Open-Label Study of IKT-001 in Pulmonary Arterial Hypertension (PAH)

NCT07632898 — Phase 3, Not yet recruiting, 484 participants, Inhibikase Therapeutics

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

Registry	NCT07632898
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	484 (Estimated)
Sponsor	Inhibikase Therapeutics (Industry)
Conditions	Pulmonary Arterial Hypertension (PAH)
Interventions	IKT-001 (Drug)
Dates	start 2026-10-23 (estimated), primary completion 2030-06-30 (estimated), completion 2030-12-30 (estimated), first posted 2026-06-08, last updated 2026-06-08

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
IKT-001	Experimental	Drug: IKT-001	IKT-001 tablets for PO administration

IKT-001 (Drug): IKT-001 tablets for PO administration

+Outcome measures

Primary outcomes

Incidence of Treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs of special interest [From baseline to end of study (up to 2 years or availability of commercial product)]: The number of participants who experience a TEAE, serious TEAE or TEAE of special interest will be reported.

Secondary outcomes

Change from baseline in 6-minute walk distance (6MWD) [From baseline to end of study (up to 2 years or availability of commercial product)]
Change from baseline in NT-proBNP [From baseline to end of study (up to 2 years or availability of commercial product)]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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.