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New shot during back surgery may boost spine healing in disc disease patients

NCT ID NCT06115512

Disease control Sponsor: Angitia Biopharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This study tests a single injection of a drug called AGA111 given directly into the spine during back fusion surgery for people with degenerative disc disease. The goal is to see if it helps the bones heal together more successfully and improves pain and function. About 412 adults aged 18 to 80 with disc disease at certain spine levels are taking part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

412 people

The number who actually took part.

Started

Dec 2023

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Degenerative disc disease

Contacts and locations

Locations

  • Beijing Jishuitan Hospital

    Beijing, Beijing Municipality, China

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, China

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, China

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, China

  • Hebei Medical University Third Hospital

    Shijiazhuang, Hebei, China

  • Nanfang Hospital

    Guangzhou, Guangdong, China

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, China

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, China

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, China

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, China

  • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, China

  • Shenyang Orthopedics Hospital

    Shenyang, Liaoning, China

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, China

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, China

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, China

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen, Guangdong, China

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, China

  • Tongji Hospital, Tongji Medical College, Huazhong Universit of Science and Technology

    Wuhan, Hubei, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, China

  • Xi'an Honghui Hospital

    Xi’an, Shanxi, China

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, China

  • Yuebei People's Hospital

    Shaoguan, Guangdong, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, China

  • Zhejiang Provincial People's Hospital Bijie Hospital

    Bijie, Guizhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.