Your session is about to expire
← Back to Search
Setrusumab for Osteogenesis Imperfecta (Orbit Trial)
Orbit Trial Summary
This trial is testing a new drug, setrusumab, to see if it can reduce the rate of fractures in people with osteogenesis imperfecta (OI), a condition that causes weak bones.
Orbit Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowOrbit Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Orbit Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I have received specific prior treatments.I have symptoms of Chiari malformation or basilar invagination, and no unstable neurological conditions in the past 2 years.I do not have severe kidney disease or disorders affecting my bones and hormones.My kidney function is very low.I haven't taken any bone-strengthening drugs in the last 6 months.I have Osteogenesis Imperfecta Type I, III, or IV confirmed by a genetic test.I have had a stroke, heart attack, mini-stroke, or severe chest pain.I have not taken Denosumab in the last 24 months.I have had cancer that spread to my bones or started in my bones.I agree not to take bisphosphonate therapy during the study.I am 18 or older and can give my consent, or if under 18, my guardian can consent for me.My vitamin D level is at least 20 ng/mL, or I've been supplementing if it was low.I have a history of spinal nerve passage narrowing not caused by scoliosis.I haven't had bone surgery in the last 6 months nor plan to in the first 3 months of the study.I have had one or more bone fractures in the last year, or two or more in the last two years, including major bones.I have been using bisphosphonates for at least 3 months.I have had radiation therapy from an external source.I have a bone condition that is not OI but causes long-bone deformities or increases my risk of fractures.I agree to use effective birth control during and up to 60 days after the study.
- Group 1: Placebo -> OL Setrusumab Selected Dose
- Group 2: Setrusumab Selected Dose -> OL Setrusumab Selected Dose
- Group 3: Low Dose Setrusumab -> Open-Label (OL) Setrusumab Selected Dose
- Group 4: High Dose Setrusumab -> OL Setrusumab Selected Dose
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How can I become a subject in this clinical trial?
"Eligibility for this study requires that patients have been diagnosed with lobstein's disease and are currently between the ages of 5 and 25. A total of 219 patients will be accepted."
In how many hospitals is this trial currently taking place?
"Presently, this study is being conducted at 29 sites which are situated in Seattle, Calgary, Tampa and 26 other cities. To limit travel commitments, patients should select the clinical trial site nearest to them."
Has this study been done before?
"Setrusumab is being used in an ongoing clinical trial that began in the year 2022. So far, the drug has been trialled across 23 cities and 12 countries. The original trial, which was sponsored by Mereo BioPharma, had 219 patients enrolled and completed both Phase 2 & 3 of testing. In the years since then, 18292 similar trials have been completed."
Does Setrusumab have a long history of research?
"At this time, there is 1 active clinical trial studying Setrusumab. Phase 3 trials are still ongoing and 59 different medical centres across Bologna and Tennessee are participating in the research."
How many individuals are experiencing this medication's effects in a controlled setting?
"That is correct. The information available on clinicaltrials.gov verifies that this trial is still looking for patients to enroll. This research was first made public on February 21st, 2022 and has since been updated October 31st, 2022. There are a total of 29 sites where the study is being conducted and they are hoping to find 219 individuals in total to participate."
Does this clinical research project have an age limit for participants?
"In order to meet the requirements for this particular clinical trial, applicants must be between 5 and 25 years old. There are 8 similar studies that welcome patients under 18 and 5 more trials open to those over 65."
Are new participants being enrolled in this trial right now?
"The clinical trial is still recruiting patients, according to the most recent update on clinicaltrials.gov. The study was first posted on February 21st, 2022 and last updated October 31st, 2022."
Share this study with friends
Copy Link
Messenger