A Phase 3 Study of AGA111 in Patients With Degenerative Disc Disease Undergoing Lumbar Interbody … (NCT06115512) | Clinical Trial Compass
TerminatedPhase 3
A Phase 3 Study of AGA111 in Patients With Degenerative Disc Disease Undergoing Lumbar Interbody Fusion
Stopped: Sponsor's strategic decision not related to safety concerns.
China412 participantsStarted 2023-12-08
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. Has radiographic evidence (e.g., X-ray and CT/magnetic resonance imaging MRI) of degenerative disc disease;
. Adults ≥ 18 and ≤ 80 years of age and skeletally mature at the time of surgery;
. Plan to undergo a single-level lumbar interbody fusion;
. Preoperative ODI score ≥ 30;
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall success rate: Proportion of subjects who achieve overall success.
. Willing and able to comply with the protocol and able to understand and sign the subject's informed consent form (ICF) ;
. 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
. 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);
. Known other significant lumbar instability;
. Lumbar scoliosis \> 30 degrees (evaluated by investigators);
. Presence of active malignancy or prior history of malignancy;
. Overt or active infection, either local to surgical space or systemic;
. Patients with a dual-energy X-ray absorption (DXA) total hip T-score ≤ -3.0;
. Body weight index (BMI) \<18.5 kg/m2 or BMI \> 35 kg/m2;
. Have received other treatments affecting fusion surgery, such as radiotherapy near the surgical site;