IKT-001 for Pulmonary Arterial Hypertension
(IMPROVE-PAH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called IKT-001 for individuals with pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the arteries of the lungs. The goal is to determine if IKT-001 is safe and improves symptoms compared to a placebo (a pill with no active medicine). It is suitable for those diagnosed with specific types of PAH, such as idiopathic or heritable PAH, who have been on stable treatment for at least 90 days. Participants will continue their current treatments while trying this new option. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that IKT-001 is likely to be safe for humans?
Research has shown that IKT-001 has been tested for safety in people with pulmonary arterial hypertension (PAH). In earlier studies, IKT-001 was generally well-tolerated. Researchers aim to demonstrate both its safety and potential to treat PAH. Although specific details on side effects aren't available, the drug's progression to this late-stage trial suggests a promising safety record. As with any treatment, some side effects might occur, but ongoing research closely monitors this to ensure participant safety.12345
Why do researchers think this study treatment might be promising for pulmonary arterial hypertension?
Most treatments for pulmonary arterial hypertension (PAH) work by relaxing blood vessels or preventing blood clots. But IKT-001 works differently, targeting the underlying mechanisms that contribute to the disease. Researchers are excited about IKT-001 because it has a novel mechanism of action that could offer more effective management of PAH symptoms. Additionally, IKT-001 is administered orally, which may offer more convenience compared to some current treatment options that require injections or intravenous administration.
What evidence suggests that IKT-001 might be an effective treatment for pulmonary arterial hypertension?
Research has shown that IKT-001 is being tested as a treatment for pulmonary arterial hypertension (PAH), a type of high blood pressure affecting the lungs. Earlier studies found that imatinib, the main ingredient in IKT-001, effectively treated PAH but caused too many side effects. IKT-001 is designed to be safer while maintaining effectiveness. In previous studies, patients demonstrated improved blood flow through their lungs, indicating less constriction in lung blood vessels. This suggests that IKT-001 might help reduce the symptoms and complications of PAH. Participants in this trial will receive either IKT-001 or a matching placebo to evaluate its effectiveness and safety.12346
Are You a Good Fit for This Trial?
This trial is for adults aged 18–75 with certain types of pulmonary arterial hypertension (PAH), including idiopathic, heritable, drug-induced, or PAH linked to connective tissue disease. Participants must be on stable PAH treatment and meet specific heart and lung function criteria.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants receive IKT-001 or placebo to evaluate the effect on Pulmonary Vascular Resistance (PVR)
Treatment Part B
Participants continue to receive IKT-001 or placebo to evaluate effects on symptoms and characteristics of PAH
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IKT-001
Trial Overview
The study compares a new drug called IKT-001 to a placebo in people with PAH. It uses a randomized, double-blind design so neither patients nor doctors know who gets the real drug or placebo. The goal is to see if IKT-001 works better than no active treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
IKT-001 tablets for PO administration
Matching placebo to IKT-001 tablets for PO administration
Find a Clinic Near You
Who Is Running the Clinical Trial?
Inhibikase Therapeutics
Lead Sponsor
Citations
IkT-001 for PAH
In that clinical study, imatinib was shown to be a highly effective therapy, but was plagued with side effects that prevented its approval in this indication.
A Phase 2 Study of IkT-001Pro in Pulmonary Arterial ...
This is a randomized, double-blind, multi-center, placebo-controlled dose-ranging clinical trial of two IkT-001Pro doses in patients with PAH
3.
tuftsmedicine.org
tuftsmedicine.org/research-clinical-trials/find-clinical-trials/phase-2b-study-ikt-001-pulmonary-arterial-hypertensionA Phase 2b Study of IKT-001 in Pulmonary Arterial ...
The primary objective of the study is to evaluate the effect of treatment with IKT on pulmonary vascular resistance and to evaluate the safety and tolerability ...
4.
pulmonaryhypertensionnews.com
pulmonaryhypertensionnews.com/news/first-patient-enrolled-phase-3-trial-pah-treatment-ikt-001/First patient enrolled in Phase 3 trial of PAH treatment IKT- ...
The first part of IMPROVE-PAH will test IKT-001 against a placebo in approximately 140 people with PAH. The main goal is to test how the therapy ...
5.
inhibikase.com
inhibikase.com/news/press-releases/detail/135/inhibikase-therapeutics-advancing-ikt-001-to-global-phase-3Inhibikase Therapeutics Advancing IKT-001 to Global ...
The Phase 3 study, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH), ...
6.
clinicaltrialvanguard.com
clinicaltrialvanguard.com/news/inhibikase-enrolls-first-patient-in-phase-3-pah-study/Inhibikase Enrolls First Patient in Phase 3 PAH Study
IMPROVE-PAH is a two-part adaptive Phase 3 program testing IKT-001, an oral prodrug of imatinib, in up to 180 global sites.
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