Evaluating AGA111 for patients with degenerative disc disease undergoing lumbar 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

This study is testing a new treatment called AGA111 for people with degenerative disc disease who are having surgery for their back pain to see if it helps them feel better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Angitia Biopharmaceuticals (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT06115512 on ClinicalTrials.gov

What this trial studies

This phase 3, randomized, double-blind, placebo-controlled study aims to assess the efficacy and safety of AGA111, administered locally in the intervertebral space, for patients with degenerative disc disease who are scheduled for lumbar interbody fusion. Approximately 400 participants will be randomly assigned to receive either AGA111 or a placebo in a 1:1 ratio. The study focuses on patients experiencing significant low back pain and who have not responded to conservative treatments for at least three months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with degenerative disc disease and significant low back pain who are scheduled for a single-level lumbar interbody fusion.

Not a fit: Patients who have not experienced significant low back pain or who have not undergone conservative treatment for at least three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate pain and improve recovery outcomes for patients undergoing lumbar fusion.

How similar studies have performed: While similar approaches have been explored, this specific intervention with AGA111 in the context of lumbar fusion is novel.

Eligibility criteria

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.

Where this trial is running

Beijing

• Peking University Third Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Trial Recruitment

Conditions Degenerative Disc Disease