Back to resultsA Phase I/II Study of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
Primary Purpose
Degenerative Disc Disease
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
AGA111
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
Sites / Locations
- Beijing Jishuitan Hospital
- Peking University Third Hospital
- The First Affiliated Hospital of Chongqing Medical University
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- The Second Affiliated Hospital of Soochow University
- The First Affiliated Hospital of Soochow University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
0.25 mg AGA111
0.5 mg AGA111
Placebo
Arm Description
0.25 mg AGA111 in autologous blood coagulum (ABC) is locally delivered at the intervertebral space.
0.5 mg AGA111 in ABC is locally delivered to the participants at the intervertebral space.
Placebo in ABC is locally delivered at the intervertebral space.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Oswestry Disability Index (ODI)
The change of point in ODI from baseline.
Pain score through Visual Analogue Scale (VAS)
The change of point in VAS from baseline.
Maximum Concentration (Cmax) of AGA111
Maximum concentration of AGA111 after dosing.
Time to maximum concentration (Tmax) of AGA111
Time to maximum concentration of AGA111 after dosing.
Area under the concentration time curve (AUC)
Definite integral of the curve describing the variation of AGA111 in blood as a function of time.
Full Information
NCT ID
NCT05574543
First Posted
September 30, 2022
Last Updated
October 7, 2022
Sponsor
Angitia Biopharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05574543
Brief Title
A Phase I/II Study of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
July 13, 2022 (Actual)
Study Completion Date
July 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Angitia Biopharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.25 mg AGA111
Arm Type
Experimental
Arm Description
0.25 mg AGA111 in autologous blood coagulum (ABC) is locally delivered at the intervertebral space.
Arm Title
0.5 mg AGA111
Arm Type
Experimental
Arm Description
0.5 mg AGA111 in ABC is locally delivered to the participants at the intervertebral space.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in ABC is locally delivered at the intervertebral space.
Intervention Type
Drug
Intervention Name(s)
AGA111
Intervention Description
AGA111 is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Description
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.
Time Frame
Up to 12 months
Title
Number of participants who develop anti-drug antibody to AGA111
Description
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.
Time Frame
Up to 90 days post operation
Secondary Outcome Measure Information:
Title
Radiographic fusion success
Description
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.
Time Frame
Up to 12 months post operation
Title
New Bone formation
Description
New bone formation is defined as the ratio of successful fusion area to the total area in the transverse plane of CT scan.
Time Frame
Up to 12 months post operation
Title
Oswestry Disability Index (ODI)
Description
The change of point in ODI from baseline.
Time Frame
Up to 12 months post operation
Title
Pain score through Visual Analogue Scale (VAS)
Description
The change of point in VAS from baseline.
Time Frame
Up to 12 months post operation
Title
Maximum Concentration (Cmax) of AGA111
Description
Maximum concentration of AGA111 after dosing.
Time Frame
90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
Title
Time to maximum concentration (Tmax) of AGA111
Description
Time to maximum concentration of AGA111 after dosing.
Time Frame
90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
Title
Area under the concentration time curve (AUC)
Description
Definite integral of the curve describing the variation of AGA111 in blood as a function of time.
Time Frame
90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angitia Medical Director
Organizational Affiliation
Angitia Medical Director
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Jishuitan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100035
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase I/II Study of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
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