A Phase 2 Study of IkT-001Pro in Pulmonary Arterial Hypertension (PAH) (NCT06643143) | Clinical Trial Compass
WithdrawnPhase 2
A Phase 2 Study of IkT-001Pro in Pulmonary Arterial Hypertension (PAH)
Stopped: Study has undergone sponsorship and design changes.
0Started 2025-06-30
Plain-language summary
This is a randomized, double-blind, multi-center, placebo-controlled dose-ranging clinical trial of two IkT-001Pro doses in patients with PAH designed to assess safety, tolerability and efficacy. It will enroll approximately 150 participants at up to 50 sites globally. The study consists of two parts, a 26 week placebo controlled treatment period (Part A) followed by a 36 month extension period (Part B).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Men and women between the ages of 18 and 70 years of age (inclusive) at the time of signing the informed consent.
✓. Capable of giving signed ICF.
✓. Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of WHO PAH Group 1 in any of the following subtypes:
✓. Idiopathic PAH
✓. Heritable PAH
✓. Drug/toxin-induced PAH
✓. PAH associated with CTD
✓. PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
Exclusion criteria
✕. Diagnosis of PAH WHO Groups 2, 3, 4, or 5
✕. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension. Exclusions in PAH Group 1 should also include schistosomiasis-associated PAH and pulmonary veno-occlusive disease
✕. Uncontrolled systemic hypertension as evidenced by sitting systolic BP \> 160 mmHg or sitting diastolic BP \> 100 mmHg during screening visit after a period of rest
✕. Personal or family history of long QT syndrome (LQTS) or sudden cardiac death
What they're measuring
1
To evaluate the effect on PVR in participants with WHO functional class II-III PAH treated with IkT-001Pro compare to placebo
Timeframe: Through study completion, an average of 26 weeks with 36 months of extension
2
To assess the safety and tolerability of two IkT-001Pro doses in PAH
Timeframe: Through study completion, an average of 26 weeks with 36 months of extension
. Pulmonary function tests (PFT) completed no more than 24 weeks before the screening period (or completed at the Screening Visit). Following criteria must are considered exclusionary
✕. Cerebrovascular accident within 3 months prior to the screening visit
✕. Currently receiving moderate or strong Cytochrome P450 (CYP) 3A4/5 inducers or CYP3A4/5 inhibitors (except for topical administration)
✕. Currently receiving or anticipated need to receive anticoagulants