Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency

Summary

Treatment of children with growth failure due to growth hormone deficiency (GHD). Primary • To evaluate the efficacy and safety of weekly MOD-4023 administration compared to daily Genotropin® administration in Japanese pre-pubertal children with GHD. Secondary • To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of three different doses of MOD-4023 in Japanese pre-pubertal children with GHD.

Timeline

Start

2017-12-07

Primary completion

2020-03-06

Completion

2020-03-06

Publications

• Horikawa R, Tanaka T, Hasegawa Y, Yorifuji T, Ng D, Rosenfeld RG, Hoshino Y, Okayama A, Ebata N, Hosoi M, Nakamuta S, Gomez R, Pastrak A, Castellanos O. Efficacy and safety of once-weekly somatrogon following up to 4 years of treatment in Japanese children with growth hormone deficiency: results from an open-label extension of a phase 3 study. Endocr J. 2026 Jan 6;73(1):21-32. doi: 10.1507/endocrj.EJ24-0625. Epub 2025 Oct 31.

Drugs

Indications