Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303570
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-02-26
Brief Title:
A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants with Dercums Disease Lipomas
Sponsor:
Caliway Biopharmaceuticals Co Ltd
Organization:
Caliway Biopharmaceuticals Co Ltd
Study Overview
Official Title:
A Single-Blind Placebo-Control Randomized Phase 2 Study to Evaluate the Efficacy and Safety of CBL-514 in Participants with Dercums Disease Lipomas
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-blind placebo-controlled randomized phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum39s Disease lipomas
Detailed Description:
This is a phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum39s disease lipomas
A total of approximately 30 participants will be randomized Eligible participants will be randomized 11 to receive either CBL-514 or placebo once every 4 weeks for up to 5 treatments for each selected lipoma This means that there will be 15 participants in each dose group CBL-514 group and placebo group Eligible participants must have at least 4 and up to 10 painful individual lipomas The injection volume per lipoma will depend on the lipoma size as determined by ultrasound
A total of approximately 30 participants will be randomized Eligible participants will be randomized 11 to receive either CBL-514 or placebo once every 4 weeks for up to 5 treatments for each selected lipoma This means that there will be 15 participants in each dose group CBL-514 group and placebo group Eligible participants must have at least 4 and up to 10 painful individual lipomas The injection volume per lipoma will depend on the lipoma size as determined by ultrasound
Study Oversight
Has Oversight DMC:
None
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?:
None