Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
ConditionGrowth Hormone Deficiency (GHD)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-11
SponsorLumos Pharma
About this trial
The OraGrowtH Phase 3 Trial is a multi-national trial. The goals of the trial are to study LUM-201 as a treatment for Pediatric Growth Hormone Deficiency (PGHD) in naive to treatment children and validate the LUM-201 predictive enrichment marker (LUM-201 PEM) strategy to select subjects likely to respond to therapy with daily oral LUM-201.
Eligibility criteria
Qualifiers
Subjects must be naïve to treatment and prepubertal
Subjects must have a maximal GH response of < 10 ng/mL from 2 prior GH stimulation tests conducted within the preceding 12 months
Impaired height defined as ≥ 2.0 standard deviations (SDs) below the mean height for chronological age and sex
Morning or random cortisol level of ≥ 7.0 μg/dL
Disqualifiers
Any medical or genetic condition which, in the opinion of the Investigator or Medical Monitor (MM), can be an independent cause of short stature and/or limit the response to exogenous growth factor treatment.
Arm span to height ratio > 2 SDs below the mean for age and sex
A medical or genetic condition that, in the opinion of the Investigator and/or MM, adds unwarranted risk to use of LUM-201
Use of any medication that, in the opinion of the Investigator and/or MM, can independently cause short stature or limit the response to exogenous growth factors
Trial design
Treatments tested in this trial
- LUM-201
- Matched Placebo (Capsules)
Treatment groups
150 Participants
are divided into 2 treatment groupsLocations
37Australia
Lumos Pharma Investigational Site4101, South BrisbaneQueensland, Australia
Lumos Pharma Investigational Site3052, ParkvilleVictoria, Australia
New Zealand
Lumos Pharma Investigational Site1142, Auckland New Zealand
Lumos Pharma Investigational Site6242, Wellington New Zealand
Sponsors and collaborators
Lumos Pharma
Lead sponsor
Source ClinicalTrials.gov