Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
NCT ID:
NCT07197866
Eligibility Criteria:
Inclusion Criteria:
* Completion of the treatment period and the week 48(V9) visit of the double-blind trial (TV56286-NDG-20039) whilst remaining compliant with trial requirements
* Females of childbearing potential may be included only if they have a negative pregnancy test at the baseline visit
* Females of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the trial and for 28 days after the last does of IMP
* Males who are potentially fertile/reproductively competent (not surgically \[eg, vasectomy\] or congenitally sterile) and their female partners who are of childbearing potential must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 28 days after the last dose of investigational medicinal product
NOTE - Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
* Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the trial
* Is of a vulnerable population (eg, people kept in detention or jail)
* Is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial
Note - Additional criteria apply, please contact the investigator for more information
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT07197866
Study Brief:
Protocol Section:
NCT07197866