Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588686
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel-group Multicenter Trial Evaluating the Efficacy and Safety of 2 Doses of Buloxibutid Over 52 Weeks in People With Idiopathic Pulmonary Fibrosis
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:
ASPIRE
Brief Summary:
The ASPIRE trial is a 52 week randomized double-blind placebo-controlled parallel-group multicenter trial in which the efficacy safety and pharmacokinetics of orally administered buloxibutid either on top of stable IPF therapy or as monotherapy are assessed in participants with IPF
Trial website wwwaspire-ipfcom
Trial website wwwaspire-ipfcom
Detailed Description:
Buloxibutid is an oral angiotensin II type 2 AT2 receptor agonist and has been shown to improve lung function in IPF over 36 weeks
Buloxibutid agonizes the AT2 receptor on alveolar epithelial type 2 cells AEC2s which are believed to play a central role in the disease Buloxibutid has been demonstrated preclinically to improve AEC2 viability alveolar integrity via surfactant secretion and epithelial repair via replenishment of gas exchange alveolar epithelial type 1 cells AEC1s This leads to decreasing downstream profibrotic signaling enhancing resolution of existing fibrotic tissue via upregulation of collagenase matrix metalloproteinases and addressing vascular disfunction associated with the disease
The trial will include participants who are on stable licensed IPF therapy or who are currently not treated with a licensed IPF therapy The latter group will include participants intolerant or not responsive to licensed IPF therapies participants ineligible to receive these therapies and participants who have voluntarily declined to receive a licensed IPF therapy after being fully informed of the potential benefits and risks of such therapy Due to the potential risk of drug-drug interactions DDIs concomitant treatment with pirfenidone is not allowed in this trial Participants who are not on antifibrotic therapy at study start may initiate such treatment during the study
The trial is planned to enroll 270 participants 90 participants on oral buloxibutid 100 mg BID 90 participants on oral buloxibutid 50 mg BID and 90 participants on oral placebo BID for 52 weeks The treatment will be blinded and treatment allocation will be randomized
The primary measurement will be based on spirometry measuring the forced vital capacity FVC
The trial consists of 3 consecutive periods a screening period of up to 6 weeks a 52-week treatment period and a follow-up period of 2-4 weeks after the 52-week visit The study procedures have been planned with focus on optimizing patient convenience while allowing a safe conduct and strict scientific rigor
Trial website wwwaspire-ipfcom
Buloxibutid agonizes the AT2 receptor on alveolar epithelial type 2 cells AEC2s which are believed to play a central role in the disease Buloxibutid has been demonstrated preclinically to improve AEC2 viability alveolar integrity via surfactant secretion and epithelial repair via replenishment of gas exchange alveolar epithelial type 1 cells AEC1s This leads to decreasing downstream profibrotic signaling enhancing resolution of existing fibrotic tissue via upregulation of collagenase matrix metalloproteinases and addressing vascular disfunction associated with the disease
The trial will include participants who are on stable licensed IPF therapy or who are currently not treated with a licensed IPF therapy The latter group will include participants intolerant or not responsive to licensed IPF therapies participants ineligible to receive these therapies and participants who have voluntarily declined to receive a licensed IPF therapy after being fully informed of the potential benefits and risks of such therapy Due to the potential risk of drug-drug interactions DDIs concomitant treatment with pirfenidone is not allowed in this trial Participants who are not on antifibrotic therapy at study start may initiate such treatment during the study
The trial is planned to enroll 270 participants 90 participants on oral buloxibutid 100 mg BID 90 participants on oral buloxibutid 50 mg BID and 90 participants on oral placebo BID for 52 weeks The treatment will be blinded and treatment allocation will be randomized
The primary measurement will be based on spirometry measuring the forced vital capacity FVC
The trial consists of 3 consecutive periods a screening period of up to 6 weeks a 52-week treatment period and a follow-up period of 2-4 weeks after the 52-week visit The study procedures have been planned with focus on optimizing patient convenience while allowing a safe conduct and strict scientific rigor
Trial website wwwaspire-ipfcom
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