← Back to Search

Peptide

BMN 111 for Achondroplasia

Phase 3
Waitlist Available
Research Sponsored by BioMarin Pharmaceutical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female >= 10 years old or who have begun menses must have a negative pregnancy test at the Baseline Visit and be willing to have additional pregnancy tests during the study
Must not have
Current therapy with medications known to alter renal function
Permanently discontinued BMN 111 or placebo prior to completion of the 111-301 study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to at least 16 years of age for females and 18 years of age for males
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing if a new drug, BMN 111, is a safe and effective treatment for children with achondroplasia.

Who is the study for?
This trial is for children with Achondroplasia who completed Study 111-301. They must be willing to use contraception if sexually active, and girls over 10 or menstruating need a negative pregnancy test. Participants should commit to study procedures, and minors require consent from guardians.
What is being tested?
The Phase 3 study tests BMN 111's effectiveness and safety in treating Achondroplasia in children. It aims to provide an additional therapeutic option by extending previous research findings from an earlier phase of the study.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions related to growth patterns since BMN 111 targets bone development disorders like Achondroplasia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a female over 10 or have started my periods and can take pregnancy tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am taking medication that affects my kidney function.
Select...
I stopped taking BMN 111 or placebo before finishing the 111-301 study.
Select...
My growth has slowed to less than 1.5 cm/year or my growth plates have closed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to at least 16 years of age for females and 18 years of age for males
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to at least 16 years of age for females and 18 years of age for males for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baselines in mean annualized growth velocity
Secondary study objectives
BMN 111 Activity Biomarkers
Effect of BMN 111 on bone morphology and quality
Final Adult Height
Other study objectives
Optional exploratory genomic biomarker analysis

Side effects data

From 2019 Phase 3 trial • 121 Patients • NCT03197766
73%
Injection site reaction
68%
Injection site erythema
38%
Injection site swelling
27%
Vomiting
27%
Nasopharyngitis
23%
Headache
17%
Pyrexia
15%
Arthralgia
13%
Injection site urticaria
13%
Upper respiratory tract infection
12%
Blood pressure decreased
12%
Cough
10%
Oropharyngeal pain
10%
Ear pain
10%
Otitis media
10%
Diarrhoea
10%
Ear infection
8%
Viral infection
8%
Injection site bruising
8%
Pain in extremity
8%
Influenza
7%
Fatigue
7%
Injection site mass
7%
Gastroenteritis viral
7%
Gastroenteritis
7%
Seasonal allergy
7%
Dizziness
7%
Fall
5%
Tonsillitis
5%
Injection site rash
5%
Nausea
5%
Arthropod bite
5%
Otorrhoea
5%
Abdominal pain
5%
Nasal congestion
5%
Dry skin
5%
Vitamin D deficiency
3%
Injection site induration
3%
Injection site inflammation
3%
Injection site vesicles
3%
Injection site pain
3%
Injection site haemorrhage
3%
Otitis externa
3%
Bronchitis
3%
Enterobiasis
3%
Abdominal pain upper
3%
Neck pain
3%
Bone contusion
3%
Ligament sprain
3%
Procedural anxiety
3%
Body temperature increased
3%
Paraesthesia
3%
Presyncope
3%
Rhinorrhoea
3%
Tympanic membrane perforation
2%
Gait disturbance
2%
Radius fracture
2%
Adenoidal hypertrophy
2%
Sleep apnoea syndrome
2%
Cellulitis
2%
Lower respiratory tract infection
2%
Influenza like illness
2%
Impetigo
2%
Otitis media acute
2%
Pharyngitis
2%
Sinusitis
2%
Tooth abscess
2%
Varicella
2%
Viral pharyngitis
2%
Viral upper respiratory tract infection
2%
Localised infection
2%
Scarlet fever
2%
Streptococcal infection
2%
Lethargy
2%
Migraine
2%
Constipation
2%
Gingival pain
2%
Arthropathy
2%
Back pain
2%
Arthropod sting
2%
Back injury
2%
Contusion
2%
Procedural dizziness
2%
Skin abrasion
2%
Thermal burn
2%
Nasal obstruction
2%
Pulmonary congestion
2%
Dermatitis allergic
2%
Drug eruption
2%
Hyperhidrosis
2%
Pruritus
2%
Rash pruritic
2%
Pallor
2%
Ocular hyperaemia
2%
Enuresis
2%
Injection site discolouration
2%
Injection site pruritus
2%
Croup infectious
2%
Hand-foot-and-mouth disease
2%
Disturbance in attention
2%
Hyperreflexia
2%
Hypotension
2%
Scratch
2%
Ear discomfort
2%
Excessive cerumen production
2%
External ear inflammation
2%
Middle ear effusion
2%
Acanthosis nigricans
2%
Acne
2%
Rash
2%
Malaise
2%
Pain
2%
Lip swelling
2%
Malpositioned teeth
2%
Device expulsion
2%
Vulvovaginal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
BMN 111 - 15 μg/kg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BMN 111Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMN 111
2016
Completed Phase 3
~310

Find a Location

Who is running the clinical trial?

BioMarin PharmaceuticalLead Sponsor
159 Previous Clinical Trials
114,955 Total Patients Enrolled
13 Trials studying Achondroplasia
2,996 Patients Enrolled for Achondroplasia

Media Library

BMN 111 (Peptide) Clinical Trial Eligibility Overview. Trial Name: NCT03424018 — Phase 3
Achondroplasia Research Study Groups: BMN 111
Achondroplasia Clinical Trial 2023: BMN 111 Highlights & Side Effects. Trial Name: NCT03424018 — Phase 3
BMN 111 (Peptide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03424018 — Phase 3
~58 spots leftby Jun 2031
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top