Study Description
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300
milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination
with prednisone tapered over 24 weeks in adult participants with PMR who have recently
relapsed. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study
with two secukinumab dose regimens in approximately 360 PMR patients who had recently
relapsed. The study consists of: screening (up to 6 weeks); treatment period (52 weeks,
with last IMP administration at 48 weeks, active drug or placebo) in combination with
prednisone tapered over 24 weeks; treatment-free follow-up (up to 24 weeks). Adult males
and females of at least 50 years of age with a recent PMR relapse (within 12 weeks from
Baseline) will be included. Dosing will be once every week for the first 4 weeks, and
once every 4 weeks thereafter via pre-filled syringe.
The primary objective is to demonstrate the efficacy of secukinumab 300 mg subcutaneously
in combination with a 24-week glucocorticoid (GC) taper regimen compared with placebo
with respect to the proportion of patients in sustained remission at Week 52. Primary
secondary objectives are to assess difference in proportion of patients achieving
complete sustained remission at Week 52, adjusted annual cumulative GC dose and time to
first use of escape treatment or rescue treatment through Week 52. Key safety data will
be collected, along with Patient Reported Outcomes.
Interventions
Placebo to secukinumab
Secukinumab 150 mg
Secukinumab 300 mg
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent must be obtained prior to participation in the study
- Male or non-pregnant, non-lactating female participants at least 50 years of age.
- Diagnosis of PMR according to the provisional American College of Rheumatology
(ACR)/European League Against Rheumatism (EULAR) classification criteria:
Participants ≥ 50 years of age with a history of bilateral shoulder pain accompanied
by elevated C-reactive protein (CRP) concentration (≥ 10 mg/L) and/or elevated
erythrocyte sedimentation rate (ESR) (≥ 30 mm/hr) who scored at least 4 points from
the following optional classification criteria:
- Morning stiffness > 45 minutes (min) (2 points)
- Hip pain or restricted range of motion (1 point)
- Absence of rheumatoid factor and/or anti-citrullinated protein antibodies (2
points)
- Absence of other joint involvement (1 point)
- Participants must have a history of being treated for at least 8 consecutive weeks
with prednisone ≥ 10 mg/day, or equivalent dose of another GC at any time prior to
screening
- Participants must have had at least one episode of PMR relapse while attempting to
taper prednisone at a dose that is ≥ 5 mg/day (or equivalent dose of another GC)
within the past 12 weeks prior to BSL. Diagnosis of a PMR relapse is defined as
participant meeting both of the following:
- Recurrence of bilateral shoulder girdle and/or bilateral hip girdle pain
associated with inflammatory stiffness with or without additional symptoms
indicative of PMR relapse (such as constitutional symptoms) within 12 weeks
prior to BSL that are in the opinion of the Investigator not due to other
diseases that may mimic PMR such as osteoarthritis in shoulders or hips,
polyarticular calcium pyrophosphate deposition disease, rotator cuff disease,
adhesive capsulitis (frozen shoulder) or fibromyalgia.
- Elevated ESR (≥ 30 mm/hr) and/or elevated CRP (> upper limit of normal (ULN))
attributable to PMR at the time of relapse and/or at screening
- Participants must have been treated as per local treatment recommendations following
the latest PMR relapse and must be on prednisone of at least 7.5 mg/day (or
equivalent) and not exceeding 25 mg/day at screening and during the screening period
Exclusion Criteria:
- Evidence/history of GCA as indicated by typical (cranial) symptoms (e.g., persistent
or recurrent localized headache, temporal artery or scalp tenderness, jaw
claudication, blurry or loss of vision, symptoms of stroke), extremity claudication,
imaging and/or temporal artery biopsy result
- Concurrent rheumatoid arthritis or other inflammatory arthritis or other connective
tissue diseases, such as but not limited to systemic lupus erythematosus, systemic
sclerosis, vasculitis, myositis, mixed connective tissue disease, and ankylosing
spondylitis
- Concurrent diagnosis or history of neuropathic muscular diseases or fibromyalgia
- Inadequately treated hypothyroidism (e.g., persistence of symptoms, lack of
normalization of serum TSH despite regular hormonal replacement treatment)
- Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or
IL-17 receptor
- Participants treated with tocilizumab or other IL-6/IL6-receptor inhibitors within
12 weeks or within 5 half-lives (whichever is longer) prior to BSL; participant who
did not respond to or experienced a relapse during treatment are excluded from
enrollment into the study Other protocol-defined inclusion/exclusion criteria may
apply
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