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A research study in children born small and who stayed small. Treatment is somapacitan once a week compared to Norditropin® once a day
EU CTIS ID: 2023-506830-66-00
What this study is testing
To evaluate the effect of somapacitan versus Norditropin® on longitudinal growth in children with short stature born SGA with no catch-up growth by 2 years of age or older
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Prepubertal children: a) Boys: o Age ≥ 2 years and 26 weeks and < 11.0 years at screening o Testis volume < 4 ml b) Girls: o Age ≥ 2 years and 26 weeks and <10.0 years at screening o Tanner stage 1 for breast development (no palpable glandular breast tissue)
- Born small for gestational age (birth length and/or weight < -2 standard deviation scores) (according to national standards).
- Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and gender at screening according to the standards of Centers for Disease Control and Prevention at screening.
- Impaired height velocity defined as annualised height velocity below the 50th 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.
- No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment.
You likely can't join if
- Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements.
- Children with hormonal deficiencies including suspected or confirmed growth hormone deficiency according to local practise.
- 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.
- 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.
- Diagnosis of attention deficit hyperactivity disorder.
See the full eligibility criteria
- Prepubertal children: a) Boys: o Age ≥ 2 years and 26 weeks and < 11.0 years at screening o Testis volume < 4 ml b) Girls: o Age ≥ 2 years and 26 weeks and <10.0 years at screening o Tanner stage 1 for breast development (no palpable glandular breast tissue)
- Born small for gestational age (birth length and/or weight < -2 standard deviation scores) (according to national standards).
- Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and gender at screening according to the standards of Centers for Disease Control and Prevention at screening.
- Impaired height velocity defined as annualised height velocity below the 50th 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.
- No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment.
- Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements.
- Children with hormonal deficiencies including suspected or confirmed growth hormone deficiency according to local practise.
- 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.
- 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.
- Diagnosis of attention deficit hyperactivity disorder.
- Prior history or presence of malignancy including intracranial tumours.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- India
- United States
- Japan
- Ukraine
- Thailand
- Israel
- United Kingdom
- Russian Federation
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; India; United States; Japan; Ukraine; Thailand and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.