STA363 in the Treatment of Lumbar Disc Herniation

NCT06022263 | Completed Phase 1

• 1 other identifier: STA-LDH01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to establish safety and tolerability of STA363 injected into a herniated intervertebral disc in patients with sciatica due to disc herniation. The main questions the trial aims to answer are:

1. 1.Is the treatment safe and tolerable?
2. 2.Does the volume of the disc and the herniation decrease?
3. 3.Is sciatica reduced? Participants will be given an injection into the herniated disc of either placebo or STA363 (one dose).

Conditions

Lumbar Disc Herniation

Keywords

Lumbar radiculopathy

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Safety and tolerability will be measured using the following outcomes: * Incidence and nature of adverse events (AEs) * Changes in * physical examination findings * blood pressure and heart rate * 12-lead electrocardiogram * Hematology and clinical chemistry * Pain intensity at the injection site during and 15 minutes after injection (numerical rating scale; NRS). NRS is reported on a 0-10 scale where 0 represents "No pain" and 10 "Worst imaginable pain" * Other aspects of intervertebral disc morphology (IVD) morphology from baseline (e.g., Modic changes)

  Baseline and 1 week and 1,3 and 6 months after intervention for all outcomes except changes in IVD morphology (time frame 1, 3 and 6 months after intervention)

Secondary Outcomes (5)

• Disc volume

  Baseline and 1,3 and 6 months after intervention

• Disc height

  Baseline and 1,3 and 6 months after intervention

• Radicular leg pain

  Baseline and 1 week and 1,3 and 6 months after intervention

• Patient Global Impression of Change (PGIC)

  Baseline and 1 week and 1,3 and 6 months after intervention

• Disc intensity

  Baseline and 1,3 and 6 months after intervention

Study Arms (2)

Placebo

PLACEBO COMPARATOR

1.5 mL of Omnipaque mixed with water for injection

Drug: Placebo

STA363

EXPERIMENTAL

1.5 mL of STA363 (lactic acid, 120 mg/mL) mixed with Omnipaque

Drug: Lactic Acid

Interventions

Lactic Acid DRUG

180 mg of STA363 will be slowly injected into a symptom-generating herniated lumbar disc

Also known as: STA363

STA363

Placebo DRUG

1.5 mL of Omnipaque in water for injection will be slowly injected into a symptom-generating herniated lumbar disc

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent prior to any study-related procedures
• Patient has a single subligamentous posteriolateral lumbar disc herniation (protrusion or extrusion) of any lumbar disc below L1/L2 diagnosed by clinical symptoms and/or physical findings and confirmed by MRI
• Patient has symptoms and/or physical findings consistent with a unilateral radiculopathy affecting one nerve root (L2-L5)
• Patient has leg pain of the dermatome consistent with the nerve root affected by the herniation
• The herniated disc is 3 or lower on the Pfirrmann scale (grade 1-5)
• Patient has experienced symptoms of a herniated disc for at least 6 weeks prior to randomisation without sufficient relief with pain medications and other conservative therapies
• Ability to understand the written and verbal information about the study
• Male and female patients 18 years or older but 50 years or younger
• Women of childbearing potential eligible if using effective contraceptives
• Patient has a body mass index (BMI) of ≥18 to ≤35 kg/m2
• Patients who meet all the following NRS selection criteria for radicular leg pain:
• Presence of at least 5 pain NRS assessments (entries) for 7 consecutive days
• NRS daily pain scores between 3-9
• Not more than 2 NRS scores of "3"

You may not qualify if:

• Treatment with any investigational product within 3 months prior to the screening visit
• Patient has a sequestered lumbar disc herniation or transligamentous/ herniation confirmed by MRI
• Patient has a bulging disc
• Patient has experienced symptoms of lumbar disc herniation for more than 6 months
• Patient has 2 or more symptomatic lumbar disc herniations (presence of non-symptomatic herniations in addition to the symptomatic herniation is allowed)
• Patient has cauda equina syndrome
• Previous intradiscal therapeutic intervention of the index disc or has had any lumbar spine surgery
• Presence of lumbar spine disease and/or clinically significant deformity other than a lumbar disc herniation which, in the opinion of the investigator, will affect evaluation of safety and/or efficacy
• Untreated, ongoing active infection and/or discitis
• Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
• Evidence of prior lumbar vertebral body fracture or trauma.
• 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 disc.
• Patients previously included in the study.
• Patients suffering from psychosomatic pain in the opinion of the Investigator.

Sponsors & Collaborators

• Stayble Therapeutics: lead
• Cromsource: collaborator
• Antaros Medical: collaborator
• VIEDOC: collaborator

Study Sites (1)

Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Ortopedii i Rehabilitacji

Lublin, Lublin Voivodeship, 20-002, Poland

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Radiculopathy

Interventions

Lactic Acid

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals

Study Officials

• Jarkko Kalliomäki, MD, PhD

  Stayble Therapeutics AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 1, 2023
• Study Start: July 25, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)