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

ConditionPulmonary Arterial Hypertension
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInhibikase Therapeutics

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Idiopathic PAH

Heritable PAH

Drug/toxin-induced PAH

PAH associated with connective tissue disease (CTD)

Disqualifiers

Diagnosis of PAH WHO Groups 2, 3, 4, or 5.

Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH, and pulmonary veno-occlusive disease.

Any of the following blood pressure-related values or abnormalities: Uncontrolled systemic hypertension as evidenced by sitting systolic BP >160 mmHg or sitting diastolic BP >100 mmHg at screening, Baseline systolic BP <90 mmHg at screening, Syncope within 3 months prior to screening

History of restrictive, constrictive, or congestive cardiomyopathy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • IKT-001

    Drug

    IKT-001 tablets for PO administration

  • Placebo

    Drug

    Placebo to IKT-001 tablets for PO administration

Treatment groups

486 Participants
are divided into 2 treatment groups
Group A: IKT-001Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

[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

Change in Pulmonary Vascular Resistance (PVR)

Time frame
Baseline to Week 24
2

[Part B] To characterize the effects of IKT-001 on symptoms and characteristics of Pulmonary Arterial Hypertension compared to placebo

Change in 6-minute walk distance (6MWD)

Time frame
Baseline to Week 24

Secondary outcomes

1

To characterize the effects of IKT-001 on WHO Functional Class

Change in WHO Functional Class

Time frame
Baseline up to Week 48
2

To characterize the effects of IKT-001 on time to clinical worsening

Time to clinical worsening

Time frame
Baseline up to Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inhibikase Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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