RecruitingGrowth Hormone Deficiency (GHD)

Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency

Eligible age

3–11 yrs

Accepts

All genders

Locations

18 states

Healthy volunteers

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About this study

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.

Sponsor: Lumos Pharma

You may qualify if…

✓ 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
✓ ≥ 3.0 years and age ≤ 10.0 years for girls and ≤ 11.0 years for boys
✓ Baseline height velocity (HV) based on ≥ 6 months of growth assessments \< 25th percentile for age and sex
✓ Bone Age delay of ≥ 12 months compared to the chronological age
✓ In girls, have genetic testing results to rule out Turner syndrome. If SHOX genetic testing results are available, they need to be negative.

You may not qualify if…

✕ 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
✕ Current inflammatory diseases requiring systemic corticosteroid treatment for \> 2 consecutive weeks within the last 3 months prior to the Screening Visit
✕ Use of hormone replacement therapy for any hormone deficiency other than thyroid deficiency
✕ Any ECG at the Screening Visit noted to have a clinically significant abnormality, as confirmed by the MM
✕ Any subjects suspected of having past or present intracranial tumor growth as confirmed by brain imaging prior to the Screening or Day 1 Visit