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A study to test product setrusumab in subjects with brittle bone syndrome.
EU CTIS ID: 2024-510919-29-00
What this study is testing
Phase II: Identify a setrusumab dosing strategy in subjects with OI Phase III: Evaluate the effect of setrusumab vs placebo on reduction in fracture rate, excluding morphometric vertebral fractures and fractures of the fingers, toes, face, and skull
- Phase II and Phase III (Integrated)
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
- Males and females 5 to < 26 years of age at time of informed consent
- Diagnosis of OI Type I, III, or IV as confirmed by identification of pathogenic or likely pathogenic genetic variants in COL1A1 or COL1A2. If a variant of uncertain significance is identified, then clinical presence of the expected phenotype can be used to confirm the diagnosis.
- ≥ 1 fracture in the past 12 months, ≥ 2 fractures in the past 24 months, or ≥ 1 tibia, femur, or humerus fracture in the past 24 months
- Serum 25-hydroxyvitamin D ≥ 20 ng/mL at the Screening Visit. If 25- hydroxyvitamin D levels are below 20 ng/mL, 25-hydroxyvitamin D testing can be repeated after a minimum of 14 days of vitamin D supplementation as directed by the treating physician
- Willing to not receive bisphosphonate therapy during the study
- From the period following informed consent to 60 days after the last dose of study drug, females of childbearing potential and fertile males must consent to use highly effective contraception. If female, agree not to become pregnant. If male, agree not to father a child or donate sperm
You likely can't join if
- For Phase 2 subjects only, a history of major bone surgery within the previous 6 months prior to Screening or planned major bone surgery for the first 3 months of the study
- Prior treatment with the following: a. Teriparatide, growth hormone, bone anabolic, or anti-resorptive medications (other than bisphosphonates) within 6 months of the first dose with study drug (Month 0) b. Denosumab within 24 months of the first dose with study drug (Month 0) c. Romosozumab at any time
- Documented alcohol and/or drug abuse within 12 months prior to dosing or evidence of such abuse, as determined by the Investigator
- Presence or history of any condition that, in the view of the Investigator, would interfere with participation, pose undue risk, or would confound interpretation of results
- Known hypersensitivity to setrusumab or its excipients that, in the judgment of the Investigator, places the subject at increased risk for adverse effects
- History of external radiation therapy
See the full eligibility criteria
Who can join
- Males and females 5 to < 26 years of age at time of informed consent
- Diagnosis of OI Type I, III, or IV as confirmed by identification of pathogenic or likely pathogenic genetic variants in COL1A1 or COL1A2. If a variant of uncertain significance is identified, then clinical presence of the expected phenotype can be used to confirm the diagnosis.
- ≥ 1 fracture in the past 12 months, ≥ 2 fractures in the past 24 months, or ≥ 1 tibia, femur, or humerus fracture in the past 24 months
- Serum 25-hydroxyvitamin D ≥ 20 ng/mL at the Screening Visit. If 25- hydroxyvitamin D levels are below 20 ng/mL, 25-hydroxyvitamin D testing can be repeated after a minimum of 14 days of vitamin D supplementation as directed by the treating physician
- Willing to not receive bisphosphonate therapy during the study
- From the period following informed consent to 60 days after the last dose of study drug, females of childbearing potential and fertile males must consent to use highly effective contraception. If female, agree not to become pregnant. If male, agree not to father a child or donate sperm
- Willing and able to provide informed consent for subjects ≥ 18 years of age, or provide assent (if possible) and have a legally authorized representative provide informed consent, after the nature of the study has been explained and prior to any research-related procedures
- Willing to provide access to medical records for the collection of radiographic data, fracture data, growth data, and disease history
- Must, in the opinion of the Investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule, and comply with the assessments
What rules you out
- For Phase 2 subjects only, a history of major bone surgery within the previous 6 months prior to Screening or planned major bone surgery for the first 3 months of the study
- Prior treatment with the following: a. Teriparatide, growth hormone, bone anabolic, or anti-resorptive medications (other than bisphosphonates) within 6 months of the first dose with study drug (Month 0) b. Denosumab within 24 months of the first dose with study drug (Month 0) c. Romosozumab at any time
- Documented alcohol and/or drug abuse within 12 months prior to dosing or evidence of such abuse, as determined by the Investigator
- Presence or history of any condition that, in the view of the Investigator, would interfere with participation, pose undue risk, or would confound interpretation of results
- Known hypersensitivity to setrusumab or its excipients that, in the judgment of the Investigator, places the subject at increased risk for adverse effects
- History of external radiation therapy
- Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study
- Use of any investigational product or investigational medical device within 4 weeks or 5 half-lives of investigational drug (whichever is longer) prior to Screening, or during the study (per discretion of the Investigator in consultation with the Medical Monitor)
- Concurrent participation in another clinical study without prior approval from the Investigator in consultation with the Medical Monitor
- History of skeletal malignancies or bone metastases at any time
- History of neural foraminal stenosis (except if due to scoliosis)
- Clinically unstable manifestations of Chiari malformation or basilar invagination within the past 2 years. Presence of any other neurologic disease that has been clinically unstable within the past 2 years requires review by the Medical Monitor.
- History of or uncontrolled concomitant diseases such as hypo/hyperparathyroidism, Paget's disease, abnormal thyroid function, thyroid disease or other endocrine disorders or conditions that could affect bone metabolism
- Rickets or any skeletal condition (other than OI) leading to bone deformities and/or increased risk of fractures
- History of stroke, myocardial infarction, TIA, or angina. Investigators should consider whether the potential benefits of treatment outweigh the potential risks in patients with other cardiovascular risk factors such as hypertension, hyperlipidemia, familial hyperlipidemia, family history of premature ischemic cardiovascular disease, smoking, diabetes mellitus, and metabolic syndrome.
- Hypocalcemia, defined as serum calcium levels below the age-adjusted normal limits after a ≥ 4 hour fast
- Estimated glomerular filtration rate ≤ 29 mL/min/1.73 m2
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Australia
- United States
- Turkey
- United Kingdom
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, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Australia; United States; Turkey; United Kingdom. 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.