Skip to content

Trial · Interventional

Active, not recruitingPhase 2Registry data

PK and PD Study of LUM-201 in Children With Idiopathic Growth Hormone Deficiency: (OraGrowtH212)

Short name OraGrowtH212

Overview

Status
Active, not recruiting
Phase
Phase 2
Enrollment
24 participants (estimated)
Sponsor
Lumos Pharma · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Chile

Start
14 Jul 2021
Primary completion
Apr 2030 (estimated)
Completion
Jul 2030 (estimated)
First posted
19 Mar 2021
Last update posted
4 Oct 2023
Conditions
Growth Hormone Deficiency

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222024202620282030
  1. Ph 2

    OraGrowtH212

    NCT04806854

    14 Jul 2021 to est. Jul 2030

Registry summary

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

The goals of this single site trial are to study the pharmacokinetics (PK) and pharmacodynamics of LUM-201 and effects of LUM-201 administration on growth hormone release over time in children with idiopathic pediatric growth hormone deficiency (PGHD).

Interventions

  • LUM-201Drug

Arms2

  • Experimental

    LUM-201 (1.6 mg/kg/day)

  • Experimental

    LUM-201 (3.2 mg/kg/day)

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Evaluation of Augmented Growth Hormone (GH) Pulsatility

    Time frame · Day 1 to Month 6

    Registry description

    12-hour mean GH concentration

  2. Pharmacokinetics of LUM-201 and M8

    Time frame · Day 1 to Month 6

    Registry description

    Plasma concentrations (Cmax/Steady State)

Secondary outcomes(2)
  1. Incidence of adverse events in children with idiopathic GHD

    Time frame · up to 8 years

    Registry description

    Number of events

  2. Height standard deviation score (SDS)

    Time frame · Day 1 to Month 12

    Registry description

    Change in HT-SDS from Baseline to Month 6 and Month 12

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 4 Years up to 9 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Have a chronological age ≥ 4.0 years and ≤ 10.0 years for girls and ≤ 12.0 years for boys. * Have a minimum body weight of 16 kg at the time of screening. * Have a bone age examination at screening or within the 6 months prior to screening that is delayed with respect to chronological age. Bone age should be based on the apparent BA of the proximal and distal phalanges, as opposed to the metacarpals, carpals and distal forearm. A central BA reader will make the final determination on BA eligibility. * Have HT-SDS ≤ -2.0 or a HT-SDS ≥ 2 SD below mean parental HT-SDS. If the other data (slow HV, low IGF-1, peak GH \< 10, and 6-month BA delay) are all consistent with idiopathic GHD, the subject may be enrolled with a height SDS \> -2.0 after consultation with the MMs. * Have an accurate baseline height velocity ≤ 5.5 cm/year based on at least 6-months of growth, if available * Within the past 6 months have a maximal GH response \> 3 and \< 10 ng/mL from at least one prior GH stimulation test within the past 6 months * Have prepubertal status as evidenced by Tanner Stage I breast development in girls and testicular volume \< 4.0 mL in boys. * Have an arm span to height ratio \> 96.5% * In girls, have genetic testing results to rule out Turner syndrome. If SHOX genetic testing results are available, they need to be negative. * Have normal thyroid function. Subjects diagnosed with hypothyroidism must have documented successful treatment for at least 30 days prior to the Baseline visit. Exclusion Criteria: * Any medical or genetic condition which, in the opinion of the PI or Medical Monitor (MM), can be an independent cause of short stature and/or limit the response to exogenous growth factor treatment (e.g., diabetes, , idiopathic short stature (ISS), SHOX-deficiency, skeletal dysplasia, constitutional growth delay, SGA, other). * A medical or genetic condition that, in the opinion of the PI and/or MM, adds unwarranted risk to use of LUM-201 (e.g., scoliosis). * Use of 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 (e.g., glucocorticoids). * Evidence or history of an intracranial mass (e.g., pituitary tumor, craniopharyngioma). * Prior treatment with growth factors including, but not limited to, GH, IGF-1, and GH secretagogues. (These may be used for limited times as a diagnostic test.) * Suspicion of absence of pituitary function as evidenced by a maximal stimulated GH ≤ 3 ng/mL or pituitary hormone deficiencies beyond GH and thyroid function or a diagnosis of Organic PGHD. * At birth, gestational age \< 36.0 weeks. * Participation in any therapeutic trial of investigational drug(s) within the prior 6 months. * History of spinal, cranial or total body irradiation. * Recent commencement of non-stimulant therapy to treat attention deficit hyperactivity disorder (ADHD).

PepBank is a research reference. Talk to a doctor before you use any peptide.