Degenerative Disc DiseasePhase 3NCT06115512
A Phase 3 Study of AGA111 in Patients With Degenerative Disc Disease Undergoing Lumbar Interbody Fusion
A Phase 3 study testing AGA111 in people with Degenerative Disc Disease, run by Angitia Biopharmaceuticals at 35 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- AGA111
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 412 participants
- Where
- 35 sitesChina
- Study dates
- 8 Dec 2023to 12 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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.
Who cannot join
- 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;
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- 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;
- 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;
- Presence of mental disease or psychiatric condition that interferes with the patient's self-assessment of function, pain, or quality of life;
- History of progressive osseous heteroplasia or fibrodysplasia ossificans progressiva;
- 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);
- Pregnant or lactating women; or plan to become pregnant within 1 year following the study surgery.
- 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.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
China35 sites
Beijing Jishuitan Hospital
Beijing, Beijing Municipality
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Peking University Third Hospital
Beijing, Beijing Municipality
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality
Zhejiang Provincial People's Hospital Bijie Hospital
Bijie, Guizhou
West China Hospital of Sichuan University
Chengdu, Sichuan
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Nanfang Hospital
Guangzhou, Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Qilu Hospital of Shandong University
Jinan, Shandong
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality
Yuebei People's Hospital
Shaoguan, Guangdong
Shenyang Orthopedics Hospital
Shenyang, Liaoning
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Shenzhen Second People's Hospital
Shenzhen, Guangdong
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong
Hebei Medical University Third Hospital
Shijiazhuang, Hebei
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Shanxi Bethune Hospital
Taiyuan, Shanxi
Tianjin First Central Hospital
Tianjin, Tianjin Municipality
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Tongji Hospital, Tongji Medical College, Huazhong Universit of Science and Technology
Wuhan, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Xi'an Honghui Hospital
Xi’an, Shanxi
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
About this study
Official title: 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.
Read the 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.
- Conditions
- Degenerative Disc Disease
- Being tested
- AGA111, Placebo
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGA111Drug
AGA111 is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.
PlaceboDrug
Placebo is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.
| Study group | Role | What they receive |
|---|---|---|
| AGA111 | Experimental | AGA111 in autologous blood coagulum (ABC) is locally delivered at the intervertebral space. Receives: Drug: AGA111 |
| Placebo | Placebo comparator | Placebo in ABC is locally delivered at the intervertebral space. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall success rate: Proportion of subjects who achieve overall success.
Measured: Up to 52 weeks
Secondary outcomes (2)
Success rate of radiographic fusion
Measured: Up to 52 weeks
Mean change of ODI (Oswestry Disability Index) score
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start8 Dec 2023
- Primary completion28 Nov 2025
- Study completion12 Jun 2026
Why it stopped: Sponsor's strategic decision not related to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angitia Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angitia Medical Director, Study director, Angitia Biopharmaceutics Guangzhou Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115512
- Sponsor's protocol ID
- ACT22-001
- Status last verified
- Jun 2026
- First submitted
- 30 Oct 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06115512
- Acronym / sponsor ID
- ACT22-001
- Conditions
- Degenerative Disc Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's strategic decision not related to safety concerns.
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Angitia BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGA111 | Experimental | Drug: AGA111AGA111 in autologous blood coagulum (ABC) is locally delivered at the intervertebral space. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo in ABC is locally delivered at the intervertebral space. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGA111AGA111 is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion. | Drug | AGA111 |
| PlaceboPlacebo is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion. | Drug | Placebo |
Primary outcome
Overall success rate: Proportion of subjects who achieve overall success.
Time frame: Up to 52 weeks
2 secondary outcomes
Success rate of radiographic fusion
Time frame: Up to 52 weeks
Mean change of ODI (Oswestry Disability Index) score
Time frame: Up to 52 weeks
Results and safety
The study was stopped early (reason given: Sponsor's strategic decision not related to safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angitia Medical Director study director
Angitia Biopharmaceutics Guangzhou Limited
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AGA111 in people with Degenerative Disc Disease, run by Angitia Biopharmaceuticals at 35 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor's strategic decision not related to safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall success rate: Proportion of subjects who achieve overall success. (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.