Clinical trial NCT04632927: Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
Psoriasis Arthropathica
Psoriatic Arthropathy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: 28 Weeks
Secondary outcomes:
measure: Proportion of patients achieving PASI 90
timeFrame: 28 Weeks
measure: Change from baseline in Patient's assessment of pain on VAS
timeFrame: 28 Weeks
measure: Change from baseline in Tender Joint Count (TJC) 68
timeFrame: 28 Weeks
measure: Change from baseline in Swollen Joint Count (SJC) 66
timeFrame: 28 Weeks
measure: Proportion of patients achieving PASI 100
timeFrame: 28 Weeks
measure: Proportion of patients achieving PASI 75
timeFrame: 28 Weeks
measure: Change from baseline in Patient's Global Assessment of Disease Activity on VAS
timeFrame: 28 Weeks
measure: Change from baseline in Patient's Global Assessment of Psoriasis and Arthritis Disease Activity on VAS
timeFrame: 28 Weeks
measure: Proportion of patients achieving Minimal Disease Activity (MDA)
timeFrame: 28 Weeks
measure: Change from baseline in the Leeds Enthesitis Index (LEI)
timeFrame: 28 Weeks
measure: Change from baseline in the Leeds Dactylitis Index (LDI)
timeFrame: 28 Weeks
measure: Change from baseline in Psoriatic Arthritis Quality of Life (PsAQoL)
timeFrame: 28 Weeks
measure: Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
timeFrame: 28 Weeks
measure: Change from baseline in Dermatology Life Quality Index (DLQI) 0/1
timeFrame: 28 Weeks
measure: Assessment of safety and tolerability of secukinumab 300 mg s.c. compared to ustekinumab
timeFrame: 28 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: