Actively Recruiting
A Multicenter, Open-label, Single-arm, Phase 3 Study of KK8398 (Infigratinib) in Patients With Achondroplasia (AOBA Study)
Led by Kyowa Kirin Co., Ltd. · Updated on 2025-04-29
6
Participants Needed
9
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy of KK8398 (Infigratinib) in children and adolescents with achondroplasia, a genetic condition affecting bone growth. This Phase 3, open-label study aims to assess how the drug impacts annualized height velocity after one year of treatment. The study is sponsored by Kyowa Kirin Co., Ltd. and focuses on measuring growth changes in patients aged between 3 and 18 years. Participants will receive repeated doses of KK8398 over a 52-week period. The study is single-arm, meaning all participants receive the study drug without comparison to a placebo or alternative treatment. The treatment is administered according to the study protocol, with monitoring throughout the year. During the study, participants will undergo assessments including height measurements to determine changes in growth rate and height Z-scores using specific growth tables for achondroplasia patients. Evaluations occur at the start and after 52 weeks of treatment. Safety and treatment effects will be closely monitored, with the total study participation lasting at least one year.
CONDITIONS
Brief Title
Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 2.5 and 17.5 years at provisional registration
- Patients meeting specific Tanner stage and bone age criteria
- Diagnosis of achondroplasia confirmed by genetic testing
You will not qualify if you...
- Patients with height outside certain criteria by age and gender on the achondroplasia growth chart at pre-registration
- Recent treatment with r-hGH or CNP analogue before pre-enrollment
- Previous or planned osteotomy or epiphyseal growth inhibition during the study period (unless fully healed without sequelae more than 26 weeks prior)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive KK8398 as the study treatment to evaluate its efficacy and safety for achondroplasia.
Multiple visits during treatment period
Trial Site Locations
Total: 9 locations
1
Aichi Children's Health and Medical Center
Ōbu, Aichi-ken, Japan
Actively Recruiting
2
Osaka University Hospital
Suita, Osaka, Japan
Actively Recruiting
3
Osaka Women's and Children's Hospital
Waizumi, Osaka, Japan
Actively Recruiting
4
Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, Japan
Actively Recruiting
5
Tottori University Hospital
Yonago, Tottori, Japan
Actively Recruiting
6
Niigata University Medical and Dental Hospital
Niigata, Japan
Actively Recruiting
7
Okayama University Hospital
Okayama, Japan
Actively Recruiting
8
ISEIKAI International General Hospital
Osaka, Japan
Actively Recruiting
9
Osaka City General Hospital
Osaka, Japan
Actively Recruiting
Research Team
K
Kyowa Kirin Co., Ltd.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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