ClinicaliQ Trial Snapshot
- An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH) — Recruiting • Phase III • Cardiology / Cardiovascular • NCT07365332.
- What is being tested: IKT-001, a novel therapeutic agent, is being evaluated for efficacy and safety in treating WHO Group 1 pulmonary arterial hypertension through an adaptive, randomized, double-blind, placebo-controlled trial design that allows for protocol modifications based on interim data.
- Patient eligibility overview: The trial enrolls adult participants diagnosed with WHO Group 1 PAH, representing the primary form of the disease across multiple UK and international healthcare centres participating in this multicenter study.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * Documented diagnosis of WHO PAH Group 1 in any of the following subtypes: * Idiopathic PAH * Heritable PAH * Drug/toxin-induced PAH * PAH associated with connective tissue disease (CTD) * PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair * Men and women 18 and 75 years of age (inclusive) * Must have a body mass index (BMI) of ≥18.5 kg/m^2 and ≤35.0 kg/m^2 at screening. * Baseline RHC performed during the Screening Period documenting a PVR of ≥ 400 dyn/sec/cm^5 ; pulmonary capillary wedge pressure (PCWP) ≤15 mmHg and mean pulmonary artery pressure (mPAP) >20 mmHg. PVR enrichment criteria to ensure population baseline PVR >700 dynes/sec/cm^5 * On stable doses of background PAH therapy including endothelin receptor antagonists, phosphodiesterase-5 inhibitors, prostacyclins, and soluble guanylate cyclase stimulators for ≥90 days prior to screening. Current use of sotatercept is not permitted. * 6MWD ≥ 100 and ≤ 475 m
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.