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)

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 Overview

• Status: Active, not recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Drug: PP353; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 43
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Denmark
  • København, Denmark, 2605 Brøndby
    • Gildhøj Privathospital København
• New Zealand
  • Christchurch, New Zealand, 8083
    • CGM Research Trust
• Spain
  • Granada, Spain
    • Hospital Vithas Granada
  • Madrid, Spain
    • Hospital Universitario La Paz
• United Kingdom
  • Coventry, United Kingdom, CV2 2DX
    • University Hospital Coventry & Warwickshire
  • Leeds, United Kingdom, LS1 3EX
    • Leeds General Infirmary
  • Oxford, United Kingdom, OX3 9DU
    • Oxford University Hospitals NHS Foundation Trust
  • Southampton, United Kingdom, SO16 6YD
    • University Hospital Southampton NHS Foundation Trust
  • Lancashire
    • Preston, Lancashire, United Kingdom, PR2 9HT
      • Royal Preston Hospital
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 4XW
      • University Hospital of Wales

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PP353	Drug: PP353; active administered by intradiscal injection
Placebo Comparator: Sham injection	Other: Placebo; Sham injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events		12 months
Change from baseline in Low Back Pain Numerical Rating Scale (LBP NRS) score	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: Low back pain intensity now; Worst low back pain intensity in the last 14 days; Average low back pain intensity over the last 14 days	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Low Back Pain Numerical Rating Scale (LBP NRS) score	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: Low back pain intensity now; Worst low back pain intensity in the last 14 days; Average low back pain intensity over the last 14 days	3, 6 & 9 months
Change from baseline in Roland Morris Disability Questionnaire-23 score		3, 6, 9 & 12 months
Clinically relevant improvement	30 percent reduction from baseline in Roland Morris Disability Questionnaire-23 score	3, 6, 9 &12 months
Change from baseline in Oswestry Disability Index		3, 6 & 12 months
Plasma pharmacokinetics - Tdur (duration above a prescribed threshold)		11 days
Plasma pharmacokinetics - tmax (the time at which Cmax was apparent)		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 - CL/F (the systemic clearance calculated from plasma)		11 days

Other Outcome Measures

Outcome Measure	Time Frame
Change from baseline of average LBP intensity NRS daily score over a 7-day period	3, 6, 9 & 12 months

Collaborators and Investigators

• Sponsor: Persica Pharmaceuticals Ltd
• Collaborators: Micron Research Ltd
• Investigators: Study Chair: Duncan McHale, MBBS MRCP, Weatherden Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Low back pain; Back pain; Lower back pain; Modic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Persica 002; 2018-004488-30 (EudraCT Number); U1111-1257-2567 (Registry Identifier: WHO Universal Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No