A Phase III Study of the Efficacy and Safety of Olokizumab in Patients With Polymyalgia Rheumatica

The primary objective of the study is to evaluate the efficacy of olokizumab (OKZ) 64 mg administered subcutaneously every 2 weeks compared with placebo in participants with polymyalgia rheumatica (PMR). The secondary objectives are to evaluate the steroid-sparing effect, inflammatory markers, safety, tolerability, immunogenicity, and pharmacokinetics of OKZ in participants with PMR compared with placebo. The exploratory objectives are to evaluate OKZ efficacy in selected participant subgroups, biomarkers of bone metabolism, pharmacodynamic parameters, glucocorticoid-related effects, and quality of life in participants with PMR compared with placebo

Inclusion Criteria: * Presence of written informed consent (IC) signed by the participant * Confirmed diagnosis of polymyalgia rheumatica (PMR) according to the 2012 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria * At the time of randomization, participants must meet one of the following conditions: 1. stable glucocorticoid (GC) therapy at a dose of ≤20 mg/day prednisone equivalent for at least 2 weeks; or 2. no glucocorticoid (GC) therapy for at least 2 weeks * PMR flare within 3 days prior to randomization meeting the following criteria: 1. Polymyalgia Rheumatica Activity Score (PMR-AS) ≥10; 2. C-reactive protein (CRP) level ≥5 mg/L in the absence of alternative causes of elevation Exclusion Criteria: * Presence of cranial symptoms of giant cell arteritis (GCA) within 12 weeks prior to screening * Presence of concomitant fibromyalgia or neuropathic pain syndrome * Presence of other systemic rheumatic diseases, including rheumatoid arthritis, Sjögren's syndrome, vasculitis (except GCA), dermatomyositis/polymyositis, and others * Presence of concomitant conditions associated with chronic pain syndrome that could potentially interfere with efficacy assessments in the study * Bilateral limitation of upper limb elevation above 90° (elevation of upper limbs \[EUL\] score 1) not related to active polymyalgia rheumatica (PMR) * Requirement for systemic glucocorticoid (GC) therapy for conditions other than PMR * Prior treatment with interleukin-6 (IL-6) inhibitors (including OKZ) or IL-6 receptor inhibitors, except when used for treatment of coronavirus disease 2019 (COVID-19). For participants treated with these agents for COVID-19, the last administration must have occurred at least 6 months prior to screening * Intravenous, intra-articular, periarticular, or intramuscular glucocorticoid administration within 4 weeks prior to screening * Use of the following medications prior to screening: 1. Janus kinase (JAK) inhibitors (including tofacitinib, baricitinib, or upadacitinib) within 4 weeks; 2. Tumor necrosis factor-alpha (TNF-α) inhibitors: etanercept within 2 weeks; adalimumab, golimumab, certolizumab, or infliximab within 8 weeks; 3. Rituximab within 12 months prior to screening; 4. Abatacept within 8 weeks prior to screening; 5. Interleukin-1 (IL-1) inhibitors: canakinumab within 12 weeks; anakinra within 72 hours; goflikicept within 8 weeks; 6. Interleukin-17 (IL-17), interleukin-23 (IL-23), or interleukin-12/23 (IL-12/23) inhibitors: secukinumab, bimekizumab, ustekinumab, tildrakizumab, risankizumab, mirikizumab, or netakimab within 16 weeks; ixekizumab, brodalumab, or guselkumab within 12 weeks; 7. Other genetically engineered biologic therapies within at least 5 half-lives prior to screening; 8. Alkylating agents, including cyclophosphamide, within 24 weeks; 9. Cyclosporine, azathioprine, or mycophenolate mofetil within 4 weeks * Initiation, discontinuation, or dose modification of methotrexate or leflunomide within 12 weeks prior to screening * Modification of other PMR therapy within 4 weeks or 5 half-lives prior to screening, whichever is longer * Administration of a live vaccine within 6 weeks prior to baseline assessment or planned live vaccination during the study * Participation in another clinical study within 30 days prior to baseline assessment or within 5 half-lives of the investigational product used in that study, whichever is longer * Previous participation in this study (participant randomized and received at least one dose of investigational product) * Hematologic disorders, including platelet, leukocyte, or erythrocyte disorders (e.g., sickle cell anemia, myelodysplastic syndrome, hematologic malignancies, multiple myeloma, hemolytic anemia, or thalassemia) or coagulopathies * Current malignancy or history of malignancy within the past 5 years, except adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin carcinoma treated at least 1 year prior to screening (with no more than 3 excised skin cancers within 5 years prior to screening) * Screening laboratory abnormalities including: 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 × upper limit of normal (ULN); 2. Platelet count \