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Completed

NCT Number: NCT04238676

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

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.

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Key information

Conditions

Chronic Low-back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Gildhøj Privathospital København, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • in the opinion of the investigator, after deep palpation of the vertebral spine, is contributing to the low back pain and/or
  • 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.

Treatment and study plan

PP353

Drug

active administered by intradiscal injection

Placebo

Other

Sham injection

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: 0 to 12 months

    All causality Treatment Emergent Adverse Events. Any event that was not present prior to the initiation of the treatment, or any event that was already present but increased in intensity or frequency following treatment, was recorded as a treatment-emergent adverse event

  2. 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." A lower score indicates less pain.

    The Low Back Pain Numerical Rating 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

    Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A.

Secondary outcomes

  1. Change From Baseline in Roland Morris Disability Questionnaire-23 Score

    Time frame: 12 months

    The Roland Morris Disability Questionnaire (RMDQ)-23 is a self-administered disability measure consisting of 23 questions. Participants are asked to read a list of 23 sentences and answer "yes" or "no" to each question depending on how the participant feels each sentence describes them today. . The total number of "yes" responses gives a score from 0 to 23. A lower score indicates less disability. Participants required a score of at least 9 to enter the study

    Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A.

  2. Clinically Relevant Improvement (≥30%) in RMDQ-23

    Time frame: 12 months

    The Roland Morris Disability Questionnaire (RMDQ)-23 is a self-administered disability measure consisting of 23 questions. Participants are asked to read a list of 23 sentences and answer "yes" or "no" to each question depending on how the participant feels each sentence describes them today. . The total number of "yes" responses gives a score from 0 to 23. A lower score indicates less disability. Participants required a score of at least 9 to enter the study

    Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A.

  3. Change From Baseline in Oswestry Disability Index

    Time frame: 12 months

    The ODI is a subject-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living. A lower score indicates less disability. Scores are interpreted as follows: 0-20%: minimal disability 21-40%: moderate disability 41-60%: severe disability 61-80% crippled 81-100%: bed-bound

    Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A.

Other outcomes

  1. Change From Baseline of Average Low Back Pain (LBP) Intensity Numerical Rating Scale (NRS) Daily Score Over a 7-day Period

    Time frame: 12 months

    Mean Low Back Pain intensity scored on a 0-10 Numerical Rating Scale daily for 7 days prior to a time point visit. Each daily score was recorded on an 11-point NRS scale where 0 = "no pain" and "10 = the worst pain you can imagine". A lower score indicates less pain.

    Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A.

Sponsors and collaborators

Lead sponsor

Persica Pharmaceuticals Ltd

Industry

Collaborators

  • Micron Research Ltd

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2020
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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