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Open-Label, Long-Term, Extension Study of Infigratinib in Children with Hypochondroplasia
EU CTIS ID: 2025-523509-13-00
What this study is testing
To evaluate the safety and tolerability of long-term, once-daily oral administration of infigratinib for the treatment of participants living with HCH. To evaluate the efficacy of long-term, once-daily oral administration infigratinib in participants with HCH assessed by 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 Participants Rolling Over from ACCEL 2/3: 1. Pediatric participants with HCH who have completed ACCEL 2/3.
- Inclusion Criteria for Participants Rolling Over from ACCEL 2/3: 2. Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche.
- Inclusion Criteria for Participants Rolling Over from ACCEL: 1. Participant must be 3 to <18 years of age at screening and have growth potential (defined as X in females and X in males).
- Inclusion Criteria for Participants Rolling Over from ACCEL: 2. Diagnosis of HCH documented clinically by the presence of disproportionate short stature and confirmed with a molecular test.
- Inclusion Criteria for Participants Rolling Over from ACCEL: 3. Participants have at least a 6-month period of growth assessment in the ACCEL study before study entry.
- Inclusion Criteria for Participants Rolling Over from ACCEL: 4. Participants are ambulatory and able to stand without assistance.
You likely can't join if
- Exclusion Criteria for Participants Rolling Over from ACCEL 2/3: 1. Participant has concurrent medical condition (ie, circumstance, syndrome, symptom, sign, etc) that, in the view of the PI and/or sponsor, would interfere with study participation or safety evaluations.
- Exclusion Criteria for Participants Rolling Over from ACCEL: 4. Currently receiving treatment with agents that are known strong X or prolonged treatment (>1 week) with medications that alter the pH of the gastrointestinal tract.
- Exclusion Criteria for Participants Rolling Over from ACCEL: 5. Participants receiving medications which could increase X
- Exclusion Criteria for Participants Rolling Over from ACCEL: 6. Regular long-term treatment (≥3 weeks) with supraphysiologic doses of glucocorticoid therapy or treatment with glucocorticoids at anti-inflammatory doses for over 3 weeks within 6 months of the screening visit.
- Exclusion Criteria for Participants Rolling Over from ACCEL: 7. Having had a fracture of the long bones or spine within 12 months of screening.
- Exclusion Criteria for Participants Rolling Over from ACCEL: 8. Current participation in an ongoing clinical study with a sponsor other than QED.
See the full eligibility criteria
Who can join
- Inclusion Criteria for Participants Rolling Over from ACCEL 2/3: 1. Pediatric participants with HCH who have completed ACCEL 2/3.
- Inclusion Criteria for Participants Rolling Over from ACCEL 2/3: 2. Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche.
- Inclusion Criteria for Participants Rolling Over from ACCEL: 1. Participant must be 3 to <18 years of age at screening and have growth potential (defined as X in females and X in males).
- Inclusion Criteria for Participants Rolling Over from ACCEL: 2. Diagnosis of HCH documented clinically by the presence of disproportionate short stature and confirmed with a molecular test.
- Inclusion Criteria for Participants Rolling Over from ACCEL: 3. Participants have at least a 6-month period of growth assessment in the ACCEL study before study entry.
- Inclusion Criteria for Participants Rolling Over from ACCEL: 4. Participants are ambulatory and able to stand without assistance.
- Inclusion Criteria for Participants Rolling Over from ACCEL: 5. Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche.
What rules you out
- Exclusion Criteria for Participants Rolling Over from ACCEL 2/3: 1. Participant has concurrent medical condition (ie, circumstance, syndrome, symptom, sign, etc) that, in the view of the PI and/or sponsor, would interfere with study participation or safety evaluations.
- Exclusion Criteria for Participants Rolling Over from ACCEL: 4. Currently receiving treatment with agents that are known strong X or prolonged treatment (>1 week) with medications that alter the pH of the gastrointestinal tract.
- Exclusion Criteria for Participants Rolling Over from ACCEL: 5. Participants receiving medications which could increase X
- Exclusion Criteria for Participants Rolling Over from ACCEL: 6. Regular long-term treatment (≥3 weeks) with supraphysiologic doses of glucocorticoid therapy or treatment with glucocorticoids at anti-inflammatory doses for over 3 weeks within 6 months of the screening visit.
- Exclusion Criteria for Participants Rolling Over from ACCEL: 7. Having had a fracture of the long bones or spine within 12 months of screening.
- Exclusion Criteria for Participants Rolling Over from ACCEL: 8. Current participation in an ongoing clinical study with a sponsor other than QED.
- Exclusion Criteria for Participants Rolling Over from ACCEL 2/3: 2. Current evidence of clinically significant X
- Exclusion Criteria for Participants Rolling Over from ACCEL 2/3: 3. Participants who developed a medical condition that requires the initiation of treatment with a prohibited medication.
- Exclusion Criteria for Participants Rolling Over from ACCEL 2/3: 4. Participants who prematurely discontinued ACCEL 2/3.
- Exclusion Criteria for Participants Rolling Over from ACCEL 2/3: 5. Participants who have reached final height or near final height (AHV X for a minimum 6-month observation period and X for males and X for females).
- Exclusion Criteria for Participants Rolling Over from ACCEL 2/3: 6. Current participation in an ongoing clinical study with a sponsor other than QED.
- Exclusion Criteria for Participants Rolling Over from ACCEL: 1. Participants who have a clinically significant concurrent disease or condition that, in the view of the PI and/or sponsor, would represent an increased risk to the participant or would interfere with study participation or safety evaluations. Complete list referenced in protocol.
- Exclusion Criteria for Participants Rolling Over from ACCEL: 2. Participants who have a history and/or current evidence of extensive ectopic tissue calcification.
- Exclusion Criteria for Participants Rolling Over from ACCEL: 3. Participants who have a history of malignancy.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- Australia
- Singapore
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 Canada; United States; Australia; Singapore. 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.