This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection，once a week，compared with recombinant human growth hormone (rhGH) in children with idiopathic short stature (ISS). It plans to enroll 300 children with ISS, who will be randomized , stratified by gender and age, and assigned to either the experimental group or the positive controlled group. Each participant will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). And the safety and efficacy will be evaluated.
Prepubertal children: boys aged ≥3 years and <11 years at screening with testicular volume <4 mL; girls aged ≥3 years and <10 years at screening with breast development at Tanner Stage I, i.e., no palpable breast glandular tissue.
Compared to chronological age, bone age is advanced by no more than 1 year or delayed by no more than 2 years (i.e., -2 years ≤ bone age - chronological age ≤ 1 year).
Height at screening is below -2 standard deviations (SD) from the mean for age and sex, with height reference to Appendix 1.
Body mass index (BMI) is within the 5th to 95th percentile for age and sex of healthy children, with reference to Appendix 2.
Individuals with closed epiphyses;
Other types of growth and developmental abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, small for gestational age, short stature due to SHOX gene abnormalities, growth delay due to malnutrition, growth delay due to hypothyroidism, and other short statures with a clear etiology; genetic testing results must be obtained before randomization to exclude short stature caused by definite genetic abnormalities;
Individuals who have participated in any other clinical trial within 3 months prior to screening and have received pharmacological or non-pharmacological interventions;
Individuals who received inhaled corticosteroids for more than 2 consecutive weeks, or oral or intravenous corticosteroids for more than 1 consecutive week, within the 3 months prior to screening;
Parallel
Inpegsomatropin Injection
DrugInpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 consecutive weeks.
Recombinant Human Growth Hormone Injection
DrugRecombinant Human Growth Hormone Injection, 350 μg/kg/week, s.c., divided into 7 doses, i.e., 50 μg/kg/day (0.15 IU/kg/day), once daily for 52 consecutive weeks.
Growth velocity (HV, cm/year).
Change in height standard deviation score from baseline (△HT SDS)
Change in growth velocity from baseline (△HV)
Change in insulin-like growth factor 1 standard deviation score from baseline (△IGF-1 SDS)
The ratio of the change in bone age to the change in chronological age (△BA/△CA)
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Xiamen Amoytop Biotech Co., Ltd.
Lead sponsor
Tongji Hospital
Collaborator
