Open-Label Study of IKT-001 in Pulmonary Arterial Hypertension (PAH)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInhibikase Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
IKT-001
DrugIKT-001 tablets for PO administration
Treatment groups
484 Participants
are divided into 1 treatment groupGroup A: IKT-001Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs of special interest
The number of participants who experience a TEAE, serious TEAE or TEAE of special interest will be reported.
Time frame
From baseline to end of study (up to 2 years or availability of commercial product)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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: