Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-27 @ 6:56 AM
Study NCT ID:
NCT06097260
Status:
TERMINATED
Last Update Posted:
2025-08-01
First Post:
2023-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis
Sponsor:
Pliant Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy and Safety of Bexotegrast (PLN-74809) for the Treatment of Idiopathic Pulmonary Fibrosis (BEACON-IPF)
Status:
TERMINATED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DSMB recommendation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF).
Detailed Description:
This is a randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of 2 doses of bexotegrast (PLN-74809) \[160 and 320 mg\] taken for 52 weeks by participants with IPF taking and not taking background therapy (ie, nintedanib or pirfenidone).
The study will consist of an up to 35-day Screening Period, a 52-week Treatment Period, and a 14 day Safety Follow-up Period. Of note, participants who are not taking background therapy at study entry will be allowed to initiate it at any time during the study.
The study will consist of an up to 35-day Screening Period, a 52-week Treatment Period, and a 14 day Safety Follow-up Period. Of note, participants who are not taking background therapy at study entry will be allowed to initiate it at any time during the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BEACON-IPF | OTHER | Pliant Therapeutics Inc | View |