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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04238676




Registration number
NCT04238676
Ethics application status
Date submitted
16/01/2020
Date registered
23/01/2020

Titles & IDs
Public title
Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain
Scientific 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)
Secondary ID [1] 0 0
2018-004488-30
Secondary ID [2] 0 0
Persica 002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low-back Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PP353
Other interventions - Placebo

Experimental: PP353 -

Placebo comparator: Sham injection -


Treatment: Drugs: PP353
active administered by intradiscal injection

Other interventions: Placebo
Sham injection
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Change from baseline in Low Back Pain Numerical Rating Scale (LBP NRS) score
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Change from baseline in Low Back Pain Numerical Rating Scale (LBP NRS) score
Timepoint [1] 0 0
3, 6 & 9 months
Secondary outcome [2] 0 0
Change from baseline in Roland Morris Disability Questionnaire-23 score
Timepoint [2] 0 0
3, 6, 9 & 12 months
Secondary outcome [3] 0 0
Clinically relevant improvement
Timepoint [3] 0 0
3, 6, 9 &12 months
Secondary outcome [4] 0 0
Change from baseline in Oswestry Disability Index
Timepoint [4] 0 0
3, 6 & 12 months
Secondary outcome [5] 0 0
Plasma pharmacokinetics - Tdur (duration above a prescribed threshold)
Timepoint [5] 0 0
11 days
Secondary outcome [6] 0 0
Plasma pharmacokinetics - tmax (the time at which Cmax was apparent)
Timepoint [6] 0 0
11 days
Secondary outcome [7] 0 0
Plasma pharmacokinetics - the area under the concentration versus time curve within a dosing interval
Timepoint [7] 0 0
11 days
Secondary outcome [8] 0 0
Plasma pharmacokinetics - Cmax (the maximum observed concentration)
Timepoint [8] 0 0
11 days
Secondary outcome [9] 0 0
Plasma pharmacokinetics - t½ (the apparent terminal half-life)
Timepoint [9] 0 0
11 days
Secondary outcome [10] 0 0
Plasma pharmacokinetics - CL/F (the systemic clearance calculated from plasma)
Timepoint [10] 0 0
11 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
43
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
København
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
Spain
State/province [3] 0 0
Granada
Country [4] 0 0
Spain
State/province [4] 0 0
Madrid
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Lancashire
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Wales
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Coventry
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Leeds
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Oxford
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Persica Pharmaceuticals Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Micron Research Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Duncan McHale, MBBS MRCP
Address 0 0
Weatherden Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04238676