A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children

Exclusion Criteria

• •Concomitant diagnosis of another form of chronic, recurrent angioedema, such as acquired angioedema (AAE), HAE with normal C1-INH, idiopathic angioedema, or recurrent angioedema associated with urticaria.
• •Dosing with an investigational drug or exposure to an investigational device within 4 weeks prior to screening.
• •Be pregnant or breastfeeding.
• •Have initiated androgen treatment (eg, stanozolol, danazol, oxandrolone, methyltestosterone, and testosterone) within 2 weeks prior to entering the observation period.
• •Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 4 weeks prior to screening.
• •Have any active infectious illness or fever defined as an oral temperature greater than (\>) 38 degree celsius (°C) (100.4 fahrenheit \[°F\]), tympanic \> 38.5°C (101.3°F) , axillary \> 38°C (100.4°F), or rectal/core \> 38.5°C (101.3°F) within 24 hours prior to the first dose of study drug in treatment period A.
• •Have any HAE attack that is not resolved prior to the first dose of study drug in treatment period A.
• •Have any of the following liver function test abnormalities: alanine aminotransferase (ALT) \> 3\*upper limit of normal (ULN), or aspartate aminotransferase (AST) \> 3\*ULN, or total bilirubin \> 2\*ULN (unless the bilirubin elevation is a result of Gilbert's syndrome).
• •Have any condition (any surgical or medical condition) that, in the opinion of the investigator or sponsor, may compromise their safety or compliance, preclude the successful conduct of the study, or interfere with interpretation of the results (eg, significant pre-existing illness or other major comorbidity that the investigator considers may confound the interpretation of study results).
• •Participant has a known hypersensitivity to the investigational product or its components.