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

Persica Pharmaceuticals

Status and phase

Completed

Phase 2

Phase 1

Conditions

Chronic Low-back Pain

Treatments

Drug: PP353

Other: Placebo

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT04238676

U1111-1257-2567 (Registry Identifier)

Persica 002

2018-004488-30 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.