Phase 1b Study of Andecaliximab in Participants With Spinal Cord Injury at Risk of Developing Heterotopic Ossification
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Ashibio Inc
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- To evaluate the safety of andecaliximab in participants with SCI at risk for HO
Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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:
- •Within 1 month of injury AND
- •AIS Grade A AND
- •Age 18 to 45 years
- •Participant or legal representative able and willing to give informed consent and to adhere to the visits schedule and study procedures.
- •Able to understand, undergo, and perform all protocol related 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 T
- •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.
- •COVID-19 vaccine within 1 month of Study Day
- •Use of the following medication:
- •Current or chronic use of tetracycline drugs
- •Activated (1,25-OH) vitamin D (vitamin D2 and D3 allowed), phosphate or calcium supplements within 1 week of Study Day 1
- •Treatment with another investigational product within 5 half lives of last dose at the time of Study Day 1 or one month, whichever is longer.
Arms & Interventions
Andecaliximab
All participants will receive andecaliximab whether at risk for developing HO or at risk for worsening of early HO.
Intervention: Andecaliximab (Drug)
Outcomes
Primary Outcomes
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)
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 participants
Time Frame: From baseline (Week 1) through Week 9 or Early Termination
PK concentration at steady state \[Ctrough\]) describing the profile of andecaliximab
Secondary Outcomes
- To describe the PD profile of andecaliximab in all participants(From baseline (Week 1) through Week 9 or Early Termination)