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

Exclusion Criteria

• •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
• •Any subject suspected of having intracranial hypertension (IH) as confirmed by fundoscopy and other assessments
• •Any subject with serum alanine transaminase (ALT), aspartate transaminase (AST), or total bilirubin \> upper limit of normal (ULN)
• •Suspicion of absent pituitary function as evidenced by a maximal stimulated GH ≤ 3.0 ng/mL on any prior standard of care GH stimulation test completed within 12 months
• •Body weight ≤ 14.0 kg
• •BMI \< -2 or \> +2 SDs for age and sex based on WHO standards
• •Birth weight for gestational age \< 3rd percentile based on WHO standards
• •Treatment with medications known to be moderate or strong inhibitors or strong inducers of cytochrome P450 (CYP) 3A/4
• •History of spinal, cranial, or total body irradiation
• •Attention deficit hyperactivity disorder (ADHD) diagnosis