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

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: Terminated
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Drug: AGA111; Drug: Placebo

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: Interventional
• Enrollment (Actual): 412
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Overall success rate: Proportion of subjects who achieve overall success.	Up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Success rate of radiographic fusion	Up to 52 weeks
Mean change of ODI (Oswestry Disability Index) score	Up to 52 weeks

Collaborators and Investigators

• Sponsor: Angitia Biopharmaceuticals
• Investigators: Study Director: Angitia Medical Director, Angitia Biopharmaceutics Guangzhou Limited

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2023
• Primary Completion (Actual): November 28, 2025
• Study Completion (Actual): June 12, 2026

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Degeneration
• Other Study ID 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