Beyond Achondroplasia

Growing together with Clara

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

| 3 Comments

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:

  • 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.
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:

  • 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
Ages Eligible for Study: 7 Years to 16 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

3 Comments

  1. Como se pude registrar o incluir a una niña de 5 años en estos procedimientos investigativos de prueva ??

  2. Tengo alguna informacion q podria salir a la venta este medicamento en 2018 sera posible ??

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