Degenerative Disc DiseasePhase 1/2NCT05574543
A Phase I/II Study of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
A Phase 1/2 study testing AGA111 in people with Degenerative Disc Disease, run by Angitia Biopharmaceuticals at 6 sites in China.
Trial summary
The objectives of the study are to evaluate the safety and preliminary efficacy of a single administration of AGA111 for lumbar interbody fusion in patients with degenerative disc disease. Read more about this study
- Who is it for?
- Ages 40 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
- 60 participants
- Where
- 6 sitesChina
- Study dates
- 1 Dec 2020to 13 Jul 2022
- Phase
- Phase 1/2
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and capable of giving signed informed consent.
- Male or female, age between 40-80 years.
- Male or female of childbearing potential must agree to use a highly effective contraception throughout the entire study period, and female subjects must have a negative pregnancy test prior to the randomization.
- Has degenerative disc disease (DDD) of the lumbosacral(L3-S1) spine that results in back pain, with or without radiating leg pain.
- Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative disc disease.
- Planning to receive single-level lumbar interbody fusion.
- Willing and capable of adhering to the protocol and visit schedule.
Who cannot join
- Prior surgical procedure at the involved or adjacent spinal levels.
- Presence or prior history of inflammatory disease of the spine.
- Presence or prior history of neoplastic disease of the spine.
- BMI <18.5 or BMI >35.
- Documented titanium allergy or intolerance.
- Presence or prior history of malignancy (except for fully resected basal cell carcinoma of the skin).
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- Presence or history of an uncontrolled, unstable, clinically significant medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's safety or ability to participate in this study.
- Active local or systemic infection.
- Female subject who is pregnant or lactating.
- Serological evidence of positive human immunodeficiency virus (HIV) antibody.
- HBsAg positive or HBeAg positive, along with positive HBV DNA test.
- Serological evidence of HCV antibody, along with HCV RNA > lower limit of detection.
- Known drug or alcohol abuser.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled, Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of Single Administration of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
The objectives of the study are to evaluate the safety and preliminary efficacy of a single administration of AGA111 for lumbar interbody fusion in patients with degenerative disc disease.
Read the detailed description
A randomized, double-blind, placebo-controlled, phase 1/2 study to evaluate the safety and preliminary efficacy of single administration of AGA111 for lumbar interbody fusion in patients with degenerative disc disease. A total of 60 participants will be enrolled and randomized to placebo, AGA111 0.25 mg, or AGA111 0.5 mg at 1: 1: 1 ratio. All participants will undergo lumbar interbody fusion and receive study treatment during the surgery.
- 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 |
|---|---|---|
| 0.25 mg AGA111 | Experimental | 0.25 mg AGA111 in autologous blood coagulum (ABC) is locally delivered at the intervertebral space. Receives: Drug: AGA111 |
| 0.5 mg AGA111 | Experimental | 0.5 mg AGA111 in ABC is locally delivered to the participants 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.
Number of participants with adverse events (AEs)
An adverse event (AE) is any untoward medical occurrence in clinical study participant, temporally associated with the use of the investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP.
Measured: Up to 12 months
Number of participants who develop anti-drug antibody to AGA111
Blood samples taken prior to the operation and 5 days, 28 days and 90 days post operation were tested for anti-AGA111 antibodies using an immunoassay method.
Measured: Up to 90 days post operation
Secondary outcomes (7)
Radiographic fusion success
Radiographic fusion success is defined as evidence of continuous bone bridging from the superior to the inferior vertebrae via CT evaluation and no evidence of motion as defined by less than 3mm translational motion and less than 5° in angular motion at the treated level via hyperextension and hyperflexion X-rays.
Measured: Up to 12 months post operation
New Bone formation
New bone formation is defined as the ratio of successful fusion area to the total area in the transverse plane of CT scan.
Measured: Up to 12 months post operation
Oswestry Disability Index (ODI)
The change of point in ODI from baseline.
Measured: Up to 12 months post operation
Pain score through Visual Analogue Scale (VAS)
The change of point in VAS from baseline.
Measured: Up to 12 months post operation
Maximum Concentration (Cmax) of AGA111
Maximum concentration of AGA111 after dosing.
Measured: 90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
Time to maximum concentration (Tmax) of AGA111
Time to maximum concentration of AGA111 after dosing.
Measured: 90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
Area under the concentration time curve (AUC)
Definite integral of the curve describing the variation of AGA111 in blood as a function of time.
Measured: 90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Dec 2020
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 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 Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574543
- Sponsor's protocol ID
- ACT19001
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- 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 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled, Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of Single Administration of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT05574543
- Acronym / sponsor ID
- ACT19001
- Conditions
- Degenerative Disc Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Angitia BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 10 Oct 2022 (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 objectives of the study are to evaluate the safety and preliminary efficacy of a single administration of AGA111 for lumbar interbody fusion in patients with degenerative disc disease.
Detailed description
A randomized, double-blind, placebo-controlled, phase 1/2 study to evaluate the safety and preliminary efficacy of single administration of AGA111 for lumbar interbody fusion in patients with degenerative disc disease. A total of 60 participants will be enrolled and randomized to placebo, AGA111 0.25 mg, or AGA111 0.5 mg at 1: 1: 1 ratio. All participants will undergo lumbar interbody fusion and receive study treatment during the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.25 mg AGA111 | Experimental | Drug: AGA1110.25 mg AGA111 in autologous blood coagulum (ABC) is locally delivered at the intervertebral space. |
| 0.5 mg AGA111 | Experimental | Drug: AGA1110.5 mg AGA111 in ABC is locally delivered to the participants at the intervertebral space. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo in ABC is locally delivered at the intervertebral space. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and capable of giving signed informed consent.
- Male or female, age between 40-80 years.
- Male or female of childbearing potential must agree to use a highly effective contraception throughout the entire study period, and female subjects must have a negative pregnancy test prior to the randomization.
- Has degenerative disc disease (DDD) of the lumbosacral(L3-S1) spine that results in back pain, with or without radiating leg pain.
- Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative disc disease.
Key exclusion criteria (13 listed)
- Prior surgical procedure at the involved or adjacent spinal levels.
- Presence or prior history of inflammatory disease of the spine.
- Presence or prior history of neoplastic disease of the spine.
- BMI <18.5 or BMI >35.
- Documented titanium allergy or intolerance.
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 | 0.25 mg AGA111, 0.5 mg AGA111 |
| PlaceboPlacebo is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion. | Drug | Placebo |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 12 months
An adverse event (AE) is any untoward medical occurrence in clinical study participant, temporally associated with the use of the investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP.
Number of participants who develop anti-drug antibody to AGA111
Time frame: Up to 90 days post operation
Blood samples taken prior to the operation and 5 days, 28 days and 90 days post operation were tested for anti-AGA111 antibodies using an immunoassay method.
7 secondary outcomes
Radiographic fusion success
Time frame: Up to 12 months post operation
New Bone formation
Time frame: Up to 12 months post operation
Oswestry Disability Index (ODI)
Time frame: Up to 12 months post operation
Pain score through Visual Analogue Scale (VAS)
Time frame: Up to 12 months post operation
Maximum Concentration (Cmax) of AGA111
Time frame: 90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
Time to maximum concentration (Tmax) of AGA111
Time frame: 90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
Area under the concentration time curve (AUC)
Time frame: 90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- 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 Medical Director
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AGA111 in people with Degenerative Disc Disease, run by Angitia Biopharmaceuticals at 6 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 7 inclusion and 13 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: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with adverse events (AEs) (time frame: Up to 12 months). The study lists 2 primary outcomes in all. 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 10 Oct 2022.