Study 111-202
A Phase 2 Study of BMN 111 to Evaluate Safety, Tolerability, and Efficacy in Children with Achondroplasia (ACH)
This study is enrolling participants by invitation only
Estimated Enrollment: 46
Study start date: January 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: December 2018
| Arms | Assigned Interventions |
|---|---|
| Experimental: BMN 111 – Subcutaneous Injection
111-202 is an open-label sequential cohort dose-escalation study. BMN 111 will be administered as a morning dose in one of the following daily dosing regimens:
|
Drug: BMN 111
BMN 111 will be administered daily for 24 months in an open-label sequential dose adjustment fashion.
|
| Ages Eligible for Study: | 5 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Study 111-205
A Study to Evaluate Long-Term Safety, Tolerability, & Efficacy of BMN 111 in Children with Achondroplasia (ACH)
This study is enrolling participants by invitation only – is an extension study
Estimated Enrollment: 46
Study Start Date: January 2016
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: October 2022
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BMN 111 – Subcutaneous Injection 111-205 is an open-label, extension study. Subjects receive the same stable dose of BMN 111 received upon completion of the 111-202 study. BMN 111 will be administered in one of the following daily dosing regimens:
|
Drug: BMN 111
BMN 111 will be administered daily for up to 260 weeks – 5 years
|
| Ages Eligible for Study: | 7 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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