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Clinical Trials/NCT07632898
NCT07632898Not yet recruitingPhase 3

Open-Label, Long-Term Extension Study to Evaluate the Safety and Tolerability of IKT-001 in Pulmonary Arterial Hypertension

Inhibikase Therapeutics0 sites484 target enrollmentStarted: October 23, 2026Last updated:
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Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Enrollment
484
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a multicenter, open-label extension (OLE), single-arm study designed to assess the long-term safety and tolerability of oral IKT-001 administered once daily.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Capable of giving signed informed consent.
  • •Participants who have completed Study IKT-001-201 or any other Phase 2 or 3 controlled clinical study with IKT-001.

Exclusion Criteria

  • •Any of the following clinical laboratory values at screening:
  • •ALT or AST levels >3× the ULN
  • •Bilirubin levels >2× the ULN
  • •ANC <1.2 ×10^9 cells/L, hemoglobin <9 g/dL, hematocrit <30%, or platelets <75 × 10^9 cells/L
  • •Absolute eGFR <30 mL/min using creatinine or cystatin C as defined by the CKD-EPI equation (2021)
  • •Currently lactating, pregnant or planning on becoming pregnant during the study.
  • •Receiving treatment with sotatercept.

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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