Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study）

Launched by KYOWA KIRIN CO., LTD. · Apr 7, 2025

Keywords

ClinConnect Summary

The AOBA Study is a clinical trial looking at a new treatment, KK8398, for children and teenagers with achondroplasia, a condition that affects bone growth and leads to shorter stature. The trial will assess how well KK8398 works in increasing height over one year when given regularly to patients. It is currently recruiting participants aged between 2.5 and 17.5 years who have been diagnosed with achondroplasia through genetic testing.

To be eligible, participants must meet specific growth criteria and cannot have had certain previous treatments or surgeries related to bone growth. If you or your child qualify and decide to participate, you can expect to receive KK8398 for a year, with regular check-ups to monitor growth and safety. This study aims to provide important information about the effectiveness of KK8398 in helping children with achondroplasia grow taller, which could improve their overall quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients who are between 2.5 and 17.5 years old of age at the time of provisional registration. Patients who meet certain criteria in terms of Tanner stage and bone age.
• • 2. Patients who have been diagnosed with achondroplasia through genetic testing.
• Exclusion Criteria:
• • 1. Patients who meet the criteria for a certain height determined by age and gender in the "Growth Chart for Patients with Achondroplasia" at the time of the pre-registration examination
• • 2. Patients who have received treatment with r-hGH or a CNP analogue within a certain period prior to the pre-enrollment examination.
• • 3. Patients who have had previous osteotomy or who are scheduled to undergo osteotomy or epiphyseal growth inhibition during the study period. Epiphyseal growth inhibition in which the plate was removed more than 26 weeks prior to the pre-registration examination will not be excluded if the patient has completely healed without sequelae, based on the judgment of the investigator or sub-investigator.