A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

November 10, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

April 30, 2026

Conditions
Achondroplasia
Interventions
DRUG

Infigratinib 0.25 mg/kg/day

Daily doses of oral Infigratinib (sprinkle capsules) at 2, 3.5, 5, 7, 10 mg

DRUG

Placebo Comparator 0.25 mg/kg/day

Daily doses of oral Placebo Comparator (sprinkle capsules) at 2, 3.5, 5, 7, 10 mg

Trial Locations (28)

3052

QED Investigative Site, Parkville

5009

QED Investigative Site, Bergen

21287

QED Investigative Site, Baltimore

29010

QED Investigative Site, Málaga

31059

QED Investigative Site, Toulouse

37232

QED Investigative Site, Nashville

45229

QED Investigative Site, Cincinnati

53792

QED Investigative Site, Madison

65212

QED Investigative Site, Columbia

69677

QED Investigative Site, Bron

75015

QED Investigative Site, Paris

80045

QED Investigative Site, Aurora

94609

QED Investigative Site, San Francisco

229899

QED Investigative Site, Singapore

C1245AAM

QED Investigative Site, Buenos Aires

T6G 2B7

QED Investigative Site, Edmonton

N6A 5W9

QED Investigative Site, London

K1H 8L1

QED Investigative Site, Ottawa

H3T 1C5

QED Investigative Site, Montreal

00168

QED Investigative Site, Rome

0372

QED Investigative Site, Oslo

01008

QED Investigative Site, Vitoria-Gasteiz

B4 6NH

QED Investigative Site, Birmingham

BS2 8BJ

QED Investigative Site, Bristol

G51 4TF

QED Investigative Site, Glasgow

SE1 7EH

QED Investigative Site, London

M13 9WL

QED Investigative Site, Manchester

S10 2TH

QED Investigative Site, Sheffield

All Listed Sponsors
lead

QED Therapeutics, Inc., a Bridgebio company

INDUSTRY

NCT06164951 - A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia | Biotech Hunter | Biotech Hunter