Heterotopic Ossification (HO)Phase 1/2ANDECA-HONCT07024407
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
A Phase 1/2 study testing Andecaliximab in people with Heterotopic Ossification (HO), run by Ashibio Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Heterotopic Ossification (HO)
- What is being tested?
- Andecaliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2025to Jan 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- AIS Grade A AND
- Male AND
- 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.
- 5. Able to understand, undergo, and perform all protocol related procedures. 6. Agrees to provide access to all relevant current and historical medical records
Who cannot join
- 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 T4.
- 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 1.
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- 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.
- History of allergy or hypersensitivity to andecaliximab or its excipients.
- Any of the following abnormalities detected on laboratory evaluation prior to Study Day 1:
- 25-OH vitamin D <16 ng/mL (<39.94 nmol/L).
- 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.
- Impaired renal function. (estimated glomerular filtration rate [eGFR] < 40 mL/min/1.73m2)
- 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).
- Absolute neutrophil count (ANC) <1,500 mm3(<1.5 × 109/L).
- Platelets <75,000/μL (<75 × 109/L).
- Breastfeeding.
- Pregnancy, planned pregnancy, or unwillingness to use acceptable birth control during the study and for 90 days after the last dose.
- Simultaneous participation in another interventional clinical trial.
- 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.
- Employees of the Sponsor, study site, or CRO involved in the conduct of the study or immediate family members thereof.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1b Study of Andecaliximab in Participants With Spinal Cord Injury at Risk of Developing Heterotopic Ossification
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.
- Conditions
- Heterotopic Ossification (HO)
- Being tested
- Andecaliximab
- Keywords
- Heterotopic Ossification, traumatic spinal cord injury
- Medical subject headings
- Ossification, Heterotopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndecaliximabDrug
Participants will receive weekly subcutaneous injections of andecaliximab during inpatient hospitalization, clinic visit, or self-administration if discharged from the hospital
| Study group | Role | What they receive |
|---|---|---|
| Andecaliximab | Experimental | All participants will receive andecaliximab whether at risk for developing HO or at risk for worsening of early HO. Receives: Drug: Andecaliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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],
Measured: 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
Measured: 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
Measured: From baseline (Week 1) through Week 9 or Early Termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start14 May 2025
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heterotopic Ossification (HO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive andecaliximab.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ashibio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Park, MD, Principal investigator, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024407
- Sponsor's protocol ID
- ASH-HO-201
- Acronym
- ANDECA-HO
- Status last verified
- Nov 2026
- First submitted
- 20 May 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study of Andecaliximab in Participants With Spinal Cord Injury at Risk of Developing Heterotopic Ossification
- ClinicalTrials.gov ID
- NCT07024407
- Acronym / sponsor ID
- ANDECA-HO / ASH-HO-201
- Conditions
- Heterotopic Ossification (HO)
- Keywords
- Heterotopic Ossification, traumatic spinal cord injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ashibio IncIndustry (pharma, biotech, devices)
- Study start
- 14 May 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive andecaliximab.
| Arm | Type | Receives |
|---|---|---|
| Andecaliximab | Experimental | Drug: AndecaliximabAll participants will receive andecaliximab whether at risk for developing HO or at risk for worsening of early HO. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (23 listed)
- History of:
- Use of the following medication:
- History of allergy or hypersensitivity to andecaliximab or its excipients.
- Any of the following abnormalities detected on laboratory evaluation prior to Study Day 1:
- Breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AndecaliximabParticipants will receive weekly subcutaneous injections of andecaliximab during inpatient hospitalization, clinic visit, or self-administration if discharged from the hospital | Drug | Andecaliximab |
Primary outcome
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 parameters (area under the time-concentration curve [AUC], maximum concentration [Cmax],
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
1 secondary outcome
To describe the PD profile of andecaliximab in all participants
Time frame: From baseline (Week 1) through Week 9 or Early Termination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Park, MD principal investigator
Craig Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Andecaliximab in people with Heterotopic Ossification (HO), run by Ashibio Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.