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NCT05250063 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of LUM-201 in Children Who Have Previously Completed the LUM-201-01 Trial (OraGrowtH213)
A Phase 2 study of Growth Hormone Deficiency, sponsored by Lumos Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 10
- Study locations
NCT05250063: Completed Phase 2 study of Growth Hormone Deficiency, sponsored by Lumos Pharma.
NCT05250063 is a Phase 2 study of Growth Hormone Deficiency that has completed, run by Lumos Pharma. The registered enrollment target is 18 participants, below the 386-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (95% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05250063, a Phase 2 study of Growth Hormone Deficiency, has completed, sponsored by Lumos Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
Mean change from day 1 to month 12, Annualized Height Velocity (AHV) Height is measured in triplicate, by a calibrated stadiometer and taking the mean value AVH equation is (h2-h1/t2-t1)\*365.25; h1 = height measured at day 1 h2 = height measured at month 12 t1 = day 1 t2 = month 12
Conditions Studied
Interventions
- DRUG LUM-201
Study Locations (10)
Other
- Klinika Endokrynologii i Chorob Metabolicznych, Instytut Centrum Zdrowia Matki Polki - Lodz
- Sonomed - Centrum Medyczne - Szczecin
- Klinika Endokrynologii i Diabetologii, Instytut "Pomnik Centrum Zdrowia Dziecka - Warsaw
California
- Rady Children's Hospital - San Diego
District of Columbia
- Children's National Hospital - Washington D.C.
Indiana
- Indiana University School of Medicine - Indianapolis
Minnesota
- M Health, Fairview Pediatric Specialty Clinics- Discovery Clinic - Minneapolis
Missouri
- The Children's Mercy Hospital - Kansas City
Ohio
- Nationwide Children's Hospital - Columbus
Virginia
- University of Virginia Health System - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-02-18 |
| Est. Completion | 2025-01-22 |
| Phase | Phase 2 |
What the finished NCT05250063 record still lists
NCT05250063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 386-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Growth Hormone Deficiency appearing as the primary indexed condition, and to 1 intervention - of which LUM-201 is the first listed.
NCT05250063 lists 10 locations in 8 states (Other, California, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT05250063 about?
NCT05250063 is a clinical study titled "Phase 2 Study of LUM-201 in Children Who Have Previously Completed the LUM-201-01 Trial (OraGrowtH213)". 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.
What is the current status of trial NCT05250063?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2022-02-18. Estimated completion is 2025-01-22.
What conditions does trial NCT05250063 study?
This clinical trial studies the following conditions: Growth Hormone Deficiency.
What interventions are being tested in trial NCT05250063?
The interventions under investigation include: LUM-201 (DRUG).
Who is sponsoring clinical trial NCT05250063?
This trial is sponsored by Lumos Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05250063 being conducted?
This trial has 10 study locations across California, District of Columbia, Indiana, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05250063's enrollment target sits among peer trials
18 15th of 16 higher than 2 of 16 other Growth Hormone Deficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Growth Hormone Deficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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