A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis

NCT02087904 | Completed Phase 2 Results

• 2 other identifiers: M13-7412013-003467-60
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase 2a, multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic effect of ABT-981 in patients with symptomatic, radiographic, and inflammatory knee osteoarthritis.

Conditions

Knee Osteoarthritis; Medial Compartment Knee Osteoarthritis

Keywords

Osteoarthritis; Synovitis; Knee; Pain

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16

  The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.

  Baseline, Week 16

• Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26

  Change in synovitis of the index knee was evaluated using quantitative magnetic resonance imaging (MRI) measurements. MRI quantitative synovitis of the index knee was defined by mean synovial membrane thickness.

  Baseline, Week 26

• Change From Baseline in Effusion Volume of the Index Knee at Week 26

  Baseline, Week 26

• Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26

  Semi-quantitative synovitis/effusion volume WORMS scores were scored as normal (0), \< 33% of maximum estimated distention (1), 33% - 66% of maximum estimated distention (2), or \> 66% of maximum estimated distention (3).

  Baseline, Week 26

Secondary Outcomes (23)

• Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16

  Baseline, Week 16

• Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26

  Baseline, Week 26

• Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52

  Baseline, Week 52

• Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26

  Baseline, Week 26

• Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52

  Baseline, Week 52

Study Arms (4)

ABT-981 low dose

EXPERIMENTAL

25 mg ABT-981 subcutaneous (SC) every 2 weeks (E2W)

Biological: ABT-981

ABT-981 medium dose

EXPERIMENTAL

100 mg ABT-981 SC E2W

Biological: ABT-981

ABT-981 high dose

EXPERIMENTAL

200 mg ABT-981 SC E2W

Biological: ABT-981

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

ABT-981 BIOLOGICAL

Also known as: Lutikizumab

ABT-981 high dose; ABT-981 low dose; ABT-981 medium dose

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 35 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiographic knee osteoarthritis with Kellgren-Lawrence Grade 2 or 3
• Body Mass Index (BMI) 18-34 kg/m2
• One or more clinical signs and symptoms of active inflammation in the index knee

You may not qualify if:

• History of allergic reaction to any constituents of the study drug, or to any Immunoglobulin G (IgG)-containing product
• History of anaphylactic reaction to any agent
• Significant trauma or surgery to the index knee
• Severe knee malalignment
• Any uncontrolled medical illness or an unstable treatment or therapy

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Fleischmann RM, Bliddal H, Blanco FJ, Schnitzer TJ, Peterfy C, Chen S, Wang L, Feng S, Conaghan PG, Berenbaum F, Pelletier JP, Martel-Pelletier J, Vaeterlein O, Kaeley GS, Liu W, Kosloski MP, Levy G, Zhang L, Medema JK, Levesque MC. A Phase II Trial of Lutikizumab, an Anti-Interleukin-1alpha/beta Dual Variable Domain Immunoglobulin, in Knee Osteoarthritis Patients With Synovitis. Arthritis Rheumatol. 2019 Jul;71(7):1056-1069. doi: 10.1002/art.40840. Epub 2019 Jun 7.

  PMID: 30653843 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Synovitis; Pain

Interventions

lutikizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

AbbVie

Study Officials

• Marc Levesque, MD

  AbbVie

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 14, 2014
• Study Start: June 4, 2014
• Primary Completion: June 7, 2016
• Study Completion: December 13, 2016
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2017-01