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NCT Number: NCT06926491

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

This trial will evaluate the efficacy of KK8398 on annualized height velocity after 52 weeks of repeated administration of KK8398 to patients with achondroplasia

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Key information

Conditions

Achondroplasia Bone Diseases Bone Diseases, Developmental Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Genetic Diseases, Inborn Musculoskeletal Diseases Osteochondrodysplasias

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aichi Children's Health and Medical Center, Ōbu, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patients who have been diagnosed with achondroplasia through genetic testing.

Exclusion criteria

  • 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
  • Patients who have received treatment with r-hGH or a CNP analogue within a certain period prior to the pre-enrollment examination.
  • 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.

Treatment and study plan

KK8398

Drug

KK8398 will be administered.

Primary outcomes

  1. Change from baseline in annualized height velocity

    Time frame: Pre-dose, Week 52

Secondary outcomes

  1. Height Z-score using growth tables in patients with achondroplasia and the change from baseline

    Time frame: Pre-dose, Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Kyowa Kirin Co., Ltd.

CONTACT

[email protected]

+81-3-5205-7200

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Open-label, Single-arm, Phase 3 Study of KK8398 (Infigratinib) in Patients With Achondroplasia (AOBA Study)

Important dates

Study start
2024
Primary completion
2029
Study completion
2031
First posted
Apr 13, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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