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History of Changes for Study: NCT04614337
Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial) (OraGrowtH210)
Latest version (submitted February 18, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 2, 2020 None (earliest Version on record)
2 December 2, 2020 Study Status and Contacts/Locations
3 December 7, 2020 Contacts/Locations and Study Status
4 December 17, 2020 Contacts/Locations and Study Status
5 December 18, 2020 Contacts/Locations and Study Status
6 December 22, 2020 Contacts/Locations and Study Status
7 January 25, 2021 Contacts/Locations and Study Status
8 February 11, 2021 Study Status, Contacts/Locations and Eligibility
9 March 8, 2021 Contacts/Locations, Study Status and Eligibility
10 March 24, 2021 Contacts/Locations and Study Status
11 April 6, 2021 Contacts/Locations and Study Status
12 April 14, 2021 Contacts/Locations and Study Status
13 April 22, 2021 Contacts/Locations and Study Status
14 May 3, 2021 Contacts/Locations and Study Status
15 May 4, 2021 Contacts/Locations and Study Status
16 June 1, 2021 Study Status and Contacts/Locations
17 June 2, 2021 Eligibility, Arms and Interventions, Contacts/Locations, Outcome Measures and Study Status
18 July 7, 2021 Study Status and Contacts/Locations
19 August 3, 2021 Study Status and Contacts/Locations
20 September 23, 2021 Contacts/Locations, Study Status, Outcome Measures, Study Description and Study Identification
21 October 21, 2021 Study Status, Eligibility and Study Description
22 November 4, 2021 Study Status and Contacts/Locations
23 January 27, 2022 Study Status and Contacts/Locations
24 February 28, 2022 Contacts/Locations and Study Status
25 March 9, 2022 Study Status and Contacts/Locations
26 March 17, 2022 Contacts/Locations and Study Status
27 March 24, 2022 Contacts/Locations and Study Status
28 April 5, 2022 Contacts/Locations and Study Status
29 April 11, 2022 Contacts/Locations and Study Status
30 June 7, 2022 Contacts/Locations, Outcome Measures, Study Status, Eligibility, Study Description and Study Identification
31 August 31, 2022 Contacts/Locations and Study Status
32 October 5, 2022 Contacts/Locations and Study Status
33 January 30, 2023 Contacts/Locations and Study Status
34 March 13, 2023 Recruitment Status, Contacts/Locations and Study Status
35 May 24, 2023 Study Status
36 August 31, 2023 Study Status and Conditions
37 October 3, 2023 Study Status
38 November 2, 2023 Study Status
39 February 18, 2024 Study Status
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Study NCT04614337
Submitted Date:  November 2, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: LUM-201-01
Brief Title: Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial) (OraGrowtH210)
Official Title: A Multicenter, 6-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2b Study of Daily Oral LUM-201 in Naïve to Treatment, Prepubertal Children With Growth Hormone Deficiency (GHD)
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2020
Overall Status: Recruiting
Study Start: October 7, 2020
Primary Completion: December 2021 [Anticipated]
Study Completion: March 2022 [Anticipated]
First Submitted: October 26, 2020
First Submitted that
Met QC Criteria:
November 2, 2020
First Posted: November 4, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
November 2, 2020
Last Update Posted: November 4, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Lumos Pharma
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects likely to respond to therapy with LUM-201.
Detailed Description:

This trial will have two screening visits over about a month with tests to assess if subjects are eligible to start study therapy. Once subjects have completed screening, and if they are determined to be eligible, they will be randomized to receive one of three oral daily doses of LUM-201 or daily injections of recombinant human growth hormone (rhGH). All subjects will have an equal chance of being placed in any of the four groups.

The trial consists of 6 months of treatment. After screening, subjects will return to clinic for 5 visits. At each clinic visit subjects will have a physical exam, blood and urine collections. There will also be 3 phone calls with study staff that will take place between the clinic visits.

Open or close this module Conditions
Conditions: Growth Hormone Deficiency
Keywords: GHD
PGHD
LUM-201
Growth hormone secretagogue
Height
Catch-up growth
PEM
Oral
Predictive Enrichment Marker
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 80 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: LUM-201 (0.8 mg/kg/day) Drug: LUM-201
Administered orally once daily
Experimental: LUM-201 (1.6 mg/kg/day) Drug: LUM-201
Administered orally once daily
Experimental: LUM-201 (3.2 mg/kg/day) Drug: LUM-201
Administered orally once daily
Active Comparator: rhGH (34 µg/kg/day) Drug: rhGH Norditropin® FlexPro® pen (34 µg/kg)
Administered subcutaneously (s.c., under the skin) once daily.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of subjects selected by PEM strategy who meet target growth
[ Time Frame: Day 1 to Month 6 ]

