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)

NCT02349451 | Completed Phase 2 Results

• 2 other identifiers: M14-1972014-003558-15
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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

Keywords

Safety; Efficacy; Methotrexate

Outcome Measures

Primary Outcomes (1)

• American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo

  Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein \[hsCRP\]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.

  Week 12

Secondary Outcomes (7)

• ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab

  Week 12

• ACR50 Response Rate at Week 12

  Week 12

• ACR70 Response Rate at Week 12

  Week 12

• ACRn at Week 12

  At Week 12

• Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12

  Baseline, Week 12

Study Arms (4)

Adalimumab

ACTIVE COMPARATOR

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

Biological: adalimumab

Placebo

PLACEBO COMPARATOR

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

Biological: ABT-122

ABT-122 120 mg

EXPERIMENTAL

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

Biological: ABT-122

ABT-122 240 mg

EXPERIMENTAL

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

Biological: ABT-122

Interventions

adalimumab BIOLOGICAL

Also known as: Humira, ABT-D2E7

Adalimumab

ABT-122 BIOLOGICAL

Also known as: remtolumab

ABT-122 120 mg; ABT-122 240 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \>= 3 swollen joints (based on 66 joint counts) at Screening
• \>= 3 tender joints (based on 68 joint counts) at Screening
• On a stable dose of methotrexate (MTX) defined as:
• Oral or parenteral treatment \>= 3 months
• On a stable dose with an unchanged mode of application for at least 4 weeks prior to baseline
• Stable MTX dose of \>= 10 mg/week and \<= the upper limit of the applicable approved local label
• Can also be on stable doses of nonsteroidal anti-inflammatory drugs, sulfasalazine and/or hydroxychloroquine as long as they are also on methotrexate

You may not qualify if:

• 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:
• Confirmed hemoglobin \< 9 g/dL for males and \< 8.5 g/dL for females
• Absolute neutrophil count (ANC) \< 1500 mm\^3, (or \< 1200 cells/µL for subjects of African descent who are black)
• Aspartate aminotransferase or alanine aminotransferase \> 1.5 x the upper limit of normal (ULN) or bilirubin \>= 3 mg/dL
• Serum creatinine \> 1.5 x the ULN
• Platelets \< 100,000 cells/\[mm\^3\] (10\^9/L),
• Clinically significant abnormal screening laboratory results as evaluated by the Investigator

Sponsors & Collaborators

• AbbVie: lead

Related Publications (2)

• 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.

  PMID: 30376130 DERIVED

• 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.

  PMID: 29855175 DERIVED

Related Links

• Humira Prescribing info

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Adalimumab; ABT-122

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Paul Peloso, MD

  AbbVie

  STUDY DIRECTOR

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: January 23, 2015
• First Posted: January 28, 2015
• Study Start: April 28, 2015
• Primary Completion: July 4, 2016
• Study Completion: July 4, 2016
• Last Updated: August 4, 2017
• Results First Posted: August 4, 2017

Record last verified: 2017-08