Ignite Creation Date:
2024-10-25 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508021
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-17
Brief Title:
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva FOP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 23 Global Multicenter Randomized Double-Blind Placebo-Controlled Two-Part Study With Open-Label Extension OLE to Assess the Efficacy and Safety of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva FOP
Status:
NOT_YET_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:
ANDECAL
Brief Summary:
This study is researching an experimental drug called andecaliximab The study will include pediatric and adult patients with fibrodysplasia ossificans progressiva FOP The study will evaluate how safe and effective andecaliximab is in patients with FOP
The study is looking at several research questions including
Safety of andecaliximab in participants with FOP
Whether andecaliximab reduces the number of new heterotopic bone lesions Heterotopic Ossification HO
Whether andecaliximab reduces the number or severity of flare-ups
Pharmacokineticspharmacodynamics PKPD How much study drug is in your blood at different times and its impact on blood biomarkers
Whether the body makes antibodies against the study drug which could make the drug less effective or could lead to side effects
The study is looking at several research questions including
Safety of andecaliximab in participants with FOP
Whether andecaliximab reduces the number of new heterotopic bone lesions Heterotopic Ossification HO
Whether andecaliximab reduces the number or severity of flare-ups
Pharmacokineticspharmacodynamics PKPD How much study drug is in your blood at different times and its impact on blood biomarkers
Whether the body makes antibodies against the study drug which could make the drug less effective or could lead to side effects
Detailed Description:
The ASH-FOP-201 Study consists of 2 parts Part 1 is a Lead-in Study to assess safety PKPD and preliminary efficacy Part 2 is the Main Study a Phase 23 randomized double-blind placebo-controlled trial
Part 1 is composed of Part 1a a Na18F positron emission tomography PETcomputed tomography less head CT Study in up to 6 participants age 15 years and Part 1b a flare-up Study in up to 6 participants 12 years of age Participants enrolled in Part 1 will be randomized to one of two dose levels for 13 weeks Participants in Part 2 will be randomized to one of two dose levels of drug vs placebo during the 52 week trial All participants in Part 1 or Part2 will receive study drug in the extension period of the trial
Part 1 is composed of Part 1a a Na18F positron emission tomography PETcomputed tomography less head CT Study in up to 6 participants age 15 years and Part 1b a flare-up Study in up to 6 participants 12 years of age Participants enrolled in Part 1 will be randomized to one of two dose levels for 13 weeks Participants in Part 2 will be randomized to one of two dose levels of drug vs placebo during the 52 week trial All participants in Part 1 or Part2 will receive study drug in the extension period of the trial
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