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

NCT03055845 | Completed Phase 1 DMC

• 2 other identifiers: STA-012015-004812-39
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• 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 Outcomes (2)

• VAS pain (leg and back)

  1, 4 and 12 weeks after injection

• Oswestry disability index (ODI) score

  12 weeks after injection

Study Arms (4)

STA363 dose 1

EXPERIMENTAL

Drug: STA363

STA363 dose 2

EXPERIMENTAL

Drug: STA363

STA363 dose 3

EXPERIMENTAL

Drug: STA363

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

STA363 DRUG

STA363, containing 3 different doses of active ingredient, in a volume of 1.5 mL. Administered as intradiscal injection.

STA363 dose 1; STA363 dose 2; STA363 dose 3

Placebo DRUG

Matching placebo solution with identical appearance to the test product, used as reference treatment. Administered as intradiscal injection.

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stayble Therapeutics: lead

Study Sites (1)

Stockholm Spine Center, Löwenströmska Sjukhuset

Upplands Vasby, 19489, Sweden

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Model Details: Following treatment of 2 patients in each dose group (injections with active drug and placebo, respectively), safety data will be reviewed. If no safety or tolerability concerns are identified, the next 3 patients in each dose group will be treated (active treatment or placebo \[2:1\]).

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 16, 2017
• Study Start: March 27, 2017
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: February 18, 2020

Record last verified: 2020-02

Locations

SE (1)