NCT05796440

A Long-Term Safety Trial of LUM-201 in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed a LUM-201 Clinical Trial (OraGrowtH211)

An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children With Idiopathic Growth Hormone Deficiency

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Lumos Pharma · Industry
• Sex: All
• Age: 5 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-national trial. The trial aims to study the long-term safety of LUM-201 in subjects with Idiopathic Pediatric Growth Hormone Deficiency (iPGHD). This study will also assess pharmacodynamics and efficacy response to therapy with LUM-201.

Detailed description

An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children with Idiopathic Growth Hormone Deficiency. This study will last for up to 36 months to allow collection of additional long-term safety and efficacy data related to LUM-201 treatment in the pediatric patient population. Subjects will enter into this trial after successful participation in a prior LUM-201 study. This study will consist of visits every 6 months through three years. There are a total of 7 in-person visits with a follow-up phone call between visits. At the clinic visits, subjects will have a physical exam and blood collection as well as efficacy assessments.

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	LUM-201	Administered orally once daily

Timeline

• Start date: 2023-08-01
• Primary completion: 2028-03-01
• Completion: 2028-04-01
• First posted: 2023-04-03
• Last updated: 2024-02-15

Locations

7 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study