A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin (GenSci004) in Treatment Naive Children With Growth Hormone Deficiency

NCT06007417 — Phase 3, Unknown, 162 participants, Changchun GeneScience Pharmaceutical Co., Ltd.

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The Efficacy and Safety of Once-weekly PEG-somatropin (GenSci004) in Treatment-naive Children With Growth Hormone Deficiency: A Randomized, Open-label, Parallel-group, Active-Controlled, Non-inferiority Phase 3 Study (ELEVATE)

Registry	NCT06007417, acronym ELEVATE
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	162 (Estimated)
Sponsor	Changchun GeneScience Pharmaceutical Co., Ltd. (Industry)
Conditions	GHD
Interventions	GenSci004, Genotropin (Drug)
Dates	start 2023-12-01 (estimated), primary completion 2025-05-01 (estimated), completion 2025-08-01 (estimated), first posted 2023-08-23, last updated 2023-09-11
Locations	1 site in United States

-Summary

The purpose of this study is to evaluate the efficacy and safety of weekly GenSci004 compared with daily Genotropin in treatment-naive children with growth failure due to GHD.

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+Detailed description

The purpose of this Phase 3 study is to evaluate the efficacy, safety, and tolerability of weekly GenSci004 compared to daily Genotropin over 52 weeks in prepubertal treatment-naïve children with growth failure due to GHD.

+Arms and interventions

Arm	Type	Interventions	Description
GenSci004	Experimental	Drug: GenSci004
Genotropin	Active comparator	Drug: Genotropin

GenSci004 (Drug): GenSci004 is a pegylated rhGH (PEG rhGH) (i.e., PEG-somatropin)
Genotropin (Drug): Genotropin

+Outcome measures

Primary outcomes

Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups [52 weeks]: Measured in centimeter per year (cm/year)

Secondary outcomes

Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups [104 weeks]: Measured in centimeter per year (cm/year)

+Eligibility

Sex: All, ages: 3 Years to 12 Years

Inclusion Criteria:

1. Prepubertal children with GHD in Tanner Stage 1
2. Baseline HT at least -2.0 SD below the mean HT for CA and sex (HT SDS ≤ 2.0).
3. Body mass index (BMI) within ±2.0 SD of the mean BMI for BA and sex.
4. Growth hormone stimulation tests: ≤10 ng/mL
5. Baseline IGF 1 level of at least 1.0 SD below the mean IGF 1 level standardized for age and sex (IGF 1 SDS ≤-1.0)
6. Normal 46 XX karyotype for girls.
7. Children with multiple hormonal deficiencies must be on stable replacement therapy for other hypothalamo-pituitary axes for at least 3 months
8. Written, signed informed consent of the parent(s) or legal guardian(s) of the participant and written assent of the participant

Exclusion Criteria:

1. BA≥CA
2. Prior exposure to rhGH, long-acting growth hormones, or IGF 1 therapy.
3. Major medical conditions or presence of contraindication to human growth hormone (hGH) treatment
4. Participation in any other trial of an investigational agent within 3 months prior to Screening.
5. Any reason per investigator's discretion

+Locations (1)

Facility	City	Country	Status
Cook Childrens	Fort Worth, Texas	United States

+Investigators

Bradley Miller, Study chair, University of Minnesota