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Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

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ClinicalTrials.gov Identifier: NCT02616562
Recruitment Status : Recruiting
First Posted : November 30, 2015
Last Update Posted : May 20, 2024
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 (somapacitan) treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency.

The trial consists of a 26 week main trial period, followed by a 26 week extension trial period, a 104 week safety extension period, a 208 week longterm safety extension trial period and a 30 day follow up period. Participants receive NNC0195-0092 (somapacitan) (0.04 mg/kg/week) during the main trial and the extension period and thereafter NNC0195-0092 (somapacitan) (0.16 mg/kg/week) during the safety extension and the long-term safety extension periods. Two additional age groups, cohort II (age below 2 years and 26 weeks at screening) and cohort III (above 9 years (girls)/ above 10 years (boys) and equal to or below 17 years at screening) are included in the 208 week long-term safety extension trial period only.


Condition or disease Intervention/treatment Phase
Growth Hormone Disorder Growth Hormone Deficiency in Children Drug: somapacitan Drug: Norditropin® FlexPro® pen Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Official Title: A Randomised, Multinational, Active-controlled, (Open-labelled), Dose Finding, (Double-blinded), Parallel Group Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency
Actual Study Start Date : March 23, 2016
Estimated Primary Completion Date : August 26, 2024
Estimated Study Completion Date : September 27, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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Arm Intervention/treatment
Experimental: Blinded NNC0195-0092 (somapacitan) (0.04 mg/kg/week)
Participants receive NNC0195-0092 (somapacitan) (0.04 mg/kg/week) during the main trial and the extension period and thereafter NNC0195-0092 (somapacitan) (0.16 mg/kg/week) during the safety extension and the long-term safety extension periods.
 Drug: somapacitan
Administered subcutaneously (s.c., under the skin) once-weekly.
Other Name: NNC0195-0092
Experimental: Blinded NNC0195-0092 (somapacitan) (0.08 mg/kg/week)
Participants receive NNC0195-0092 (somapacitan) (0.08 mg/kg/week) during the main trial and the extension period and thereafter NNC0195-0092 (somapacitan) (0.16 mg/kg/week) during the safety extension and the long-term safety extension periods.
 Drug: somapacitan
Administered subcutaneously (s.c., under the skin) once-weekly.
Other Name: NNC0195-0092
Experimental: Blinded NNC0195-0092 (somapacitan) (0.16 mg/kg/week)
Participants receive the same dose (0.16 mg/kg/week) of NNC0195-0092 (somapacitan) during all 4 trial periods.
 Drug: somapacitan
Administered subcutaneously (s.c., under the skin) once-weekly.
Other Name: NNC0195-0092
Active Comparator: Open labelled daily Norditropin® (0.034 mg/kg/day)
Participants receive Norditropin during the main trial, the extension period and the safety extension period and thereafter NNC0195-0092 (somapacitan) (0.16 mg/kg/week) during the long-term safety extension periods.
 Drug: somapacitan
Administered subcutaneously (s.c., under the skin) once-weekly.
Other Name: NNC0195-0092

Drug: Norditropin® FlexPro® pen
Administered subcutaneously (s.c., under the skin) once daily.


Outcome Measures
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Primary Outcome Measures :
  1. Cohort I: Height velocity (HV) during the first 26 weeks of treatment, measured as standing height with stadiometer [ Time Frame: Week 0-26 ]
    cm/year

  2. Cohort II and III: Incidence of adverse events, including injection site reactions, in children with GHD [ Time Frame: During 208 weeks ]
    Number of events


Secondary Outcome Measures :
  1. Change in height standard deviation score (SDS) [ Time Frame: Week 0-26 ]
    Typically -10 to +10

  2. Change in height standard deviation score (SDS) [ Time Frame: Week 0-52 ]
    Typically -10 to +10

  3. Change in height standard deviation score (SDS) [ Time Frame: Week 26-52 ]
    Typically -10 to +10

  4. Change in HV (height velocity) SDS [ Time Frame: Week 0-26 ]
    Typically -10 to +10. Baseline (week 0) HV SDS is derived from reported pre-trial standing height measured at minimum 6 months and maximum 18 months prior to screening visit to standing height at baseline (week 0)

  5. Change in HV (height velocity) SDS [ Time Frame: Week 0-52 ]
    Baseline (week 0) HV SDS is derived from reported pre-trial standing height measured at minimum 6 months and maximum 18 months prior to screening visit to standing height at baseline (week 0)

  6. Insulin-like growth factor 1 (IGF-I) SDS [ Time Frame: Week 0-26 ]
    Typically -10 to +10

  7. Insulin-like growth factor 1 (IGF-I) SDS [ Time Frame: Week 0-52 ]
    Typically -10 to +10

  8. Insulin-like growth factor 1 (IGF-I) SDS [ Time Frame: Week 26-52 ]
    Typically -10 to +10

  9. Insulin-like growth factor binding protein 3 (IGFBP-3) SDS [ Time Frame: Week 0-26 ]
    Typically -10 to +10

  10. Insulin-like growth factor binding protein 3 (IGFBP-3) SDS [ Time Frame: Week 0-52 ]
    Typically -10 to +10

  11. Insulin-like growth factor binding protein 3 (IGFBP-3) SDS [ Time Frame: Week 26-52 ]
    Typically -10 to +10

  12. Height velocity [ Time Frame: Week 52 ]
    cm/year, derived from standing height from baseline (week 0) to week 52

  13. Bone age [ Time Frame: Week 52 ]
    X-Ray of left hand and wrist, central assessed according to Greulich & Pyle atlas progression vs. chronological age

  14. Serum NNC0195-0092 (somapacitan) concentrations [ Time Frame: Week 52 ]
    ng/mL

  15. Changes in emotional well-being score, physical health score, social well-being score and total score in Treatment Related Impact Measure - Child Growth Hormone Deficiency- Observer (TRIM-CGHD-O) [ Time Frame: Week 0-26 ]
    The scores range from 0-100. A lower score indicates a better health state.

