A Phase 3 Adaptive Study of IKT-001 Tablets to Treat Pulmonary Arterial Hypertension in Adults

What this Trial Is About

Researchers are evaluating the efficacy and safety of a drug called IKT-001 in adults with Pulmonary Arterial Hypertension PAH, specifically those classified as WHO Group 1. This adaptive, randomized, double-blind, placebo-controlled study aims to compare IKT-001 with placebo in a controlled setting to better understand its effects on this serious lung condition. Participants will be randomly assigned to receive either IKT-001 tablets or matching placebo tablets taken by mouth. The study is divided into two parts Part A focuses on measuring changes in Pulmonary Vascular Resistance over 24 weeks, and Part B looks at the effects of IKT-001 on symptoms and characteristics of PAH over the same period. There is also monitoring of WHO Functional Class and time to clinical worsening up to 48 weeks. During the study, participants will undergo various assessments including hemodynamic measurements through right heart catheterization at screening, physical tests like the 6-minute walk test, and monitoring of clinical symptoms and safety parameters. The study involves regular visits over at least 24 to 48 weeks to collect data on lung and heart function, symptoms, and overall health. The total participation may last up to several months, allowing researchers to thoroughly evaluate the impact of IKT-001 compared to placebo.

An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)