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Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)

NCT04614337 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

  • Growth Hormone Deficiency

Interventions

DRUG

LUM-201

Administered orally once daily

DRUG

rhGH Norditropin® pen (34 µg/kg)

Administered subcutaneously (s.c., under the skin) once daily.

Sponsors & Collaborators

  • Lumos Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2024-09-04
Completion
2024-09-04
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Israel
  • New Zealand
  • Poland
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04614337 on ClinicalTrials.gov