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

A 28-week, Randomized, Double-blind, Active Controlled, Multicenter Study to Evaluate the Efficacy of Subcutaneously Administered Secukinumab Compared to Ustekinumab in Adult Patients With Psoriatic Arthritis and Failure of TNFα- Inhibitor Treatment (AgAIN)

ClinicalTrials.gov Identifier: NCT04632927

Novartis Reference Number: CAIN457FDE04

Last Update: Jan 31, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Condition

Psoriatic Arthritis

Phase

Phase 3

Overall status

Recruiting

Start date

Dec 21, 2020

Completion date

Apr 16, 2023

Gender

All

Age(s)

18 Years and older (Adult, Older Adult)

Interventions

Biological

Secukinumab

Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Biological

Ustekinumab

Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Eligibility 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