?hronic discogenic low back pain MedDRA version: 21.0 Level: LLT Classification code 10024891 Term: Low back pain System Organ Class: 100000004859
Conditions
Sponsors
Stayble Therapeutics AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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: a. 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). b. Patients with treatable IVD(s) of grade 2 must have all other lumbar discs rated as grade 1. c. Not more than two IVDs of grade 3 at any lumbar level. d. No IVDs of grade 4 or 5 at any lumbar level. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 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. 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 suffering from psychosomatic pain in the opinion of the Investigator. Leg pain of compressive origin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to investigate the efficacy of a single intradiscal injection of STA363 into one or two IVDs as compared to placebo by the following primary efficacy endpoint: •Change from baseline at Month 6 in mean pain intensity measured on a 0-10 Numerical rating scale (NRS) for 7 consecutive days;Secondary Objective: 1. to investigate the efficacy of a single intradiscal injection of STA363 into one or two IVDs as compared to placebo by the following secondary efficacy endpoints: •Change from baseline at Month 1, Month 3 and Month 12 in mean pain intensity measured on the NRS for 7 consecutive days •Changes from baseline at Month 1, Month 3, Month 6 and Month 12 using the following questionnaires: oOswestry Disability Index (ODI) oEQ-5D-5L •Quantitative changes in nucleus pulposus (NP) water content (reflecting transformation of NP into connective tissue) at Month 6 and Month 12 (T2-weighted magnetic resonance imaging [MRI] and quantification of T2) 2. to investigate the safety of intradiscal injection of STA363 compared to placebo 3. to investigate the efficacy of a single intradiscal injection of STA363 into one or two IVDs compared to placebo by the exploratory efficacy endpoints;Primary end point(s): Change from baseline at Month 6 in mean pain intensity measured on a 0-10 Numerical rating scale (NRS) for 7 consecutive days;Timepoint(s) of evaluation of this end point: baseline and Month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): efficacy endpoints: • Change from baseline at Month 1, Month 3 and Month 12 in mean pain intensity measured on the NRS for 7 consecutive days • Changes from baseline at Month 1, Month 3, Month 6 and Month 12 using the following questionnaires: o Oswestry Disability Index (ODI) o EQ-5D-5L • Quantitative changes in nucleus pulposus (NP) water content (reflecting transformation of NP into connective tissue) at Month 6 and Month 12 (T2-weighted magnetic resonance imaging [MRI] and quantification of T2) safety endpoints: • Incidence and nature of adverse events • Changes in physical examination findings • Changes in vital signs (blood pressure and heart rate) • Changes in 12-lead electrocardiogram (ECG) • Changes in laboratory tests (hematology, clinical chemistry) • Pain intensity at the injection site during and 15 minutes after injection (NRS) • Changes in IVD height (T2-weighted MRI) • Other changes in IVD morphology (e.g. frequency of asymptomatic/symptomatic disc protrusions, Modic changes, high-intensity zone [HIZ] as well as other radiology findings) (T2-weighted MRI) exploratory efficacy endpoints: • Percentage of patients achieving >or= 30% reduction in mean NRS pain intensity score from baseline to Month 6 • Percentage of patients achieving >or=50% reduction in mean NRS pain intensity score from baseline to Month 6 • Percentage of patients achieving >or=30% improvement in ODI score • Percentage of patients with success outcome defined as =50% improvement in NRS accompanied by a >or=30% improvement in ODI • Consumption of analgesics • Return to work • Time to spinal fusion surgery • Patient Global Impression of Change (PGIC) at Month 1, Month 3, Month 6, Month 12 measured by a 7-point Likert Scale;Timepoint(s) of evaluation of this end point: baseline, Month 1, Month 3, Month 6 and Month 12 | — |
Countries
Netherlands, Russian Federation, Spain
Contacts
Public ContactAndreas Gerward, CEO
Stayble Therapeutics AB
Outcome results
None listed