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

Completed · Phase 2

Conditions studied: Growth Hormone Deficiency

In brief

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.

Key facts

Study ID

NCT05250063

Run by

Lumos Pharma

People needed

15

Starts

2022-02-18

Expected to finish

2025-01-22

Last updated by the study team

2026-05-15

Who can join

Age: 3 and older, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Rady Children's Hospital — San Diego, California, United States
• Children's National Hospital — Washington D.C., District of Columbia, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• M Health, Fairview Pediatric Specialty Clinics- Discovery Clinic — Minneapolis, Minnesota, United States
• The Children's Mercy Hospital — Kansas City, Missouri, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Klinika Endokrynologii i Chorob Metabolicznych, Instytut Centrum Zdrowia Matki Polki — Lodz, Poland
• Sonomed - Centrum Medyczne — Szczecin, Poland
• Klinika Endokrynologii i Diabetologii, Instytut "Pomnik Centrum Zdrowia Dziecka — Warsaw, Poland

Full record on ClinicalTrials.gov

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