An Extension Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia

Part of paid clinical trials in Oakland, California.

Sponsor
BioMarin Pharmaceutical
Study ID
NCT03424018
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Achondroplasia

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMN 111 — DRUG
    Subcutaneous injection of recommended dose of BMN 111 based on weight-band dosing once daily.

Study Details

The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia

Key Dates

Start date
Dec 12, 2017
Status verified
Mar 2026
Primary completion
Jun 30, 2031
Completion
Jun 30, 2031

Study Design

Enrollment
119 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BMN 111

Primary Outcome Measure

Change from baselines in mean annualized growth velocity [ Time Frame: Through study completion, an average of 1 year ]

Locations (11)

FacilityCityStateZIPSite coordinators
Children's Hospital & Research Center OaklandOaklandCalifornia94609-
Harbor - UCLA Medical CenterTorranceCalifornia90509-
Alfred I. duPont Hospital for ChildrenWilmingtonDelaware19803-
Emory UniversityAtlantaGeorgia30322-
Ann and Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611-
Johns Hopkins UniversityBaltimoreMaryland21287-
University of MissouriColumbiaMissouri65201-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Baylor College of MedicineHoustonTexas77030-
Seattle Children's HospitalSeattleWashington98105-
Medical College of Wisconsin, Children's HospitalMilwaukeeWisconsin53226-

Find similar trials in Oakland, CA

By research site
Children's Hospital & Research Center Oakland· Oakland, CAHarbor - UCLA Medical Center· Torrance, CAAlfred I. duPont Hospital for Children· Wilmington, DEEmory University· Atlanta, GAAnn and Robert H. Lurie Children's Hospital of Chicago· Chicago, ILJohns Hopkins University· Baltimore, MD

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