Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462547
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
ADAPT Study Long-term Safety Study of INZ-701 in Patients With ENPP1 Deficiency and ABCC6 Deficiency
Sponsor:
Inozyme Pharma
Organization:
Inozyme Pharma
Study Overview
Official Title:
The ADAPT Study An Open-label Long-term Safety Study of INZ-701 in Patients With ENPP1 Deficiency and ABCC6 Deficiency
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The purpose of this study Study INZ701-304 ADAPT is to assess the long-term safety of INZ-701 in patients with ENPP1 Deficiency or ABCC6 Deficiency who have received INZ-701 in an existing clinical study and choose to continue dosing for the potential treatment of their condition
Detailed Description:
The investigational product INZ-701 is being developed as a therapeutic protein for the treatment of ectonucleotide pyrophosphatasephosphodiesterase 1 ENPP1 Deficiency and adenosine triphosphate ATP-binding cassette subfamily C member 6 ABCC6 Deficiency INZ-701 is a recombinant fusion protein that contains the extracellular domains of human ENPP1 coupled with an Fc fragment from an immunoglobulin Ig G1 antibody
The ADAPT Study INZ701-304 is an open-label study to assess the long-term safety of INZ-701 in patients with ENPP1 Deficiency or ABCC6 Deficiency who have received INZ-701 in an existing clinical study and choose to continue dosing for the potential treatment of their condition
The study will consist of a 30-day Screening Period followed by an open-label Treatment Period during which all participants will receive once-weekly subcutaneous SC doses of INZ-701 and continue with treatment until INZ-701 is commercially available in the countryregion of the participants residence or until Inozyme chooses to discontinue development of INZ-701 Participants will complete an End of Study EOS safety follow-up visit approximately 30 days after their last designated study visit assigned by the Investigator andor Sponsor
The ADAPT Study INZ701-304 is an open-label study to assess the long-term safety of INZ-701 in patients with ENPP1 Deficiency or ABCC6 Deficiency who have received INZ-701 in an existing clinical study and choose to continue dosing for the potential treatment of their condition
The study will consist of a 30-day Screening Period followed by an open-label Treatment Period during which all participants will receive once-weekly subcutaneous SC doses of INZ-701 and continue with treatment until INZ-701 is commercially available in the countryregion of the participants residence or until Inozyme chooses to discontinue development of INZ-701 Participants will complete an End of Study EOS safety follow-up visit approximately 30 days after their last designated study visit assigned by the Investigator andor Sponsor
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