Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency (NCT07129759) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency
150 participantsStarted 2027-02
Plain-language summary
This is a Multi-national Trial. The Goal of the Trial is to Offer Subjects Who Complete 12 Months in the LUM-201-10 Phase 3 Trial up to an Additional 36 Months of Treatment of LUM-201 While Evaluating Safety and Tolerability of LUM-201.
Who can participate
Age range
4 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Parent/caregiver must be willing to provide written informed consent, and the subject must sign the assent, as applicable.
* Subject must have successfully completed 12 months of participation in the LUM-201 Phase 3 GHD trial, and be eligible for continuation of treatment, pending all other enrollment criteria are met.
* Subject who is sexually active must use an acceptable form of contraception.
* Subject must be eligible for the Day 1 visit as confirmed by the Investigator.
Exclusion Criteria:
* Subject has a medical or genetic condition that, in the opinion of the Investigator and/or MMs, adds unwarranted risk to use of LUM-201.
* Pregnancy.
* Subject has planned or is receiving current long-term treatment with medications known to prolong the QT interval or act as substrates, inducers, or inhibitors of the cytochrome system cytochrome P450 type 3A4 that metabolizes LUM-201 (see Appendix 6 for list of example medications). Subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the Investigator in consultation with the MMs.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a long-term safety extension study of LUM-201, what do we currently know about LUM-201's safety profile from the earlier phases, and are there any side effects my child's doctor would want to watch closely over time?
2This trial is listed as 'not yet recruiting' — how long might we realistically need to wait before it opens, and should we be considering other treatment options in the meantime rather than waiting for this study?
3Because this Phase 3 study is focused specifically on long-term safety and tolerability rather than proving the drug works, what would my child actually gain from participating compared to standard growth hormone injection therapy that's already approved?
4Would my child need to have been part of an earlier LUM-201 study to be eligible for this extension, or is this something new patients might also be considered for?
5What does long-term follow-up in a study like this actually involve for my child day-to-day — how many clinic visits, tests, or monitoring appointments should we expect, and how might that affect school and family life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the long-term safety and tolerability of LUM-201