Study to evaluate the pharmacokinetics, safety and tolerability of intravenous secukinumab infusions in adults with giant cell arteritis or polymyalgia rheumatica

Kriterien zur Teilnahme
Inclusion criteria for GCA: 1. Male or non-pregnant, non-breastfeeding female participants aged 50 years or older 2. Diagnosis of GCA and fulfillment of all of the following criteria: • Clear cranial GCA symptoms (e.g., new onset local headache, scalp or temporal artery tenderness, temporary or permanent ischemia-related vision loss, or otherwise unexplained mouth or jaw pain when chewing), and/or clear symptoms of polymyalgia rheumatica (PMR) (characterized by shoulder girdle and/or bilateral hip girdle pain associated with inflammatory morning stiffness), and/or symptoms of limb ischemia (claudication) • Temporal artery biopsy with features of GCA, cross-sectional imaging such as ultrasound (e.g., cranial or axillary scan), MRI/MRA, computed tomography angiography (CTA), or a PET-CT with evidence of Vasculitis. 3. Active giant cell arteritis (GCA) within 6 weeks prior to baseline, defined by meeting both of the following criteria: • Presence of signs or symptoms consistent with active GCA that are not related to previous impairment (e.g., loss of vision that occurred without new findings) • Elevated ESR ≥ 30 mm/h or CRP ≥ 10 mg/L consistent with active GCA or active GCA on temporal biopsy (TAB) or imaging study Inclusion criteria for PMR: 1. Male or non-pregnant, non-breastfeeding female participants aged 50 years or older 2. Diagnosis of PMR according to the ACR/EULAR provisional classification criteria: Participants ≥ 50 years, with a history of bilateral shoulder pain associated with elevated CRP (≥ 10 mg/L) and/or elevated ESR (≥ 30 mm/h) and at least 4 points of the following optional Have met the classification criteria: • Morning stiffness > 45 minutes (min) (2 points) • Hip pain or limitation of motion (1 point) • Absence of rheumatoid factor and/or anti-citrullinated protein antibodies (2 points) • Absence of other joint involvement (1 point) 3. Active PMR disease within 6 months prior to baseline, defined by signs and symptoms attributable to PMR that meet the following criteria: • Bilateral shoulder girdle and/or bilateral hip girdle pain associated with inflammatory stiffness with or without additional symptoms suggestive of PMR recurrence (such as constitutional symptoms) that, in the opinion of the investigator, are not due to other conditions 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. (BASEC)

Ausschlusskriterien
Exclusion criteria for GCA and PMR: 1. History of hypersensitivity or contraindication to any of the study treatments or their excipients or to drugs of similar chemical classes. 2. Use of other investigational medicinal products within 5 half-lives prior to study entry or within 30 days (e.g. small molecule drugs) or until the expected pharmacodynamic effect on the BSL has subsided (e.g. biologics), whichever is longer; or longer if required by local regulations 3. History of clinically significant liver disease or liver injury as evidenced by clinically significantly abnormal liver function tests (LFTs) such as SGOT (AST), SGPT (ALT) and serum bilirubin. The investigator should use the following criteria: • AST (aspartate aminotransferase) and ALT (alanine aminotransferase) must not exceed 3 times the upper limit of normal (ULN). • Total bilirubin concentration must not exceed 1.5 x ULN. (BASEC)