A phase III study of JR-401 in patients with SHOX dificiency

A phase III study of JR-401 in short stature patients with SHOX deficiency

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223889

Enrollment

Registered

2018-04-26

Start date

2018-08-31

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

Short stature patients with SHOX deficiency

Interventions

investigational material(s) Generic name etc : JR-401 INN of investigational material : somatropin Therapeutic category code : 241 Pituitary hormone preparations Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.The children have a diagnosis of SHOX deficiency by geneanalysis. 2.A girl patients who is clearly not a Turner syndrome base on chromosome testing.

Exclusion criteria

Exclusion criteria: Pediatric patients who have received continuous GH treatment. Pediatric patients who have received any treatment that may have effect on the growth stimulation. Pediatric patients with a disease that causes a short stature unrelated to SHOX deficiency. Pediatric patients with diagnosis of Langer type middle limb bone dysplasia.

Design outcomes

Primary

Measure	Time frame
efficacy confirmatory Change in Height Standard Deviation Score (SDS) for chronogical Age	—

Secondary

Measure	Time frame
efficacy Height Standard Deviation Score (SDS) for chronogical Age	—

Countries

Japan

Contacts

Public ContactRyo Ibaraki

JCR Pharmaceuticals Co., Ltd.

clinical_development@jp.jcrpharm.com+81-797-34-3897

Outcome results

None listed

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