Angioedema
Conditions
Keywords
Drug Therapy
Brief summary
The main aim of this study is to check if repeated subcutaneous (SC) injections of lanadelumab can prevent angioedema attacks in teenagers and adults with non-histaminergic angioedema with normal C1-INH. Another aim is to check if they tolerate the repeated SC injections. Participants will receive a SC injection of lanadelumab every two weeks for 26 weeks. The first two doses of lanadelumab will be given at the study clinic. Once a participant (and/or parent/caregiver) has been appropriately trained, lanadelumab can be self-injected. Visits to the study clinic are planned for the first, third and fourth week and then every 4 weeks.
Detailed description
This study consists of non-histaminergic normal C1-INH angioedema population with 12 years of age and above. Participants will be randomized 2:1 to receive repeated SC administrations of lanadelumab or placebo in a double-blind fashion. Randomization will be stratified based on baseline angioedema attack rate (1 to less than (\<) 2 attacks/4 weeks, and greater than (\>=) 2 attacks/4 weeks), as well as subtype (known mutations, family history and unknown mutation, idiopathic).
Interventions
OTHERPlacebo
Placebo-matching lanadelumab SC injection.
DRUGLanadelumab
Lanadelumab solution in a PFS for injection.
Sponsors
Takeda Development Center Americas, Inc.
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The Participant will not be considered eligible for the study without meeting all of the applicable population criteria below. * Males and females, 12 years of age and older for participants with non-histaminergic normal C1-INH angioedema at the time of signing of the informed consent form (ICF). * Documented clinical history of recurrent attacks of angioedema in the absence of wheals/urticaria. * Investigator-confirmed diagnosis of non-histaminergic bradykinin-mediated angioedema with normal C1-INH as documented by a history of angioedema attack(s) at screening and occurrence of attacks during the observation period: * History of recurrent angioedema with at least an average of 1 angioedema attack per 4 weeks prior to screening and this attack rate must be confirmed during the observation period while treated with chronic high-dose antihistamine (cetirizine 40 milligram per day \[mg/day\] or equivalent high-dose second-generation antihistamine medication). * Diagnostic testing results obtained during screening from a sponsor-approved central laboratory that confirm C1-INH function \>= 50 percent (%) of normal and C4 level not below the normal range. With prior sponsor approval, participants may be retested during the observation period if results are incongruent with clinical history. * Clinical history of not responding to high-dose antihistamine treatment (cetirizine 40 mg/day or equivalent high-dose second-generation antihistamine medication), which must be confirmed during the observation period with at least 1 angioedema attack per 4 weeks with chronic high-dose antihistamine treatment and no significant difference (as assessed by the investigator and in consultation with the sponsor's medical monitor, as necessary) from the historic attack rate without high-dose antihistamine treatment. * Agree to adhere to the protocol-defined schedule of treatments, assessments, and procedures. * Participants \>= 18 years of age must be willing to use icatibant as the rescue medication during the observation and treatment period. During the observation period, participants need to be treated with icatibant for at least 2 angioedema attacks or at least 1 moderate or severe attack. In the opinion of the investigator, participants with no response to icatibant for acute angioedema attacks in the past medical history/screening, or no improvement or worsened attack severity 2 hours after icatibant treatment during the observation period (based on totality of assessments), will not be included. Note: For participants 12 to \< 18 years of age, standard of care therapy per local protocols should be provided. * Males, or non-pregnant, non-lactating females who are of child-bearing 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. Female participants of childbearing potential must have a negative serum pregnancy test at screening and must be willing to undergo pregnancy tests throughout the study. Females of non-childbearing potential are defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months. * The participants (or the participant'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). * If the participants is an adult, be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed. OR \- If the participants is a minor (i.e. \< 18 years of age), have a parent/legal guardian who is informed of the nature of the study provide written informed consent (i.e. permission) for the minor to participate in the study before any study-specific procedures are performed. Assent will be obtained from minor participants.
