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

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ABT-981

Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Immunogenicity, Safety, Tolerability, Osteoarthritis, Pharmacokinetics

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Site Reference ID/Investigator# 78613

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Randomized 7 drug/2 placebo by group

Outcomes

Primary Outcome Measures

Number of participants with Adverse Events

Collect all adverse events at each visit

Physical Exam including vital signs

Blood pressure, heart rate and body temperature

Clinical Lab Testing

Hematology, Chemistry, and Urinalysis

Change from Baseline in Electrocardiogram (ECG)

ECGs done in triplicate

Maximum observed serum concentration (Cmax) of ABT-981

Cmax

Time to Cmax (Tmax) of ABT-981

Time to Cmax

The area under the time curve (AUC) of ABT-981

AUC

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

Measurement of ADA

Full Information

NCT ID

NCT01668511

First Posted

August 1, 2012

Last Updated

November 16, 2017

Sponsor

AbbVie (prior sponsor, Abbott)

1. Study Identification

Unique Protocol Identification Number

NCT01668511

Brief Title

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

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

Immunogenicity, Safety, Tolerability, Osteoarthritis, Pharmacokinetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Randomized 7 drug/2 placebo by group

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Randomized 7 drug/2 placebo by group

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Randomized 7 drug/2 placebo by group

Arm Title

Group 4

Arm Type

Experimental

Arm Description

Randomized 7 drug/2 placebo by group

Intervention Type

Biological

Intervention Name(s)

ABT-981

Intervention Description

Injection

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Placebo Injection

Primary Outcome Measure Information:

Title

Number of participants with Adverse Events

Description

Collect all adverse events at each visit

Time Frame

From date of first dose of ABT-981 until 70 days after the last dose of ABT-981

Title

Physical Exam including vital signs

Description

Blood pressure, heart rate and body temperature

Time Frame

From date of first dose of ABT-981 until 70 days after last dose of ABT-981

Title

Clinical Lab Testing

Description

Hematology, Chemistry, and Urinalysis

Time Frame

From date of first dose of ABT-981 until 70 days after the last dose of ABT-981

Title

Change from Baseline in Electrocardiogram (ECG)

Description

ECGs done in triplicate

Time Frame

Prior to dose and 8 hours post dose on each day of dosing

Title

Maximum observed serum concentration (Cmax) of ABT-981

Description

Cmax

Time Frame

Prior to first dose up to 70 days after the last dose of ABT-981

Title

Time to Cmax (Tmax) of ABT-981

Description

Time to Cmax

Time Frame

Prior to first dose up to 70 days after the last dose of ABT-981

Title

The area under the time curve (AUC) of ABT-981

Description

AUC

Time Frame

Prior to first dose up until 70 days after the last dose of ABT-981

Title

The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981

Description

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

Secondary Outcome Measure Information:

Title

Measurement of anti-drug anti-bodies (ADA) of ABT-981

Description

Measurement of ADA

Time Frame

Prior to each dose and up until 70 days after the last dose of ABT-981

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susanne X. Wang, MD

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 78613

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28964890

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.

Results Reference

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

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