RecruitingHeterotopic Ossification (HO)
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
Eligible age
18–89 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Ashibio Inc
You may qualify if…
- ✓ 1. Age 18 to 89 years.
- ✓ 2. History of traumatic SCI that occurred a minimum of 10 days prior to first study dose.
- ✓ 3. 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 HO The Early HO Group: The third phase on TPBS shows minimal extraskeletal uptake
- ✓ The Prophylactic High-Risk Group: No findings consistent with increased risk of HO but meets all of the following clinical risk factors for HO:
- ✓ 1. Within 1 month of injury AND
- ✓ 2. AIS Grade A AND
- ✓ 3. Male AND
You may not qualify if…
- ✕ 1. History of:
- ✕ 1. Known monogenic disorder associated with HO.
- ✕ 2. Bone or mineral disorder unrelated to HO or SCI.
- ✕ 3. 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 review. Hyperthyroidism is defined by the presence of both a TSH level below the normal range and elevated T4.
- ✕ 4. 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 mild COVID-19-like symptoms, they should wait until they are asymptomatic and/or rule out COVID-19 infection by local COVID-19 PCR testing prior to on-site screening.) Asymptomatic patients are not required to undergo COVID-19 testing.
- ✕ 5. COVID-19 vaccine within 1 month of Study Day 1.
- ✕ 2. Use of the following medication:
- ✕ 1. Current or chronic use of tetracycline drugs
Where it's recruiting
Colorado
Denver
Source: ClinicalTrials.gov · NCT07024407 · last updated 2025-06-17