completion."

Answered by AI

In what geographic locations is this research project currently active?

"At the moment, 6 medical centres are open for enrollment. These locations include Camperdown, Albuquerque and Sydney with 3 other spots available to choose from. To minimize travel costs it is important that you pick a clinic close by if you join this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (PAH) (TROPOS Study).

2023. "A Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (PAH) (TROPOS Study).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05975905.

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