EUCTR2019-004246-15-DEActive, not recruitingPhase 1
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 TNFa-inhibitor treatment (AgAIN) - AgAI
ovartis Pharma GmbH0 sites310 target enrollmentStarted: May 12, 2020Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 310
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Informed consent must be obtained before any assessment is performed.
- •2. Male or non-pregnant, non-lactating female subjects at least 18 years of age.
- •3. Diagnosis of PsA as classified by CASPAR criteria for at least 6 months before randomization.
- •4. 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).
- •5. Inadequate response or intolerance to previous or current treatment with at least one TNFa-inhibitor administered at an approved dose for the given duration according to the respective Summary of Product Characteristics (SmPC).
- •6. Inadequate response or intolerance to conventional disease modifying anti-rheumatic drugs (cDMARDs) and to at least one TNFa-inhibitor must have been documented in the patient’s medical history or reported by the patient or determined by the investigator at Screening.
- •7. Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibodies negative at screening.
- •8. Diagnosis of active plaque psoriasis, with at least one psoriatic plaque or nail changes consistent with psoriasis or documented history of plaque psoriasis.
- •Other protocol-defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
- •1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
- •2. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and minimum 16 weeks or longer if local label requires it after the last dose (e.g. 20 weeks for secukinumab, 15 weeks for ustekinumab in the European Union (EU)).
- •3. Previous exposure to secukinumab, ustekinumab or any other biologic drug directly targeting IL-17, IL-17 receptor, IL-12 or IL-23.
- •4. Patients for whom the use of secukinumab or ustekinumab is contraindicated.
- •5. Use of any other investigational drug within 4 weeks or within a period of 5 half-lives of the investigational treatment prior to the Baseline Visit, whichever is longer, until the expected pharmacodynamic effect has vanished. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents (e.g., alemtuzumab (Campath®), anti-CD4, anti-CD5, anti-CD3, and anti-CD19).
- •6. Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process obtained within 3 months prior to Screening and evaluated by a qualified physician.
- •7. Patients receiving high potency opioid analgesics including but not limited to methadone, hydromorphone, and morphine.
- •8. Ongoing use of prohibited psoriasis treatments/medications (e.g., topical corticosteroids or ultraviolet therapy at randomization).
- •Other protocol-defined exclusion criteria may apply.
Investigators
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