Chronic Low-back PainPhase 1/2NCT04238676

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

A Phase 1/2 study testing PP353 in people with Chronic Low-back Pain, run by Persica Pharmaceuticals Ltd at 10 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Low-back Pain
What is being tested?: PP353
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 43 participants
Where: 10 sitesin 4 countries
Study dates: 20 Jan 2020to 9 Dec 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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.

Trial locations and contacts

10 sites in 4 countries.

Country

City, postcode or hospital

10 sites in 4 countries

United Kingdom6 sites

University Hospital Of Wales
Cardiff, Wales, CF14 4XW
University Hospital Coventry & Warwickshire
Coventry, CV2 2DX
Leeds General Infirmary
Leeds, LS1 3EX
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxford, OX3 9DU
Royal Preston Hospital
Preston, Lancashire, PR2 9HT
University Hospital Southampton Nhs Foundation Trust
Southampton, SO16 6YD

Other trials in United Kingdom

Spain2 sites

Hospital Vithas Granada
Granada
Hospital Universitario LA PAZ
Madrid

Other trials in Spain

Denmark1 site

Gildhøj Privathospital København
Copenhagen, 2605 Brøndby

Other trials in Denmark

New Zealand1 site

CGM Research Trust
Christchurch, 8083

Other trials in New Zealand

About this study

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)

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.

Read the 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.

Conditions: Chronic Low-back Pain
Being tested: PP353, Placebo
Keywords: Back pain, Low back pain, Lower back pain, Modic
Medical subject headings: Back Pain, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PP353Drug
active administered by intradiscal injection
PlaceboOther
Sham injection

Study groups in NCT04238676
Study group	Role	What they receive
PP353	Experimental	Not described Receives: Drug: PP353
Sham injection	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Adverse Events
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
Measured: 0 to 12 months
Change From Baseline in Low Back Pain Numerical Rating Scale (LBP NRS) Score
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:
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
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.
Measured: 12 months

Secondary outcomes (3)

Change From Baseline in Roland Morris Disability Questionnaire-23 Score
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.
Measured: 12 months
Clinically Relevant Improvement (≥30%) in RMDQ-23
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.
Measured: 12 months
Change From Baseline in Oswestry Disability Index
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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 20209 Dec 2024

First posted23 Jan 2020
Study start20 Jan 2020
Primary completion9 Dec 2024
Study completion9 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Part A is open label Part B is parallel placebo controlled
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04238676
Sponsor's protocol ID: Persica 002
Other IDs: 2018-004488-30, U1111-1257-2567, 2018
Status last verified: Feb 2026
First submitted: 16 Jan 2020
Last updated: 27 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tripathi SS, Sneath R, Golash A, Desai P, McHale D, Guest S, Brindley C, Cummings P, Smith S, Stroud C, Scott G, Ruston S, Czaplewski L. Pharmacokinetics of PP353, a formulation of linezolid for intervertebral disc administration, in patients with chronic low back pain and Modic change Type 1: A first-in-human, Phase 1b, open-label, single-dose study. JOR Spine. 2024 Nov 14;7(4):e70009. doi: 10.1002/jsp2.70009. eCollection 2024 Dec.
PubMed 39544354
Lassen MR, Scarborough M, Gilchrist N, Tripathi SS, Price C, Horcajadas A, DeAndres J, Baranidharan G, Ahuja S, Otte KS, Wood E, Guest S, Czaplewski LG, McHale D; Modic Trial (TMT) group. Intradiscal linezolid (PP353) treatment for chronic low back pain associated with Modic change type 1: an international, first-in-human, randomised, sham procedure-controlled, double-blind, phase 1b clinical trial. EClinicalMedicine. 2026 Feb 2;92:103764. doi: 10.1016/j.eclinm.2026.103764. eCollection 2026 Feb.
PubMed 41768986

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Chronic Low-back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT04238676
Acronym / sponsor ID: Persica 002
Conditions: Chronic Low-back Pain
Keywords: Back pain, Low back pain, Lower back pain, Modic
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Persica Pharmaceuticals LtdIndustry (pharma, biotech, devices)
Collaborators: Micron Research Ltd
Study start: 20 Jan 2020 (actual)
Primary completion: 9 Dec 2024 (actual)
Study completion: 9 Dec 2024 (actual)
First posted: 23 Jan 2020 (actual)
Results: Posted 27 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Part A is open label Part B is parallel placebo controlled

