Actively Recruiting

Phase 2
Age: 3Years - 11Years
All Genders
NCT06382155

A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature

Led by BioMarin Pharmaceutical · Updated on 2026-05-08

100

Participants Needed

47

Research Sites

632 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate i) the effect of multiple doses of vosoritide and ii) the effect of the therapeutic dose of vosoritide compared to human growth hormone (hGH)(hGH; only in the United States), in children with idiopathic short stature (ISS).

CONDITIONS

Official Title

A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature

Who Can Participate

Age: 3Years - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Height Z-score of -2.25 or lower compared to general population for age and sex using CDC growth charts
  • For children 5 years or older, must be Tanner Stage I at screening
  • Historic growth hormone stimulation test showing serum or plasma GH level greater than 10 μg/L or normal serum IGF-1 level for age (-1.00 to +2.00 SDs)
Not Eligible

You will not qualify if you...

  • Known chromosomal or genetic conditions causing short stature, including Laron syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, disproportionate skeletal dysplasias, abnormal SHOX gene, Rasopathies including Noonan syndrome, or ACAN deficiency
  • Prior treatment with any growth-promoting agent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 47 locations

1

Consano Clinical Research, LLC

California City, California, United States, 78231

Actively Recruiting

2

Rady Children's Hospital - San Diego

California City, California, United States, 92123

Actively Recruiting

3

Children's Hospital of Orange County Main Campus - Orange

California City, California, United States, 92868

Actively Recruiting

4

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

5

Children's Hospital Oakland Research Institute

Oakland, California, United States, 94609

Actively Recruiting

6

Center Of Excellence in Diabetes and Endocrinology

Sacramento, California, United States, 95821

Actively Recruiting

7

Lundquist Institute for Biomedical Innovation (LA BioMed)

Torrance, California, United States, 90502

Actively Recruiting

8

The Children's National Research Institute

Washington D.C., District of Columbia, United States, 20012

Actively Recruiting

9

Nemours Children's Specialty Care Jacksonville

Jacksonville, Florida, United States, 32207

Actively Recruiting

10

Nicklaus Children's Hospital

Miami, Florida, United States, 33155

Actively Recruiting

11

Optimal Research Sites

Orange City, Florida, United States, 32763

Actively Recruiting

12

Nemours Children's Health System - Corporate Headquarters

Pensacola, Florida, United States, 32514

Actively Recruiting

13

Centricity Research

Columbus, Georgia, United States, 31904

Actively Recruiting

14

St. Luke's Children's Endocrinology

Boise, Idaho, United States, 83712

Actively Recruiting

15

Rocky Mountain Clinical Research - Idaho Falls

Idaho Falls, Idaho, United States, 83404

Actively Recruiting

16

University of Iowa Stead Family Children's Hospital

Iowa City, Iowa, United States, 52242

Actively Recruiting

17

Kentucky Children's Hospital

Lexington, Kentucky, United States, 40536

Actively Recruiting

18

University of Louisville School of Medicine

Louisville, Kentucky, United States, 40202

Actively Recruiting

19

Velocity Clinical Research - MedPharmics - Lafayette

Lafayette, Louisiana, United States, 70508

Actively Recruiting

20

Ochsner Health Center for Children - New Orleans

New Orleans, Louisiana, United States, 70121

Withdrawn

21

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

22

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, United States, 55454

Actively Recruiting

23

UBMD Pediatrics

Buffalo, New York, United States, 14203

Actively Recruiting

24

NYU Langone Ambulatory Care Garden City

Garden City, New York, United States, 11530

Withdrawn

25

Atlantic Health Children's Specialty Center at Morristown

New York, New York, United States, 07960

Actively Recruiting

26

The Clinical and Translational Science Institute

New York, New York, United States, 10016

Actively Recruiting

27

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

28

Children's Hospital at Montefiore

The Bronx, New York, United States, 10467

Actively Recruiting

29

University of North Carolina Children's Specialty Clinic

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

30

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

31

Prisma Health Children's Hospital - Midlands

Columbia, South Carolina, United States, 29203

Actively Recruiting

32

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

33

Cook Children's Endocrinology

Fort Worth, Texas, United States, 76104

Actively Recruiting

34

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

35

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

36

Murdoch Children's Research Institute

Parkville, Victoria, Australia, 3052

Actively Recruiting

37

Centre Hospitalier Universitaire d'Angers

Angers, France, 49 933

Actively Recruiting

38

Hôpital de la Timone - Enfants

Marseille, France, 13005

Actively Recruiting

39

CHU de Toulouse - Hôpital des Enfants

Toulouse, France, 31059

Actively Recruiting

40

Hôpital Bicêtre

Le Kremlin-Bicêtre, Île-de-France Region, France, 94270

Actively Recruiting

41

Universitätsklinikum des Saarlandes

Homburg, Saarland, Germany, 66421

Actively Recruiting

42

Azienda Ospedaliero Universitaria - Ospedale Pediatrico Meyer

Florence, Florence, Italy, 50139

Actively Recruiting

43

Ospedale Pediatrico Bambino Gesù

Roma, Rome, Italy, 00165

Actively Recruiting

44

IRCCS Istituto Giannina Gaslini

Genova, Italy, 16147

Actively Recruiting

45

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea, 13620

Actively Recruiting

46

Inha University Hospital

Incheon, South Korea, 22332

Actively Recruiting

47

Chungnam National University Sejong Hospital (CNUSH)

Sejong, South Korea, 30099

Actively Recruiting

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Research Team

T

Trial Specialist

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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