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NCT Number: NCT07632898

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

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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Key information

Conditions

Pulmonary Arterial Hypertension (PAH) Hypertension, Pulmonary Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IKT-001

Drug

IKT-001 tablets for PO administration

Primary outcomes

  1. Incidence of Treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs of special interest

    Time frame: 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

  1. Change from baseline in 6-minute walk distance (6MWD)

    Time frame: From baseline to end of study (up to 2 years or availability of commercial product)

  2. Change from baseline in NT-proBNP

    Time frame: From baseline to end of study (up to 2 years or availability of commercial product)

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Director, Inhibikase Therapeutics

CONTACT

[email protected]

1-302-295-3800

Sponsors and collaborators

Lead sponsor

Inhibikase Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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