Actively Recruiting
An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)
Led by Inhibikase Therapeutics · Updated on 2026-05-12
486
Participants Needed
2
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an adaptive, 2-part, randomized, multicenter, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of IKT-001 in adult participants with WHO Group 1 PAH.
CONDITIONS
Official Title
An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of WHO PAH Group 1 including idiopathic, heritable, drug/toxin-induced, connective tissue disease-associated, or repaired congenital shunt PAH
- Men and women aged 18 to 75 years
- Body mass index (BMI) between 18.5 and 35.0 kg/m² at screening
- Baseline right heart catheterization showing pulmonary vascular resistance (PVR) ≥ 400 dyn/sec/cm⁵, pulmonary capillary wedge pressure ≤ 15 mmHg, and mean pulmonary artery pressure > 20 mmHg
- Stable doses of background PAH therapy for at least 90 days prior to screening (excluding current use of sotatercept)
- Six-minute walk distance between 100 and 475 meters
You will not qualify if you...
- Diagnosis of PAH WHO Groups 2, 3, 4, or 5
- Certain PAH Group 1 subtypes including HIV-associated, portal hypertension-associated, schistosomiasis-associated, and pulmonary veno-occlusive disease
- Uncontrolled hypertension (systolic BP >160 mmHg or diastolic BP >100 mmHg), systolic BP <90 mmHg, or syncope within 3 months
- History of restrictive, constrictive, or congestive cardiomyopathy
- ECG abnormalities with prolonged QT interval or history of long QT syndrome or sudden cardiac death
- Presence of implanted hemodynamic monitoring devices
- Forced vital capacity <70% on pulmonary function test or significant interstitial lung disease
- History of atrial fibrillation, atrial flutter, cerebrovascular accidents, intracranial hemorrhage, or recent head trauma
- Recent acute right heart failure or significant heart disease
- History of pneumonectomy or untreated obstructive sleep apnea
- Active hepatitis B or C infection
- Bleeding disorders or significant bleeding history
- Current use of strong CYP3A inducers/inhibitors or anticoagulants
- Recent initiation or planned start of cardiopulmonary rehabilitation exercise program
- Recent atrial septostomy
- Participation in another investigational trial or prior participation in an IKT-001 study
- Social, behavioral, or medical reasons preventing study completion
- Pregnancy, lactation, or planning pregnancy during study
- Prior solid organ or stem cell transplant
- Planned surgery that would interrupt study treatment
- Recent malignancy within 5 years except certain treated cancers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Norton Healthcare
Louisville, Kentucky, United States, 40202
Actively Recruiting
2
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
Research Team
M
Medical Director, Inhibikase Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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