Growth Hormone DeficiencyPhase 2OraGrowtH211NCT05796440
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)
A Phase 2 study testing LUM-201 in people with Growth Hormone Deficiency, run by Lumos Pharma at 7 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- LUM-201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 1 Aug 2023to Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
United States6 sites
Texas Tech University Health Sciences Center
Amarillo, Texas, 79106
University of South Carolina
Charleston, South Carolina, 29425
University of Iowa
Iowa City, Iowa, 52242
Children's Mercy Hospital
Kansas City, Missouri, 64111
Seattle Children's Hospital
Seattle, Washington, 98105
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
Australia1 site
Canberra Hospital
Garran, Australian Capital Territory, 2605
About this study
Official title: An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children With Idiopathic Growth Hormone Deficiency
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.
Read the detailed description
An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children with Idiopathic Growth Hormone Deficiency. This study will last for up to 36 months to allow collection of additional long-term safety and efficacy data related to LUM-201 treatment in the pediatric patient population. Subjects will enter into this trial after successful participation in a prior LUM-201 study. This study will consist of visits every 6 months through three years.
There are a total of 7 in-person visits with a follow-up phone call between visits. At the clinic visits, subjects will have a physical exam and blood collection as well as efficacy assessments.
- Conditions
- Growth Hormone Deficiency
- Being tested
- LUM-201
- Keywords
- LUM-201, PGHD, GHD, Growth hormone secretagogue, Oral, Height
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUM-201Drug
Administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| LUM-201 (1.6 mg/kg/day) | Experimental | Not described Receives: Drug: LUM-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Number of events
Measured: Day 1 to Month 36
Secondary outcomes (6)
Growth Hormone Concentrations in subjects
Serum GH concentration
Measured: Day 1 to Month 36
Insulin-like growth factor 1 concentration
Serum concentrations of insulin-like growth factor 1
Measured: Day 1 to Month 36
Height standard deviation score (SDS)
Change in HT-SDS
Measured: Day 1 to Month 36
Change in Weight SDS
Change in Weight
Measured: Day 1 to Month 36
Annualized Height Velocity (AHV) achieved by daily dosing 1.6mg/kg of LUM-201
(AHV) measured as standing height with stadiometer
Measured: Day 1 to Month 36
Change in Bone Age (BA)
Change in Bone Age (BA) compared to Chronological Age
Measured: Day 1 to Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Aug 2023
- Primary completionMar 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumos Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796440
- Sponsor's protocol ID
- LUM-201-02
- Acronym
- OraGrowtH211
- Status last verified
- Feb 2024
- First submitted
- 19 Mar 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children With Idiopathic Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT05796440
- Acronym / sponsor ID
- OraGrowtH211 / LUM-201-02
- Conditions
- Growth Hormone Deficiency
- Keywords
- LUM-201, PGHD, GHD, Growth hormone secretagogue, Oral, Height
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lumos PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children with Idiopathic Growth Hormone Deficiency. This study will last for up to 36 months to allow collection of additional long-term safety and efficacy data related to LUM-201 treatment in the pediatric patient population. Subjects will enter into this trial after successful participation in a prior LUM-201 study. This study will consist of visits every 6 months through three years.
There are a total of 7 in-person visits with a follow-up phone call between visits. At the clinic visits, subjects will have a physical exam and blood collection as well as efficacy assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| LUM-201 (1.6 mg/kg/day) | Experimental | Drug: LUM-201 |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUM-201Administered orally once daily | Drug | LUM-201 (1.6 mg/kg/day) |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: Day 1 to Month 36
Number of events
6 secondary outcomes
Growth Hormone Concentrations in subjects
Time frame: Day 1 to Month 36
Insulin-like growth factor 1 concentration
Time frame: Day 1 to Month 36
Height standard deviation score (SDS)
Time frame: Day 1 to Month 36
Change in Weight SDS
Time frame: Day 1 to Month 36
Annualized Height Velocity (AHV) achieved by daily dosing 1.6mg/kg of LUM-201
Time frame: Day 1 to Month 36
Change in Bone Age (BA)
Time frame: Day 1 to Month 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LUM-201 in people with Growth Hormone Deficiency, run by Lumos Pharma at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: Day 1 to Month 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.