NCT06115512|Active Not RecruitingPhase 3

A Phase 3 Study of AGA111 in Patients With Degenerative Disc Disease Undergoing Lumbar Interbody Fusion

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

Angitia Biopharmaceuticals ClinicalTrials.gov

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1 other identifier

ACT22-001

Study Type

interventional

Target

412

Locations

1 country

Sites

Timeline

RegisteredNov 2023

StartedDec 2023

CompletionNov 2026

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

412

participants targeted

Target at P50-P75 for phase_3

Timeline

7mo left

Started Dec 2023

Typical duration for phase_3

Geographic Reach

1 country

35 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

Study Progress81%

Dec 2023Nov 2026

First Submitted

Initial submission to the registry

October 30, 2023

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed

1 month until next milestone

Study Start

First participant enrolled

December 8, 2023

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2025

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

October 30, 2023

Last Update Submit

January 26, 2026

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

Overall success rate: Proportion of subjects who achieve overall success.
Up to 52 weeks

Secondary Outcomes (2)

Success rate of radiographic fusion
Up to 52 weeks
Mean change of ODI (Oswestry Disability Index) score
Up to 52 weeks

Study Arms (2)

AGA111

EXPERIMENTAL

AGA111 in autologous blood coagulum (ABC) is locally delivered at the intervertebral space.

Drug: AGA111

Placebo

PLACEBO COMPARATOR

Placebo in ABC is locally delivered at the intervertebral space.

Drug: Placebo

Interventions

AGA111DRUG

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

AGA111

PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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;
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.

Contact the study team to confirm eligibility.