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ANDECA-HO

Andecaliximab for Heterotopic Ossification Prevention in Spinal Cord Injury Patients

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What is being tested

Andecaliximab

Drug
Who is being recruted

Heterotopic Ossification (HO)

From 18 to 89 Years
+33 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 1
Interventional
Study Start: May 2025

See protocol details

Summary

Principal SponsorAshibio Inc
Study Contactashibio ashibio Clinical Study Inquiries
Last updated: June 17, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: May 14, 2025Actual date on which the first participant was enrolled.

This study focuses on testing a medicine called andecaliximab for people who have experienced a spinal cord injury. These individuals are at risk of developing a condition called heterotopic ossification, where bone tissue forms outside the skeleton. The study aims to assess the safety of andecaliximab for these patients and understand how the drug behaves in the body. By investigating these aspects, the study might help prevent unwanted bone growth in people with spinal cord injuries, potentially improving their quality of life. Participants in the study will receive andecaliximab, though the method of administration is not specified. Researchers will monitor the participants to gather data on how the drug is processed in the body, referred to as pharmacokinetics (PK), and how it affects the body, known as pharmacodynamics (PD). This information helps determine the safety and effectiveness of andecaliximab in preventing heterotopic ossification. The study does not specify any risks or benefits for participants, but such studies typically aim to ensure that any risks are minimized while assessing the potential benefits of the treatment.

Official TitlePhase 1b Study of Andecaliximab in Participants With Spinal Cord Injury at Risk of Developing Heterotopic Ossification 
Principal SponsorAshibio Inc
Study Contactashibio ashibio Clinical Study Inquiries
Last updated: June 17, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
10 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 89 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Heterotopic Ossification (HO)
Criteria
10 inclusion criteria required to participate
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
he Inflammatory Group: Inflammation consistent with developing HO The Early HO Group: The third phase on TPBS shows minimal extraskeletal uptake

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23 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
All participants will receive andecaliximab whether at risk for developing HO or at risk for worsening of early HO.
Study Objectives
Primary Objectives

Incidence and severity of all serious adverse events (SAEs) and all treatment-emergent adverse events (TEAEs)

PK parameters (area under the time-concentration curve \[AUC\], maximum concentration \[Cmax\],

PK concentration at steady state \[Ctrough\]) describing the profile of andecaliximab
Secondary Objectives

Andecaliximab MMP9 target coverage in plasma over time

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Craig HospitalDenver, United StatesSee the location
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One Study Center