Annualized height velocity (AHV) measured as standing height with stadiometer
Secondary Outcome Measures:
1. Comparison of 6-month, AHVs achieved by daily rhGH and three dose levels of LUM-201
[ Time Frame: Day 1 to Month 6 ]

6-month Annualized Height Velocity (AHV) measured as standing height with stadiometer
2. Degree of concordance between the first and second assessment with the PEM strategy.
[ Time Frame: Screening to Day 1 ]

Peak serum concentration of GH in response to a single provocative dose of LUM-201
3. Incidence of adverse events in children with GHD
[ Time Frame: Day 1 to Month 6 ]

Number of events
4. Height standard deviation score (SDS)
[ Time Frame: Day 1 to Month 6 ]

Change in HT-SDS from Baseline to Month 6
5. Change in Weight
[ Time Frame: Day 1 to Month 6 ]

Change in Weight from Baseline to Month 6
6. Change in Weight SDS
[ Time Frame: Day 1 to Month 6 ]

Change in Weight-SDS from Baseline to Month 6
7. Change in BMI
[ Time Frame: Day 1 to Month 6 ]

Change in BMI from Baseline to Month 6
8. Change in BMI SDS
[ Time Frame: Day 1 to Month 6 ]

Change in BMI SDS from Baseline to Month 6
9. Bone Age
[ Time Frame: Day 1 to Month 6 ]

Change in bone age, measured by X-ray of left hand and wrist using Greulich & Pyle atlas
10. Pharmacokinetics of LUM-201
[ Time Frame: Day 1 to Month 6 ]

Serum concentrations (Cmax/Steady State)
11. GH Concentration on maintenance treatment
[ Time Frame: Day 1 to Month 6 ]

Serum GH concentration
12. Insulin-like growth factor 1
[ Time Frame: Day 1 to Month 6 ]

Serum concentrations of insulin-like growth factor 1
Open or close this module Eligibility
Minimum Age: 3 Years
Maximum Age: 10 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Have an established diagnosis of PGHD as determined by standard diagnostic criteria. Eligible subjects must be naïve-to-treatment and be prepubertal.
  • Peak cortisol > 20 µg/dL on a glucagon, ACTH or insulin test.
  • At Screening, be ≥ 3.0 years and < 10.0 years for girls and < 11.0 years for boys.
  • Have HT-SDS < -2.0.
  • Have a bone age examination at Screening or within the 6 months prior to Screening that, in the interpretation of the Investigator, is delayed with respect to chronological age.
  • Have prepubertal status as evidenced by Tanner Stage I breast development in girls and testicular volume < 4.0 mL in boys.
  • 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 Day 1.

Exclusion Criteria:

  • Any medical or genetic condition which, in the opinion of the Investigator or Medical Monitor (MM), can be an independent cause of short stature and/or limit the response to exogenous growth factor treatment. (Examples: diabetes, named syndromes).
  • A medical or genetic condition that, in the opinion of the Investigator and/or MM, adds unwarranted risk to use of LUM-201 or rhGH.
  • Use of any medication that, in the opinion of the Investigator and/or MM, can independently cause short stature or limit the response to exogenous growth factors (Example: glucocorticoids).
  • Evidence or history of an intracranial mass (e.g., pituitary tumor, craniopharyngioma).
  • Suspicion of absent pituitary function as evidenced by a maximal stimulated GH ≤ 3 ng/mL or pituitary deficiencies beyond GH and thyroid function.
  • Malnutrition as evidenced by medical history or a body weight < 5th percentile for current height.
  • BMI > 95th percentile.
  • Gestational age-adjusted birth weight < 5th percentile (small for gestational age).
  • History of spinal, cranial, or total body irradiation.
  • A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) and/or use of medications to treat ADHD.
Open or close this module Contacts/Locations
Central Contact Person: Lumos Pharma
Telephone: 515-598-2921
Email: clinical.trials@lumos-pharma.com
Locations: United States, California
Center of Excellence in Diabetes and Endocrinology
[Recruiting]
Sacramento, California, United States, 95821
Contact:Contact: Mila Melnik 916-570-2750 cedelead@yahoo.com
Contact:Principal Investigator: Gnanagurudasan Prakasam, M.D.
United States, Georgia
Van Meter Pediatric Endocrinology, P.C.
[Recruiting]
Atlanta, Georgia, United States, 30318
Contact:Contact: Mary Bertossi 678-961-2100 mbertossi@pediatricendo.com
Contact:Principal Investigator: Quentin Van Meter, M.D.
United States, Texas
Diabetes & Glandular Disease Clinic, P.A.
[Recruiting]
San Antonio, Texas, United States, 78229
Contact:Contact: Benilde Perez 210-614-8612 Ext. 1574 benilde.perez@dgdclinic.com
Contact:Principal Investigator: Mark Kipnes, M.D.
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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