Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab in Patients With GCA or PMR

Key Inclusion Criteria:

Inclusion Criteria for GCA:

1. Male or non-pregnant, non-lactating female participants at least 50 years of age

2. Diagnosis of GCA based on meeting all of the following criteria:

• Unequivocal cranial symptoms of GCA (e.g., new-onset localized headache, scalpor temporal artery tenderness, permanent or temporary ischemia-related visionloss, or otherwise unexplained mouth or jaw pain upon mastication), and/orunequivocal symptoms of PMR (defined as shoulder and/or hip girdle painassociated with inflammatory morning stiffness) and/or symptoms of limbischemia (claudication)

• Temporal artery biopsy (TAB) revealing features of GCA and/or cross-sectionalimaging study such as ultrasound (e.g., cranial or axillary), MRI/MRA, CTA, orPET-CT with evidence of vasculitis

3. Active GCA disease within 6 months prior to Baseline as defined by meeting both ofthe following:

• Presence of signs or symptoms attributed to active GCA and not related to priordamage (e.g., vision loss that occurred without new findings)

• Elevated ESR >= 30 mm/hr or CRP >= 10 mg/L attributed to active GCA or activeGCA on TAB or on imaging study

Inclusion Criteria for PMR:

1. Male or non-pregnant, non-lactating female participants at least 50 years of age

2. Diagnosis of PMR according to the provisional ACR/EULAR classification criteria:Participants >= 50 years of age with a history of bilateral shoulder painaccompanied by elevated CRP concentration (>= 10 mg/L) and/or elevated ESR (>= 30mm/hr) who scored at least 4 points from the following optional classificationcriteria:

• Morning stiffness >45 min (2 points)

• Hip pain or restricted range of motion (1 point)

• Absence of rheumatoid factor and/or anti-citrullinated protein antibodies (2points)

• Absence of other joint involvement (1 point)

3. Active PMR disease within 6 months prior to Baseline as defined by signs andsymptoms attributable to PMR meeting the following:

• Bilateral shoulder girdle and/or bilateral hip girdle pain associated withinflammatory stiffness with or without additional symptoms indicative of a PMRrelapse (such as constitutional symptoms) that are in the opinion of theInvestigator not due to other diseases that may mimic PMR such asosteoarthritis in shoulders or hips, polyarticular calcium pyrophosphatedeposition disease, rotator cuff disease, adhesive capsulitis (frozen shoulder)or fibromyalgia

Key Exclusion Criteria:

Exclusion Criteria for GCA:

1. Pregnant or nursing (lactating) women where pregnancy is defined as the state of afemale after conception and until the termination of gestation, confirmed by apositive human chorionic gonadotropin (hCG) laboratory test

2. History of hypersensitivity or contraindication to any of the study treatments orits excipients or to drugs of similar chemical classes

3. Use of other investigational drugs within 5 half-lives of enrollment or within 30days (e.g., small molecules) or until the expected pharmacodynamic effect hasreturned to BSL (e.g., biologics), whichever is longer; or longer if required bylocal regulations

4. History of clinically significant liver disease or liver injury as indicated byclinically significantly abnormal liver function tests (LFTs), such as SGOT (AST),SGPT (ALT) and serum bilirubin. The Investigator should be guided by the followingcriteria:

• AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase) may notexceed 3 x the upper limit of normal (ULN)

• Total bilirubin concentration may not exceed 1.5 x ULN Any one of theseparameters, if elevated above ULN, should be re-checked once more as soon aspossible, and in all cases, at least prior to enrollment, to rule-outlaboratory error.

5. Active infections or history of ongoing, chronic or recurrent infectious diseaseincluding but not limited to below:

• Active infections during the last 2 weeks prior to BSL

• Known infection with human immunodeficiency virus (HIV), hepatitis B (HBV) orhepatitis C (HCV) at screening or BSL, except for HCV successfully treated andcured, according to local/global guidelines

• Evidence of tuberculosis (TB) infection as defined by a positive QuantiFERONTB-Gold Plus test. Participants with a positive test may participate in thestudy if further work-up (according to local practice/guidelines) establishesconclusively that the participant has no evidence of active TB. If the testresult is indeterminate, the Investigator may repeat the test once or mayproceed directly to perform the work-up for TB as per local procedures. Ifpresence of latent TB is established, then treatment must be initiated prior toBSL (both treatment and timing prior to BSL according to local countryguidelines)

6. Active inflammatory bowel disease or active uveitis

7. Active ongoing diseases which in the opinion of the Investigator immuno-compromisesthe participant and/or places the participant at unacceptable risk for treatmentwith immunomodulatory therapy

