Clinical trial NCT01668511: A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-981 in Patients With Osteoarthritis of the Knee
Official title: A Randomized, Double-Blind, Placebo Controlled Study in Patients With Osteoarthritis of the Knee to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of ABT-981
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Keywords: Immunogenicity
Safety
Tolerability
Osteoarthritis
Pharmacokinetics
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-08-20
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with osteoarthritis of the knee.

Detailed description: This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Thirty-six patients with osteoarthritis of the knee will be selected to participate. Patients will be randomized to receive either ABT-981 or placebo. ABT-981 or placebo will be administered as subcutaneous (under the skin) injections in four dosing groups. Subjects will be administered subcutaneous injections of ABT-981 for up to 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Adult male or female, 40 to 70 years of age, inclusive.
* History of symptomatic osteoarthritis (OA) of the knee joint for at least 3 months, with typical Osteoarthritis (OA) symptoms
* Radiographic Osteoarthritis (OA) of Kellgren-Lawrence (K-L) grade 1, 2 or 3
* Patients assessment of Osteoarthritis (OA) pain intensity of the study joint is between 40 and 80 on the 0 - 100 mm VAS scale
* Other than Osteoarthritis (OA) of the study joint, patient should be in general good health

Exclusion Criteria:

* Radiographic OA of Kellgren-Lawrence grade 4 or chronic opioid user due to severe knee OA
* History of allergic reaction or significant sensitivity to any constituents of the study drug and acetominophen or history of anaphylactic reaction to any agent
* Significant trauma or surgery to the study joint within the last year or arthroscopy within 6 months, or, scheduled for major surgery to the study joint
* Diagnosis of rheumatoid arthritis, other autoimmune disorders or any arthritis other than Osteoarthritis (OA) of the knee.
* Any uncontrolled medical illness including unstable treatment or therapy.

Primary outcomes:
measure: Number of participants with Adverse Events
timeFrame: From date of first dose of ABT-981 until 70 days after the last dose of ABT-981
measure: Physical Exam including vital signs
timeFrame: From date of first dose of ABT-981 until 70 days after last dose of ABT-981
measure: Clinical Lab Testing
timeFrame: From date of first dose of ABT-981 until 70 days after the last dose of ABT-981
measure: Change from Baseline in Electrocardiogram (ECG)
timeFrame: Prior to dose and 8 hours post dose on each day of dosing
measure: Maximum observed serum concentration (Cmax) of ABT-981
timeFrame: Prior to first dose up to 70 days after the last dose of ABT-981
measure: Time to Cmax (Tmax) of ABT-981
timeFrame: Prior to first dose up to 70 days after the last dose of ABT-981
measure: The area under the time curve (AUC) of ABT-981
timeFrame: Prior to first dose up until 70 days after the last dose of ABT-981
measure: The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981
timeFrame: Prior to the last dose up to 70 days after the last dose of ABT-981
Secondary outcomes:
measure: Measurement of anti-drug anti-bodies (ADA) of ABT-981
timeFrame: Prior to each dose and up until 70 days after the last dose of ABT-981
Other outcomes:
Locations:
city: Miami
country: United States
facility: Site Reference ID/Investigator# 78613
state: Florida
Study officials:
affiliation: AbbVie
name: Susanne X. Wang, MD
role: STUDY_DIRECTOR
References:
citation: Wang SX, Abramson SB, Attur M, Karsdal MA, Preston RA, Lozada CJ, Kosloski MP, Hong F, Jiang P, Saltarelli MJ, Hendrickson BA, Medema JK. Safety, tolerability, and pharmacodynamics of an anti-interleukin-1alpha/beta dual variable domain immunoglobulin in patients with osteoarthritis of the knee: a randomized phase 1 study. Osteoarthritis Cartilage. 2017 Dec;25(12):1952-1961. doi: 10.1016/j.joca.2017.09.007. Epub 2017 Sep 28.