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

Chronic Low-back Pain Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04238676
• Other study ID #: Persica 002
• Secondary ID: 2018-004488-30U1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: January 20, 2020
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Persica Pharmaceuticals Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Drug:
• PP353
active administered by intradiscal injection

Other:
• Placebo
Sham injection

Locations

Country	Name	City	State
Denmark	Gildhøj Privathospital København	København
New Zealand	CGM Research Trust	Christchurch
Spain	Hospital Vithas Granada	Granada
Spain	Hospital Universitario LA PAZ	Madrid
United Kingdom	University Hospital Of Wales	Cardiff	Wales
United Kingdom	University Hospital Coventry & Warwickshire	Coventry
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United Kingdom	Royal Preston Hospital	Preston	Lancashire
United Kingdom	University Hospital Southampton Nhs Foundation Trust	Southampton

Sponsors (2)

Lead Sponsor	Collaborator
Persica Pharmaceuticals Ltd	Micron Research Ltd

Countries where clinical trial is conducted

Denmark,  New Zealand,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline of average LBP intensity NRS daily score over a 7-day period		3, 6, 9 & 12 months
Primary	Incidence of adverse events		12 months
Primary	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."; 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	12 months
Secondary	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."; 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	3, 6 & 9 months
Secondary	Change from baseline in Roland Morris Disability Questionnaire-23 score		3, 6, 9 & 12 months
Secondary	Clinically relevant improvement	30 percent reduction from baseline in Roland Morris Disability Questionnaire-23 score	3, 6, 9 &12 months
Secondary	Change from baseline in Oswestry Disability Index		3, 6 & 12 months
Secondary	Plasma pharmacokinetics - Tdur (duration above a prescribed threshold)		11 days
Secondary	Plasma pharmacokinetics - tmax (the time at which Cmax was apparent)		11 days
Secondary	Plasma pharmacokinetics - the area under the concentration versus time curve within a dosing interval		11 days
Secondary	Plasma pharmacokinetics - Cmax (the maximum observed concentration)		11 days
Secondary	Plasma pharmacokinetics - t½ (the apparent terminal half-life)		11 days
Secondary	Plasma pharmacokinetics - CL/F (the systemic clearance calculated from plasma)		11 days