8. Current severe progressive or uncontrolled disease, which in the judgment of theInvestigator renders the participant unsuitable for the trial, including but notlimited to below:

• Major ischemic event (e.g., myocardial infarction, stroke, etc.) or transientischemic attack (TIA) within 12 weeks of screening

• Significant medical conditions or diseases, including but not limited to thefollowing: uncontrolled hypertension, congestive heart failure (New York HeartAssociation (NYHA) status of class III or IV) and uncontrolled diabetesmellitus

• Any other current severe progressive or uncontrolled diseases per theInvestigator's discretion

9. Confirmed diagnosis of any primary form of systemic vasculitis, other than GCA

Exclusion Criteria for PMR:

1. Pregnant or nursing (lactating) women where pregnancy is defined as the state of afemale after conception and until the termination of gestation, confirmed by apositive human chorionic gonadotropin (hCG) laboratory test

2. History of hypersensitivity or contraindication to any of the study treatments orits excipients or to drugs of similar chemical classes

3. Use of other investigational drugs within 5 half-lives of enrollment or within 30days (e.g., small molecules) or until the expected pharmacodynamic effect hasreturned to BSL (e.g., biologics), whichever is longer; or longer if required bylocal regulations

4. History of clinically significant liver disease or liver injury as indicated byclinically significantly abnormal liver function tests (LFTs), such as SGOT (AST),SGPT (ALT) and serum bilirubin. The Investigator should be guided by the followingcriteria:

• AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase) may notexceed 3 x the upper limit of normal (ULN)

• Total bilirubin concentration may not exceed 1.5 x ULN Any one of theseparameters, if elevated above ULN, should be re-checked once more as soon aspossible, and in all cases, at least prior to enrollment, to rule-outlaboratory error.

5. Active infections or history of ongoing, chronic or recurrent infectious diseaseincluding but not limited to below:

• Active infections during the last 2 weeks prior to BSL

• Known infection with human immunodeficiency virus (HIV), hepatitis B (HBV) orhepatitis C (HCV) at screening or BSL, except for HCV successfully treated andcured, according to local/global guidelines

• Evidence of TB infection as defined by a positive QuantiFERON TB-Gold Plustest. Participants with a positive test may participate in the study if furtherwork-up (according to local practice/guidelines) establishes conclusively thatthe participant has no evidence of active TB. If the test result isindeterminate, the Investigator may repeat the test once or may proceeddirectly to perform the work-up for TB as per local procedures. If presence oflatent TB is established, then treatment must be initiated prior to BSL (bothtreatment and timing prior to BSL according to local country guidelines)

6. Active inflammatory bowel disease or active uveitis

7. Active ongoing diseases which in the opinion of the Investigator immuno-compromisesthe participant and/or places the participant at unacceptable risk for treatmentwith immunomodulatory therapy

8. Current severe progressive or uncontrolled disease, which in the judgment of theInvestigator renders the participant unsuitable for the trial, including but notlimited to below:

• Major ischemic event (e.g., myocardial infarction, stroke, etc.) or transientischemic attack (TIA) within 12 weeks of screening

• Significant medical conditions or diseases, including but not limited to thefollowing: uncontrolled hypertension, congestive heart failure (New York HeartAssociation (NYHA) status of class III or IV) and uncontrolled diabetesmellitus

• Any other current severe progressive or uncontrolled diseases per theInvestigator's discretion

9. Evidence of GCA as indicated by typical (cranial) symptoms (e.g., persistent orrecurrent localized headache, temporal artery or scalp tenderness, jaw claudication,blurry or loss of vision, symptoms of stroke), extremity claudication, imagingand/or temporal artery biopsy result

• Note: Imaging and/or temporal artery biopsy are not standard of care for PMRmanagement and diagnosis and are therefore not mandated as part of the screening;Patients with PMR symptoms only who have a temporal artery biopsy in line with GCAand/or radiologic signs of vasculitis may be eligible for the GCA cohort

10. Concurrent rheumatoid arthritis or other inflammatory arthritis or other connectivetissue diseases, such as but not limited to systemic lupus erythematosus, systemicsclerosis, vasculitis, myositis, mixed connective tissue disease, and ankylosingspondylitis

11. Concurrent diagnosis or history of neuropathic muscular diseases includingfibromyalgia

12. Inadequately treated hypothyroidism (e.g., persistence of symptoms, lack ofnormalization of serum TSH despite regular hormonal replacement treatment)

Additional protocol-defined inclusion / exclusion criteria may apply.