Phase 3
Completed N=119
Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment
Source: ClinicalTrials.gov NCT04632927 ↗Enrolled (actual)
119
Serious AEs
4.2%
Results posted
Oct 2025
Primary outcomePrimary: Proportion of Patients With Health Assessment Questionnaire - Disability Index (HAQ-DI) Response at Week 28 — 32; 17 Participants — p=0.002
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Health Assessment Questionnaire - Disability Index (HAQ-DI) Response at Week 28 |
32; 17 | 0.002 sig |
| SECONDARY Number of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 28 |
27; 25 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain on VAS at Week 28 |
-27.1; -16.4 | — |
| SECONDARY Change From Baseline in Tender Joint Count (TJC) 68 at Week 28 |
-9.6; -7.6 | — |
| SECONDARY Change From Baseline in Swollen Joint Count (SJC) 66 at Week 28 |
-6.8; -5.3 | — |
| SECONDARY Number of Patients Achieving PASI 100 at Week 28 |
21; 17 | — |
| SECONDARY Number of Patients Achieving PASI 75 at Week 28 |
34; 29 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity on VAS |
-26.0; -15.5 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Psoriasis and Arthritis Disease Activity on VAS |
-28.1; -16.2 | — |
| SECONDARY Number of Patients Achieving Minimal Disease Activity (MDA) at Week 28 |
20; 14 | — |
| SECONDARY Change From Baseline in the Leeds Enthesitis Index (LEI) |
-0.9; -0.5 | — |
| SECONDARY Change From Baseline in the Leeds Dactylitis Index (LDI) |
-9.7; -7.2 | — |
| SECONDARY Change From Baseline in Psoriatic Arthritis Quality of Life (PsAQoL) |
-2.5; -2.0 | — |
| SECONDARY Percentage of Participants Achieving a Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Response at Week 28 |
40; 32 | — |
| SECONDARY Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Response at Week 28 |
30; 32 | — |
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
Data sourced from ClinicalTrials.gov (NCT04632927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.