At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 104 enrolled / 104 target
Drug / intervention
LUM-201 +1 moredrug
Likely dose
rhGH Norditropin® pen (34 µg/kg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, 24-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children With Idiopathic Growth Hormone Deficiency (GHD)
In Brief
A Phase 2 clinical trial evaluating LUM-201 and rhGH Norditropin® pen (34 µg/kg) for Growth Hormone Deficiency. Completed, enrolled 104 participants across 43 sites in 6 countries.
Signals
Enrolling slower than its timeline implies
Detailed Summary
This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects likely to respond to therapy with LUM-201.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Hormone Deficiency
CountriesAustralia, Israel, New Zealand, Poland, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartDec 2020
Primary CompletionSep 2024
TodayJul 2026
First PostedNov 4, 2020
Enrollment StartDec 31, 2020
Primary CompletionSep 4, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 5.7 years ago
Arms & Interventions
LUM-201 (0.8 mg/kg/day)experimental
Drug: LUM-201
LUM-201 (1.6 mg/kg/day)experimental
Drug: LUM-201
LUM-201 (3.2 mg/kg/day)experimental
Drug: LUM-201
rhGH (34 µg/kg/day)active_comparator
Drug: rhGH Norditropin® pen (34 µg/kg)
Interventions
LUM-201drug
Administered orally once daily
rhGH Norditropin® pen (34 µg/kg)drug
Administered subcutaneously (s.c., under the skin) once daily.