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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2022

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 34 participants.

Interventions

  • Drug: PP353
    • active administered by intradiscal injection
  • Drug: PP353-B
    • placebo administered by intradiscal injection

Arms, Groups and Cohorts

  • Experimental: PP353
  • Placebo Comparator: PP353-B

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of adverse events
    • Time Frame: 12 months
  • Change from baseline in Low Back Pain Numerical Rating Scale (LBP NRS) score
    • Time Frame: 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: 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

Secondary Measures

  • Change from baseline in Low Back Pain Numerical Rating Scale (LBP NRS) score
    • Time Frame: 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: 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
  • Change from baseline in Roland Morris Disability Questionnaire-23 score
    • Time Frame: 3, 6, 9 & 12 months
  • Clinically relevant improvement
    • Time Frame: 3, 6, 9 &12 months
    • 30 percent reduction from baseline in Roland Morris Disability Questionnaire-23 score
  • Change from baseline in Oswestry Disability Index
    • Time Frame: 3, 6 & 12 months
  • Plasma pharmacokinetics – Tdur (duration above a prescribed threshold)
    • Time Frame: 11 days
  • Plasma pharmacokinetics – tmax (the time at which Cmax was apparent)
    • Time Frame: 11 days
  • Plasma pharmacokinetics – the area under the concentration versus time curve within a dosing interval
    • Time Frame: 11 days
  • Plasma pharmacokinetics – Cmax (the maximum observed concentration)
    • Time Frame: 11 days
  • Plasma pharmacokinetics – t½ (the apparent terminal half-life)
    • Time Frame: 11 days
  • Plasma pharmacokinetics – CL/F (the systemic clearance calculated from plasma)
    • Time Frame: 11 days

Participating in This Clinical Trial

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. – Current episode of chronic low back pain has lasted for ≥ 6 months and < 5 years 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:

  • The presence of a deformity associated with the disc – A clear alternative cause for back pain – 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 – Concomitant medications contraindicated with PP353

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Persica Pharmaceuticals Ltd
  • Collaborator
    • Micron Research Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Duncan McHale, MBBS MRCP, Study Chair, Weatherden Ltd
  • Overall Contact(s)
    • Operations and Project Director, +44 1227 910152, info@persicapharmaceuticals.com

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