Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug targets spine pain from bone marrow lesions

NCT ID NCT04238676

Symptom relief Sponsor: Persica Pharmaceuticals Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called PP353 in 43 adults with long-term low back pain linked to a specific type of bone marrow change (Modic 1) seen on MRI. The main goals were to check safety and see if the drug reduces pain better than a placebo. Participants rated their pain on a 0-10 scale, and researchers also tracked daily function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

43 people

The number who actually took part.

Started

Jan 2020

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic low back pain are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Back Pain Low Back Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic low back pain

Contacts and locations

Locations

  • CGM Research Trust

    Christchurch, 8083, New Zealand

  • Gildhøj Privathospital København

    Copenhagen, 2605 Brøndby, Denmark

  • Hospital Universitario LA PAZ

    Madrid, Spain

  • Hospital Vithas Granada

    Granada, Spain

  • Leeds General Infirmary

    Leeds, LS1 3EX, United Kingdom

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxford, OX3 9DU, United Kingdom

  • Royal Preston Hospital

    Preston, Lancashire, PR2 9HT, United Kingdom

  • University Hospital Coventry & Warwickshire

    Coventry, CV2 2DX, United Kingdom

  • University Hospital Of Wales

    Cardiff, Wales, CF14 4XW, United Kingdom

  • University Hospital Southampton Nhs Foundation Trust

    Southampton, SO16 6YD, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.