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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Phase 2 Study of LUM-201 in Children Who Have Previously Completed the LUM-201-01 Trial (OraGrowtH213)

Short name OraGrowtH213

NCTNCT05250063 (opens ClinicalTrials.gov in a new tab)Other idLUM-201-04
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
15 participants (actual)
Sponsor
Lumos Pharma · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
2 countries

United States, Poland

Start
18 Feb 2022
Primary completion
22 Jan 2025
Completion
22 Jan 2025
First posted
22 Feb 2022
Last update posted
15 May 2026
Conditions
Growth Hormone Deficiency

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222023202420252026
  1. Ph 2

    OraGrowtH213

    NCT05250063

    18 Feb 2022 to 22 Jan 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LUM-201Drug

Arms1

  • Experimental

    LUM-201 (3.2 mg/kg/day)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Annualized Height Velocity (AHV) Measured as Standing Height With Stadiometer

    Time frame · Day 1 to Month 12

    Registry description

    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

Secondary outcomes(11)

  1. Occurrence of Adverse Events in Children With Growth Hormone Deficiency (GHD)

    Time frame · Day 1 to Month 12

    Registry description

    Number of events

  2. Growth Hormone (GH) Values

    Time frame · Day 1 to Month 12

    Registry description

    Mean GH Values change from Day 1 to month 12 (Pre-Dose and 1 hour Post-Dose)

  3. Insulin-Like Growth Factor 1 (IGF-1) Values

    Time frame · Day 1 to Month 12

    Registry description

    Mean change from Day 1 to month 12 (IGF-1 Values Pre-Dose)

  4. Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3) Values

    Time frame · Day 1 to Month 12

    Registry description

    Mean change from day 1 to month 12 (IGFBP-3 Values Pre-Dose)

  5. Height (HT) Standard Deviation Score (SDS)

    Time frame · Day 1 to Month 12

    Registry description

    Mean change from day 1 to month 12 in HT-SDS

  6. Change in Weight

    Time frame · Day 1 to Month 12

    Registry description

    Mean change in Weight from day 1 to month 12

  7. Change in Weight - Standard Deviation Score (SDS)

    Time frame · Day 1 to Month 12

    Registry description

    Mean change in Weight-SDS from day 1 to month 12

  8. Change in Body Mass Index (BMI)

    Time frame · Day 1 to Month 12

    Registry description

    Mean change from day 1 to month 12 in BMI

  9. Change in Body Mass Index (BMI) - Standard Deviation Score (SDS)

    Time frame · Day 1 to Month 12

    Registry description

    Mean change from Day 1 to month 12 in BMI-SDS

  10. Change in Bone Age

    Time frame · Month 6

    Registry description

    Mean change from day 1 to month 6 in bone age, measured by X-ray of left hand and wrist using Greulich \& Pyle atlas

  11. Insulin-Like Growth Factor 1 (IGF-1) - Standard Deviation Score (SDS)

    Time frame · Day 1 to Month 12

    Registry description

    Mean Change from day 1 to month 12 for IGF-1 - SDS Pre-dose Values

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Day 1 to Month 12

Annualized Height Velocity (AHV) Measured as Standing Height With Stadiometer

GroupValue (cm/year)Spread
LUM-201 (3.2 mg/kg/Day)0.0980.775
Secondary and other outcome results(7)
Secondary outcomeNumber· Day 1 to Month 12

Occurrence of Adverse Events in Children With Growth Hormone Deficiency (GHD)

GroupValue (occurences)
LUM-201 (3.2 mg/kg/Day)42
Secondary outcomeMean· Day 1 to Month 12

Growth Hormone (GH) Values

GroupValue (ng/ml)Spread
LUM-201 (3.2 mg/kg/Day)-0.050.68
Secondary outcomeMean· Day 1 to Month 12

Insulin-Like Growth Factor 1 (IGF-1) Values

GroupValue (nmol/L)Spread
LUM-201 (3.2 mg/kg/Day)-8.7514.59
Secondary outcomeMean· Day 1 to Month 12

Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3) Values

GroupValue (nmol/L)Spread
LUM-201 (3.2 mg/kg/Day)-58.03333.092
Secondary outcomeMean· Day 1 to Month 12

Height (HT) Standard Deviation Score (SDS)

GroupValue (Standard Deviation Score)Spread
LUM-201 (3.2 mg/kg/Day)0.082290.20574
Secondary outcomeMean· Day 1 to Month 12

Change in Weight

GroupValue (kg)Spread
LUM-201 (3.2 mg/kg/Day)4.191.74
Secondary outcomeMean· Day 1 to Month 12

Change in Weight - Standard Deviation Score (SDS)

GroupValue (Standard Deviation Score)Spread
LUM-201 (3.2 mg/kg/Day)0.622790.30934

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
LUM-201 (3.2 mg/kg/Day)LUM-201: Administered orally once daily0 / 150 / 1513 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 3 Years up to 13 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Criteria: * 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

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