160 Participants NeededMy employer runs this trial

BMN 333 vs Vosoritide for Achondroplasia

(ASPEN Trial)

Recruiting at 3 trial locations
TS
SM
Overseen ByStudy Manager
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a multicenter, multinational, randomized, active-controlled, operationally seamless Phase 2/3 study of BMN 333 in treatment-naïve pediatric participants with achondroplasia (ACH). The study consists of a Phase 2 part and a Phase 3 part.

Who Is on the Research Team?

MD

Medical Director, PhD

Principal Investigator

BioMarin Pharmaceutical

Are You a Good Fit for This Trial?

Inclusion Criteria

I can walk and stand on my own without help.
I am between 2 and 10 years old (Phase 2) or 2 and 17 years old (Phase 3).
I have achondroplasia confirmed by genetic testing and my bone growth plates are still open.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 9 weeks

Treatment

Participants receive BMN 333 or vosoritide for growth promotion

52 weeks
BMN 333: once weekly; Vosoritide: once daily

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 9 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BMN 333

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Active Control

Group I: Phase 3: BMN 333 at selected dose after Phase 2Experimental Treatment1 Intervention
Group II: Phase 2: Medium DoseExperimental Treatment1 Intervention
Group III: Phase 2: Low DoseExperimental Treatment1 Intervention
Group IV: Phase 2: High DoseExperimental Treatment1 Intervention
Group V: Phase 3: VosoritideActive Control1 Intervention
Group VI: Phase 2: VosoritideActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BioMarin Pharmaceutical

Lead Sponsor

Trials
162
Recruited
115,000+
Alexander Hardy profile image

Alexander Hardy

BioMarin Pharmaceutical

Chief Executive Officer since 2023

MBA from INSEAD

Greg Friberg profile image

Greg Friberg

BioMarin Pharmaceutical

Chief Medical Officer

MD from New York Medical College