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The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature

ConditionTurner Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age2-12
SponsorXiamen Amoytop Biotech Co., Ltd.

About this trial

This is a multicenter, randomized, open-label, positive-controlled phase III confirmatory clinical study. A total of 84 children with short stature due to Turner Syndrome (TS) are planned to be enrolled. Stratified by age and karyotype, subjects will be randomized at a 1:1 ratio to either the test group or the positive control group with continuous treatment for 52 weeks. The study aims to compare the efficacy and safety of Inpegsomatropin-Injection versus Givopegsomatropin Solution Injection in children with TS-related short stature, so as to provide evidence for the new indication application of the investigational drug.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Prepubertal girls at Tanner stage I, with age ≥ 2 years and < 12 years at the time of informed consent signature.

With clinical manifestations of Turner syndrome and a confirmed diagnosis of Turner syndrome based on peripheral blood karyotype analysis (karyotype analysis of at least 30 metaphase cells).

At screening, bone age is delayed relative to chronological age or advanced by no more than 1 year (i.e., bone age - chronological age ≤ 1 year).

At screening, height is below -2 standard deviations (-2SD) of the mean for age and gender; height reference is shown in Appendix 1.

Disqualifiers

Subjects with closed epiphyses.

Patients with Turner syndrome carrying Y chromosome or Y-chromosome-derived fragments and without gonadectomy.

Other types of growth and development abnormalities, including but not limited to growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, and growth retardation caused by malnutrition.

Participation in any other clinical trial within 3 months prior to screening with pharmacological or non-pharmacological intervention received.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inpegsomatropin-Injection

    Drug

    Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.

  • Givopegsomatropin Solution Injection

    Drug

    Givopegsomatropin Solution Injection, 200 μg/kg/week, s.c., once weekly, for 52 weeks.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Inpegsomatropin Injection GroupExperimental treatment 1 intervention
Group B: Givopegsomatropin Solution Injection GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Growth velocity (HV, cm/year).

Time frame
Week 52

Secondary outcomes

1

Change in height standard deviation score from baseline (△HT SDS)

Time frame
From baseline to all follow-up time points at Week 52
2

Change in height velocity from baseline (△HV)

Time frame
From baseline to all follow-up time points at Week 52
3

Change in insulin-like growth factor 1 standard deviation score from baseline (△IGF-1 SDS)

Time frame
From baseline to all follow-up time points at Week 52
4

Ratio of change in bone age from baseline to change in chronological age from baseline (△BA/△CA)

Time frame
Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiamen Amoytop Biotech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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