Non-radiographic axial spondyloarthritis MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 100000004859
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Participant must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed. -Male or non-pregnant, non-lactating female participants at least 18 years of age. -Clinical diagnosis of axSpA AND according to ASAS axSpA criteria: a. Inflammatory back pain for at least 6 months b. Onset before 45 years of age c. Sacroiliitis on MRI (as assessed by central reader) with = 1 SpA feature OR HLA-B-27 positive with =2 SpA features -Objective signs of inflammation at screening, evident by either •MRI with Sacroiliac Joint inflammation (as assessed by central reader) AND / OR •hsCRP > ULN (as defined by the central lab) -Active axSpA as assessed by total BASDAI = 4 cm (0-10 cm) at baseline. -Spinal pain as measured by BASDAI question #2 = 4 cm (0-10 cm) at baseline. -Total back pain as measured by VAS = 40 mm (0-100 mm) at baseline. -Participants should have been on at least 2 different NSAIDs at the highest recommended dose for at least 4 weeks in total prior to baseline with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindications. -Participants who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their axSpA therapy are required to be on a stable dose for at least 2 weeks before baseline. -Participants who have previously been on a TNFa inhibitor will be allowed entry into study only if they discontinued the treatment with TNFa inhibitor due to a reason other than efficacy (primary or secondary lack of efficacy, inadequate response) such as intolerance and only after appropriate wash-out period prior to baseline was observed: •4 weeks for etanercept – with a terminal half-life of 102 ± 30 hours •8 weeks for infliximab – with a terminal half-life of 8.0-9.5 days •10 weeks for adalimumab – with a terminal half-life of 10-20 days (average 2 weeks) •10 weeks for golimumab – with a terminal half-life of 11-14 days •10 weeks for certolizumab – with a terminal half-life of 14 days -Participants taking MTX (= 25 mg/week) or sulfasalazine (= 3 g/day) are allowed to continue their medication, must have taken it for at least 3 months and have to be on a stable dose for at least 4 weeks prior to baseline. -Participants on MTX must be on stable folic acid supplementation before baseline. -Participants who are on a DMARD other than MTX or sulfasalazine must discontinue the DMARD 4 weeks prior to baseline except for leflunomide, which has to be discontinued for 8 weeks prior to baseline unless a cholestyramine washout has been performed. -Participants taking systemic corticosteroids have to be on a stable dose of = 10 mg/day prednisone or equivalent for at least 2 weeks before baseline. 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 340 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Participants with radiographic evidence for sacroiliitis, grade = 2 bilaterally or grade = 3 unilaterally (radiological criterion according to the modified New York diagnostic criteria for AS) as assessed by central reader. -Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months of screening and evaluated by a qualified physician. -Taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine). -Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor or previous treatment with immunomodulatory biologic agents including those targeting TNFa (unless participants discontinued the treatment with TNFa inhibitor due to a reason other than efficacy [primary or secondary lack of efficacy, inadequate response] and only after appropriate wash-out period prior to baseline was observed). -History of hypersensitivity to the study drug or its excipients or to drugs of similar chemical classes. -Use of any investigational drug and/or devices within 4 weeks of baseline, or a period of 5 half-lives of the investigational drug, whichever is longer. -Any therapy by intra-articular injections (e.g., corticosteroid) within 4 weeks before baseline. -Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19). -Pregnant or nursing (lactating) women -Women of child-bearing potential unless they are using effective methods of contraception for the entire duration of the study or longer if required by locally approved prescribing information (e.g. 20 weeks in EU). -Active ongoing inflammatory diseases other than nr-axSpA that might confound the evaluation of the benefit of secukinumab therapy, including uveitis. -Active inflammatory bowel disease -History of fibromyalgia or an ongoing inflammatory arthritis of a different etiology than spondyloarthritis. -Underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which in the opinion of the Investigator immunocompromises the participant and/or places the participant at unacceptable risk for participation in an immunomodulatory therapy. -History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed). -Any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol. -History or evidence of ongoing alcohol or drug abuse, which in the opinion of the Investigator will prevent the participant from adhering to the protocol and completing the study. -History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by either a positive purified protein derivative (PPD) skin test or a positive QuantiFERON TB-Gold test at screening. -Active systemic infections during the last two weeks (exception: common cold) prior to Baseline. -Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C prior to baseline except for hepatitis C successfully treated and cured. -Plans f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether continuous secukinumab treatment is superior to placebo in preventing flares during Treatment Period 2 in participants who achieved a state of remission in Treatment Period 1;Secondary Objective: -To evaluate efficacy of secukinumab on preventing the onset of flares in participants in a state of remission during Treatment Period 2 in participants who achieved a state of remission in Treatment Period 1 -To assess overall safety and tolerability of secukinumab over time up to follow-up visit ;Primary end point(s): -The proportion of participants remaining flare-free at Week 120;Timepoint(s) of evaluation of this end point: Week 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Time to flare during Treatment Period 2 -Safety and tolerability demonstrated by assessing: -Adverse events (AEs) and serious adverse events (SAEs) (incidence, severity, and relationship with study drug) -Clinically significant changes in laboratory parameters and vital signs ;Timepoint(s) of evaluation of this end point: Week 128 | — |
Countries
Belgium, Brazil, Colombia, Czechia, Czech Republic, France, Germany, Guatemala, Hungary, Israel, Italy, Malaysia, Mexico, Netherlands, Philippines, Poland, Romania, Thailand, Turkey, Viet Nam
Contacts
Public ContactInformation&Communication Médicales
Novartis Pharma S.A.S
Outcome results
None listed