Status
Completed
Phase
Phase 3
Enrollment
200
Locations
135
Results
Posted
Publications
4
Study summary
The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.
Interventions
DRUG
Somapacitan will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.
DRUG
Norditropin® will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.
Timeline
First posted
Jan 22, 2019
Study start
May 20, 2019
Primary completion
Nov 10, 2021
Study completion
Sep 30, 2025
Results posted
Aug 4, 2023
Registry updated
May 22, 2026
Outcomes
Height Velocity: In-trial Observation Period
Time frame · From baseline (week 0) to visit 7 (week 52)
Height velocity (HV) was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.
Height Velocity: On-treatment Observation Period
Time frame · From baseline (week 0) to visit 7 (week 52)
Height velocity was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 or 14 days after last administration, whichever comes first.
Change in Bone Age
Time frame · Baseline (week -2), week 52
Change from baseline (week -2) in bone age at week 52 is presented. X-ray images of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.
Change in Height Standard Deviation Score (HSDS)
Time frame · Baseline (week 0), week 52
Change from baseline (week 0) in HSDS at week 52 is presented. HSDS was derived using Centre for Disease Control and Prevention (CDC) standards. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.
Change in Height Velocity Standard Deviation Score (HV SDS)
Time frame · Baseline (week 0), week 52
Change from baseline (week 0) in HV SDS at week 52 is presented. HV SDS was calculated using the formula: HV SDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HV SDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender. Positive value in change from baseline in HV SDS indicated that HV SDS was better than baseline HV SDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.
Change in Fasting Plasma Glucose (FPG) at Week 52
Time frame · Baseline (week -2), week 52
Change from baseline (week -2) in FPG at week 52 is presented.
Change in FPG at Week 104
Time frame · Baseline (week -2), week 104
Change in FPG at Week 156
Time frame · Baseline (week -2), week 156
Change in FPG at Week 208
Time frame · Baseline (week -2), week 208
Change in Homeostatic Model Assessment Steady State Beta Cell Function (HOMA-B) at Week 52
Time frame · Baseline (week -2), week 52
Change from baseline (week -2) in HOMA-B at week 52 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 \* fasting insulin (picomoles per liter \[pmol/L\]) \* 1/6(microunit per milliliter \[µU/mL\]))/ FPG(mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.
Change in HOMA-B at Week 104
Time frame · Baseline (week -2), week 104
Change in HOMA-B at Week 156
Time frame · Baseline (week -2), week 156
Eligibility
Inclusion Criteria: * Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less than 11.0 years at screening. Testis volume less than 4 ml. b) Girls: Age more than or equal to 2 years and 26 weeks and less than 10.0 years at screening. Tanner stage 1 for breast development (no palpable glandular breast tissue) * Confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of less than or equal to 10.0 ng/ml using the World Health Organisation (WHO) International Somatropin 98/574 standard * Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of Center for Disease Control and Prevention * Impaired height velocity, defined as annualised height velocity below the 25th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening * Insulin-like Growth Factor-I (IGF-I) less than -1.0 SDS at screening, compared to age and gender normalized range measured at central laboratory * No prior exposure to growth hormone therapy or IGF-I treatment Exclusion Criteria: * Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements * Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening * Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 μg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening * Diagnosis of attention deficit hyperactivity disorder * Concomitant administration of other treatments that may have an effect on growth, e.g. but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder * Prior history or presence of malignancy including intracranial tumours
Study locations
Algeria · Austria · Canada · Denmark · Estonia · France · Germany · Hungary · India · Ireland · Israel · Italy · Japan · Latvia · Norway · Poland · Russia · Serbia · Slovenia · South Korea · Spain · Switzerland · Thailand · Ukraine · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Univ of AL at Birmingham_BRM
Birmingham, Alabama, United States
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Children's Hosp Of Orange
Orange, California, United States
Sutter Valley Med Fdt Ped Endo
Sacramento, California, United States
Rocky Mt Ped and Endo
Centennial, Colorado, United States
Ped Endo Assoc PC-G.V
Greenwood Village, Colorado, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
A.I. duPont Hospital for Children/Nemours
Wilmington, Delaware, United States
Pediatric Endocrine & Wellness Center
Aventura, Florida, United States
Van Meter Pediatric Endo PC
Atlanta, Georgia, United States
Riley Hospital For Children
Indianapolis, Indiana, United States
University OF Iowa
Iowa City, Iowa, United States
Univ of Minnesota M.C.H.
Minneapolis, Minnesota, United States
Children's Minnesota
Saint Paul, Minnesota, United States
Children's Mercy Clinics
Kansas City, Missouri, United States
The Docs
Las Vegas, Nevada, United States
Goryeb Children's Hospital
Morristown, New Jersey, United States
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, United States
NYU Langone Hospital-LI
Mineola, New York, United States
WakeMed Childn Endo-Dbt_Raleig
Raleigh, North Carolina, United States
CCHMC_Cinc
Cincinnati, Ohio, United States
Univ Oklahoma Sci Ctr OK City
Oklahoma City, Oklahoma, United States
UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, United States
Publications
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