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

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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

Study Locations

Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60590
Hesse
Germany
Novartis Investigative Site
Recruiting
Rendsburg, 24768
Schleswig Holstein
Germany
Novartis Investigative Site
Recruiting
Aachen, 52074
-
Germany
Novartis Investigative Site
Recruiting
Bad Bramstedt, 24576
-
Germany
Novartis Investigative Site
Recruiting
Bad Pyrmont, 31812
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 12203
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 12435
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 13125
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 14059
-
Germany
Novartis Investigative Site
Recruiting
Bochum, 44791
-
Germany
Novartis Investigative Site
Recruiting
Chemnitz, 09130
-
Germany
Novartis Investigative Site
Recruiting
Cottbus, 03042
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01067
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Ehringshausen, 35630
-
Germany
Novartis Investigative Site
Recruiting
Erlangen, 91056
-
Germany
Novartis Investigative Site
Recruiting
Freiburg, 79106
-
Germany
Novartis Investigative Site
Recruiting
Gommern, 39245
-
Germany
Novartis Investigative Site
Recruiting
Gottingen, 37075
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 20253
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 22143
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 22391
-
Germany
Novartis Investigative Site
Recruiting
Herne, 44649
-
Germany
Novartis Investigative Site
Recruiting
Kiel, 24105
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 50937
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Novartis Investigative Site
Recruiting
Ludwigshafen, D-67063
-
Germany
Novartis Investigative Site
Recruiting
Magdeburg, 39104
-
Germany
Novartis Investigative Site
Recruiting
Magdeburg, 39110
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Novartis Investigative Site
Recruiting
Muenchen, 81541
-
Germany
Novartis Investigative Site
Recruiting
Planegg, 82152
-
Germany
Novartis Investigative Site
Recruiting
Potsdam, 14469
-
Germany
Novartis Investigative Site
Recruiting
Puettlingen/saar, 66346
-
Germany
Novartis Investigative Site
Recruiting
Ratingen, 40878
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

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