A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.

Part of paid clinical trials in Denver, Colorado.

Sponsor
Ashibio Inc
Study ID
NCT07024407
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Heterotopic Ossification (HO)

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Andecaliximab — DRUG
    Participants will receive weekly subcutaneous injections of andecaliximab during inpatient hospitalization, clinic visit, or self-administration if discharged from the hospital

Study Details

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.

Key Dates

Start date
May 14, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2025
Completion
Jan 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Andecaliximab
    All participants will receive andecaliximab whether at risk for developing HO or at risk for worsening of early HO.

Primary Outcome Measure

To evaluate the safety of andecaliximab in participants with SCI at risk for HO [ 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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Craig HospitalDenverColorado80113
Andrew Park, MD

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By research site
Craig Hospital· Denver, CO