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

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ClinicalTrials.gov Identifier: NCT04238676
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : July 21, 2022
Sponsor:
Collaborator:
Micron Research Ltd
Information provided by (Responsible Party):
Persica Pharmaceuticals Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Drug: PP353 Other: Placebo Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The pharmacist and injector will not be blinded to treatment allocation
Primary Purpose: Treatment
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)
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: PP353 Drug: PP353
active administered by intradiscal injection
Placebo Comparator: Sham injection Other: Placebo
Sham injection


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 12 months ]
  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."

    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


Secondary Outcome Measures :
  1. 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:

    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

  2. Change from baseline in Roland Morris Disability Questionnaire-23 score [ Time Frame: 3, 6, 9 & 12 months ]
  3. Clinically relevant improvement [ Time Frame: 3, 6, 9 &12 months ]
    30 percent reduction from baseline in Roland Morris Disability Questionnaire-23 score

  4. Change from baseline in Oswestry Disability Index [ Time Frame: 3, 6 & 12 months ]
  5. Plasma pharmacokinetics - Tdur (duration above a prescribed threshold) [ Time Frame: 11 days ]
  6. Plasma pharmacokinetics - tmax (the time at which Cmax was apparent) [ Time Frame: 11 days ]
  7. Plasma pharmacokinetics - the area under the concentration versus time curve within a dosing interval [ Time Frame: 11 days ]
  8. Plasma pharmacokinetics - Cmax (the maximum observed concentration) [ Time Frame: 11 days ]
  9. Plasma pharmacokinetics - t½ (the apparent terminal half-life) [ Time Frame: 11 days ]
  10. Plasma pharmacokinetics - CL/F (the systemic clearance calculated from plasma) [ Time Frame: 11 days ]

Other Outcome Measures:
  1. Change from baseline of average LBP intensity NRS daily score over a 7-day period [ Time Frame: 3, 6, 9 & 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04238676


Contacts
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Contact: Operations and Project Director +44 1227 910152 info@persicapharmaceuticals.com

Locations
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New Zealand
CGM Research Trust Recruiting
Christchurch, New Zealand, 8083
Contact: Nigel Gilchrist, MB ChB FRACP    +64 3 3377821    nigel.gilchrist@cdhb.health.nz   
Spain
Metge Adjunt. Servei de Medicina Física i Rehabilitació Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035 Barcelona
Contact: Judith Sanchez-Raya, PT, MD, PhD    +34 93 489 3494    jusanchez@vhebron.net   
Hospital Vithas Granada Recruiting
Granada, Spain
Contact: Angel Horcajadas Almansa, MD, PhD    +34653610410    angel.horcajadas@gmail.com   
Hospital Universitario LA PAZ Recruiting
Madrid, Spain
Contact: Javier De Andres Ares, MD, PhD    +34 606 978 779    javierdeandresares@gmail.com   
Hospital Clínico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: Carlos Tornero, MD, PhD    +34 610 408 381    carlostornero@gmail.com   
Hospital Clinico Universitario Not yet recruiting
Valladolid, Spain, 47003
Contact: David César Noriega González, MD, PhD    +34 983420000    dcnoriega1970@gmail.com   
United Kingdom
Royal Preston Hospital Recruiting
Preston, Lancashire, United Kingdom, PR2 9HT
Contact: Shiva Tripathi, MBBS MD FRCA    +44 1772 524185    FIH@LTHTR.nhs.uk   
University Hospital Coventry & Warwickshire Active, not recruiting
Coventry, United Kingdom, CV2 2DX
Leeds General Infirmary Recruiting
Leeds, United Kingdom, LS1 3EX
Contact: Ganesan Baranidharan, MBBS, FRCA    +44 113 3922634    leedsth-tr.leedspainresearch@nhs.net   
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Matthew Scarborough, MD       matthew.scarborough@ouh.nhs.uk   
University Hospital Southampton Nhs Foundation Trust Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Cathy Price, MD FFPMRCA       c.m.price@soton.ac.uk   
Sponsors and Collaborators
Persica Pharmaceuticals Ltd
Micron Research Ltd
Investigators
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Study Chair: Duncan McHale, MBBS MRCP Weatherden Ltd
More Information
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Responsible Party: Persica Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT04238676    
Other Study ID Numbers: Persica 002
2018-004488-30 ( EudraCT Number )
U1111-1257-2567 ( Registry Identifier: WHO Universal Trial Number )
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Persica Pharmaceuticals Ltd:
Back pain
Low back pain
Lower back pain
Modic
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations