NCT06926491 Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study）
| NCT ID | NCT06926491 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Kyowa Kirin Co., Ltd. |
| Condition | Achondroplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2029-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 6 participants in total. It began in 2024-12-01 with a primary completion date of 2029-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Yu Sato
STUDY DIRECTOR
Kyowa Kirin Co., Ltd.
Frequently Asked Questions
Who can join the NCT06926491 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Achondroplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06926491 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 6 participants.
Is NCT06926491 currently recruiting?
Yes, NCT06926491 is actively recruiting participants. Contact the research team at clinical.info.jp@kyowakirin.com for enrollment information.
Where is the NCT06926491 trial being conducted?
This trial is being conducted at Ōbu, Japan, Suita, Japan, Waizumi, Japan, Fuchū, Japan and 5 additional locations.
Who is sponsoring the NCT06926491 clinical trial?
NCT06926491 is sponsored by Kyowa Kirin Co., Ltd.. The principal investigator is Yu Sato at Kyowa Kirin Co., Ltd.. The trial plans to enroll 6 participants.