A Phase I/II Study of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease

Degenerative Disc Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05574543
• Other study ID #: ACT19001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 1, 2020
• Est. completion date: July 13, 2022

Study information

• Verified date: September 2022
• Source: Angitia Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 13, 2022
• Est. primary completion date: July 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Willing and capable of giving signed informed consent.

2. Male or female, age between 40-80 years.

3. 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.

4. Has degenerative disc disease (DDD) of the lumbosacral(L3-S1) spine that results in back pain, with or without radiating leg pain.

5. Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative disc disease.

6. Planning to receive single-level lumbar interbody fusion.

7. Willing and capable of adhering to the protocol and visit schedule.

Exclusion Criteria:

1. Prior surgical procedure at the involved or adjacent spinal levels.

2. Presence or prior history of inflammatory disease of the spine.

3. Presence or prior history of neoplastic disease of the spine.

4. BMI <18.5 or BMI >35.

5. Documented titanium allergy or intolerance.

6. Presence or prior history of malignancy (except for fully resected basal cell carcinoma of the skin).

7. 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.

8. Active local or systemic infection.

9. Female subject who is pregnant or lactating.

10. Serological evidence of positive human immunodeficiency virus (HIV) antibody.

11. HBsAg positive or HBeAg positive, along with positive HBV DNA test.

12. Serological evidence of HCV antibody, along with HCV RNA > lower limit of detection.

13. Known drug or alcohol abuser.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Diseases

Intervention

Drug:
• AGA111
AGA111 is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.
• Placebo
Placebo is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.

Locations

Country	Name	City	State
China	Beijing Jishuitan Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Angitia Biopharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 months
Primary	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.	Up to 90 days post operation
Secondary	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.	Up to 12 months post operation
Secondary	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.	Up to 12 months post operation
Secondary	Oswestry Disability Index (ODI)	The change of point in ODI from baseline.	Up to 12 months post operation
Secondary	Pain score through Visual Analogue Scale (VAS)	The change of point in VAS from baseline.	Up to 12 months post operation
Secondary	Maximum Concentration (Cmax) of AGA111	Maximum concentration of AGA111 after dosing.	90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
Secondary	Time to maximum concentration (Tmax) of AGA111	Time to maximum concentration of AGA111 after dosing.	90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
Secondary	Area under the concentration time curve (AUC)	Definite integral of the curve describing the variation of AGA111 in blood as a function of time.	90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.