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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Low-back Pain | Drug: PP353 Other: Placebo | Phase 1 Phase 2 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: PP353 |
Drug: PP353
active administered by intradiscal injection |
Placebo Comparator: Sham injection |
Other: Placebo
Sham injection |
- 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
- 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 ]
- Change from baseline of average LBP intensity NRS daily score over a 7-day period [ Time Frame: 3, 6, 9 & 12 months ]

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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 |
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:
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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.

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
Contact: Operations and Project Director | +44 1227 910152 | info@persicapharmaceuticals.com |
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 |
Study Chair: | Duncan McHale, MBBS MRCP | Weatherden Ltd |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Back pain Low back pain Lower back pain Modic |
Back Pain Low Back Pain Pain Neurologic Manifestations |