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A study to evaluate long-term Infigratinib in children with Achondroplasia
EU CTIS ID: 2024-513857-55-00
What this study is testing
1. To evaluate the safety and tolerability of long-term administration of daily doses of oral infigratinib in subjects with ACH. 2. To evaluate the efficacy of long-term administration of daily doses of oral infigratinib in subjects with ACH as assessed as changes over time in standing height Z-score.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Inclusion Criteria for Rollover Subjects 1. Pediatric subjects with ACH who have completed a previous QEDsponsored interventional study with infigratinib. 2. Subjects and parent(s), legal guardians, or caregivers are willing and able to comply with study visits and study procedures. 3. Subjects are able to swallow oral medication. 4. Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche. 5. If sexually active, subject must be willing to use a highly effective method of contraception while taking study drug and for 1 month after the last dose of study drug. 6. The PI, or a person designated by the PI, will obtain written informed consent from each subject's parents(s), legal guardian(s), or caregiver(s) and the subject's assent, when applicable, before any study-specific activity is performed.
- Inclusion Criteria for Treatment Naïve Subjects 1. Subject must be 3 to <18 years of age at screening and have growth potential 2. Subjects and parent(s), legal guardian(s), or caregiver(s) are willing and able to comply with study visits and study procedures. 3. Subjects are able to swallow oral medication. 4. Subjects who have a diagnosis of ACH, documented clinically and confirmed by genetic testing. 5. Subjects have at least a 6-month period of growth assessment in the PROPEL study (Protocol QBGJ398-001) before study entry. 6. Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche. 7. If sexually active, subject must be willing to use a highly effective method of contraception while taking study drug and for 1 month after the last dose of study drug. 8. The PI, or a person designated by the PI, will obtain written informed consent from each subject's parent(s), legal guardian(s), or caregiver(s) and the subject's assent, when applicable, before any study-specific activity is performed.
You likely can't join if
- Exclusion Criteria for Rollover Subjects 1. Subject has concurrent circumstance, disease, or condition that, in the view of the PI and/or sponsor, would interfere with study participation or safety evaluations. 2. Subjects who developed a medical condition that will require the initiation of treatment with a prohibited medication. 3. Subjects that prematurely discontinued a prior QED-sponsored interventional study with infigratinib. 4. Current participation in an ongoing clinical study with a sponsor other than QED. 5. Subjects that have reached final height or near final height
- Exclusion Criteria for Treatment Naïve Subjects 1. Subjects who have hypochondroplasia or short stature condition other than ACH (eg, trisomy 21, pseudoachondroplasia, psychosocial short stature). 2. Subjects who have significant concurrent disease or condition that, in the view of the PI and/or sponsor, would represent an increased risk to the subject or would interfere with study participation or safety evaluations 3. Subjects who have a history of malignancy. 4. Subjects who are currently receiving treatment with agents that are known strong inducers or inhibitors of cytochrome P450 (CYP) 3A4 5. Subjects who discontinued treatment with prohibited medications for at least 5 half-lives before screening are eligible. 6. Subjects who have received treatment with growth hormone, insulinlike growth factor 1 (IGF 1), anabolic steroids or any investigational or approved drug for the treatment of ACH in the previous 6 months. 7. Subjects who have significant abnormality in screening laboratory results. 8. Subjects who have had a fracture within 12 months of screening.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Canada
- Australia
- United Kingdom
- Singapore
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Canada; Australia; United Kingdom; Singapore; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.