This clinical trial is focused on studying a condition called Achondroplasia, which is a genetic disorder affecting bone growth and resulting in shorter stature. The study is investigating a treatment called Infigratinib, which is a type of medication known as a tyrosine kinase inhibitor. This medication works by blocking certain proteins that can affect bone growth. In this study, Infigratinib is given in the form of capsules that are taken orally.
The purpose of the study is to evaluate how effective and safe Infigratinib is for children aged 3 to under 18 years who have Achondroplasia and still have the potential to grow. The study will compare the effects of Infigratinib to a placebo, which is a substance with no active medication. Participants will be randomly assigned to receive either Infigratinib or the placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The treatment period will last up to 52 weeks, during which various measurements related to growth and development will be taken to assess the medication’s impact.
Throughout the study, researchers will monitor changes in growth rates, body proportions, and other health indicators to determine the effectiveness of Infigratinib. The study will also track any side effects or adverse events to ensure the safety of the participants. By the end of the study, the goal is to gather enough information to understand how Infigratinib can help children with Achondroplasia grow and develop more effectively.



France
Germany
Italy
Norway
Spain