A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day

• Register: EUCTR
• Last refreshed on: 21 August 2023
• Main ID: EUCTR2018-000231-27-AT
• Date of registration: 02/04/2019
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day
• Scientific title: A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4
• Date of first enrolment: 22/05/2019
• Target sample size: 192
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-000231-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Canada, Denmark, Estonia, European Union, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Norway, Poland, Russian Federation, Serbia, Slovenia, Spain, Switzerland, Thailand, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Transparency (1452)
• Affiliation: Novo Nordisk A/S

• Name: Clinical Transparency (1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion criteria:
- Prepubertal children:
- Boys:
- Age greater than or equal to 2 years and 26 weeks and less than 11.0 years at screening
- Testis volume less than 4 mL
- Girls:
- Age greater 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 Standard Deviation Score at screening, compared to age and gender normalized range measured at central laboratory
- No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I treatment
Are the trial subjects under 18? yes
Number of subjects for this age range: 192
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Growth hormone deficiency in children
MedDRA version: 20.0 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Intervention(s)

Product Name: somapacitan 5 mg/1.5ml PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: somapacitan
CAS Number: 1338578-34-9
Other descriptive name: SOMAPACITAN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 3.3-

Product Name: somapacitan 10 mg/1.5ml PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: somapacitan
CAS Number: 1338578-34-9
Other descriptive name: SOMAPACITAN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.7-

Product Name: somapacitan 15 mg/1.5ml PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: somapacitan
CAS Number: 1338578-34-9
Other descriptive name: SOMAPACITAN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: Norditropin FlexPro 10 mg/1.5 ml
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
CAS Number: 12629-01-5
Other descriptive name: SOMATROPIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.7-

Primary Outcome(s)

Main Objective: To compare the effect of somapacitan vs Norditropin® on longitudinal growth in children with
growth hormone deficiency.

Timepoint(s) of evaluation of this end point: From baseline (week 0) to visit 7 (week 52)

Primary end point(s): Height velocity

Secondary Objective: To compare the safety of somapacitan vs Norditropin® in children with growth hormone deficiency.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1: From screening (week -2) to visit 7 (week 52)
2 & 3: From baseline (week 0) to visit 7 (week 52)
4-6: From screening (week -2) to visit 7 (week 52); from screening (week -2) to visit 11 (week 104); from screening (week -2) to visit 15 (week 156); from screening (week -2) to visit 19 (week 208)
7 & 8: From baseline (week 0) to visit 7 (week 52); from baseline (week 0) to visit 11 (week 104); from baseline (week 0) to visit 15 (week 156); from baseline (week 0) to visit 19 (week 208)

Secondary end point(s): 1. Change in bone age
2. Change in Height Standard Deviation Score
3. Change in Height Velocity Standard Deviation Score
4. Change in fasting plasma glucose
5. Change in homeostatic model assessment
6. Change in Glycated haemoglobin (HbA1c)
7. Change in Insulin-like growth factor I (IGF-I) Standard Deviation
Score
8. Change in Insulin-like growth factor binding protein 3 (IGFBP-3)
Standard Deviation Score

Secondary ID(s)

2018-000231-27-DE

NN8640-4263

Source(s) of Monetary Support

Novo Nordisk A/S

Ethics review

Status: Approved
Approval date: 20/05/2019
Contact: