NCT05250063

Phase 2 Study of LUM-201 in Children Who Have Previously Completed the LUM-201-01 Trial (OraGrowtH213)

A Multicenter, Open-Label, Phase 2 Study to Evaluate Growth and Safety of LUM-201 Following 12 Months of Daily rhGH Treatment in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed the LUM-201-01 Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Lumos Pharma · Industry
• Sex: All
• Age: 3 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-national trial. The goals of the trial are to study the growth response to LUM-201 administration in children with idiopathic growth hormone deficiency (GHD) previously treated with daily rhGH for 12 months in the LUM-201-01 trial.

Detailed description

This trial will have one screening/baseline visit with tests to assess if subjects are eligible to start study therapy. The screening/baseline visit can coincide with the Month 12 visit in the LUM-201-01 trial. Subjects will receive the same dose of LUM-201 as a daily oral dose each morning. LUM-201 will be adjusted for body weight increments at each clinic visit, as applicable. The trial consists of 12 months of treatment. After screening, subjects will return to the clinic for 5 visits. During four of these clinic visits, safety laboratory samples will be collected.

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	LUM-201	Administered orally once daily

Timeline

• Start date: 2022-02-18
• Primary completion: 2025-01-22
• Completion: 2025-01-22
• First posted: 2022-02-22
• Last updated: 2026-04-13
• Results posted: 2026-04-13

Locations

10 sites across 2 countries: United States, Poland

Regulatory

• FDA-regulated drug study