A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)

NCT ID: NCT02349451

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-28
• Study Completion Date: 2016-07-04

Brief Summary

This study is a Phase 2 randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in participants with active PsA who are inadequately responding to MTX treatment.

Conditions

Psoriatic Arthritis

Study Design

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

Study Groups

Adalimumab

Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks

Group Type: ACTIVE_COMPARATOR

adalimumab

Intervention Type: BIOLOGICAL

Placebo

Double-blind placebo administered every week (EW) for 12 weeks

Group Type: PLACEBO_COMPARATOR

ABT-122

Intervention Type: BIOLOGICAL

ABT-122 120 mg

Double-blind ABT-122 120 mg administered EW for 12 weeks

Group Type: EXPERIMENTAL

ABT-122

Intervention Type: BIOLOGICAL

ABT-122 240 mg

Double-blind ABT-122 240 mg administered EW for 12 weeks

Group Type: EXPERIMENTAL

ABT-122

Intervention Type: BIOLOGICAL

Interventions

adalimumab

Intervention Type: BIOLOGICAL

ABT-122

Intervention Type: BIOLOGICAL

Other Intervention Names

Humira; ABT-D2E7; remtolumab

Eligibility Criteria

Inclusion Criteria

• PsA diagnosis of at least 3 months duration prior to the date of first screening with ClASsification of Psoriatic ARthritis (CASPAR) confirmed diagnosis at Screening.
• Have active psoriasis defined by at least 1 psoriasis lesion >= 2 cm diameter in areas other than the axilla or groin.
• Have active arthritis defined by minimum disease activity criteria:

1. >= 3 swollen joints (based on 66 joint counts) at Screening

2. >= 3 tender joints (based on 68 joint counts) at Screening

• On a stable dose of methotrexate (MTX) defined as:

1. Oral or parenteral treatment >= 3 months

2. On a stable dose with an unchanged mode of application for at least 4 weeks prior to baseline

3. Stable MTX dose of >= 10 mg/week and <= the upper limit of the applicable approved local label

4. Can also be on stable doses of nonsteroidal anti-inflammatory drugs, sulfasalazine and/or hydroxychloroquine as long as they are also on methotrexate

Exclusion Criteria

• Up to 30% (approximately 66 subjects) with prior exposure to a TNF inhibitor may be enrolled if the TNF inhibitor was not discontinued due to lack of efficacy or safety concerns. Subjects must be washed out for at least 5 half-lives of these drugs prior to the Baseline visit.
• Subjects on prior adalimumab may not be enrolled in the study
• Prior exposure to other non-TNF inhibitor biological disease-modifying antirheumatic drugs (DMARDs) will be permitted if the subject is washed out at least 5 half-lives of these drugs prior to the baseline visit.
• Current treatment with traditional oral/intramuscular DMARDs, including conventional synthetic DMARDs (csDMARDs; except for concomitant treatment with sulfasalazine and/or hydroxychloroquine in addition to MTX). Oral DMARDs must be washed out for at least 5 half-lives of a drug apart from MTX prior to the Baseline visit.

a. Subject could have been exposed to prior Janus kinase (JAK) or phosphodiesterase type 4 (PDE4) inhibitors so long as they have been off therapy for at least 5 half-lives.

• Stable prescribed dose of oral prednisone or prednisone equivalent > 10 mg/day within the 30 days of the Baseline visit.
• Intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks of the Baseline visit. Inhaled corticosteroids for stable medical conditions are allowed.
• Laboratory values of the following at the Screening Visit:

1. Confirmed hemoglobin < 9 g/dL for males and < 8.5 g/dL for females

2. Absolute neutrophil count (ANC) < 1500 mm^3, (or < 1200 cells/µL for subjects of African descent who are black)

3. Aspartate aminotransferase or alanine aminotransferase > 1.5 x the upper limit of normal (ULN) or bilirubin >= 3 mg/dL

4. Serum creatinine > 1.5 x the ULN

5. Platelets < 100,000 cells/[mm^3] (10^9/L),

6. Clinically significant abnormal screening laboratory results as evaluated by the Investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Peloso, MD

Role: STUDY_DIRECTOR

AbbVie

References

Khatri A, Klunder B, Peloso PM, Othman AA. Exposure-response analyses demonstrate no evidence of interleukin 17A contribution to efficacy of ABT-122 in rheumatoid or psoriatic arthritis. Rheumatology (Oxford). 2019 Feb 1;58(2):352-360. doi: 10.1093/rheumatology/key312.

Reference Type: DERIVED

PMID: 30376130 (View on PubMed)

Mease PJ, Genovese MC, Weinblatt ME, Peloso PM, Chen K, Othman AA, Li Y, Mansikka HT, Khatri A, Wishart N, Liu J. Phase II Study of ABT-122, a Tumor Necrosis Factor- and Interleukin-17A-Targeted Dual Variable Domain Immunoglobulin, in Patients With Psoriatic Arthritis With an Inadequate Response to Methotrexate. Arthritis Rheumatol. 2018 Nov;70(11):1778-1789. doi: 10.1002/art.40579.

Reference Type: DERIVED

PMID: 29855175 (View on PubMed)

Related Links

http://rxabbvie.com

Humira Prescribing info

Other Identifiers

2014-003558-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M14-197

Identifier Type: -

Identifier Source: org_study_id