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

Last updated: April 28, 2025
Sponsor: Kyowa Kirin Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Severe Short Stature

Treatment

KK8398

Clinical Study ID

NCT06926491
8398-001
jRCT2031240562
  • Ages 3-18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who are between 2.5 and 17.5 years old of age at the time of provisionalregistration. Patients who meet certain criteria in terms of Tanner stage and boneage.

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

Exclusion

Exclusion Criteria:

  1. Patients who meet the criteria for a certain height determined by age and gender inthe "Growth Chart for Patients with Achondroplasia" at the time of thepre-registration examination

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

  3. Patients who have had previous osteotomy or who are scheduled to undergo osteotomyor epiphyseal growth inhibition during the study period. Epiphyseal growthinhibition in which the plate was removed more than 26 weeks prior to thepre-registration examination will not be excluded if the patient has completelyhealed without sequelae, based on the judgment of the investigator orsub-investigator.

Study Design

Total Participants: 6
Treatment Group(s): 1
Primary Treatment: KK8398
Phase: 3
Study Start date:
December 01, 2024
Estimated Completion Date:
May 31, 2031

Connect with a study center

  • Aichi Children's Health and Medical Center

    Ōbu, Aichi
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Suita, Osaka
    Japan

    Active - Recruiting

  • Osaka Women's and Children's Hospital

    Waizumi, Osaka
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Children's Medical Center

    Fuchū, Tokyo
    Japan

    Active - Recruiting

  • Tottori University Hospital

    Yonago, Tottori
    Japan

    Active - Recruiting

  • Niigata University Medical and Dental Hospital

    Niigata,
    Japan

    Active - Recruiting

  • Okayama University Hospital

    Okayama,
    Japan

    Active - Recruiting

  • ISEIKAI International General Hospital

    Osaka,
    Japan

    Active - Recruiting

  • Osaka City General Hospital

    Osaka,
    Japan

    Active - Recruiting

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