Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635850
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
A Study of Mosliciguat in PH-ILD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Placebo-Controlled Trial to Assess the Efficacy and Safety of Mosliciguat in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Status:
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:
PHocus
Brief Summary:
This is a Phase 2 randomized double-blind placebo-controlled multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease PH-ILD
Detailed Description:
This study is a randomized double-blind placebo-controlled study with an extension
The study consists of 2 periods a blinded placebo-controlled period 24 weeks and an extension beyond 24 weeks
Participants will be randomized to receive mosliciguat or placebo in the 24-week double-blind treatment period
All participants who complete the 24-week double-blind period may continue to participate in the extension period where all participants will receive mosliciguat
The study consists of 2 periods a blinded placebo-controlled period 24 weeks and an extension beyond 24 weeks
Participants will be randomized to receive mosliciguat or placebo in the 24-week double-blind treatment period
All participants who complete the 24-week double-blind period may continue to participate in the extension period where all participants will receive mosliciguat
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