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

NCT01668511 | Completed Phase 1

• 1 other identifier: M12-756
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis

Keywords

Immunogenicity; Safety; Tolerability; Osteoarthritis; Pharmacokinetics

Outcome Measures

Primary Outcomes (8)

• Number of participants with Adverse Events

  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

  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

  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)

  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

  Cmax

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

• Time to Cmax (Tmax) 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

  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

  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 Outcomes (1)

• 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

Study Arms (4)

Group 1

EXPERIMENTAL

Randomized 7 drug/2 placebo by group

Biological: ABT-981; Biological: Placebo

Group 2

EXPERIMENTAL

Randomized 7 drug/2 placebo by group

Biological: ABT-981; Biological: Placebo

Group 3

EXPERIMENTAL

Randomized 7 drug/2 placebo by group

Biological: ABT-981; Biological: Placebo

Group 4

EXPERIMENTAL

Randomized 7 drug/2 placebo by group

Biological: ABT-981; Biological: Placebo

Interventions

ABT-981 BIOLOGICAL

Injection

Group 1; Group 2; Group 3; Group 4

Placebo BIOLOGICAL

Placebo Injection

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (1)

Site Reference ID/Investigator# 78613

Miami, Florida, 33136, United States

Location

Related Publications (1)

• 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.

  PMID: 28964890 RESULT

MeSH Terms

Conditions

Osteoarthritis

Interventions

lutikizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Susanne X. Wang, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 20, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 20, 2017

Record last verified: 2013-11

Locations

US (1)