Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515002
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
A Study to Test How Well BI 3720931 is Tolerated and Whether it Improves Lung Function in People With Cystic Fibrosis Lenticlair 1
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Seamless Phase III Trial With an Initial Open-label Dose Escalation Part and a Subsequent Randomised Double-blind Placebo-controlled Expansion Part to Evaluate the Safety Tolerability and Efficacy of a Single Dose of BI 3720931 an Inhaled Lentiviral Vector Gene Therapy in Adult People With Cystic Fibrosis Who Are Ineligible for CFTR Modulators Lenticlair 1
Status:
RECRUITING
Status Verified Date:
2024-09
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 study is open to adult men with cystic fibrosis and adult women with cystic fibrosis who cannot have children People with cystic fibrosis can join if they are not eligible to receive cystic fibrosis transmembrane conductance regulator modulator therapy CFTR-MT The purpose of this study is to find out how well a medicine called BI 3720931 is tolerated and whether it improves lung function in people with cystic fibrosis In this study BI 3720931 is given to humans for the first time
This study has two phases In Phase 1 participants are put in one of 3 groups one group after the other Each group gets a different dose of BI 3720931 Group 1 starts with the lowest dose followed by group 2 with the middle and group 3 with the high dose In Phase 2 participants are put into 3 groups by chance but at the same time 2 groups get different doses of BI 3720931 and 1 group gets placebo All study participants get only 1 dose of BI 3720931 or placebo and they use a special inhaler to take the study medicine The placebo inhaler looks like the BI 3720931 inhaler but does not contain any medicine During the study participants continue taking their usual medicines
Doctors closely monitor participants health at the study site for the first 3 days after receiving BI 3720931 Participants visit their doctors regularly thereafter The doctors check the health of the participants and note any health problems that could have been caused by BI 3720931 Study participants regularly do a standard lung function test to measure how well their lungs are working Participants in either Phase 1 or Phase 2 are in the study for 7 months After completion of this study participants will take part in a long-term follow-up study 1504-0003
This study has two phases In Phase 1 participants are put in one of 3 groups one group after the other Each group gets a different dose of BI 3720931 Group 1 starts with the lowest dose followed by group 2 with the middle and group 3 with the high dose In Phase 2 participants are put into 3 groups by chance but at the same time 2 groups get different doses of BI 3720931 and 1 group gets placebo All study participants get only 1 dose of BI 3720931 or placebo and they use a special inhaler to take the study medicine The placebo inhaler looks like the BI 3720931 inhaler but does not contain any medicine During the study participants continue taking their usual medicines
Doctors closely monitor participants health at the study site for the first 3 days after receiving BI 3720931 Participants visit their doctors regularly thereafter The doctors check the health of the participants and note any health problems that could have been caused by BI 3720931 Study participants regularly do a standard lung function test to measure how well their lungs are working Participants in either Phase 1 or Phase 2 are in the study for 7 months After completion of this study participants will take part in a long-term follow-up study 1504-0003
Detailed Description:
None
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