A Phase 3 Study of AGA111 in Patients With Degenerative Disc Disease Undergoing Lumbar Interbody Fusion

June 25, 2026 updated by: Angitia Biopharmaceuticals

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Lntervertebral Local Administration of AGA111 in Patients With Degenerative Disc Disease Undergoing Lumbar Lnterbody Fusion

The primary objective of the study is to assess the overall efficacy of a single intervertebral local administration of AGA111 in patients with degenerative disc disease undergoing lumbar interbody fusion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single intervertebral local administration of AGA111 in patients with degenerative disc disease undergoing lumbar interbody fusion. About 400 subjects who meet the eligibility criteria will be randomly assigned to the following two treatment groups in a 1:1 ratio.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
412

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, China
        • Beijing Tsinghua Changgung Hospital
      • Beijing, Beijing Municipality, China
        • Peking Union Medical College Hospital
      • Beijing, Beijing Municipality, China
        • Xuanwu Hospital Capital Medical University
      • Beijing, Beijing Municipality, China
        • Beijing Jishuitan Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • The First Affiliated Hospital of Chongqing Medical University
    • Fujian
      • Fuzhou, Fujian, China
        • The First Affiliated Hospital of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, China
        • Nanfang Hospital
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Guangzhou, Guangdong, China
        • Guangdong Provincial People's Hospital
      • Shaoguan, Guangdong, China
        • Yuebei People's Hospital
      • Shenzhen, Guangdong, China
        • Peking University Shenzhen Hospital
      • Shenzhen, Guangdong, China
        • Shenzhen Second People's Hospital
      • Shenzhen, Guangdong, China
        • The University of Hong Kong - Shenzhen Hospital
    • Guizhou
      • Bijie, Guizhou, China
        • Zhejiang Provincial People's Hospital Bijie Hospital
    • Hebei
      • Shijiazhuang, Hebei, China
        • Hebei Medical University Third Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Wuhan, Hubei, China
        • Tongji Hospital, Tongji Medical College, Huazhong Universit of Science and Technology
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing Drum Tower Hospital
      • Suzhou, Jiangsu, China
        • The First Affiliated Hospital of Soochow University
      • Suzhou, Jiangsu, China
        • The Second Affiliated Hospital of Soochow University
    • Liaoning
      • Shenyang, Liaoning, China
        • Shenyang Orthopedics Hospital
    • Ningxia
      • Yinchuan, Ningxia, China
        • General Hospital of Ningxia Medical University
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital of Shandong University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Shanghai, Shanghai Municipality, China
        • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
    • Shanxi
      • Taiyuan, Shanxi, China
        • Shanxi Bethune Hospital
      • Taiyuan, Shanxi, China
        • Second Hospital of Shanxi Medical University
      • Xi’an, Shanxi, China
        • Xi'an Honghui Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital of Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Tianjin First Central Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Provincial People's Hospital
      • Hangzhou, Zhejiang, China
        • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Wenzhou, Zhejiang, China
        • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Has degenerative disc disease of L3-S1 with low back pain, with or without a history of radiating leg or buttock pain, paresthesia, numbness or weakness secondary to radiculopathy of the corresponding spinal segment;
  2. Has radiographic evidence (e.g., X-ray and CT/magnetic resonance imaging MRI) of degenerative disc disease;
  3. Adults ≥ 18 and ≤ 80 years of age and skeletally mature at the time of surgery;
  4. Plan to undergo a single-level lumbar interbody fusion;
  5. Preoperative ODI score ≥ 30;
  6. Has not respond to conservative treatment (e.g, bed rest, physical therapy, drugs, local injections, manipulation and other non-surgical treatments) for a period of at least 3 months;
  7. Willing and able to comply with the protocol and able to understand and sign the subject's informed consent form (ICF) ;
  8. Female subjects of child-bearing potential must agree to use a highly effective method of birth control during the study and for 1 year after the administration of investigational drug, and must have a negative pregnancy test prior to the randomization.

Exclusion Criteria:

  1. Has undergone other decompression, fusion, and/or other non-fusion spinal surgery at the spinal segment intended to undergo the surgery prior to the screening (except for transforaminal endoscopic discectomy);
  2. Known other significant lumbar instability;
  3. Lumbar scoliosis > 30 degrees (evaluated by investigators);
  4. Presence of active malignancy or prior history of malignancy;
  5. Overt or active infection, either local to surgical space or systemic;
  6. Patients with a dual-energy X-ray absorption (DXA) total hip T-score ≤ -3.0;
  7. Body weight index (BMI) <18.5 kg/m2 or BMI > 35 kg/m2;
  8. Have received other treatments affecting fusion surgery, such as radiotherapy near the surgical site;
  9. Presence of other co-morbidities of the spine or upper/lower extremities that may affect the investigator's assessment of the lumbosacral nervous system and/or pain;
  10. Presence of mental disease or psychiatric condition that interferes with the patient's self-assessment of function, pain, or quality of life;
  11. History of progressive osseous heteroplasia or fibrodysplasia ossificans progressiva;
  12. Known hypersensitivity or allergy to bone morphogenetic protein (BMP) products or their excipient; and/or instrumentation materials in surgery, e.g., titanium, titanium alloy, cobalt chrome, cobalt chrome alloy, or polyetheretherketone (PEEK);
  13. Pregnant or lactating women; or plan to become pregnant within 1 year following the study surgery.
  14. Other conditions that, in the opinion of the investigator, would interfere with the subject's ability to comply with the protocol, and other conditions that will make the subject inappropriate for participation in the study as judged by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo in ABC is locally delivered at the intervertebral space.
Drug: Placebo
Placebo is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.
Experimental: AGA111
AGA111 in autologous blood coagulum (ABC) is locally delivered at the intervertebral space.
Drug: AGA111
AGA111 is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall success rate: Proportion of subjects who achieve overall success.
Time Frame: Up to 52 weeks
Up to 52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Success rate of radiographic fusion
Time Frame: Up to 52 weeks
Up to 52 weeks
Mean change of ODI (Oswestry Disability Index) score
Time Frame: Up to 52 weeks
Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Angitia Biopharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Angitia Medical Director, Angitia Biopharmaceutics Guangzhou Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACT22-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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