Evaluate the Efficacy and Safety of KK8398 in Patients Wi... | NCT06926491

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

NCT06926491

Sponsor

Kyowa Kirin Co., Ltd.

Status

Recruiting

Last Update Posted

Apr 29, 2025Actual

Enrollment

6Estimated

Phase

Phase 3

Conditions

Achondroplasia

Interventions

KK8398

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
jRCT2031240562	Registry Identifier	Japan Registry of Clinical Trials (jRCT)

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2024Actual

Primary Completion Date

May 31, 2029Estimated

Completion Date

May 31, 2031Estimated

First Submitted Date

Apr 1, 2025

First Submission Date that Met QC Criteria

Apr 7, 2025

First Posted Date

Apr 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2025

Last Update Posted Date

Apr 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Estimated

Label	Type	Description	Intervention Names
KK8398	Experimental		Drug: KK8398

Name	Type	Description	Arm Group Labels	Other Names
KK8398	Drug	KK8398 will be administered.	KK8398

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in annualized height velocity		Pre-dose, Week 52

Secondary Outcomes

Measure	Description	Time Frame
Height Z-score using growth tables in patients with achondroplasia and the change from baseline		Pre-dose, Week 52

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kyowa Kirin Co., Ltd.	Contact	+81-3-5205-7200		clinical.info.jp@kyowakirin.com

Overall Officials

Name	Affiliation	Role
Yu Sato	Kyowa Kirin Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aichi Children's Health and Medical Center	Recruiting	Ōbu	Aichi-ken		Japan

IPD Sharing Statement Module

Plan to Share IPD

Description

There is not a plan to make IPD available.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000130	Achondroplasia

Ancestor Terms

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided