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A Phase 2 Study of IkT-001Pro in Pulmonary Arterial Hypertension (PAH)

NCT06643143 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-06-13

No results posted yet for this study

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).

Conditions

  • Pulmonary Arterial Hypertension (PAH)
  • Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)

Interventions

DRUG

IkT-001Pro

IkT-001Pro

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Inhibikase Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06643143 on ClinicalTrials.gov