A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the… (NCT07024407) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
United States10 participantsStarted 2025-05-14
Plain-language summary
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.
Who can participate
Age range18 Years – 89 Years
SexALL
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Inclusion 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:
✓. 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.
Exclusion criteria
✕. 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 review. Hyperthyroidism is defined by the presence of both a TSH level below the normal range and elevated T4.
✕. 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.
What they're measuring
1
To evaluate the safety of andecaliximab in participants with SCI at risk for HO
Timeframe: From signing of the informed consent form until the end of the Safety Follow-up Period (4 weeks after week 9 or Early Termination)
2
To describe the PK profile of andecaliximab in all participants
Timeframe: From baseline (Week 1) through Week 9 or Early Termination
3
To describe the PK profile of andecaliximab in all participants
Timeframe: From baseline (Week 1) through Week 9 or Early Termination