24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis

Novartis

Status and phase: Completed; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Biological: Secukinumab; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01989468

2013-004002-25 (EudraCT Number)

CAIN457F2318

Details and patient eligibility

About

The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.

Enrollment: 414 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.
• Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.
• Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
• Inadequate control of symptoms with NSAID.

Exclusion criteria

• Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
• Subjects taking high potency opioid analgesics.
• Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
• Ongoing use of prohibited psoriasis treatments / medications.
• Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα.
• Previous treatment with any cell-depleting therapies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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414 participants in 3 patient groups, including a placebo group

Secukinumab (AIN457) 150 mg s.c.

Experimental group

Description:

1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.

Treatment:

Biological: Secukinumab

Secukinumab (AIN457) 300 mg s.c.

Experimental group

Description:

2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.

Treatment:

Biological: Secukinumab

Placebo

Placebo Comparator group

Description:

Matching Placebo at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.

Treatment:

Biological: Placebo