Psoriatic arthritis MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: SECUKINUMAB
CAS Number: 1229022-83-6
Current
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that secukinumab 300 mg s.c. is superior to ustekinumab 45/90 mg s.c. at week 28 based on the proportion of patients achieving an improvement in health assessment questionnaire-disability index (HAQ-DI©) score = 0.35 versus Baseline. ;Secondary Objective: To demonstrate • The efficacy of secukinumab 300 mg s.c. is higher to ustekinumab 45/90 mg s.c. at Week 28 based on the proportion of patients achieving a psoriasis area and severity index (PASI) 90 response. • Secukinumab 300 mg s.c. shows a beneficial effect compared to ustekinumab 45/90 mg s.c. at Week 28 based on the proportion of patients achieving an improvement of = 10 mm for the patient’s assessment of pain (visual analog scale, VAS). • The mean change from Baseline on secukinumab 300 mg s.c. is higher to ustekinumab 45/90 mg s.c. at week 28 for the tender joint count (TJC) 68. • The mean change from Baseline on secukinumab 300 mg s.c. is higher to ustekinumab 45/90 mg s.c. at week 28 for the swollen joint count (SJC) 66. • To evaluate the safety and tolerability of secukinumab 300 mg s.c. compared with ustekinumab 45/90 mg s.c. as assessed by vital signs, clinical laboratory values, and AE monitoring. Other protocol-defined secondary objectives may apply.;Primary end point(s): Proportion of patients achieving a HAQ-DI© response at Week 28.;Timepoint(s) of evaluation of this end point: Week 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients achieving a PASI 90 response at Week 28. • Proportion of patients achieving an improvement on VAS at Week 28 for patient’s assessment of pain. • Between-treatment difference in change from baseline to Week 28 for the TJC. • Between-treatment difference in change from baseline to Week 28 for the SJC. • Number and proportion of patients with treatment-emergent AEs as well as descriptive description of vital signs and clinical laboratory values. Other protocol-defined secondary endpoints may apply.;Timepoint(s) of evaluation of this end point: Week 28 | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed