Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment (AgAIN)

Novartis

Status and phase: Completed; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Biological: Secukinumab; Biological: Ustekinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04632927

2019-004246-15 (EudraCT Number)

CAIN457FDE04

Details and patient eligibility

About

The purpose of this study is to compare the safety and efficacy of secukinumab and ustekinumab in patients with active psoriatic arthritis who showed failure to previous TNFα-inhibitor treatment

Enrollment: 119 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosis of PsA as classified by CASPAR criteria for at least 6 months before randomization.
• Active PsA at baseline defined as ≥ 3 tender joints out of 68 and ≥ 3 swollen joints out of 66 (dactylitis of a digit counts as one joint each).
• Inadequate response or intolerance to previous or current treatment with at least one TNFα inhibitor
• Inadequate response or intolerance to conventional disease modifying anti-rheumatic drugs (cDMARDs)
• Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter and/or nail changes consistent with psoriasis and/or documented history of plaque psoriasis.
• Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibodies negative at screening.

Key Exclusion Criteria:

• Pregnant or nursing women,
• Previous exposure to secukinumab, ustekinumab or any other biologic drug directly targeting IL-17, IL-17 receptor, IL-12 or IL-23.
• Patients for whom the use of secukinumab or ustekinumab is contraindicated.
• Use of any other investigational drug. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents
• Evidence of ongoing infectious or malignant process
• Subjects receiving high potency opioid analgesics
• Ongoing use of prohibited psoriasis treatments/medications

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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119 participants in 2 patient groups

Secukinumab

Experimental group

Description:

AIN457

Treatment:

Biological: Ustekinumab

Biological: Secukinumab

Ustekinumab

Experimental group

Treatment:

Biological: Ustekinumab

Biological: Secukinumab