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Tests treatment safety and results for Gene Mutations
Official title ADAPT Study: Long-term Safety Study of INZ-701 in Patients With ENPP1 Deficiency and ABCC6 Deficiency
ClinicalTrials.gov ID: NCT06462547
What this study is testing
What is INZ-701?
INZ-701 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for gene mutations.
Also referred to as rhENPP1-Fc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older
You may be able to join if
- Individuals eligible to participate must meet all of the following
- Provide written or electronic informed consent after the nature of the study has been explained, and prior to any research-related procedures, per...
- Provide assent in accordance with local regulations, if \<18 years of age
- Male or female, greater than 1 year of age
- Must have completed the protocol-required safety and PK/PD and/or how well it works period(s) of a previous INZ-701 clinical study in ENPP1 or ABCC6...
You likely can't join if
- will not be eligible to participate:
- In the opinion of the Investigator, presence of any clinically significant disease or laboratory abnormality not associated with ENPP1 Deficiency or...
- Known intolerance to INZ-701 or any of its excipients
- Concurrent participation in another treatment clinical study and/or has received an investigational drug other than INZ-701 within 5 half-lives or...
- Pregnant, trying to become pregnant, or breastfeeding
- Male participants trying to father a child
See the full eligibility criteria
- Individuals eligible to participate must meet all of the following
- Provide written or electronic informed consent after the nature of the study has been explained, and prior to any research-related procedures, per International Council for Harmonisation of Technical Requirements for...
- Provide assent in accordance with local regulations, if \<18 years of age
- Male or female, greater than 1 year of age
- Must have completed the protocol-required safety and PK/PD and/or how well it works period(s) of a previous INZ-701 clinical study in ENPP1 or ABCC6 Deficiency, as confirmed by the Sponsor
- Female participants of childbearing potential who are sexually active must be using or agree to use 1 highly effective form of contraception (per CTFG 2020) from at least 1 month before the first dose of INZ-701 through...
- Male participants who are sexually active must agree to use condoms from the period following the first dose of INZ-701 through 30 days after the last dose of INZ-701; participants must agree to not donate sperm from...
- In the opinion of the Investigator, able to complete all aspects of the study Individuals who meet any of the following
- will not be eligible to participate:
- In the opinion of the Investigator, presence of any clinically significant disease or laboratory abnormality not associated with ENPP1 Deficiency or ABCC6 Deficiency, that will preclude study participation and/or may...
- Known intolerance to INZ-701 or any of its excipients
- Concurrent participation in another treatment clinical study and/or has received an investigational drug other than INZ-701 within 5 half-lives or within 4 weeks prior to the first dose of INZ-701 in this study...
- Pregnant, trying to become pregnant, or breastfeeding
- Male participants trying to father a child
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
- Eatontown, New Jersey, United States
- Paris, France
- Hamburg, Germany
- Oxford, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States; Eatontown, New Jersey, United States; Paris, France; Hamburg, Germany; Oxford, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.