Open-Label Study of IKT-001 in Pulmonary Arterial Hypertension (PAH) (NCT07632898) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Open-Label Study of IKT-001 in Pulmonary Arterial Hypertension (PAH)
484 participantsStarted 2026-10-23
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs of special interest
Timeframe: From baseline to end of study (up to 2 years or availability of commercial product)