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

Phase 1

Completed

• Conditions: Chronic Low-back Pain
• Interventions: Other: Placebo; Drug: PP353

• Registration Number: NCT04238676
• Lead Sponsor: Persica Pharmaceuticals Ltd

Brief 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.

Study Timeline

• Study First Submitted: 2020-01-16
• Study Start: 2020-01-20
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-23
• Primary Completion: 2024-12-09
• Study Completion: 2024-12-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham injection	Placebo	-
PP353	PP353	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Low Back Pain Numerical Rating Scale (LBP NRS) score	12 months	Each question will be assessed by the subject on an 11-point scale with 0 = "no pain" and 10 = "the worst possible pain you can imagine."; The LBP NRS score throughout this protocol is defined as the average of the score of the three questions: 1. Low back pain intensity now; 2. Worst low back pain intensity in the last 14 days; 3. Average low back pain intensity over the last 14 days
Incidence of adverse events	12 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Roland Morris Disability Questionnaire-23 score	3, 6, 9 & 12 months
Change from baseline in Low Back Pain Numerical Rating Scale (LBP NRS) score	3, 6 & 9 months	Each question will be assessed by the subject on an 11-point scale with 0 = "no pain" and 10 = "the worst possible pain you can imagine."; The LBP NRS score throughout this protocol is defined as the average of the score of the three questions: 1. Low back pain intensity now; 2. Worst low back pain intensity in the last 14 days; 3. Average low back pain intensity over the last 14 days
Clinically relevant improvement	3, 6, 9 &12 months	30 percent reduction from baseline in Roland Morris Disability Questionnaire-23 score
Plasma pharmacokinetics - Tdur (duration above a prescribed threshold)	11 days
Plasma pharmacokinetics - the area under the concentration versus time curve within a dosing interval	11 days
Plasma pharmacokinetics - Cmax (the maximum observed concentration)	11 days
Plasma pharmacokinetics - t½ (the apparent terminal half-life)	11 days
Plasma pharmacokinetics - tmax (the time at which Cmax was apparent)	11 days
Change from baseline in Oswestry Disability Index	3, 6 & 12 months
Plasma pharmacokinetics - CL/F (the systemic clearance calculated from plasma)	11 days

Trial Locations

Locations (10)

CGM Research Trust; 🇳🇿 Christchurch, New Zealand

Gildhøj Privathospital København; 🇩🇰 København, Denmark

Hospital Vithas Granada; 🇪🇸 Granada, Spain

Royal Preston Hospital; 🇬🇧 Preston, Lancashire, United Kingdom

University Hospital Of Wales; 🇬🇧 Cardiff, Wales, United Kingdom

University Hospital Coventry & Warwickshire; 🇬🇧 Coventry, United Kingdom

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

Oxford University Hospitals NHS Foundation Trust; 🇬🇧 Oxford, United Kingdom

University Hospital Southampton Nhs Foundation Trust; 🇬🇧 Southampton, United Kingdom

Hospital Universitario LA PAZ; 🇪🇸 Madrid, Spain