Andecaliximab for Ectopic Ossification

(ANDECA-HO Trial)

Overseen By ashibio ashibio Clinical Study Inquiries

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ashibio Inc

Must not be taking: Tetracyclines, Vitamin D, Calcium

Disqualifiers: Malignancy, COVID-19, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called andecaliximab to determine if it can safely prevent unwanted bone growth in muscles and other soft tissues after a spinal cord injury. The study aims to understand how the drug moves through and affects the body. Suitable participants have experienced a recent traumatic spinal cord injury and have not yet developed significant abnormal bone growth. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications, like tetracycline drugs and specific vitamin D, phosphate, or calcium supplements, before joining the trial. The protocol does not specify other medications, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that andecaliximab is likely to be safe for humans?

Research has shown that andecaliximab has been tested in people before. In earlier studies, participants generally tolerated it well, meaning most did not experience serious problems. These studies provide extensive safety information, suggesting that andecaliximab is safe for use. While side effects can occur with any treatment, serious side effects have not been commonly reported with andecaliximab. Consulting a healthcare provider before joining any trial is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for ectopic ossification, which typically involve surgery or anti-inflammatory medications, andecaliximab offers a novel approach by targeting the underlying biological processes. This treatment is unique because it is an antibody that inhibits matrix metalloproteinase 9 (MMP-9), an enzyme involved in the formation of abnormal bone growth. Researchers are excited about andecaliximab because it has the potential to not only prevent the development of heterotopic ossification (HO) but also to stop the progression of early-stage HO, offering a proactive and potentially more effective strategy compared to current options.

What evidence suggests that andecaliximab might be an effective treatment for ectopic ossification?

Research shows that andecaliximab might help stop unwanted bone growth in soft tissues, such as muscles and tendons, after a spinal cord injury. Studies have found that this treatment targets specific proteins involved in bone growth, potentially preventing new bone from forming in undesired areas. Previous patients with conditions similar to abnormal bone growth experienced less bone development while using andecaliximab. Although more research is needed, early results suggest it could be a promising option for those at risk of unusual bone growth. All participants in this trial will receive andecaliximab, whether they are at risk for developing heterotopic ossification (HO) or for worsening of early HO. ^{1 6 7 8 9}

Who Is on the Research Team?

Andrew Park, MD

Principal Investigator

Craig Hospital

Are You a Good Fit for This Trial?

This trial is for individuals who have recently experienced a traumatic spinal cord injury and are at risk of developing abnormal bone growth in soft tissues. Specific eligibility criteria were not provided, so participants should consult with the study team to determine if they meet the necessary requirements.

Inclusion Criteria

- Early HO Group: The third phase on TPBS shows minimal extraskeletal uptake

I had a spinal cord injury at least 10 days ago.

- Prophylactic High-Risk Group: No findings consistent with increased risk of HO but meets specific clinical risk factors for HO.

Exclusion Criteria

I haven't had COVID-19 or been treated for it in the last month.

I do not have any untreated active infections.

I received a COVID-19 vaccine within the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive andecaliximab to assess safety, pharmacokinetics, and pharmacodynamics

9 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Andecaliximab

Trial Overview The study is testing Andecaliximab, a medication aimed at preventing ectopic ossification (bone growth outside the normal skeleton) after spinal cord injuries. It's an open-label trial, meaning everyone knows they're getting the drug, focusing on its safety and effects on the body.

How Is the Trial Designed?

Group I: Andecaliximab Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Ashibio Inc

Lead Sponsor

Trials

1

Recruited

90+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06508021

NCT06508021 | A Study of Andecaliximab in Participants ... This study is researching an experimental drug called andecaliximab. The study will include pediatric and adult patients with fibrodysplasia ossificans ...

2. ashibio.com ashibio.com/ashibio-doses-first-patient-in-phase-1b-trial-of-andecaliximab-in-patients-with-spinal-cord-injury-sci-at-risk-of-heterotopic-ossification-ho/

āshibio Doses First Patient in Phase 1b Trial of ... The trial signals a strategic expansion of the andecaliximab clinical development program into non-hereditary heterotopic ossification (NHHO).

3. patlynk.com patlynk.com/trial/NCT07024407

Andecaliximab for Heterotopic Ossification Prevention in ... This study focuses on testing a medicine called andecaliximab for people who have experienced a spinal cord injury. These individuals are at risk of ...

4. ifopa.org ifopa.org/andecaliximab

ANDECAL Trial (andecaliximab) The ANDECAL study will evaluate the safety and efficacy of andecaliximab in participants living with FOP to block excess bone formation (heterotopic bone) and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06508021?term=AREA%5BConditionSearch%5D(Fibrodysplasia%20ossificans%20progressiva%20OR%20%22fop%22%20OR%20%22%20progressive%20myositis%20ossificans%22%20OR%20%22%20progressive%20ossifying%20myositis%22%20OR%20%22%20stone%20man%20syndrome%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=5

NCT06508021 | A Study of Andecaliximab in Participants ... This study is researching an experimental drug called andecaliximab. The study will include pediatric and adult patients with fibrodysplasia ossificans ...

6. withpower.com withpower.com/trial/phase-2-ossification-heterotopic-4-2025-09c32

Andecaliximab for Ectopic Ossification (ANDECA-HO Trial) 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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07024407

NCT07024407 | A Study of Andecaliximab in People With ... 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 ( ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548730/

Medical guidelines for fibrodysplasia ossificans progressiva RJP is a co-inventor for the use of Andecaliximab in conditions of heterotopic ossification. Data availability. Not applicable. References. 1. Pignolo RJ ...

9. endocrinenews.endocrine.org endocrinenews.endocrine.org/pharma-fridays-january-24-2025/

Pharma Fridays - January 24, 2025 - Endocrine News Andecaliximab has extensive prior human clinical experience and safety data. Our team is dedicated to advancing this potential first-in ...