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Kinase Inhibitor
Infigratinib for Achondroplasia (PROPEL3 Trial)
Phase 3
Waitlist Available
Research Sponsored by QED Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject must be 3 to <18 years of age at screening with growth potential defined as annualized height velocity of >1.5 cm/year over a period of at least 6 months, pubertal Tanner stage ≤4, and bone age ≤13 years in females and ≤15 years in males.
Subjects are ambulatory and able to stand without assistance. Sex and Contraceptive/Barrier Requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
Pivotal Trial
Summary
This trial tests a drug to help children and teens with achondroplasia. It's randomized, double-blind, and placebo-controlled.
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Possible side effects of Infigratinib may include joint pain, gastrointestinal issues like nausea or diarrhea, liver problems indicated by blood tests changes, fatigue, and potential growth plate fusion affecting height.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
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I can stand and walk without help.
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I am not pregnant or have tested negative for pregnancy.
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My ACH diagnosis is confirmed by clinical assessment and genetic testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change from BL in attention assessed by age-appropriate computerized tests (Identification Test)
Change from BL in the Physical Functioning dimension of the Pediatric Quality of Life Generic Core Scale Short Form
Change from BL in visual learning assessed by age-appropriate computerized tests (One Card Learning Test)
+2 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
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
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Who is running the clinical trial?
QED Therapeutics, Inc.Lead Sponsor
9 Previous Clinical Trials
1,018 Total Patients Enrolled
3 Trials studying Achondroplasia
634 Patients Enrolled for Achondroplasia
QED Therapeutics, Inc. Medical Director, Clinical DevelopmentStudy DirectorQED Therapeutics