Phase 3 study of JR-142 in pediatric patients with growth hormone deficiency

An open-label, multicenter, randomized, parallel-group, Phase III study to evaluate the efficacy and safety of once-weekly administration of JR-142 versus daily administration of GROWJECT in Japanese pediatric patients with growth hormone deficiency

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240282

Enrollment

Registered

2024-08-20

Start date

2024-09-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth hormone deficiency in children

Interventions

[Investigational product] JR-142 (INN: redalsomatropin alfa) 0.75 mg/kg/week or 0.5 mg/kg/week, weekly subcutaneous injection [Comparatar product] INN: Somatropin (genetical recombination) 0.175 mg/k

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Change in height SDS for chronological age from the first administration (Week 53)	—

Secondary

Measure	Time frame
1) Change in height SDS for chronological age from the first administration over time 2) Height SDS for chronological age over time 3) Growth velocity 4) Change in growth velocity from the first administration 5) Growth velocity SDS over time 6) Height 7) Bone age 8) Bone age relative to chronological age 9) Change in bone age from the first administration 10) Ratio of change in bone age relative to change in chronological age	—

Measure

Time frame

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

—

Contacts

Public ContactTsubasa Hirayama

JCR Pharmaceuticals Co., Ltd.

clinical_development@jp.jcrpharm.com+81-797-32-8582

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026