Status:
COMPLETED
Phase 2 Study of LUM-201 in Children Who Have Previously Completed the LUM-201-01 Trial (OraGrowtH213)
Lead Sponsor:
Lumos Pharma
Conditions:
Growth Hormone Deficiency
Eligibility:
All Genders
3-13 years
Phase:
PHASE2
Brief 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 da...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05250063
Start Date
February 18 2022
End Date
January 22 2025
Last Update
September 29 2025
Active Locations (10)
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1
Rady Children's Hospital
San Diego, California, United States, 92123
2
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
3
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
4
M Health, Fairview Pediatric Specialty Clinics- Discovery Clinic
Minneapolis, Minnesota, United States, 55454