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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04632927
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis
Arms & Interventions

Arms

Experimental: Secukinumab

AIN457

Experimental: Ustekinumab

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Novartis Investigative Site, Frankfurt, Hesse, Germany

Status

Recruiting

Address

Novartis Investigative Site

Frankfurt, Hesse, 60590

Novartis Investigative Site, Aachen, Germany

Status

Recruiting

Address

Novartis Investigative Site

Aachen, , 52074

Novartis Investigative Site, Bad Bramstedt, Germany

Status

Recruiting

Address

Novartis Investigative Site

Bad Bramstedt, , 24576

Novartis Investigative Site, Bad Pyrmont, Germany

Status

Recruiting

Address

Novartis Investigative Site

Bad Pyrmont, , 31812

Novartis Investigative Site, Berlin, Germany

Status

Recruiting

Address

Novartis Investigative Site

Berlin, , 12203

Novartis Investigative Site, Berlin, Germany

Status

Recruiting

Address

Novartis Investigative Site

Berlin, , 12435

Novartis Investigative Site, Berlin, Germany

Status

Recruiting

Address

Novartis Investigative Site

Berlin, , 13125

Novartis Investigative Site, Berlin, Germany

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Recruiting

Address

Novartis Investigative Site

Berlin, , 13353

Novartis Investigative Site, Berlin, Germany

Status

Recruiting

Address

Novartis Investigative Site

Berlin, , 14059

Novartis Investigative Site, Bochum, Germany

Status

Recruiting

Address

Novartis Investigative Site

Bochum, , 44791

Novartis Investigative Site, Chemnitz, Germany

Status

Recruiting

Address

Novartis Investigative Site

Chemnitz, , 09130

Novartis Investigative Site, Dresden, Germany

Status

Recruiting

Address

Novartis Investigative Site

Dresden, , 01067

Novartis Investigative Site, Dresden, Germany

Status

Recruiting

Address

Novartis Investigative Site

Dresden, , 01307

Novartis Investigative Site, Ehringshausen, Germany

Status

Recruiting

Address

Novartis Investigative Site

Ehringshausen, , 35630

Novartis Investigative Site, Erlangen, Germany

Status

Recruiting

Address

Novartis Investigative Site

Erlangen, , 91056

Novartis Investigative Site, Freiburg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Freiburg, , 79106

Novartis Investigative Site, Gommern, Germany

Status

Recruiting

Address

Novartis Investigative Site

Gommern, , 39245

Novartis Investigative Site, Gottingen, Germany

Status

Recruiting

Address

Novartis Investigative Site

Gottingen, , 37075

Novartis Investigative Site, Hamburg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Hamburg, , 20253

Novartis Investigative Site, Hamburg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Hamburg, , 22143

Novartis Investigative Site, Hamburg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Hamburg, , 22391

Novartis Investigative Site, Herne, Germany

Status

Recruiting

Address

Novartis Investigative Site

Herne, , 44649

Novartis Investigative Site, Kiel, Germany

Status

Recruiting

Address

Novartis Investigative Site

Kiel, , 24105

Novartis Investigative Site, Koeln, Germany

Status

Recruiting

Address

Novartis Investigative Site

Koeln, , 50937

Novartis Investigative Site, Leipzig, Germany

Status

Recruiting

Address

Novartis Investigative Site

Leipzig, , 04103

Novartis Investigative Site, Ludwigshafen, Germany

Status

Recruiting

Address

Novartis Investigative Site

Ludwigshafen, , D-67063

Novartis Investigative Site, Magdeburg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Magdeburg, , 39104

Novartis Investigative Site, Magdeburg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Magdeburg, , 39110

Novartis Investigative Site, Mainz, Germany

Status

Recruiting

Address

Novartis Investigative Site

Mainz, , 55131

Novartis Investigative Site, Muenchen, Germany

Status

Recruiting

Address

Novartis Investigative Site

Muenchen, , 81541

Novartis Investigative Site, Planegg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Planegg, , 82152

Novartis Investigative Site, Potsdam, Germany

Status

Recruiting

Address

Novartis Investigative Site

Potsdam, , 14469

Novartis Investigative Site, Ratingen, Germany

Status

Recruiting

Address

Novartis Investigative Site

Ratingen, , 40878

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