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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Medial Compartment Knee Osteoarthritis; Knee Osteoarthritis

Treatments: Other: Placebo; Biological: ABT-981

Study type: Interventional

Funder types: Industry

Identifiers

NCT02087904

M13-741

2013-003467-60 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: All

Ages: 35 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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350 participants in 4 patient groups, including a placebo group

ABT-981 low dose

Experimental group

Description:

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

Treatment:

Biological: ABT-981

ABT-981 medium dose

Experimental group

Description:

100 mg ABT-981 SC E2W

Treatment:

Biological: ABT-981

ABT-981 high dose

Experimental group

Description:

200 mg ABT-981 SC E2W

Treatment:

Biological: ABT-981

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo