BridgeMD
A Long-term Study to Evaluate Safety, Tolerability, and Efficacy of BMN 111 in Children with Achondroplasia
EU CTIS ID: 2023-508754-26-00
What this study is testing
Primary Objective: To evaluate the long-term safety and tolerability of daily SC injections of BMN 111 in children with ACH
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Must have completed 24 months (± 14 days) of BMN 111 treatment in Study 111-202.
- Parent(s) or guardian(s) are willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to performance of any researchrelated procedure. Also, subjects under the age of 18 are willing and able to provide written assent (if required by local regulations or the IRB/EC) after the nature of the study has been explained and prior to performance of any researchrelated procedure.
- If sexually active, is willing to use a highly effective method of contraception while participating in the study
- Females ≥ 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
- Are willing and able to perform all study procedures as physically possible
- Caregivers are willing to administer daily injections to the subjects and complete the required training – not applicable in France
You likely can't join if
- Requires any investigational agent prior to completion of study period
- Have a condition or circumstance that, in the view of the Investigator, places the subject at high risk for poor treatment compliance or for not completing the study
- Concurrent disease or condition that, in the view of the Investigator, would interfere with study participation or safety evaluations for any reason
- Permanently discontinued BMN 111 during the 111-202 study
- Subject is pregnant at the Baseline visit or planning to become pregnant (self or partner) at any time during the study
- Current chronic therapy with any of the following restricted medications: • Antihypertensive medications • Angiotensin-converting enzyme (ACE) inhibitors • Angiotensin II receptor blockers • Diuretics • Beta-blockers • Calcium-channel blockers • Cardiac glycosides • Systemic anticholinergic agents • Any medication that may impair or enhance compensatory tachycardia, diuretics, or other drugs known to alter renal or tubular function
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.