Study Investigating STA363 Compared to Placebo in Patients With Chronic Discogenic Low Back Pain

NCT04673461 | Completed Phase 2

• 2 other identifiers: STA-022019-004943-54
• Study Type: interventional
• Target: 110
• Locations: 3 countries
• Sites: 17

Brief Summary

This is a phase IIb, prospective, multi-country, multicenter, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and transformation of NP following single intradiscal injection of STA363 (lactic acid) into one or two IVDs compared to placebo for the treatment of discogenic low back pain. This study will be conducted in Russia, Spain and the Netherlands.

Conditions

Discogenic Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity at 6 months on a Numerical rating scale

  Change from baseline at Month 6 in mean pain intensity measured on a Numerical rating scale (minimum value: 0; maximum value: 10) for 7 consecutive days. Lower scores means a better outcome.

  6 months

Secondary Outcomes (4)

• Pain intensity at Month 1, Month 3 and Month 12 on a Numerical rating scale

  1 month, 3 months and 12 months

• Oswestry Disability Index

  1 month, 3 months, 6 months and 12 months

• EuroQoL 5-dimension 5-level

  1 month, 3 months, 6 months and 12 months

• Nucleus pulposus transformation

  6 and 12 months

Study Arms (3)

STA363 containing 90 mg (60 mg/mL) lactic acid

EXPERIMENTAL

STA363 containing 90 mg (60 mg/mL) lactic acid will be injected into the center of up to two intervertebral discs. Patients with two discs appropriate for treatment will be treated at both affected levels by two separate injections. Each patient will have 5 visits to study site and 1 telephone call. The patient's total time in the study will be approximately 61 weeks (\~15 months) including an 8-week screening period.

Drug: STA363 containing 90 mg (60 mg/mL) lactic acid

STA363 containing 180 mg (120 mg/mL) lactic acid

EXPERIMENTAL

STA363 containing 180 mg (120 mg/mL) lactic acid will be injected into the center of up to two intervertebral discs. Patients with two discs appropriate for treatment will be treated at both affected levels by two separate injections. Each patient will have 5 visits to study site and 1 telephone call. The patient's total time in the study will be approximately 61 weeks (\~15 months) including an 8-week screening period.

Drug: STA363 containing 180 mg (120 mg/mL) lactic acid

Placebo

PLACEBO COMPARATOR

Placebo will be injected into the center of up to two intervertebral discs. Patients with two discs appropriate for treatment will be treated at both affected levels by two separate injections. Each patient will have 5 visits to study site and 1 telephone call. The patient's total time in the study will be approximately 61 weeks (\~15 months) including an 8-week screening period.

Drug: Placebo

Interventions

STA363 containing 180 mg (120 mg/mL) lactic acid DRUG

STA363 (180 mg) will be injected into maximally two pain-generating degenerated intervertebral discs

STA363 containing 180 mg (120 mg/mL) lactic acid

Placebo DRUG

Placebo will be injected into maximally two pain-generating degenerated intervertebral discs

Placebo

STA363 containing 90 mg (60 mg/mL) lactic acid DRUG

STA363 (90 mg) will be injected into maximally two pain-generating degenerated intervertebral discs

STA363 containing 90 mg (60 mg/mL) lactic acid

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to any study related procedures.
• Male and female patients ≥18 and ≤70 years.
• Chronic discogenic low back pain present for more than 6 months prior to the screening visit.
• Insufficient response or lack of response to at least 6 months of non-operative treatment (analgesics and/or anti-inflammatory medications \[paracetamol, non-steroidal anti-inflammatory agents (NSAIDs), opioids\], physiotherapy, rehabilitation therapy etc.).
• Patients who meet all the following NRS selection criteria:
• Presence of ≥5 pain NRS assessments (entries) for 7 consecutive days.
• NRS daily pain scores between 3-9.
• Not more than two ratings "3".
• One or two treatable IVDs of Pfirrmann grade 2 to 3 on MRI at L2/3 to L5/S1 as confirmed by a central reader, AND the following criteria are met:
• Treatable IVD(s) must be IVD(s) with the highest Pfirrmann grade observed in the patient (e.g. a patient with one IVD of grade 3 and four IVDs of grade 2 is considered eligible only if IVD of grade 3 will be injected).
• Patients with treatable IVD(s) of grade 2 must have all other lumbar discs rated as grade 1.
• Not more than two IVDs of grade 3 at any lumbar level.
• No IVDs of grade 4 or 5 at any lumbar level.
• Ability to understand the written and verbal information about the study.

You may not qualify if:

• Treatment with any investigational product within 3 months prior to the screening visit.
• Patients with more than two painful IVDs.
• A painful IVD above L2/3 level.
• Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
• Previous lumbar spine surgery.
• Previous disc invasive treatment procedures at the affected level(s) (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation).
• Evidence of prior lumbar vertebral body fracture or trauma.
• Need for spinal decompression assessed by the Investigator.
• Presence of IVD extrusion or sequestration, or other radiologic findings that in the opinion of the investigator disqualify the patient from being included.
• Spondylolisthesis or retrolisthesis Grade 2 and above or spondylolysis at the index or adjacent level(s).
• Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index IVD.
• Patients previously included in the study.
• Patients suffering from psychosomatic pain in the opinion of the Investigator.
• Leg pain of compressive origin.
• Patients requiring continuous treatment with warfarin or other anticoagulant therapy.

Sponsors & Collaborators

• Stayble Therapeutics: lead

Study Sites (17)

Alrijne Ziekenhuis Leiderdorp

Leiderdorp, Netherlands

Location

Rijnstate Hospital Anesthesiology and Pain

Velp, Netherlands

Location

Belgorod Regional Clinical Hospital of Saint Joasaph

Belgorod, Russia

Location

Regional Clinical Hospital #3

Chelyabinsk, Russia

Location

Kirov State Medical University

Kirov, Russia

Location

Ochapovsky Regional Clinical Hospital #1

Krasnodar, Russia

Location

Krasnoyarsk Interdistrict Clinical Emergency Hospital

Krasnoyarsk, Russia

Location

Siberian Research Clinical Center

Krasnoyarsk, Russia

Location

Privolzhsky Research Medical University

Nizhny Novgorod, Russia

Location

Bekhterev Psychiatry and Neurology Center

Saint Petersburg, Russia

Location

LLC MART

Saint Petersburg, Russia

Location

Smolensk Regional Clinical Hospital

Smolensk, Russia

Location

Tula Regional Clinical Hospital

Tula, Russia

Location

Hospital Quirónsalud Córdoba

Córdoba, Spain

Location

Complejo Hospitalario Ruber Juan Bravo

Madrid, Spain

Location

Hm Puerta Del Sur

Móstoles, Spain

Location

Hospital Universitario Quirónsalud Madrid

Pozuelo de Alarcón, Spain

Location

MeSH Terms

Interventions

Lactic Acid

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals

Study Officials

• Jan Willem Kallewaard, MD, PhD

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The test and reference IMPs will be identical in appearance. The kits will not contain any other information about treatment. Therefore, all site staff and patients will be blinded at treatment administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three treatment groups: * STA363 60 mg/mL * STA363 120 mg/mL * Placebo

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 17, 2020
• Study Start: July 31, 2020
• Primary Completion: September 1, 2023
• Study Completion: October 31, 2023
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (11); ES (4); NL (2)