A Study Comparing the Safety and Analgesic Efficacy of ABT-110 in Subjects with Chronic Low Back Pain

A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Study Comparing the Safety and Analgesic Efficacy of ABT-110 to Placebo in Subjects with Chronic Low Back Pain

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002143-95-PL

Enrollment

330

Registered

2011-12-20

Start date

2012-03-29

Completion date

Unknown

Last updated

2013-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain MedDRA version: 15.1 Level: LLT Classification code 10008837 Term: Chronic back pain System Organ Class: 100000004859

Interventions

Product Code: ABT-110 Pharmaceutical Form: Lyophilisate for solution for injection Current Sponsor code: ABT-110 Other descriptive name: Humanized anti-Nerve Growth Factor IgG4 kappa monoclonal antibo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Between 18 and 70 years of age, 2) History of CLBP below the 12th thoracic vertebrae and above the crease of the buttocks, = 6 months duration, 3) Subject requires therapeutic doses of at least 1 oral analgesic for CLBP pain (NSAIDS, COX-2 inhibitors, Tramadol or tapentadol, opioids) during the previous 3 months, with a stable dose for at least 4 days per week during the 4 weeks prior to the Screening Visit. 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 1) Has CLBP with any of the following a) pain with distal extremity radiation b) pain with radiation and neurologic findings c) spinal nerve root compression, 2) Has any of the following spinal cord conditions a) tumor, b) infection of the spinal cord or surrounding structures within the past 5 years, c) spinal stenosis with neurogenic claudication, d) spondylolisthesis with distal radiation and/or neurologic findings, e) seronegative spondylarthropathy 3) Has osteoarthritis of the large joints as evidenced by a) history or prior diagnosis of OA in the knee, hip or shoulder, b) clinical findings consistent with ACR Clinical and Radiographic Criteria for OA of the knee, hip or shoulder, or radiographic findings of OA in the knee, hip or shoulder (Kellgren-Lawrence = 2), 4) History of osteonecrosis or rapidly progressive osteoarthritis in any joint.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: The secondary objective of this study is to explore population pharmacokinetics of ABT 110 in subjects with CLBP.;Primary end point(s): Change from baseline to Week 16 in pain intensity as measured by a 100 mm Visual Analog Scale (VAS);Timepoint(s) of evaluation of this end point: 16 weeks;Main Objective: The primary objective for this study is to compare the safety, tolerability and the analgesic efficacy of ABT-110 administered subcutaneously (SC) once every 8 weeks (q8w) for a total of two doses to placebo in subjects with CLBP.	—

Measure

Time frame

Secondary Objective: The secondary objective of this study is to explore population pharmacokinetics of ABT 110 in subjects with CLBP.;Primary end point(s): Change from baseline to Week 16 in pain intensity as measured by a 100 mm Visual Analog Scale (VAS);Timepoint(s) of evaluation of this end point: 16 weeks;Main Objective: The primary objective for this study is to compare the safety, tolerability and the analgesic efficacy of ABT-110 administered subcutaneously (SC) once every 8 weeks (q8w) for a total of two doses to placebo in subjects with CLBP.

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Secondary

Measure	Time frame
Secondary end point(s): Roland-Morris Disability Questionnaire, EQ-5D, WPAI;Timepoint(s) of evaluation of this end point: 8 and 16 weeks	—

Countries

Argentina, Australia, Chile, Czech Republic, Finland, France, Germany, Italy, Mexico, Norway, Poland, Singapore, South Africa, Sweden

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd.

euclinicaltrials@abbott.com+441628644475

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026