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

JRCT ID: jRCT2031240282

Registered date:20/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Growth hormone deficiency in children
• Date of first enrollment: 02/09/2024
• Target sample size: 54
• Study type: Interventional

Intervention(s)

[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/kg/week, daily subcutaneous injection

Outcome(s)

• Primary Outcome: Change in height SDS for chronological age from the first administration (Week 53)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 3age old
• Age maximum: < 10age old
• Gender: Both

Include 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

Exclude 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 diagnosed with Small for Gestational Age
6) Patients diagnosed with diabetes mellitus and whose blood glucose is not controlled by diet and exercise therapy

Related Information

• Primary Sponsor: Ibaraki Ryo