Andecaliximab for Bone Growth After Spinal Cord Injury
This study is looking at andecaliximab to see if it can help people with spinal cord injuries who are at risk of developing extra bone growth (heterotopic ossification or HO) in places like muscles or tendons. Researchers want to understand if andecaliximab is safe, how much of the drug stays in your body over time, and how it affects your body. You may be able to join if you are between 18 and 89 years old and have had a spinal cord injury at least 10 days ago, with signs of developing HO. The study is currently unclear about its recruitment status and plans to enroll 10 participants.
- Study design
- This is an open-label study, meaning both you and the study team will know you are receiving andecaliximab. It plans to enroll 10 participants.
- What's involved
- You will receive weekly subcutaneous injections of andecaliximab, which can happen during hospitalization, clinic visits, or self-administered if you are discharged.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from when you sign the consent form until 4 weeks after week 9, or if you leave the study early.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Andrew Park, MD · PRINCIPAL_INVESTIGATOR · Craig Hospital
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- To evaluate the safety of andecaliximab in participants with SCI at risk for HOFrom signing of the informed consent form until the end of the Safety Follow-up Period (4 weeks after week 9 or Early Termination)
Incidence and severity of all serious adverse events (SAEs) and all treatment-emergent adverse events (TEAEs)
- To describe the PK profile of andecaliximab in all participantsFrom baseline (Week 1) through Week 9 or Early Termination
PK parameters (area under the time-concentration curve \[AUC\], maximum concentration \[Cmax\],
- To describe the PK profile of andecaliximab in all participantsFrom baseline (Week 1) through Week 9 or Early Termination
PK concentration at steady state \[Ctrough\]) describing the profile of andecaliximab