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

NCT04632927 | Completed Phase 3 Results

• 2 other identifiers: CAIN457FDE042019-004246-15
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 28

Brief Summary

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

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis; Psoriasis Arthropathica; Psoriatic Arthropathy

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Health Assessment Questionnaire - Disability Index (HAQ-DI) Response at Week 28

  The disability assessment component of the HAQ evaluated a subject's level of functional ability through 20 questions grouped into 8 categories: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item began with the prompt "Over the past week, are you able to…" and is scored on a 4-point scale: 0 (no difficulty), 1 (some difficulty), 2 (much difficulty), and 3 (unable to do). The overall score was calculated by averaging the scores across all answered domains, resulting in a total score ranging from 0 (no disability) to 3 (severe disability). A HAQ-DI response was defined as an improvement of ≥0.35 points from baseline at Week 28. Missing values were imputed as non-responders

  Baseline, Week 28

Secondary Outcomes (14)

• Number of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 28

  Baseline, Week 28

• Change From Baseline in Patient's Assessment of Pain on VAS at Week 28

  Baseline, Week 28

• Change From Baseline in Tender Joint Count (TJC) 68 at Week 28

  Baseline, Week 28

• Change From Baseline in Swollen Joint Count (SJC) 66 at Week 28

  Baseline, Week 28

• Number of Patients Achieving PASI 100 at Week 28

  Bseline, Week 28

Study Arms (2)

Secukinumab

EXPERIMENTAL

AIN457

Biological: Secukinumab; Biological: Ustekinumab

Ustekinumab

EXPERIMENTAL

Biological: Secukinumab; Biological: Ustekinumab

Interventions

Secukinumab BIOLOGICAL

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

Also known as: AIN457

Secukinumab; Ustekinumab

Ustekinumab BIOLOGICAL

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

Secukinumab; Ustekinumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (28)

Novartis Investigative Site

Rendsburg, Schleswig-Holstein, 24768, Germany

Location

Novartis Investigative Site

Aachen, 52074, Germany

Location

Novartis Investigative Site

Bad Bentheim, 48455, Germany

Location

Novartis Investigative Site

Bad Doberan, 18209, Germany

Location

Novartis Investigative Site

Berlin, 12435, Germany

Location

Novartis Investigative Site

Berlin, 13125, Germany

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Bochum, 44791, Germany

Location

Novartis Investigative Site

Cologne, 50937, Germany

Location

Novartis Investigative Site

Cologne, 51149, Germany

Location

Novartis Investigative Site

Cottbus, 03042, Germany

Location

Novartis Investigative Site

Dresden, 01067, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Ehringshausen, 35630, Germany

Location

Novartis Investigative Site

Erlangen, 91056, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

Gommern, 39245, Germany

Location

Novartis Investigative Site

Göttingen, 37075, Germany

Location

Novartis Investigative Site

Hamburg, 22391, Germany

Location

Novartis Investigative Site

Herne, 44649, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Magdeburg, 39104, Germany

Location

Novartis Investigative Site

Magdeburg, 39110, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

München, 81541, Germany

Location

Novartis Investigative Site

Planegg, 82152, Germany

Location

Novartis Investigative Site

Ratingen, 40878, Germany

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

secukinumab; Ustekinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@Novartis.com

+1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 17, 2020
• Study Start: December 21, 2020
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (28)