A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-981 in Patients With Osteoarthritis of the Knee

Sponsor

AbbVie (prior sponsor, Abbott) (Industry)

Overall Status

Completed

CT.gov ID

NCT01668511

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Biological: ABT-981 Biological: Placebo	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Randomized 7 drug/2 placebo by group	Biological: ABT-981 Injection Biological: Placebo Placebo Injection
Experimental: Group 2 Randomized 7 drug/2 placebo by group	Biological: ABT-981 Injection Biological: Placebo Placebo Injection
Experimental: Group 3 Randomized 7 drug/2 placebo by group	Biological: ABT-981 Injection Biological: Placebo Placebo Injection
Experimental: Group 4 Randomized 7 drug/2 placebo by group	Biological: ABT-981 Injection Biological: Placebo Placebo Injection

Outcome Measures

Primary Outcome Measures

Number of participants with Adverse Events [From date of first dose of ABT-981 until 70 days after the last dose of ABT-981]
Collect all adverse events at each visit
Physical Exam including vital signs [From date of first dose of ABT-981 until 70 days after last dose of ABT-981]
Blood pressure, heart rate and body temperature
Clinical Lab Testing [From date of first dose of ABT-981 until 70 days after the last dose of ABT-981]
Hematology, Chemistry, and Urinalysis
Change from Baseline in Electrocardiogram (ECG) [Prior to dose and 8 hours post dose on each day of dosing]
ECGs done in triplicate
Maximum observed serum concentration (Cmax) of ABT-981 [Prior to first dose up to 70 days after the last dose of ABT-981]
Cmax
Time to Cmax (Tmax) of ABT-981 [Prior to first dose up to 70 days after the last dose of ABT-981]
Time to Cmax
The area under the time curve (AUC) of ABT-981 [Prior to first dose up until 70 days after the last dose of ABT-981]
AUC
The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981 [Prior to the last dose up to 70 days after the last dose of ABT-981]
The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981

Secondary Outcome Measures

Measurement of anti-drug anti-bodies (ADA) of ABT-981 [Prior to each dose and up until 70 days after the last dose of ABT-981]
Measurement of ADA

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.