BMN-111 Phase 2: study 111-202 and extension study 111-205

May 13, 2016 by inesp.alves | 3 Comments

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: Cohort 1: 2.5 microgram/kg, Cohort 2: 7.5 microgram/kg, Cohort 3: 15.0 microgram/kg, Cohort 4: 30.0 microgram/kg Cohort 5: up to 60.0 microgram/kg	Drug: BMN 111 BMN 111 will be administered daily for 24 months in an open-label sequential dose adjustment fashion.

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: 15 µg/kg 30 µg/kg up to 60 µg/kg daily	Drug: BMN 111 BMN 111 will be administered daily for up to 260 weeks – 5 years

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

Beyond Achondroplasia