Arm	Type	Receives
PP353	Experimental	Drug: PP353
Sham injection	Placebo comparator	Other: Placebo

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (10 listed)

Any vertebra with Modic 2 only lesions which:
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PP353active administered by intradiscal injection	Drug	PP353
PlaceboSham injection	Other	Sham injection

Primary outcome

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
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: 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 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 secondary outcomes

Change From Baseline in Roland Morris Disability Questionnaire-23 Score
Time frame: 12 months
Clinically Relevant Improvement (≥30%) in RMDQ-23
Time frame: 12 months
Change From Baseline in Oswestry Disability Index
Time frame: 12 months

Results and safety

Results posted to the registry on 27 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A PP353	3	3
Part B PP353	20	18
Part B Placebo	20	19

Primary outcome: Incidence of Adverse Events

Time frame: 0 to 12 months. Count of participants. Unit: Participants

Measure	Part A PP353 n = 3	PP353 n = 20	Placebo n = 20
Value	3	15	18

Population analysed: Full Analysis Set (FAS) consisted of all enrolled subjects who received at least one dose of PP353 or placebo and had a valid post-baseline measurement for at least one efficacy variable.

Primary outcome: Change From Baseline in Low Back Pain Numerical Rating Scale (LBP NRS) Score

Time frame: 12 months. Least squares mean (Standard Error). Unit: Units on a scale

Measure	PP353 n = 18	Placebo n = 19
Value	-3.36 (0.494)	-2.00 (0.488)

PP353 vs Placebo: Least Squares Mean difference: -1.37, p = 0.0284, Mixed Models Analysis

Population analysed: The Full Analysis Set (FAS) consisted of all enrolled participants who received at least one dose of PP353 or one sham procedure and had a post-baseline measurement for at least one efficacy variable. The primary efficacy analysis used a one-sided test at the 5% significance level. Change from baseline was assessed using a mixed model repeated measures model (MMRM).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up, up to 12 months from randomisation. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A PP353	0 of 3 (0%)	3 of 3 (100%)	0 of 3
PP353	0 of 20 (0%)	15 of 20 (75%)	0 of 20
Placebo	1 of 20 (5%)	18 of 20 (90%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 39544354Tripathi SS, Sneath R, Golash A, Desai P, McHale D, Guest S, Brindley C, Cummings P, Smith S, Stroud C, Scott G, Ruston S, Czaplewski L. Pharmacokinetics of PP353, a formulation of linezolid for intervertebral disc administration, in patients with chronic low back pain and Modic change Type 1: A first-in-human, Phase 1b, open-label, single-dose study. JOR Spine. 2024 Nov 14;7(4):e70009. doi: 10.1002/jsp2.70009. eCollection 2024 Dec.
Results publication: PubMed 41768986Lassen MR, Scarborough M, Gilchrist N, Tripathi SS, Price C, Horcajadas A, DeAndres J, Baranidharan G, Ahuja S, Otte KS, Wood E, Guest S, Czaplewski LG, McHale D; Modic Trial (TMT) group. Intradiscal linezolid (PP353) treatment for chronic low back pain associated with Modic change type 1: an international, first-in-human, randomised, sham procedure-controlled, double-blind, phase 1b clinical trial. EClinicalMedicine. 2026 Feb 2;92:103764. doi: 10.1016/j.eclinm.2026.103764. eCollection 2026 Feb.
Intradiscal linezolid (PP353) treatment for chronic low back pain associated with Modic change type 1: an international, first-in-human, randomised, sham procedure-controlled, double-blind, phase 1b clinical trialLink provided by the sponsor.
Pharmacokinetics of PP353, a formulation of linezolid for intervertebral disc administration, in patients with chronic low back pain and Modic change Type 1: A first-in-human, Phase 1b, open-label, single-dose studyLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Chronic Low-back Pain

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Duncan McHale, MBBS MRCP study chair

Weatherden Ltd

10 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PP353 in people with Chronic Low-back Pain, run by Persica Pharmaceuticals Ltd at 10 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United Kingdom, Spain, Denmark, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (time frame: 0 to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04238676, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.