臨床研究等提出・公開システム

An open-label, multicenter, randomized, parallel-group, phase III study to verify the superiority and evaluate the efficacy and safety of daily administration of JR-401 (0.3 mg/kg/week) versus daily administration of JR-401 (0.175 mg/kg/week) in pediatric patients with growth hormone deficiency

Phase III dose-comparison study of JR-401 in pediatric patients with growth hormone deficiency

Utsunomiya Yuto

JCR Pharmaceuticals Co., Ltd.

11-18, Kusunoki-cho, Ashiya-shi, 659-0015, Hyogo

clinical_development@jp.jcrpharm.com

Utsunomiya Yuto

JCR Pharmaceuticals Co., Ltd.

11-18, Kusunoki-cho, Ashiya-shi, 659-0015, Hyogo

+81-797-32-8582

clinical_development@jp.jcrpharm.com

Recruiting

Mar. 01, 2026

Interventional

randomized controlled trial

open(masking not used)

dose comparison control

parallel assignment

treatment purpose

1) Patients who have not yet reached puberty at the time of screening (Tanner Stage 1)
2) Patients who are between 3 and 10 years of age for boys and between 3 and 8 years of age for girls at the time of the screening test
3) Patients whose calendar age equivalent height at the time of screening test and first dose is less than -2.0 SD of standard height or whose height is in the reference range but whose growth rate is less than -1.5 SD of standard value for more than 2 years

1) Patients previously treated with GH preparations
2) Patients who have received concomitant treatment within 12 months prior to the screening test that may have an effect on growth promotion
3) Patients using inhaled steroids at doses greater than 400 ug/day of inhaled budesonide or its equivalent within 12 months prior to screening test
4) Patients with conditions other than pediatric GHD that cause short stature (e.g., endocrine disorders, chromosomal abnormalities, malformation syndromes, and bone system diseases)
5) Patients whose birth weight and height were below the 10th percentile for the corresponding number of weeks of gestation, and birth weight or height was less than the [standard value - 2SD] for the corresponding number of weeks of gestation
6) Patients diagnosed with diabetes mellitus and whose blood glucose is not controlled by diet and exercise therapy

Both

Growth hormone deficiency in children

Investigational product name: JR-401 (INN: somatropin)
Dosage and Administration: 0.175 mg/kg or 0.3 mg/kg, administered subcutaneously, divided into 7 doses per week

Change in height SDS for chronological age from the first administration (Week 52)

1) Change in height SDS for chronological age from the first administration over time
2) Height SDS for chronological age over time
3) Change in growth velocity from the first administration
4) Growth velocity
5) Change in bone age from the first administration
6) Bone age
7) Bone age SDS for chronological age over time
8) Bone age relative to chronological age
9) Ratio of change in bone age relative to change in chronological age
10) Change in serum Insulin-like Growth Factor-1 (IGF-1) SDS from the first administration

+81-742-46-6001

Feb. 05, 2026

No

none