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NCT07169279 · ClinicalTrials.gov registry record · Phase 2
Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH)
A Phase 2 study of Achondroplasia, sponsored by QED Therapeutics, a BridgeBio company.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
- 13
- Study locations
NCT07169279 is a Phase 2 study of Achondroplasia that is actively recruiting participants, run by QED Therapeutics, a BridgeBio company. The registered enrollment target is 77 participants, below the 142-participant average among 9 other Achondroplasia trials with a reported enrollment target (46% lower). The trial reports 13 study locations across 7 states.
The verdict
NCT07169279, a Phase 2 study of Achondroplasia, is actively recruiting participants, sponsored by QED Therapeutics, a BridgeBio company.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
- 13
- Study locations
Study Summary
This is a Phase 2, multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of infigratinib in participants \< 3 years old with ACH. The purposes of the SAD and Phase 2 portions are to identify and confirm the dose of infigratinib to be used in the Phase 2b portion, based on safety and PK. The purpose of the Phase 2b, placebo-controlled portion is to evaluate the safety and efficacy of infigratinib in children \< 3 years old with ACH at the selected dose.
Conditions Studied
Interventions
- DRUG Infigratinib is provided as a single dose of minitablets for oral administration
- DRUG Infigratinib is provided as sprinkle capsules for daily oral administration
- DRUG Infigratinib or placebo comparator is provided as sprinkle capsules for daily oral administration
Study Locations (13)
Other
- Paediatric Clinical Research Unit at Oslo University Hospital - Oslo
- KK Women's and Children's Hospital - Singapore
- Unidad de Cirugia Artroscopica (UCA) - Vitoria-Gasteiz
- NHS Greater Glasgow and Clyde - Glasgow
- Guy's and Saint Thomas' NHS Foundation Trust - London
- Manchester University NHS Foundation Trust - Manchester
- Sheffield Children's NHS Foundation Trust - Sheffield
California
- UCSF Benioff Children's Hospital - Oakland
Maryland
- Johns Hopkins University - Baltimore
Wisconsin
- University of Wisconsin Madison - Waisman Center Bone Dysplasia Clinic - Madison
Victoria
- Murdoch Children's Research Institute - Parkville
Ontario
- Children's Hospital of Eastern Ontario Research Institute - Ottawa
Quebec
- Université de Montréal - Centre Hospitalier Universitaire Sainte-Justine - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2025-11-19 |
| Est. Completion | 2032-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07169279
The ClinicalTrials.gov registry entry for NCT07169279 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 142-participant average among 9 other Achondroplasia trials with a reported enrollment target (46% lower). The listed sponsor is QED Therapeutics, a BridgeBio company, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Achondroplasia appearing as the primary indexed condition, and to 3 interventions - of which Infigratinib is provided as a single dose of minitablets for oral administration is the first listed.
NCT07169279 reports 13 study locations spanning 7 distinct geographic areas - top geographies include Other, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT07169279 about?
NCT07169279 is a clinical study titled "Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH)". This is a Phase 2, multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of infigratinib in participants \< 3 years old with ACH. The purposes of the SAD and Phase 2 portions are to identify and confirm the dose of infigratinib to be used in the Phase 2b portion, base...
What is the current status of trial NCT07169279?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2025-11-19. Estimated completion is 2032-03.
What conditions does trial NCT07169279 study?
This clinical trial studies the following conditions: Achondroplasia.
What interventions are being tested in trial NCT07169279?
The interventions under investigation include: Infigratinib is provided as a single dose of minitablets for oral administration (DRUG), Infigratinib is provided as sprinkle capsules for daily oral administration (DRUG), Infigratinib or placebo comparator is provided as sprinkle capsules for daily oral administration (DRUG).
Who is sponsoring clinical trial NCT07169279?
This trial is sponsored by QED Therapeutics, a BridgeBio company, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07169279 being conducted?
This trial has 13 study locations across California, Maryland, Wisconsin, Victoria, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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