A study for children and adolescents with hypochondroplasia

The ACCEL clinical program includes multiple studies grounded in learning more about hypochondroplasia and evaluating an oral treatment option for children and adolescents with this type of skeletal dysplasia.

smiling toddler with hypochondroplasia wearing a blue shirt

What is the purpose
of the ACCEL clinical program?

What will be measured
in ACCEL?

The first phase of the ACCEL clinical program is an observational study. Children and adolescents participating in this phase will not receive any medication. Specific measurements will be taken by a healthcare provider over a period of up to 2 years.5

Participants are required to complete at least 6 months in the ACCEL observational study to be eligible to move on to Phase 2 or Phase 3, in which eligible participants may receive an oral medication called infigratinib. Infigratinib is being studied for its ability to help bones grow in children and adolescents with HCH.3

All eligible children and adolescents who participate in Phase 2 or Phase 3 will have the option to receive infigratinib at some point, including those who receive placebo in Phase 3.

What will be measured
in ACCEL?

Four horizontal bars with icons and text under the header 'What will be measured in ACCEL?' The first bar is labeled 'Growth and body proportions' with a ruler icon. The second bar states 'Medical challenges or surgeries related to HCH, either before or during the study' with a medical cross icon. The third bar is labeled 'Physical function' with a person icon. The fourth bar reads 'Levels of a substance in the blood that is related to growth' with a syringe icon.

Overview of the ACCEL studies

The measurements collected in ACCEL will lead to a better understanding of the growth, physical characteristics, thinking ability, and possible medical challenges that people with HCH can experience.

Children and adolescents must participate in the ACCEL observational trial for 6 months or longer to be eligible for participation in the Phase 2 or Phase 3 studies.

A detailed chart titled 'The ACCEL clinical program has multiple phases,' describing different phases of the ACCEL study for children with HCH. On the left, an observational study box explains that children aged 2.5 to less than 11 years will undergo baseline growth measurements without treatment. The central green box labeled 'Phase 2 study' outlines safety and efficacy tests of infogratinib for children ages 5 to 11 who complete six months in ACCEL, with all participants receiving infogratinib. Below, 'Phase 3 study' specifies that children aged 3 to less than 18 will be randomized to receive either infogratinib or a placebo. The rightmost box mentions an open-label extension for long-term safety, where eligible participants may continue with infogratinib. A disclaimer at the bottom states that infogratinib is not approved for HCH by the FDA or other health authorities. A detailed chart titled 'The ACCEL clinical program has multiple phases,' describing different phases of the ACCEL study for children with HCH. On the left, an observational study box explains that children aged 2.5 to less than 11 years will undergo baseline growth measurements without treatment. The central green box labeled 'Phase 2 study' outlines safety and efficacy tests of infogratinib for children ages 5 to 11 who complete six months in ACCEL, with all participants receiving infogratinib. Below, 'Phase 3 study' specifies that children aged 3 to less than 18 will be randomized to receive either infogratinib or a placebo. The rightmost box mentions an open-label extension for long-term safety, where eligible participants may continue with infogratinib. A disclaimer at the bottom states that infogratinib is not approved for HCH by the FDA or other health authorities.

Who can participate in ACCEL?

icon depicting a group of people arranged in three rows, representing children and adolescents eligible to participate in the ACCEL study

Children and adolescents ages 2.5 to less than 17 years (at the start of the study) with a diagnosis of HCH confirmed by genetic testing

icon of a globe symbolizing the geographic locations where ACCEL study visits may take place

For a complete list of the requirements to participate in the study, and the locations where study visits can take place, click here.

smiling parents holding their child

References