Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643143
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
A Phase 2 Study of IkT-001Pro in Pulmonary Arterial Hypertension PAH
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Trial of IkT-001Pro in Pulmonary Arterial Hypertension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized double-blind multi-center placebo-controlled dose-ranging clinical trial of two IkT-001Pro doses in patients with PAH designed to assess safety tolerability and efficacy It will enroll approximately 150 participants at up to 50 sites globally The study consists of two parts a 26 week placebo controlled treatment period Part A followed by a 36 month extension period Part B
Detailed Description:
This is a randomized double-blind multi-center placebo-controlled dose-ranging clinical trial of two IkT-001Pro doses in patients with PAH This study will enroll approximately 150 participants at up to 50 sites globally
The study consists of two parts a 26 week placebo controlled treatment period Part A followed by a 36 month extension period Part B Those participants that pass the screening process will be randomized during the baseline visit to either the low dose 300mg or placebo in a 21 ratio
After two weeks participants will return to the clinic upon confirmation that the participants are tolerating their dose those that are on active treatment will be randomized to either 300mg or 500mg active treatment arms in a 11 manner Those participants on placebo will remain on placebo for the rest of the 26-week placebo controlled treatment period The final randomization structure for the 26-week placebo controlled treatment period will be such that participants are randomized in a 111 scheme to the 300 mg 500 mg or placebo groups
Participants who have not discontinued early will transition to a 36 month extension period Participants who transition to the extension period will remain on the dose that they were assigned to after the two week acclimation period Participants who were randomized to the placebo group will be re-randomized 11 to either the 300mg or 500mg IkT-001Pro treatment groups The study will be unblinded and investigators will be given treatment assignments once the primary endpoint analysis is completed
The study consists of two parts a 26 week placebo controlled treatment period Part A followed by a 36 month extension period Part B Those participants that pass the screening process will be randomized during the baseline visit to either the low dose 300mg or placebo in a 21 ratio
After two weeks participants will return to the clinic upon confirmation that the participants are tolerating their dose those that are on active treatment will be randomized to either 300mg or 500mg active treatment arms in a 11 manner Those participants on placebo will remain on placebo for the rest of the 26-week placebo controlled treatment period The final randomization structure for the 26-week placebo controlled treatment period will be such that participants are randomized in a 111 scheme to the 300 mg 500 mg or placebo groups
Participants who have not discontinued early will transition to a 36 month extension period Participants who transition to the extension period will remain on the dose that they were assigned to after the two week acclimation period Participants who were randomized to the placebo group will be re-randomized 11 to either the 300mg or 500mg IkT-001Pro treatment groups The study will be unblinded and investigators will be given treatment assignments once the primary endpoint analysis is completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None