Clinical trial NCT04238676: Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Low-back Pain
Keywords: Back pain
Low back pain
Lower back pain
Modic
Lead sponsor: Persica Pharmaceuticals Ltd
Sponsor class: INDUSTRY
Collaborators: name: Micron Research Ltd
First posted: 2020-01-23
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part A is open label Part B is parallel placebo controlled
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 12 months
measure: Change from baseline in Low Back Pain Numerical Rating Scale (LBP NRS) score
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline in Low Back Pain Numerical Rating Scale (LBP NRS) score
timeFrame: 3, 6 & 9 months
measure: Change from baseline in Roland Morris Disability Questionnaire-23 score
timeFrame: 3, 6, 9 & 12 months
measure: Clinically relevant improvement
timeFrame: 3, 6, 9 &12 months
measure: Change from baseline in Oswestry Disability Index
timeFrame: 3, 6 & 12 months
measure: Plasma pharmacokinetics - Tdur (duration above a prescribed threshold)
timeFrame: 11 days
measure: Plasma pharmacokinetics - tmax (the time at which Cmax was apparent)
timeFrame: 11 days
measure: Plasma pharmacokinetics - the area under the concentration versus time curve within a dosing interval
timeFrame: 11 days
measure: Plasma pharmacokinetics - Cmax (the maximum observed concentration)
timeFrame: 11 days
measure: Plasma pharmacokinetics - t½ (the apparent terminal half-life)
timeFrame: 11 days
measure: Plasma pharmacokinetics - CL/F (the systemic clearance calculated from plasma)
timeFrame: 11 days
Other outcomes:
measure: Change from baseline of average LBP intensity NRS daily score over a 7-day period
timeFrame: 3, 6, 9 & 12 months
Locations:
city: København
country: Denmark
facility: Gildhøj Privathospital København
city: Christchurch
country: New Zealand
facility: CGM Research Trust
city: Granada
country: Spain
facility: Hospital Vithas Granada
city: Madrid
country: Spain
facility: Hospital Universitario LA PAZ
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
state: Lancashire
city: Cardiff
country: United Kingdom
facility: University Hospital Of Wales
state: Wales
city: Coventry
country: United Kingdom
facility: University Hospital Coventry & Warwickshire
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton Nhs Foundation Trust
Study officials:
affiliation: Weatherden Ltd
name: Duncan McHale, MBBS MRCP
role: STUDY_CHAIR
References: