A Long-Term Safety Trial of LUM-201 in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed a LUM-201 Clinical Trial (OraGrowtH211)

Short name OraGrowtH211

NCTNCT05796440Other idLUM-201-02

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Enrolling by invitation
Phase: Phase 2
Enrollment: 60 participants (estimated)
Sponsor: Lumos Pharma · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 2 countries
United States, Australia
Start: 1 Aug 2023
Primary completion: Mar 2028 (estimated)
Completion: Apr 2028 (estimated)
First posted: 3 Apr 2023
Last update posted: 15 Feb 2024
Conditions: Growth Hormone Deficiency

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2023202420252026202720282029

Ph 2
OraGrowtH211
NCT05796440
1 Aug 2023 to est. Apr 2028

Registry summary

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

This is a multi-national trial. The trial aims to study the long-term safety of LUM-201 in subjects with Idiopathic Pediatric Growth Hormone Deficiency (iPGHD). This study will also assess pharmacodynamics and efficacy response to therapy with LUM-201.

Interventions

LUM-201Drug

Arms1

Experimental
LUM-201 (1.6 mg/kg/day)

Primary outcomes1

Outcomes the sponsor listed as primary.

Incidence of treatment-emergent adverse events
Time frame · Day 1 to Month 36
Registry description
Number of events

Secondary outcomes(6)

Growth Hormone Concentrations in subjects
Time frame · Day 1 to Month 36
Registry description
Serum GH concentration
Insulin-like growth factor 1 concentration
Time frame · Day 1 to Month 36
Registry description
Serum concentrations of insulin-like growth factor 1
Height standard deviation score (SDS)
Time frame · Day 1 to Month 36
Registry description
Change in HT-SDS
Change in Weight SDS
Time frame · Day 1 to Month 36
Registry description
Change in Weight
Annualized Height Velocity (AHV) achieved by daily dosing 1.6mg/kg of LUM-201
Time frame · Day 1 to Month 36
Registry description
(AHV) measured as standing height with stadiometer
Change in Bone Age (BA)
Time frame · Day 1 to Month 36
Registry description
Change in Bone Age (BA) compared to Chronological Age

Posted results

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

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

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 5 Years up to 14 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 successfully participated in a pediatric LUM-201 GHD study through at least the 12-month visit, and be eligible for continuation of treatment, pending all other enrollment criteria are met. Exclusion Criteria: * Medical or genetic condition that, in the opinion of the PI and/or MMs, adds unwarranted risk to the use of LUM-201 * 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. Subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the PI in consultation with the MMs.

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