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

Recruiting Phase 3 Interventional Study
Achondroplasia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
3 – 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
6 (estimated)
Sponsor
Kyowa Kirin Co., Ltd. · Industry
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About This Trial

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

Trial Locations
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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. …
Contacts

Kyowa Kirin Co., Ltd.

+81-3-5205-7200

clinical.info.jp@kyowakirin.com

CONTACT