NCT06115512

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: Angitia Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	AGA111	AGA111 is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.
DRUG	Placebo	Placebo is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.

Timeline

• Start date: 2023-12-08
• Primary completion: 2025-11-28
• Completion: 2026-11-30
• First posted: 2023-11-03
• Last updated: 2026-01-28

Locations

35 sites across 1 country: China