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

Degenerative Disc Disease Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06115512
Study type Interventional
Source Angitia Biopharmaceuticals
Contact Trial Recruitment
Phone +862062329812
Email info@angitiabio.com
Status Recruiting
Phase Phase 3
Start date December 8, 2023
Completion date October 31, 2025
View Details
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