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

NCT07024407 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ASH-HO-201
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Heterotopic Ossification (HO)

Keywords

Heterotopic Ossification; traumatic spinal cord injury

Outcome Measures

Primary Outcomes (3)

• 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)

  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 \[Cmax\],

  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

  From baseline (Week 1) through Week 9 or Early Termination

Secondary Outcomes (1)

• To describe the PD profile of andecaliximab in all participants

  From baseline (Week 1) through Week 9 or Early Termination

Other Outcomes (4)

• Exploratory: To evaluate the efficacy of andecaliximab to inhibit new HO or continued development of HO in all participants

  From baseline (Week 1) to Week 9

• To evaluate the response to adecaliximab in participant function

  From baseline (Week 1) to Week 9

• To evaluate the response to adecaliximab in participant function

  From baseline (Week 1) to Week 9

Study Arms (1)

Andecaliximab

EXPERIMENTAL

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

Drug: Andecaliximab

Interventions

Andecaliximab DRUG

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

Andecaliximab

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• \. Able to understand, undergo, and perform all protocol related procedures. 6. Agrees to provide access to all relevant current and historical medical records

You may not qualify if:

• 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.
• 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:
• 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)

Sponsors & Collaborators

• Ashibio Inc: lead

Study Sites (1)

Craig Hospital

Denver, Colorado, 80113, United States

RECRUITING

MeSH Terms

Conditions

Ossification, Heterotopic

Interventions

andecaliximab

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Park, MD

  Craig Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ashibio ashibio Clinical Study Inquiries

CONTACT

650-360-0036; ASH-HO-201@ashibio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will receive andecaliximab.

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 17, 2025
• Study Start: May 14, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

US (1)