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RecruitingNCT07024407ANDECA-HOUpdated Jun 17, 2025

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

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

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heterotopic Ossification (HO)

Keywords

  • Heterotopic Ossification
  • traumatic spinal cord injury
03

In context

Spinal Cord Injuries

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18 to 89 years.
  2. History of traumatic SCI that occurred a minimum of 10 days prior to first study dose.
  3. 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:

  1. Within 1 month of injury AND
  2. AIS Grade A AND
  3. Male AND
  4. 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.
  1. Able to understand, undergo, and perform all protocol related procedures. 6. Agrees to provide access to all relevant current and historical medical records

Exclusion criteria

Exclusion Criteria:

  1. History of:

    1. Known monogenic disorder associated with HO.
    2. Bone or mineral disorder unrelated to HO or SCI.
    3. 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.
    4. 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.
    5. COVID-19 vaccine within 1 month of Study Day 1.
  2. Use of the following medication:

    1. Current or chronic use of tetracycline drugs
    2. Activated (1,25-OH) vitamin D (vitamin D2 and D3 allowed), phosphate or calcium supplements within 1 week of Study Day 1
    3. 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.
  3. History of allergy or hypersensitivity to andecaliximab or its excipients.
  4. Any of the following abnormalities detected on laboratory evaluation prior to Study Day 1:

    1. 25-OH vitamin D \<16 ng/mL (\<39.94 nmol/L).
    2. Current albumin corrected serum calcium level \<8.0 mg/dL or >11 mg/dL, or requiring treatment with IV fluids and/or bisphosphonates for hypercalcemia at time of enrollment.
    3. Impaired renal function. (estimated glomerular filtration rate [eGFR] \< 40 mL/min/1.73m2)
    4. Hepatic panel [aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, lactate dehydrogenase (LDH)] >3 × ULN for ageHemoglobin \<9.5 g/dL (\<5.9 mmol/L).
    5. Absolute neutrophil count (ANC) \<1,500 mm3(\<1.5 × 109/L).
    6. Platelets \<75,000/μL (\<75 × 109/L).
  5. Breastfeeding.
  6. Pregnancy, planned pregnancy, or unwillingness to use acceptable birth control during the study and for 90 days after the last dose.
  7. Simultaneous participation in another interventional clinical trial.
  8. Any other significant medical condition or disability or biochemical or hematologic abnormalities, that in the opinion of the Investigator would expose the participant to undue risk, prevent the conduct of study procedures, or confound the study results.
  9. Employees of the Sponsor, study site, or CRO involved in the conduct of the study or immediate family members thereof.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Andecaliximab

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

    Drug: Andecaliximab

Interventions

  • DrugAndecaliximab

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

06

What researchers measure

Primary outcomes

  1. 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)

  2. 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

  3. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

1 of 1 sites recruiting
  • Craig Hospital
    Denver, Colorado 80113, United States
    • Andrew Park, MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07024407
Lead sponsor
Ashibio Inc
Responsible party
Sponsor
First posted
Jun 17, 2025
Start date
May 14, 2025
Primary completion
Dec 2025 (estimated)
Completion
Jan 2026 (estimated)
Last update
Jun 17, 2025

Study contacts

ashibio ashibio Clinical Study Inquiries
Contact
ASH-HO-201@ashibio.com
650-360-0036
Andrew Park, MD
principal investigator · Craig Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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