MedDataX Logo

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

NCT ID: NCT02087904

Last Updated: 2019-08-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-04

Study Completion Date

2016-12-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01668511

Osteoarthritis
COMPLETED PHASE1

A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis

NCT02384538

Erosive Hand Osteoarthritis
COMPLETED PHASE2

A Safety and Tolerability Study of UBX0101 in Patients With Osteoarthritis of the Knee

NCT03513016

Osteoarthritis, Knee
COMPLETED PHASE1

A Study to Assess the Safety and Efficacy of an Investigational Drug (MK-686) in Patients With Osteoarthritis (0686-006)

NCT00296569

Osteoarthritis
COMPLETED PHASE2

A Study to Assess the Safety and Efficacy of a Single Dose of UBX0101 in Patients With Osteoarthritis of the Knee

NCT04129944

Osteoarthritis, Knee
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis Medial Compartment Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ABT-981 low dose

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

Group Type EXPERIMENTAL

ABT-981

Intervention Type BIOLOGICAL

ABT-981 medium dose

100 mg ABT-981 SC E2W

Group Type EXPERIMENTAL

ABT-981

Intervention Type BIOLOGICAL

ABT-981 high dose

200 mg ABT-981 SC E2W

Group Type EXPERIMENTAL

ABT-981

Intervention Type BIOLOGICAL

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABT-981

Intervention Type BIOLOGICAL

Placebo

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lutikizumab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marc Levesque, MD

Role: STUDY_CHAIR

AbbVie

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30653843 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-003467-60

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-741

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
NCT02536833 COMPLETED PHASE2
Study of Efficacy, Safety and Tolerability of DFV890 in Patients With Knee Osteoarthritis
NCT04886258 COMPLETED PHASE2
A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee
NCT01444365 COMPLETED PHASE2
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee
NCT00689273 COMPLETED PHASE2
Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Osteoarthritis (OA) of the Knee
NCT00878501 TERMINATED PHASE2
A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee
NCT01207115 COMPLETED PHASE2
Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain
NCT02558439 COMPLETED PHASE2
A Study of the Efficacy and Safety of MEDI7352 in Participants With Painful Osteoarthritis of the Knee
NCT04675034 COMPLETED PHASE2
A Trial of SB-061 in Osteoarthritis of the Knee
NCT02802709 COMPLETED PHASE1/PHASE2
A Study of Single and Repeat Dose Administration of UBX0101 in Patients With Osteoarthritis of the Knee
NCT04229225 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1026706 in Male and Female Healthy Subjects and Patients With Osteoarthritis of the Knee
NCT02126826 COMPLETED PHASE1
Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
NCT03727022 COMPLETED PHASE2
Dose Finding Study of Bone Morphogenetic Protein 7 (BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
NCT01111045 COMPLETED PHASE2
Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)
NCT02095548 COMPLETED PHASE1
A Study of MEDI7352 in Painful Osteoarthritis of the Knee
NCT02508155 COMPLETED PHASE1
An Observational Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis
NCT02951026 COMPLETED
A First-in-human Study to Investigate Safety and Tolerability of SAR446959 in Participants With Osteoarthritis of the Knee
NCT06704932 COMPLETED PHASE1
Efficacy and Safety Study Evaluating ADL5859 and ADL5747 in Participants With Pain Due to Osteoarthritis of the Knee
NCT00979953 COMPLETED PHASE2
A Phase 3 Study to Assess the Efficacy and Safety of PK101 in Patients With Knee Osteoarthritis
NCT04858659 UNKNOWN PHASE3
A Placebo Controlled, Double Blind, Randomised, 8-week Phase IIa Proof of Concept Study to Assess the Efficacy and Safety of AKR 202 in Patients With Osteoarthritis Pain
NCT02003118 COMPLETED PHASE2
A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain
NCT03660943 COMPLETED PHASE3
Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee
NCT02205814 COMPLETED PHASE2
Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part II
NCT01598415 COMPLETED PHASE2
A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis
NCT02067611 COMPLETED PHASE2
Efficacy and Safety of XT-150 in Osteoarthritis of the Knee
NCT04124042 COMPLETED PHASE2