BridgeMD
A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to grow
EU CTIS ID: 2023-506927-27-00
What this study is testing
To confirm non-inferiority of once-weekly somapacitan compared with once-daily Norditropin® in terms of longitudinal growth measured by height velocity at week 52 in children with each of the four indications: SGA, TS, NS or ISS.
- Therapeutic confirmatory (Phase III)
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
- No prior exposure to growth promoting therapy, including but not limited to growth hormone, IGF-I and ghrelin analogues.
- Applicable to children with SGA: Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards). Japan: Please see local requirements in Appendix 11 (Section 10.11).
- Applicable to children with SGA: Prebubertal Children: a) Boys: - Age above er equal to 2 years and 26 weeks and below 11.0 years at screening. - Testis volume below 4 mL b) Girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. Tanner stage 1 for breast development: No palpable glandular breast tissue
- Applicable to girls with TS: Confirmed diagnosis of TS: CCI United Kingdom: Please see local requirements in Appendix 11 (Section 10.11).
- Applicable to girls with TS: Prepubertal girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. - Tanner stage 1 for breast development: No palpable glandular breast tissue)
- Applicable to children with NS: Clinical diagnosis of NS according to van der Burgt score list (See Table 7) Japan: Please see local requirements in Appendix 11 (Section 10.11).
You likely can't join if
- Children with suspected or confirmed growth hormone deficiency according to local practice.
- Children diagnosed with diabetes mellitus or screening values from the central laboratory of a. fasting plasma glucose above or equal to 126 mg/dL (7.0 mmol/L) or b. HbA1c above or equal to 6.5%.
- Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
See the full eligibility criteria
- No prior exposure to growth promoting therapy, including but not limited to growth hormone, IGF-I and ghrelin analogues.
- Applicable to children with SGA: Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards). Japan: Please see local requirements in Appendix 11 (Section 10.11).
- Applicable to children with SGA: Prebubertal Children: a) Boys: - Age above er equal to 2 years and 26 weeks and below 11.0 years at screening. - Testis volume below 4 mL b) Girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. Tanner stage 1 for breast development: No palpable glandular breast tissue
- Applicable to girls with TS: Confirmed diagnosis of TS: CCI United Kingdom: Please see local requirements in Appendix 11 (Section 10.11).
- Applicable to girls with TS: Prepubertal girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. - Tanner stage 1 for breast development: No palpable glandular breast tissue)
- Applicable to children with NS: Clinical diagnosis of NS according to van der Burgt score list (See Table 7) Japan: Please see local requirements in Appendix 11 (Section 10.11).
- Applicable to children with NS: Prepubertal children: a) Boys: - Age above or equal to 2 years and 26 weeks and below 11.0 years at screening. - Testis volume below 4mL b) Girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. -Tanner stage 1 for breast development: No palpable glandular breast tissue
- Applicable to children with ISS: Prepubertal children: a) Boys: - Age above or equal to 2 years and 26 weeks and below 11.0 years at screening. - Testis volume below 4mL b) Girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. -Tanner stage 1 for breast development: No palpable glandular breast tissue
- Applicable to children with ISS: Bone age: a) Boys: - Bone age below or equal to 12 years. - Bone age not delayed or advanced mor than 2 years compared to chronological age. b) Girls: - Bone age below or equal to 11 years - Bone age not delayed or advanced more than 2 years compared to chronological age.
- Children with suspected or confirmed growth hormone deficiency according to local practice.
- Children diagnosed with diabetes mellitus or screening values from the central laboratory of a. fasting plasma glucose above or equal to 126 mg/dL (7.0 mmol/L) or b. HbA1c above or equal to 6.5%.
- Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- United Kingdom
- China
- Serbia
- Canada
- Japan
- India
- Saudi Arabia
- Brazil
- Switzerland
- Israel
- South Africa
- Korea, Republic of
- Mexico
- Malaysia
- United States
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 Thailand; United Kingdom; China; Serbia; Canada; Japan and 10 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.