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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Inhibikase Therapeutics
Study ID
NCT07365332
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • IKT-001 — DRUG
    IKT-001 tablets for PO administration
  • Placebo — DRUG
    Placebo to IKT-001 tablets for PO administration

Study Details

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.

Key Dates

Start date
Apr 23, 2026
Status verified
May 2026
Primary completion
Jun 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
486 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IKT-001
    IKT-001 tablets for PO administration
  • Placebo Comparator: Placebo
    Matching placebo to IKT-001 tablets for PO administration

Primary Outcome Measure

[Part A] To evaluate the effect on Pulmonary Vascular Resistance (PVR) in participants with WHO Group 1 PAH treated with IKT-001 compared to placebo [ Time Frame: Baseline to Week 24 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Norton HealthcareLouisvilleKentucky40202-
Tufts Medical CenterBostonMassachusetts02111-

Find similar trials in Louisville, KY

By research site
Norton Healthcare· Louisville, KYTufts Medical Center· Boston, MA

Related Studies