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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
LUM-201
Drug1.6 mg/kg/day, administered orally once daily
Matched Placebo (Capsules)
Other interventionAdministered orally once daily
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: LUM-201Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
AHV after 12 months on LUM-201 compared to placebo
Annualized height velocity (AHV) measured as standing height with stadiometer
Time frame
Day 1 to Month 12Other outcomes
1
Percentage of subjects selected by PEM strategy who meet target growth
Annualized height velocity (AHV) measured as standing height with stadiometer
Time frame
Day 1 to Month 12Sponsors and contacts
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Source ClinicalTrials.gov