  16. Changes in emotional well-being score, physical health score, social well-being score and total score in Treatment Related Impact Measure - Child Growth Hormone Deficiency- Observer (TRIM-CGHD-O) [ Time Frame: Week 0-52 ]
    The scores range from 0-100. A lower score indicates a better health state.

  17. Total score of The Treatment Burden Measure - Child Growth Hormone Deficiency - Observer (TB-CGHD-O) [ Time Frame: Week 26 ]
    The scores range from 0-100. A lower score indicates a better health state.

  18. Total score of The Treatment Burden Measure - Child Growth Hormone Deficiency - Observer (TB-CGHD-O) [ Time Frame: Week 52 ]
    The scores range from 0-100. A lower score indicates a better health state.

  19. Total score of The Treatment Burden Measure - Child Growth Hormone Deficiency - Parent/Guardian (TB-CGHD-P) [ Time Frame: Week 26 ]
    The scores range from 0-100. A lower score indicates a better health state.

  20. Total score of The Treatment Burden Measure - Child Growth Hormone Deficiency - Parent/Guardian (TB-CGHD-P) [ Time Frame: Week 52 ]
    The scores range from 0-100. A lower score indicates a better health state.

  21. Incidence of adverse events, including injection site reactions [ Time Frame: Week 364 ]
    Number of events

  22. Occurrence of anti-NNC0195-0092 (somapacitan) antibodies [ Time Frame: Week 364 ]
    Yes/no

  23. Occurrence of anti-hGH antibodies [ Time Frame: Week 364 ]
    Yes/no


Eligibility Criteria
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Ages Eligible for Study:   30 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Cohort I:

  • Boys: Tanner stage 1 for pubic hair and testis volume below 4 ml , age at least 2 years and 26 weeks and below or equal to 10.0 years at screening
  • Girls: Tanner stage 1 for breast development (no palpable glandular breast tissue) and pubic hair, age at least 2 years and 26 weeks and below or equal to 9.0 years at screening
  • Confirmed diagnosis of GHD (growth hormone deficiency) within 12 months prior to screening as determined by two different GH (growth hormone) stimulation tests, defined as a peak GH level of below or equal to 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test is needed
  • No prior exposure to GH therapy and/or IGF-I (insulin-like growth factor I) treatment
  • Height of at least 2.0 standard deviations below the mean height for chronological age (CA) and gender according to the standards of Centers for Disease Control and Prevention 2-20 years: Girls/Boys stature-for-age and weight-for-age percentiles CDC at screening
  • Annualized height velocity (HV) below the 25th percentile for CA (chronological age) and gender or below -0.7 SD (standard deviation) score for CA and sex, according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months

Cohort II:

  • Below 2 years and 26 weeks and a minimum weight of 5 kg at screening.
  • Confirmed diagnosis of GHD, the GHD diagnosis must be confirmed by investigator according to local practice.
  • For GH treatment naïve subjects, no prior exposure to GH therapy and/or IGF-I treatment.
  • For GH treatment naïve subjects, IGF-1 SDS below -1.0 at screening, compared to age and sex normalized range according to central laboratory measurements.

Cohort III:

Age:

  • Girls: Above 9.0 years and below or equal to 17.0 years at screening.
  • Boys: Above 10.0 years and below or equal to 17.0 years at screening.

  • Confirmed diagnosis of GHD

    1. for GH treatment naïve subjects, confirmed diagnosis within 12 months prior to screening as determined by two different GH stimulation tests, defined as a peak GH level of equal to or below 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test is needed. FOR JAPAN ONLY: Confirmed diagnosis of GHD within 12 months prior to screening as determined by one GH stimulation tests for patients with intracranial organic disease or symptomatic hypoglycaemia and two different GH stimulation test for other patients, defined as a peak GH level of equal to or below 6 ng/ml by assay using recombinant GH standard.
    2. for non-GH treatment naïve subjects, confirmed GHD diagnosis by investigator according to local practice
  • For GH treatment naïve subjects, no prior exposure to GH therapy and/or IGF-I treatment.
  • Open epiphyses; defined as bone age below 14 years for females and bone age below 16 years for males.

Exclusion Criteria:

  • Any clinically significant abnormality likely to affect growth or the ability to evaluate
  • growth with standing/length measurements: Chromosomal aneuploidy and significant gene mutations causing medical "syndromes" with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, or absence of GH receptors. Congenital abnormalities (causing skeletal abnormalities), including but not limited to Russell-Silver Syndrome, skeletal dysplasias. Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants
  • Children born small for gestational age (SGA - birth weight and/or birth length below-2 SD for gestational age)
  • Concomitant administration of other treatments that may have an effect on growth, including but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD)
  • Prior history or presence of malignancy and/or intracranial tumour
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616562


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02616562    
Other Study ID Numbers: NN8640-4172
2015-000531-32 ( EudraCT Number )
U1111-1166-7062 ( Other Identifier: WHO )
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: May 20, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
 Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases