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

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lumos Pharma

Criteria

Inclusion Criteria:

• Parent/caregiver must sign the informed consent, and the subject must sign the assent, as applicable.

• Must have previously completed 12 months of daily rhGH treatment as part of the LUM-201-01 PGHD trial.

• Is eligible for study participation as confirmed by the principal investigator (PI)

Exclusion Criteria:

• Has a medical condition that, in the opinion of the PI and/or MM, adds unwarranted risk to use of LUM-201.

• Uses any medication that, in the opinion of the PI and/or MM, can independently cause short stature or limit the response to exogenous growth factors.

• Has planned or is receiving current long-term treatment with medications known to act as substrates, inducers, or inhibitors of the cytochrome system CYP3A4 that metabolizes LUM-201