Phase III study of efficacy and safety of secukinumab versus placebo, in combination with glucocorticoid taper regimen, in patients with polymyalgia rheumatica (PMR)

JRCT ID: jRCT2061230010

Registered date:29/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Polymyalgia Rheumatica
• Date of first enrollment: 15/05/2023
• Target sample size: 36
• Countries of recruitment: Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,Czech Republic,Japan,Denmark,Japan,France,Japan,Germany,Japan,Hungary,Japan,Italy,Japan,Lebanon,Japan,Mexico,Japan,Poland,Japan,South Africa,Japan,Spain,Japan,Switzerland,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: Secukinumab 300 mg
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
Other Name: AIN457
Drug: Secukinumab 150 mg
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
Other Name: AIN457
Other: Placebo to secukinumab
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

Outcome(s)

Primary Outcome

Proportion of participants achieving sustained remission [ Time Frame: at Week 52 ]
Sustained remission at Week 52 is defined as a participant meeting all of the following:
- achieved remission at Week 12
AND all of the following, sustained from Week 12 to Week 52:
- no recurrence of signs or symptoms, attributable to PMR, that requires escape treatment or rescue treatment
- no new diagnosis of Giant cell arteritis (GCA), that requires escape treatment or rescue treatment
Remission at Week 12 is defined as a participant meeting all of the following at Week 12:
- no use of escape treatment or rescue treatment prior to Week 12
- no signs or symptoms attributable to PMR, that requires escape treatment or use of rescue treatment, at Week 12
- no new diagnosis of GCA, that requires escape treatment or rescue treatment, at Week 12

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include 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/milliliter (mL)) 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)
- Participant must have a history of being treated for at least 8 consecutive weeks with
prednisone (=> 10 mg/day or equivalent) at any time prior to screening.
- Participant 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) 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.

Exclude criteria

- Evidence 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.
- 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.

Related Information

• Primary Sponsor: Iwasaki Ryohei
• Secondary ID(s): NCT05767034