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

NCT ID: NCT02384538

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-07-31

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to compare the safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis.

Conditions

Erosive Hand Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo for ABT-981

Intervention Type: BIOLOGICAL

Placebo for ABT-981 administered by subcutaneous injection

ABT-981

ABT-981 200 mg every two weeks (Q2W) for 24 weeks.

Group Type: EXPERIMENTAL

ABT-981

Intervention Type: BIOLOGICAL

ABT-981 administered by subcutaneous injection

Interventions

ABT-981

ABT-981 administered by subcutaneous injection

Intervention Type: BIOLOGICAL

Placebo for ABT-981

Placebo for ABT-981 administered by subcutaneous injection

Intervention Type: BIOLOGICAL

Other Intervention Names

lutikizumab

Eligibility Criteria

Inclusion Criteria

1. Male or female between the ages of 35 to 80.

2. Must fulfill 1990 American College of Rheumatology (ACR) hand osteoarthritis (OA) criteria

3. Must have radiographic evidence of erosive hand OA

4. Have one or more clinical signs and symptoms of active inflammation in at least three hand joints

5. Subject Assessment of Hand Pain Intensity in at least one hand is ≥ 6.

Exclusion Criteria

1. Previous exposure to any anti-interleukin-1 treatment, to corticosteroids within 1 month prior to Screening, to intra-articular hyaluronic acid injection into hand joint(s) within 6 months prior to Screening, to any immunosuppressive biologic therapy within 1 month or 5 half-lives (whichever is longer) prior to the first dose of study drug, OR current use of immunosuppressive oral medications within 3 months or 5 half-lives (whichever is longer) prior to the first dose of study drug.

2. Absolute neutrophil count < 2,000 per mm3

3. Diagnosis of one or more of the following:

• Fibromyalgia,
• Inflammatory arthritis such as rheumatoid arthritis, peripheral seronegative spondyloarthropathy,
• Psoriatic arthritis, psoriasis,
• Microcrystalline (including gout and pseudo gout) arthritis affecting the hands,
• Any OA of the hands due to an infectious origin or acute traumatic episode, secondary OA or OA linked to cartilage and bone dysplasia,
• Other chronic painful syndromes that could interfere with assessment of pain at the hand(s).

4. Any uncontrolled medical illness or an unstable treatment or therapy.

5. Any reason that prohibits a subject to undergo an MRI.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc

Role: STUDY_DIRECTOR

AbbVie

References

Kloppenburg M, Peterfy C, Haugen IK, Kroon F, Chen S, Wang L, Liu W, Levy G, Fleischmann RM, Berenbaum F, van der Heijde D, Bansal P, Wittoek R, Feng S, Fang Y, Saltarelli M, Medema JK, Levesque MC. Phase IIa, placebo-controlled, randomised study of lutikizumab, an anti-interleukin-1alpha and anti-interleukin-1beta dual variable domain immunoglobulin, in patients with erosive hand osteoarthritis. Ann Rheum Dis. 2019 Mar;78(3):413-420. doi: 10.1136/annrheumdis-2018-213336. Epub 2018 Dec 14.

Reference Type: DERIVED

PMID: 30552176 (View on PubMed)

Other Identifiers

2014-001096-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M14-171

Identifier Type: -

Identifier Source: org_study_id