A Phase 3 interventional study of Infigratinib 0.25 mg/kg/day and Placebo Comparator 0.25 mg/kg/day in Achondroplasia, sponsored by QED Therapeutics, a BridgeBio company. Completed at 27 sites in 10 countries. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by QED Therapeutics, a BridgeBio company (part of BridgeBio) · Phase 3, Interventional, and Treatment
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).
47 studies on the registry are indexed under Achondroplasia; 13 are open to participants now.
This study's enrollment of 114 is above the median of 74 across 28 interventional studies indexed under Achondroplasia.
Browse Achondroplasia studies →QED Therapeutics, a BridgeBio company is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 of participation in the PROPEL observational study (QBGJ398-001), pubertal Tanner stage ≤4, and bone age ≤13 years in females and ≤15 years in males.
Type of Subject and Disease Characteristics
Subjects are ambulatory and able to stand without assistance.
Sex and /Barrier Requirements
If sexually active, subjects, whether male or female, must be willing to use a highly effective method of contraception while taking study drug and for 3 months after the last dose of study drug.
Exclusion Criteria:
Medical Conditions
History of .
Prior/Concomitant Therapy
Current evidence of endocrine alterations of calcium/phosphorus homeostasis.
Diagnostic assessments
Subjects who have significant abnormality in screening laboratory results.
Other Exclusions
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infigratinib at 2, 3.5, 5, 7, 10 mg
Drug: Infigratinib 0.25 mg/kg/day
Placebo Comparator at 2, 3.5, 5, 7, 10 mg
Drug: Placebo Comparator 0.25 mg/kg/day
Drug page: Infigratinib
Daily doses of oral Infigratinib (sprinkle capsules) at 2, 3.5, 5, 7, 10 mg
Daily doses of oral Placebo Comparator (sprinkle capsules) at 2, 3.5, 5, 7, 10 mg
Change from baseline (BL) in annualized height velocity (cm/year)
Time frame: Week 52
Change from BL in height Z-score (in relation to ACH tables)
Time frame: Week 52
Change from BL in upper to lower body segment ratio
Time frame: Week 52
Change from BL in height Z-score (in relation to non-ACH tables)
Time frame: Week 52
Annualized height velocity (cm/year)
Time frame: Week 52
Absolute and change from baseline in upper arm to forearm length ratio (cm)
Time frame: Week 52
Absolute and change from baseline in upper leg to lower leg length ratio (cm)
Time frame: Week 52
Absolute and change from baseline in arm span (cm) to standing height ratio
Time frame: Week 52
Absolute and change from baseline in head circumference (cm) to standing height ratio
Time frame: Week 52
Absolute value and change in body mass index
Time frame: Week 52
Incidence of adverse events
Time frame: Week 52
Change from BL in annualized height velocity (cm/year) in children 5 years old and older, compared to placebo
Time frame: Week 52
Change from BL in the Physical Functioning dimension of the Pediatric Quality of Life Generic Core Scale Short Form
Scale scores 0-100. Higher score=better Health-Related Quality of Life
Time frame: Week 52
Change in psychomotor function assessed by age-appropriate computerized tests (Detection Test), compared to placebo
Lower score=better performance. Range values=2-6
Time frame: Week 52
Change from BL in attention assessed by age-appropriate computerized tests (Identification Test)
Lower score=better performance. Range values=2-6
Time frame: Week 52
Change from BL in visual learning assessed by age-appropriate computerized tests (One Card Learning Test)
Higher score=better performance. Range values=0-1.6
Time frame: Week 52
Change from BL in working memory assessed by age-appropriate computerized tests (One Back Test)
Lower score=better performance. Range values=2-6
Time frame: Week 52
Pharmacokinetic profile of infigratinib by assessment of maximum concentration (Cmax)
Time frame: Week 52
Pharmacokinetic profile of infigratinib by assessment of time-to-maximum concentration (Tmax)
Time frame: Week 52
Change from BL in collagen X marker concentration (ug/L)
Time frame: Week 52
Evaluate the acceptability and palatability of infigratinib using a 5-point hedonic scale
Time frame: Week 13
Plan to share: No
Ran from Nov 2023 to primary completion in Dec 2025, 25 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Infigratinib
QED Therapeutics, a BridgeBio company →