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A Long-term Follow-up Study of Participants who Received INZ-701 in a previous clinical study
EU CTIS ID: 2024-512715-42-00
What this study is testing
To assess the long-term safety of INZ-701
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP)
- 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 efficacy period(s) of the INZ-701-101, INZ701-201, INZ701-104, or INZ701-106 clinical studies in ENPP1 or ABCC6 Deficiency, as confirmed by the Sponsor
- Women of childbearing potential (WOCBP), as defined in Clinical Trials Coordination Group [CTCG 2024]) must have a negative serum pregnancy test at Screening and must not be breastfeeding
- Males 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
You likely can't join if
- 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 confound interpretation of study results
- Known intolerance to INZ-701 or any of its excipients
- Concurrent participation in another interventional 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, whichever is longer, or use of an investigational device
- Pregnant, trying to become pregnant, or breastfeeding
- Male participants trying to father a child
See the full eligibility criteria
- 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 Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP)
- 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 efficacy period(s) of the INZ-701-101, INZ701-201, INZ701-104, or INZ701-106 clinical studies in ENPP1 or ABCC6 Deficiency, as confirmed by the Sponsor
- Women of childbearing potential (WOCBP), as defined in Clinical Trials Coordination Group [CTCG 2024]) must have a negative serum pregnancy test at Screening and must not be breastfeeding
- Males 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
- WOCBP and partners of fertile males who are WOCBP must be using or agree to use a highly effective form of contraception (as per CTCG 2024) from at least 1 month before the first dose of INZ-701 through 30 days after the last dose of INZ-701 (greater than 5 half-lives of INZ-701)
- In the opinion of the Investigator, able to complete all aspects of the study
- 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 confound interpretation of study results
- Known intolerance to INZ-701 or any of its excipients
- Concurrent participation in another interventional 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, whichever is longer, or use of an investigational device
- 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
- United States
- 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, 18-64 years, 0-17 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; 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 EU CTIS; the study team decides eligibility.