NCT04238676

Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain

A Phase 1b Study Investigating the Safety, Tolerability and Efficacy of PP353 in the Treatment of Patients With Chronic Low Back Pain Associated With Vertebral Body Endplate Bone Oedema (Modic 1)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Persica Pharmaceuticals Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1b study to investigate the efficacy of PP353 compared to placebo in the treatment of chronic low back pain associated with bone oedema.

Detailed description

A 2-part study. In the first part the safety, tolerability and pharmacokinetics will be assessed in up to 6 participants. In the second part, the safety, tolerability and efficacy of PP353 will be assessed in up to 40 participants.

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
DRUG	PP353	active administered by intradiscal injection
OTHER	Placebo	Sham injection

Timeline

• Start date: 2020-01-20
• Primary completion: 2024-12-09
• Completion: 2024-12-09
• First posted: 2020-01-23
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

10 sites across 4 countries: Denmark, New Zealand, Spain, United Kingdom