BridgeMD
New treatment option for Heterotopic Ossification (HO)
Official title A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
ClinicalTrials.gov ID: NCT07024407
What this study is testing
What is Andecaliximab?
Andecaliximab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for heterotopic ossification (ho).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label study of andecaliximab in participants at risk of developing bone where bone should not be, such as in muscle, tendons, and other soft tissues following traumatic spinal cord injury. The goal of this study is to assess the safety of andecaliximab, how much drug is in the body over time (pharmacokinetics/PK), and how it affects the body (pharmacodynamics/PD) in participants who have had a recent traumatic spinal cord injury.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- Age 18 to 89 years.
- History of traumatic SCI that occurred a minimum of 10 days prior to first study dose.
- No significant HO identified by CT as defined in the Imaging Charter and meeting one of the following sets of criteria based on TPBS at end of...
- Within 1 month of injury AND
- AIS Grade A AND
You likely can't join if
- History of:
- Known monogenic disorder associated with HO.
- Bone or mineral disorder unrelated to HO or SCI.
- Malignancy (within the past 5 years). Untreated active infection at the time of enrollment Uncontrolled hypoparathyroidism or hyperparathyroidism...
- Current infection with COVID-19 or COVID-19 infection within 1 month of Study Day 1 if treated with nirmatrelvir/ritonavir or other COVID-19...
- COVID-19 vaccine within 1 month of Study Day 1.
See the full eligibility criteria
- Age 18 to 89 years.
- History of traumatic SCI that occurred a minimum of 10 days prior to first study dose.
- No significant HO identified by CT as defined in the Imaging Charter and meeting one of the following sets of criteria based on TPBS at end of screening: The Inflammatory Group: Inflammation consistent with developing...
- Within 1 month of injury AND
- AIS Grade A AND
- Male AND
- Age 18 to 45 years 4. Participant or legal representative able and willing to give informed consent and to adhere to the visits schedule and study procedures. 5\. Able to understand, undergo, and perform all protocol...
- History of:
- Known monogenic disorder associated with HO.
- Bone or mineral disorder unrelated to HO or SCI.
- Malignancy (within the past 5 years). Untreated active infection at the time of enrollment Uncontrolled hypoparathyroidism or hyperparathyroidism Uncontrolled hyperthyroidism, based on participant report or chart...
- Current infection with COVID-19 or COVID-19 infection within 1 month of Study Day 1 if treated with nirmatrelvir/ritonavir or other COVID-19 antiviral with a risk of rebound. (If a potential participant is experiencing...
- COVID-19 vaccine within 1 month of Study Day 1.
- Use of the following medication:
- Current or chronic use of tetracycline drugs
- Activated (1,25-OH) vitamin D (vitamin D2 and D3 allowed), phosphate or calcium supplements within 1 week of Study Day 1
- Treatment with another investigational product within 5 half lives of last dose at the time of Study Day 1 or one month, whichever is longer.
- History of allergy or hypersensitivity to andecaliximab or its excipients.
- Any of the following abnormalities detected on laboratory evaluation prior to Study Day 1:
- 25-OH vitamin D \<16 ng/mL (\<39.94 nmol/L).
- Current albumin corrected serum calcium level \ 11 mg/dL, or requiring treatment with IV fluids and/or bisphosphonates for hypercalcemia at time of enrollment.
- Impaired renal function. (estimated glomerular filtration rate [eGFR] \< 40 mL/min/1.73m2)
- Hepatic panel [aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, lactate dehydrogenase (LDH)] \>3 × ULN for ageHemoglobin \<9.5 g/dL (\<5.9 mmol/L).
- Absolute neutrophil count (ANC) \<1,500 mm3(\<1.5 × 109/L).
- Platelets \<75,000/μL (\<75 × 109/L).
- Breastfeeding.
- Pregnancy, planned pregnancy, or unwillingness to use acceptable birth control during the study and for 90 days after the last dose.
- Simultaneous participation in another treatment clinical trial.
- Any other significant medical condition or disability or biochemical or hematologic abnormalities, that in the opinion of the Investigator would expose the participant to undue risk, prevent the conduct of study...
- Employees of the Sponsor, study site, or CRO involved in the conduct of the study or immediate family members thereof.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, 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, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, 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 ClinicalTrials.gov; the study team decides eligibility.