Actively Recruiting
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
Led by Ashibio Inc · Updated on 2025-06-17
10
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 89 years
- History of traumatic spinal cord injury at least 10 days before first study dose
- No significant heterotopic ossification by CT scan
- Either inflammation or minimal extraskeletal uptake on TPBS scan at screening, or meets criteria for high risk of HO (within 1 month of injury, AIS Grade A, male, age 18 to 45)
- Able and willing to provide informed consent and follow study procedures
- Able to understand and perform all study tasks
- Agrees to provide access to relevant medical records
You will not qualify if you...
- Known monogenic disorder related to heterotopic ossification
- Bone or mineral disorders unrelated to HO or spinal cord injury
- Cancer within past 5 years
- Untreated active infection at enrollment
- Uncontrolled parathyroid or thyroid disorders
- Current or recent COVID-19 infection or recent COVID-19 vaccination
- Current or chronic use of tetracycline drugs
- Use of activated vitamin D, phosphate, or calcium supplements within 1 week before study start
- Recent treatment with another investigational product
- Allergy or hypersensitivity to andecaliximab or its ingredients
- Low vitamin D levels (<16 ng/mL)
- Abnormal calcium levels requiring treatment
- Impaired kidney function (eGFR < 40 mL/min/1.73m2)
- Liver function tests more than 3 times the upper limit of normal
- Low hemoglobin (<9.5 g/dL), neutrophils (<1,500/mm3), or platelets (<75,000/uL)
- Breastfeeding
- Pregnancy, planned pregnancy, or unwillingness to use birth control
- Participation in another interventional clinical trial
- Any other significant medical condition or abnormality that increases risk or interferes with the study
- Employment or immediate family employment with the study sponsor, site, or CRO
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Craig Hospital
Denver, Colorado, United States, 80113
Actively Recruiting
Research Team
A
ashibio ashibio Clinical Study Inquiries
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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