NCT06649747

Safety and Efficacy Study on AFA-281 for the Treatment of Low Back Pain

A Double-blind, Placebo-controlled, Multi-center Phase II Study of the Safety, Tolerability, Efficacy and Pharmacokinetics of Oral AFA-281 in Patients With Painful Lumbosacral Radiculopathy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: Afasci Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate if the drug candidate AFA-281 works to treat chronic low back and leg pain caused by painful lumbosacral radiculopathy (PLSR) in adults. This trial will also evaluate the safety of AFA-281. The main questions it aims to answer are: * Does AFA-281 mitigate pain? * What are the side effects (if any)? Researchers will compare AFA-281 to a placebo (a look-alike substance that contains no drug) to see if AFA-281 works to treat chronic low back and leg pain. Participants will: * Take drug AFA-281 or a placebo three times every day for 4 weeks * Visit the clinic once every 2 weeks for checkups and tests * Keep a diary of their pain scores and about mood and sleep questionnaires, and the number of times they use a rescue pain medicines.

Detailed description

This is a randomized, double-blind, placebo-controlled, multicenter Phase II study of the efficacy, safety, tolerability, and PK of oral AFA-281 in 300 patients with painful lumbosacral radiculopathy (PLSR). Patients will be randomized in to the placebo group or doses of AFA-281, titrated over 2 weeks to reach planned daily doses for Weeks 3 and 4. Trials will be conducted simultaneously at 3 sites to meet enrollment targets. The primary efficacy endpoint is 24-hour average pain score based on the 0-10-point Numeric Pain Rating Scale (NPRS) and key secondary endpoint is Oswestry Disability Index (ODI), rates of adverse events, and PK, among others.

Conditions

• Lumbosacral Radiculopathy

Interventions

Type	Name	Description
DRUG	AFA-281	A small molecule, orally available

Timeline

• Start date: 2027-04-01
• Primary completion: 2032-03-31
• Completion: 2032-03-31
• First posted: 2024-10-21
• Last updated: 2025-06-26

Regulatory

• FDA-regulated drug study