A Phase 1/2 interventional study of Andecaliximab in Heterotopic Ossification (HO), sponsored by Ashibio Inc. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by Ashibio Inc · Phase 1/2, Interventional, and Prevention
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.
Safety: To evaluate the safety profile of andecaliximab in participants with spinal cord injurySCI at risk for Heterotopic Ossification.
PK: To describe the PK profile of andecaliximab in all participants.
Secondary Objective:
PD: To describe the PD profile of andecaliximab in all participants.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 10 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Ashibio Inc is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
History of:
Use of the following medication:
Any of the following abnormalities detected on laboratory evaluation prior to Study Day 1:
All participants will receive andecaliximab whether at risk for developing HO or at risk for worsening of early HO.
Drug: Andecaliximab
Participants will receive weekly subcutaneous injections of andecaliximab during inpatient hospitalization, clinic visit, or self-administration if discharged from the hospital
To evaluate the safety of andecaliximab in participants with SCI at risk for HO
Incidence and severity of all serious adverse events (SAEs) and all treatment-emergent adverse events (TEAEs)
Time frame: From signing of the informed consent form until the end of the Safety Follow-up Period (4 weeks after week 9 or Early Termination)
To describe the PK profile of andecaliximab in all participants
PK parameters (area under the time-concentration curve \[AUC\], maximum concentration \[Cmax\],
Time frame: From baseline (Week 1) through Week 9 or Early Termination
To describe the PK profile of andecaliximab in all participants
PK concentration at steady state \[Ctrough\]) describing the profile of andecaliximab
Time frame: From baseline (Week 1) through Week 9 or Early Termination
To describe the PD profile of andecaliximab in all participants
Andecaliximab MMP9 target coverage in plasma over time
Time frame: From baseline (Week 1) through Week 9 or Early Termination
Exploratory: To evaluate the efficacy of andecaliximab to inhibit new HO or continued development of HO in all participants
Radiographic studies to determine percent of participants with new HO lesion; and percent of participants with critical new HO volume
Time frame: From baseline (Week 1) to Week 9
To evaluate the response to adecaliximab in participant function
Changes in passive range of motion testing (PROM)/active range of motion testing (AROM)
Time frame: From baseline (Week 1) to Week 9
To evaluate the response to adecaliximab in participant function
Changes in International Standard for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time frame: From baseline (Week 1) to Week 9
To evaluate the response to andecaliximab in participant pain
Changes in International Spinal Cord Society (ISCOS) Spinal Cord Injury Pain Classification
Time frame: From baseline (Week 1) to Week 9
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Ashibio Inc