A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD) (SELECT - PsA 2)

AbbVie

Status and phase: Active, not recruiting; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: Placebo; Drug: Upadacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03104374

2016-004152-30 (EudraCT Number)

M15-554

Details and patient eligibility

About

The study objectives of Period 1 are to compare the efficacy, safety, and tolerability of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo for the treatment of signs and symptoms in adults with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to biologic disease-modifying anti-rheumatic drug (bDMARD).

The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants who have completed Period 1.

Full description

The study includes a 35-day screening period, a 56-week blinded period (Period 1), a long-term extension period of up to a total treatment duration of approximately 3 years (Period 2), and a 30-day follow-up call or visit.

Period 1 includes 24 weeks of randomized, double-blind, parallel-group, placebo-controlled treatment followed by an additional 32 weeks of blinded treatment where all participants were to receive upadacitinib; at Week 24 participants assigned to placebo will be switched to upadacitinib according to their randomization assignment.

Participants who meet eligibility criteria will be randomized in a 2:2:1:1 ratio to one of four treatment groups:

• Group 1: Upadacitinib 15 mg
• Group 2: Upadacitinib 30 mg
• Group 3: Placebo for 24 weeks followed by upadacitinib 15 mg
• Group 4: Placebo for 24 weeks followed by upadacitinib 30 mg

Participants who complete the Week 56 visit (end of Period 1) will enter the long-term extension portion of the study, Period 2, and continue study treatment as assigned in Period 1 in a blinded manner until the last participant completes the last visit of Period 1 (Week 56), when study drug assignment in both periods will be unblinded and study drug will be dispensed in an open-label fashion until the completion of Period 2.

At Week 16, rescue therapy will be offered to participants classified as non-responders (defined as not achieving at least 20% improvement in tender joint count (TJC) and/or swollen joint count (SJC) at both Week 12 and Week 16). Starting at Week 36, participants who fail to demonstrate at least 20% improvement in either or both TJC and SJC compared to Baseline at 2 consecutive visits will be discontinued from study drug treatment. Additionally, in participants continuing on study drug, starting at the Week 36 visit, initiation of or change in background PsA medication(s) is allowed as per local label.

Enrollment: 642 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria
• Participant has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
• Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
• Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) or intolerance to treatment with at least 1 bDMARD.

Exclusion criteria

• Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib)
• Current treatment with > 2 non-biologic DMARDs or use of DMARDs other than methotrexate (MTX), sulfasalazine (SSZ), leflunomide (LEF), apremilast, hydroxychloroquine (HCQ), bucillamine or iguratimod or use of MTX in combination with LEF at Baseline.
• History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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642 participants in 4 patient groups, including a placebo group

Upadacitinib 15 mg

Experimental group

Description:

Period 1: Participants receive upadacitinib 15 mg once daily for 56 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Treatment:

Drug: Upadacitinib

Upadacitinib 30 mg

Experimental group

Description:

Period 1: Participants receive upadacitinib 30 mg once daily for 56 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Treatment:

Drug: Upadacitinib

Placebo then Upadacitinib 15 mg

Placebo Comparator group

Description:

Period 1: Participants receive placebo once daily for 24 weeks followed by upadacitinib 15 mg once daily for 32 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Treatment:

Drug: Upadacitinib

Drug: Placebo

Placebo then Upadacitinib 30 mg

Placebo Comparator group

Description:

Period 1: Participants receive placebo once daily for 24 weeks followed by upadacitinib 30 mg once daily for 32 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Treatment:

Drug: Upadacitinib

Drug: Placebo