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

CompletedPhase 1, Phase 2NCT04238676
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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)
Interventions
Sponsor
Persica Pharmaceuticals Ltd
Collaborators
Micron Research Ltd
Start date
2020-01-20
Primary completion
2024-12-09
Sex
All
Age range
from 18 Years to 70 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Denmark, New Zealand, Spain, United Kingdom
Total sites listed
10

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Aged between 18 and 70 years, inclusive. * Chronic low back pain in the area associated with vertebral body endplate bone oedema (Modic 1) or vertebral body endplate bone oedema and fat (Modic 1 and 2) at a single lumbar level. * Average LBP NRS score at screening and at Day 1 pre-randomisation ≥ 4 on chronic pain medication and ≥ 6 if not on chronic pain medication; it should be higher than the leg pain NRS score * RMDQ-23 score ≥ 9 at screening and at Day 1 pre-randomisation. * Current episode of chronic low back pain has lasted for ≥ 6 months at the time of randomisation. * Bodyweight of ≥ 50 kg and ≤ 120 kg. * Failure of standard of care therapies used by their treating physician Exclusion Criteria: * Any vertebra with Modic 2 only lesions which: 1. in the opinion of the investigator, after deep palpation of the vertebral spine, is contributing to the low back pain and/or 2. are present within 2 vertebrae from the target lumbar disc. * The target lumbar disc has lost more than half its original anticipated height at the centre or it is \< 5mm in height over the central 15 mm portion * A clear alternative cause for back pain * Gross facet joint degeneration or cases where the investigator believes the primary pain generator to be the facet joints * Interventional back procedure in the 6 months prior to screening or major surgery in the 12 weeks prior to screening * History of alcohol abuse or drugs of abuse in the past 2 years * Any other significant illness * Previously been treated with antimicrobial agents for their low back pain or previously received any antimicrobial intradiscal injection.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04238676