angioedema severe swelling
Conditions
Interventions
Subjects may receive lanadelumab 300 mg every 2 weeks (q2wks)
or may consider lanadelumab 300 mg q4wks if they have been well-controlled (eg,
attack-free) for 26 consecutive weeks across Study SHP643
Sponsors
Takeda
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Males and females, 12 years of age and older diagnosed with nonhistaminergic normal C1-INH angioedema at the time of enrollment into the antecedent Study SHP643-303. 2. Subjects must have completed the treatment period (through Day 182) of Study SHP643-303 without reporting a clinically significant treatment-emergent adverse event (TEAE) that would preclude subsequent exposure to lanadelumab. 3. Agree to adhere to the protocol-defined schedule of treatments, assessments, and procedures. 4. Males, or non-pregnant, non-lactating females who are of childbearing potential and who agree to be abstinent or agree to comply with the applicable contraceptive requirements of this protocol for the duration of the study; or females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months. 5. The subject (or the subject's parent/legal guardian, if applicable) has provided written informed consent approved by the institutional review board/research ethics board/ethics committee (IRB/REB/EC) at any time prior to study start. If the subject is a minor (ie,
Exclusion criteria
Exclusion criteria: 1. Discontinued from Study SHP643-303 after enrollment but before Visit 26 for any reason. 2. Presence of important safety concerns identified in Study SHP643-303 that would preclude participation in this study. 3. Dosing with an investigational product (IP, not including IP defined in antecedent Study SHP643-303) or exposure to an investigational device within 4 weeks prior to Day 0. 4. Subject has a known hypersensitivity to the investigational product or its components. 5. Have any condition (surgical or medical) 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 comorbidities that the investigator considers may confound the interpretation of study results).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety measures, including: - Adverse events (AEs), including serious adverse events (SAEs) and adverse events of special interest (AESI) - Clinical laboratory testing (hematology, clinical chemistry, coagulation, and urinalysis) - Vitals signs including blood pressure, heart rate (HR), body temperature - Weight and height (height for subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number of investigator-confirmed angioedema attacks during the treatment period - Number of moderate or severe angioedema attacks during the treatment period - Number of high-morbidity angioedema attacks during the treatment period; a high-morbidity angioedema attack is defined as any attack that has at least one of the following characteristics: severe, results in hospitalization (except hospitalization for observation | — |
Countries
Netherlands
Outcome results
None listed