A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects with Active Psoriatic Arthritis Who Have an InadequateResponse to Methotrexate

Phase 1

• Conditions: Psoriatic Arthritis; MedDRA version: 19.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-003558-15-DE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-26
• Last Update Posted: 10 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Adult male or female, 18 years of age or older.
2. PsA diagnosis of at least 3 months duration prior to the date of first Screening with CASPAR confirmed diagnosis at Screening.
3. Have active psoriasis defined by at least 1 psoriasis lesion = 2 cm diameter in areas other than the axilla or groin.
4. 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.
5. On a stable dose of 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.
• Subject can also be on stable doses of NSAIDs, sulfasalazine and/or hydroxychloroquine as long as they are also on methotrexate.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Prior exposure to any TNF inhibitors including:
- 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 of efficiacy or for 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 DMARDs will be permitted if the subject is washed out at least 5 half-lives of these drugs prior to the Baseline visit.
2. Current treatment with traditional oral DMARDs, including 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.
• Subject may have prior exposure to JAK inhibitors or to PDE4 inhibitors as long as they have been off therapy for at least 5 half-lives.
3. Stable prescribed dose of oral prednisone or prednisone equivalent > 10 mg/day within 30 days of the Baseline visit.
4. Intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks of the Baseline visit. Inhaled corticosteroids for stable medical conditions are allowed.
5. 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/mm3 (or < 1200 cells/µL for subjects of African descent who are black),
• AST or ALT > 1.5 × the upper limit of normal (ULN) or bilirubin = 3 mg/dL,
• Serum creatinine > 1.5 × the ULN,
• Platelets < 100,000 cells/(mm3) (109/L),
• Clinically significant abnormal screening laboratory results as evaluated by the Investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objectives are to compare the efficacy of ABT-122 versus placebo in subjects on background methotrexate (MTX) as assessed by ACR20 at Week 12 and to assess the safety and tolerability of ABT-122 in subjects with the active psoriatic arthritis (PsA).;Secondary Objective: ? To compare the efficacy of ABT-122 versus adalimumab as assessed by ACR20 at Week 12<br>? To assess additional efficacy endpoints of ABT-122 as measured by:<br>- ACR50/70 response rates at Week 12<br>- Empirical cumulative distribution function of ACRn at Week 12<br>- Change from baseline in the DAS28[hsCRP] and PASDAS at Week 12<br>- Change from baseline in the Psoriasis Target Lesion Scores at Week 12<br>;Primary end point(s): ACR20 response rate at Week 12 with a primary comparison between ABT-122 versus placebo.;Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Comparison of efficacy of ABT-122 versus adalimumab as assessed by ACR20 at Week 12<br>• Additional efficacy endpoints of ABT-122 as measured by:<br>o ACR50/70 response rates at Week 12<br>o Empirical cumulative distribution function of ACRn at Week 12<br>o Change from baseline in the DAS28[hsCRP] and PASDAS at Week 12<br>o Change from baseline in the Target Lesion Score at Week 12<br>;Timepoint(s) of evaluation of this end point: Week 12