NCT04632927CompletedPhase 3
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)
Source: ClinicalTrials.gov · Last updated 16 Oct 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 119 (actual)
- First submitted
- 4 Nov 2020
- Start date
- 21 Dec 2020
- Primary completion date
- 22 Oct 2024
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT04632927
- EudraCT number
- 2019-004246-15
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 119
- From 21 Dec 2020 to the primary completion date, 22 Oct 2024
- 23 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous exposure to secukinumab, ustekinumab or any other biologic drug directly targeting IL-17, IL-17 receptor, IL-12 or IL-23.
- Use of any other investigational drug. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents
- Subjects receiving high potency opioid analgesics
- Ongoing use of prohibited psoriasis treatments/medications
- Other protocol-defined inclusion/exclusion criteria may apply
Other illness
- Evidence of ongoing infectious or malignant process
Other
- Pregnant or nursing women,
- Patients for whom the use of secukinumab or ustekinumab is contraindicated.
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.