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

November 16, 2017 updated by: AbbVie (prior sponsor, Abbott)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Site Reference ID/Investigator# 78613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Adverse Events
Time Frame: 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
From date of first dose of ABT-981 until 70 days after the last dose of ABT-981
Physical Exam including vital signs
Time Frame: From date of first dose of ABT-981 until 70 days after last dose of ABT-981
Blood pressure, heart rate and body temperature
From date of first dose of ABT-981 until 70 days after last dose of ABT-981
Clinical Lab Testing
Time Frame: From date of first dose of ABT-981 until 70 days after the last dose of ABT-981
Hematology, Chemistry, and Urinalysis
From date of first dose of ABT-981 until 70 days after the last dose of ABT-981
Change from Baseline in Electrocardiogram (ECG)
Time Frame: Prior to dose and 8 hours post dose on each day of dosing
ECGs done in triplicate
Prior to dose and 8 hours post dose on each day of dosing
Maximum observed serum concentration (Cmax) of ABT-981
Time Frame: Prior to first dose up to 70 days after the last dose of ABT-981
Cmax
Prior to first dose up to 70 days after the last dose of ABT-981
Time to Cmax (Tmax) of ABT-981
Time Frame: Prior to first dose up to 70 days after the last dose of ABT-981
Time to Cmax
Prior to first dose up to 70 days after the last dose of ABT-981
The area under the time curve (AUC) of ABT-981
Time Frame: Prior to first dose up until 70 days after the last dose of ABT-981
AUC
Prior to first dose up until 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
Time Frame: 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
Prior to the last dose up to 70 days after the last dose of ABT-981

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of anti-drug anti-bodies (ADA) of ABT-981
Time Frame: Prior to each dose and up until 70 days after the last dose of ABT-981
Measurement of ADA
Prior to each dose and up until 70 days after the last dose of ABT-981

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Susanne X. Wang, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

August 1, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (ESTIMATE)

August 20, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12-756

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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