An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children with Idiopathic Growth Hormone Deficiency

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504020-25-00

Acronym

LUM-201-02

Enrollment

Registered

2023-10-02

Start date

2023-12-28

Completion date

Unknown

Last updated

2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Growth Hormone Deficiency

Brief summary

1. Occurrence of AEs, SAEs; laboratory results, and physical examination findings.

Detailed description

1. GH values: actual and change over time (every 6 months)., 2. IGF-1 values: actual and change over time (every 6 months)., 3. IGFBP-3 values: actual and change over time (every 6 months)., 4. Change in height standard deviation score (HT-SDS) every 6 months., 5. Change in weight and weight SDS every 6 months., 6. Change in body mass index (BMI) and BMI SDS every 6 months., 7. Change in Bone Age (BA) compared to Chronological Age (CA) (e.g., BA/CA) ratio assessed annually.

Interventions

DRUGLUM-201

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Secondary

Measure	Time frame
1. GH values: actual and change over time (every 6 months)., 2. IGF-1 values: actual and change over time (every 6 months)., 3. IGFBP-3 values: actual and change over time (every 6 months)., 4. Change in height standard deviation score (HT-SDS) every 6 months., 5. Change in weight and weight SDS every 6 months., 6. Change in body mass index (BMI) and BMI SDS every 6 months., 7. Change in Bone Age (BA) compared to Chronological Age (CA) (e.g., BA/CA) ratio assessed annually.	—

Measure

Time frame

—

Primary

Measure	Time frame
1. Occurrence of AEs, SAEs; laboratory results, and physical examination findings.	—

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026