Infigratinib for Achondroplasia
(PROPEL3 Trial)

Recruiting in Palo Alto (17 mi)

+30 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: QED Therapeutics, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of infigratinib in children and adolescents with achondroplasia (ACH) who have completed at least 26 weeks of participation in the QED-sponsored study PROPEL (QBGJ398-001).

Research Team

QED Therapeutics, Inc. Medical Director, Clinical Development

Principal Investigator

QED Therapeutics

Eligibility Criteria

This trial is for children and adolescents aged 3 to <18 with achondroplasia, who are still growing and have completed at least 26 weeks in the PROPEL study. They must be able to swallow pills, stand without help, not be fully sexually mature, and girls of a certain age or menstruating must test negative for pregnancy.

Inclusion Criteria

If you are sexually active, you must be willing to use a very effective form of birth control while taking the study drug and for 3 months after stopping the study drug.

I am between 3 and 18 years old, growing more than 1.5 cm a year, not fully through puberty, and meet the bone age requirement.

I can stand and walk without help.

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Treatment Details

Interventions

Infigratinib (Kinase Inhibitor)
Placebo Comparator (Drug)

Trial OverviewThe trial tests Infigratinib against a placebo in participants with achondroplasia. It's a Phase 3 study where patients are randomly assigned to receive either the drug or an inactive substance (placebo), but neither they nor the doctors know which one they're getting.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Infigratinib 0.25 mg/kg/dayExperimental Treatment1 Intervention

Infigratinib at 2, 3.5, 5, 7, 10 mg

Group II: Placebo 0.25 mg/kg/dayPlacebo Group1 Intervention

Placebo Comparator at 2, 3.5, 5, 7, 10 mg