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Peptide

BMN 111 for Achondroplasia (ACH Trial)

Phase 2
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
Parents/caregivers willing to administer daily injections to the subjects and complete the required training
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

ACH Trial Summary

This trial is to study the long-term effects of a medication given to children with achondroplasia, a form of dwarfism. The study will track the children's safety and tolerability of the medication over a period of time.

Who is the study for?
This trial is for children with Achondroplasia who have already completed 24 months of BMN 111 treatment in a previous study. They must be able to perform study procedures, use contraception if sexually active, and not be pregnant. Those reaching legal adult age during the study will need to consent again.Check my eligibility
What is being tested?
The trial tests the long-term safety and effectiveness of daily injections of BMN 111 in children with Achondroplasia over an extended period after they've been treated for two years in a prior study (111-202).See study design
What are the potential side effects?
While specific side effects are not listed here, the trial aims to monitor any adverse reactions from long-term use of BMN 111 through daily injections administered by parents or caregivers.

ACH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My caregiver is ready to give me daily injections and has completed the necessary training.

ACH Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary outcome measures
Body Proportions (Efficacy)
Final Adult Height
Growth Parameters (Efficacy)
+1 more

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%
Ear pain
10%
Oropharyngeal pain
10%
Otitis media
10%
Diarrhoea
10%
Ear infection
8%
Viral infection
8%
Pain in extremity
8%
Injection site bruising
8%
Influenza
7%
Fatigue
7%
Gastroenteritis
7%
Gastroenteritis viral
7%
Injection site mass
7%
Seasonal allergy
7%
Dizziness
7%
Fall
5%
Arthropod bite
5%
Nausea
5%
Tonsillitis
5%
Injection site rash
5%
Otorrhoea
5%
Abdominal pain
5%
Nasal congestion
5%
Dry skin
5%
Vitamin D deficiency
3%
Ligament sprain
3%
Neck pain
3%
Procedural anxiety
3%
Bone contusion
3%
Injection site induration
3%
Body temperature increased
3%
Injection site vesicles
3%
Bronchitis
3%
Otitis externa
3%
Injection site pain
3%
Injection site haemorrhage
3%
Enterobiasis
3%
Injection site inflammation
3%
Abdominal pain upper
3%
Paraesthesia
3%
Presyncope
3%
Rhinorrhoea
3%
Tympanic membrane perforation
2%
Localised infection
2%
Streptococcal infection
2%
Thermal burn
2%
Drug eruption
2%
Arthropod sting
2%
Skin abrasion
2%
Gingival pain
2%
Nasal obstruction
2%
Pharyngitis
2%
Procedural dizziness
2%
Pallor
2%
Viral pharyngitis
2%
Back injury
2%
Dermatitis allergic
2%
Rash pruritic
2%
Hyperhidrosis
2%
Adenoidal hypertrophy
2%
Impetigo
2%
Migraine
2%
Otitis media acute
2%
Viral upper respiratory tract infection
2%
Scarlet fever
2%
Tooth abscess
2%
Pruritus
2%
Enuresis
2%
Cellulitis
2%
Influenza like illness
2%
Lower respiratory tract infection
2%
Back pain
2%
Contusion
2%
Sleep apnoea syndrome
2%
Ocular hyperaemia
2%
Arthropathy
2%
Sinusitis
2%
Radius fracture
2%
Varicella
2%
Constipation
2%
Pulmonary congestion
2%
Gait disturbance
2%
Lethargy
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

ACH Trial Design

1Treatment groups
Experimental Treatment
Group I: BMN 111 - Subcutaneous InjectionExperimental Treatment1 Intervention
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, initially up to 30 μg/kg. BMN 111 will be administered by weight-band dosing regimen.
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
157 Previous Clinical Trials
189,981 Total Patients Enrolled
13 Trials studying Achondroplasia
3,085 Patients Enrolled for Achondroplasia
Medical Director, MDStudy DirectorBioMarin Pharmaceutical
77 Previous Clinical Trials
16,382 Total Patients Enrolled
6 Trials studying Achondroplasia
914 Patients Enrolled for Achondroplasia

Media Library

BMN 111 (Peptide) Clinical Trial Eligibility Overview. Trial Name: NCT02724228 — Phase 2
Achondroplasia Research Study Groups: BMN 111 - Subcutaneous Injection
Achondroplasia Clinical Trial 2023: BMN 111 Highlights & Side Effects. Trial Name: NCT02724228 — Phase 2
BMN 111 (Peptide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02724228 — Phase 2
~9 spots leftby Dec 2027
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