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Tyrosine Kinase Inhibitor

Infigratinib for Achondroplasia

Phase 2
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
Subjects who have a diagnosis of ACH, documented clinically and confirmed by genetic testing
Subject must be 3 to <18 years of age at screening and have growth potential
Must not have
Subjects who have hypochondroplasia or short stature condition other than ACH (e.g., trisomy 21, pseudoachondroplasia, psychosocial short stature)
Subjects that have reached final height or near final height
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the long-term safety, tolerability, and efficacy of a drug to treat ACH, and also assesses the quality of life of those affected.

Who is the study for?
This trial is for children with Achondroplasia (ACH) aged 3 to <18 who have growth potential and completed a previous infigratinib study or have been assessed for growth over 6 months. They must be able to swallow pills, comply with the study plan, and use contraception if applicable. Those with recent fractures, other short stature conditions, or using certain drugs can't join.
What is being tested?
The trial tests the long-term safety and effectiveness of Infigratinib, an FGFR inhibitor, in kids who've taken it before or are new to it after a specific dose has been identified. It's an open-label extension study where all participants receive the drug and their quality of life is monitored.
What are the potential side effects?
While not explicitly listed here, side effects may include issues related to organ function due to FGFR inhibition. As this is a tyrosine kinase inhibitor being tested on children with ACH, close monitoring will occur for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My ACH diagnosis is confirmed by clinical assessment and genetic testing.
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I am between 3 and 17 years old and still growing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition causing short stature, but it's not ACH.
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I have reached my full adult height.
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I need to start a medication that is not allowed in the trial.
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I have had a bone fracture in the last year.
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I am not taking medication that strongly affects liver enzyme CYP3A4.
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I have had cancer before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: Treatment naïve subjectsExperimental Treatment1 Intervention
Children naïve to infigratinib
Group II: Arm 1: Rollover subjectsExperimental Treatment1 Intervention
Children who have completed QED-sponsored interventional study with infigratinib (Phase 2 or Phase 3)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Infigratinib
2020
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

QED Therapeutics, Inc.Lead Sponsor
9 Previous Clinical Trials
828 Total Patients Enrolled
3 Trials studying Achondroplasia
444 Patients Enrolled for Achondroplasia
QED Therapeutics VP, Clinical DevelopmentStudy DirectorQED Therapeutics
2 Previous Clinical Trials
334 Total Patients Enrolled
2 Trials studying Achondroplasia
334 Patients Enrolled for Achondroplasia
QED Therapeutics SVP, Clinical DevelopmentStudy DirectorQED Therapeutics

Media Library

Infigratinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05145010 — Phase 2
Achondroplasia Research Study Groups: Arm 2: Treatment naïve subjects, Arm 1: Rollover subjects
Achondroplasia Clinical Trial 2023: Infigratinib Highlights & Side Effects. Trial Name: NCT05145010 — Phase 2
Infigratinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05145010 — Phase 2
~200 spots leftby Dec 2031
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