A Single Ascending Dose Study of Safety and Tolerability of STA363 Compared to Placebo in 15 Patients With Chronic Discogenic Low Back Pain

A Prospective, Randomised, Double-blinded, Placebo-controlled, Single Ascending Dose Study Investigating the Safety and Local Tolerability of STA363 Compared to Placebo in 15 Patients With Chronic Discogenic Low Back Pain

A phase I, randomized, double-blinded, placebo-controlled, single ascending dose study to investigate the safety, local tolerability and transformation of nucleus pulposus following intradiscal injection of STA363 or placebo in patients with discogenic low back pain.

15 patients will participate in either of 3 dose groups, each comprising 5 patients:

• Group 1: STA363 dose 1 (3 patients) or placebo (2 patients)
• Group 2: STA363 dose 2 (3 patients) or placebo (2 patients)
• Group 3: STA363 dose 3 (3 patients) or placebo (2 patients)

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: STA363; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Upplands Väsby, Sweden, 19489
    • Stockholm Spine Center, Löwenströmska Sjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed informed consent prior to any study-related procedures
• Chronic discogenic low back pain present for more than 6 months prior to the screening visit
• 20 to 60 years of age at the screening visit
• Insufficient response to at least 6 months of non-operative treatment (analgesics and/or antiinflammatory medication, physiotherapy etc.)
• A single lumbar disc appropriate for treatment at L3/4 to L5/S1, based on clinical evaluation by the investigator
• Pfirrmann grade II-III
• Ability to understand the written and verbal information about the study

Exclusion Criteria:

• Treatment with any investigational product within 3 months prior to the screening visit
• More than one painful intervertebral disc
• A painful intervertebral disc above L3/4 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)
• Pfirrmann grade I, IV and V
• Evidence of prior lumbar vertebral body fracture or trauma
• Need for spinal decompression assessed by the investigator
• Presence of disc extrusion or sequestration
• Patients previously included in the study
• Patients suffering from psychosomatic pain in the opinion of the investigator
• Referred leg pain of compressive origin
• Known alcohol and/or drug abuse
• Severe intercurrent illness (e.g. rheumatic disease or chronic pain syndrome) or concomitant treatment (e.g. immunosuppressive drugs), which, in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study
• Clinically significant abnormalities in clinical chemistry or haematology parameters as assessed by the investigator
• Pregnant or lactating females or intention to become pregnant within the study period
• Known allergy to any of the components of the drug product or placebo
• Known opioid allergy or intolerance
• Patients requiring treatment with warfarin or other anticoagulant therapy
• Unwillingness to refrain from treatment with non-steroidal anti-inflammatory drugs (NSAIDs) within 5 days before the planned study treatment
• Body weight less than 50 kg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo solution with identical appearance to the test product, used as reference treatment. Administered as intradiscal injection.
Experimental: STA363 dose 1	Drug: STA363; STA363, containing 3 different doses of active ingredient, in a volume of 1.5 mL. Administered as intradiscal injection.
Experimental: STA363 dose 2	Drug: STA363; STA363, containing 3 different doses of active ingredient, in a volume of 1.5 mL. Administered as intradiscal injection.
Experimental: STA363 dose 3	Drug: STA363; STA363, containing 3 different doses of active ingredient, in a volume of 1.5 mL. Administered as intradiscal injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Local injection site reactions	Up to 4 weeks after injection
Frequency and severity of adverse events	Up to 12 weeks after injection
Changes in routine safety laboratory parameters	Up to 12 weeks after injection
Visual analogue scale (VAS) pain (injection site)	Up to 15 minutes after injection
Changes in vital signs	Up to 12 weeks after injection
Changes in electrocardiogram (ECG)	1 day after injection
Changes in physical examination findings	1 and 12 weeks after injection
Changes in body weight	12 weeks after injection

Secondary Outcome Measures

Outcome Measure	Time Frame
Transformation of nucleus pulposus into connective tissue by magnetic resonance imaging (MRI)	12 weeks after injection
Disc height by MRI	12 weeks after injection

Other Outcome Measures

Outcome Measure	Time Frame
VAS pain (leg and back)	1, 4 and 12 weeks after injection
Oswestry disability index (ODI) score	12 weeks after injection

Collaborators and Investigators

• Sponsor: Stayble Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Actual): August 29, 2019
• Study Completion (Actual): August 29, 2019

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: STA-01; 2015-004812-39 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No