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Not yet recruiting NCT07129759

Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency

Phase III Interventional Growth Hormone Deficiency (GHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LUM-201.
Who it may be relevant to
Registry conditions: Growth Hormone Deficiency (GHD). Basic parameters: 4 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Long-term Extension Study to Evaluate the Safety and Tolerability of Daily Oral LUM-201 in Children With Growth Hormone Deficiency (GHD)

Overview

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.

Interventions

  • Drug LUM-201
    1.6 mg/kg/day, administered orally once daily

Primary outcome measures

  • To evaluate the long-term safety and tolerability of LUM-201 [Time frame: Day 1 - Month 36]
Secondary outcome measures (2)
  • To evaluate the long-term effect of LUM-201 on growth. [Time frame: Day 1 - Month 36]
  • To evaluate the long-term effect of LUM-201 on pharmacodynamic (PD) markers. [Time frame: Day 1 - Month 36]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07129759 · LUM-201-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