Exclusion criteria
The participant will be excluded from the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | Day 0 through Day 182 | An angioedema attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by the number of days the participant contributed to the specified period multiplied by 28 days. Number of investigator-confirmed angioedema attacks during the treatment period of Day 0 through Day 182 was assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | Day 0 Through Day 182 | Angioedema attack was defined as symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of tongue, palate, uvula, or larynx). Overall severity of the participant's angioedema attack was determined by site using the following definitions: 1. Mild: Transient or mild discomfort; 2. Moderate: Mild to moderate limitation in activity some assistance needed; 3. Severe: Marked limitation in activity, assistance required. Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by number of days the participant contributed to the specified period multiplied by 28 days. |
| Number of Investigator-Confirmed Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 | Day 70 through Day 182 | An angioedema attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Number of investigator-confirmed angioedema attacks during the presumed steady state period of day 70 through day 182 were assessed. Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by the number of days the participant contributed to the specified period multiplied by 28 days. |
| Number of Participants Achieving Attack-Free Status During the Presumed Steady State Period of Day 70 Through Day 182 | Day 70 through Day 182 | An angioedema attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). A participant was considered as attack free during a time period if the participant has no investigator-confirmed angioedema attacks during that time period. For participants who discontinue the study prior to completion of the analysis period, participants were classified as attack-free or not based on the observed contribution to the analysis period. Number of participants achieving attack-free status during the presumed steady state period of day 70 through day 182 was assessed. |
| Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 | Day 0 through Day 182 | An angioedema attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Number of participants with maximum attack severity during treatment period of day 0 through day 182 was assessed. Angioedema attack severity was calculated per participant based on the severity categories as follows: No attack, Mild, Moderate, and Severe. |
| Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 | Day 70 through Day 182 | An angioedema attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by the number of days the participant contributed to the specified period multiplied by 28 days. Number of investigator-confirmed moderate or severe angioedema attacks during the presumed steady state period of day 70 through day 182 were assessed. |
| Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 | Day 70 through Day 182 | An angioedema attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Number of participants with maximum attack severity during the presumed steady state period of day 70 through day 182 was assessed. Angioedema attack severity was calculated per participant based on the severity categories as follows: No attack, Mild, Moderate, and Severe. |
| Time to First Angioedema Attack After Day 0 Through Day 182 | Day 0 Through Day 182 | The time to the first angioedema attack (days) after Day 0 for the efficacy evaluation period of Day 0 through Day 182 was calculated from the date and time of the first dose of lanadelumab for the efficacy evaluation period (Day 0 through Day 182) to the date and time of the first in angioedema attack after the first dose for the efficacy evaluation period of Day 0 through Day 182. Participants with attacks occurring were the events. Participants who discontinue/complete the study prior to having an angioedema attack were censored. The data is reported for baseline angioedema attack rate groups i.e. 1 to \< 2 Attacks/Month and \>=2 Attacks/Month. |
| Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182 | Day 0 through Day 182 | An angioedema attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). A participant was considered as attack free during a time period if the participant has no investigator-confirmed angioedema attacks during that time period. For participants who discontinue the study prior to completion of the analysis period, participants were classified as attack-free or not based on the observed contribution to the analysis period. Number of participants achieving attack-free status during the treatment period of day 0 through day 182 was assessed. |
| Number of Participants Achieving at Least 50 %, 70%, 90% and 100% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks During Each of the Efficacy Evaluation Periods Relative to the Observation Period NNA | Day 0 Through Day 182 | The normalized number of investigator-confirmed angioedema attacks (NNA) during each efficacy evaluation period was expressed as a monthly (28 days) angioedema attack rate. Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by the number of days the participant contributed to the specified period multiplied by 28 days. Number of participants achieving at least 50 percent (%), 70%, 90% and 100% reduction in the investigator-confirmed normalized number of attacks per 4 weeks during each of the efficacy evaluation periods relative to the observation period NNA was assessed. The percentage reduction groups are not mutually exclusive, participants may appear in more than one group as applicable based on their percentage reduction. |
| Number of Participants Achieving Normalized Number of Attacks (NNA) Less Than (<)1.0 Per 4 Weeks During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 70 through Day 182 | The normalized number of investigator-confirmed angioedema attacks (NNA) during each efficacy evaluation period was expressed as a monthly (28 days) angioedema attack rate. Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by the number of days the participant contributed to the specified period multiplied by 28 days. Number of participants achieving normalized number of attacks \< 1.0 per 4 weeks during each of the efficacy evaluation periods was assessed. The percentage reduction groups are not mutually exclusive, participants may appear in more than one group as applicable based on their percentage reduction. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) | From the first study drug administration up to follow-up (Day 196) | TEAE was defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product (IP) or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. SAE=untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not and at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, congenital abnormality/birth defect, an important medical event. AESI included hypersensitivity reactions, events of disordered coagulation such as bleeding AESI, hypercoagulable AESI. |
| Plasma Concentrations of Lanadelumab | Pre-dose and post-dose at Days 0, 4, 14, 28, 56, 84, 112, 140, 168 and 182 | — |
| Plasma Kallikrein (pKal) Activity | Pre-dose and post-dose at Days 4, 14, 28, 56, 84, 112, 140, 168 and 182 | Plasma Kallikrein activity was measured by biomarker cleaved high molecular weight kininogen (cHMWK ) level to assess pharmacodynamics of lanadelumab. |
| Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Pre-dose and post-dose at Days 28, 56, 84, 112, 140, 168 and 182 | Number of participants with neutralizing or non-neutralizing antidrug antibodies in plasma was assessed. |
| Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline through Day 182 | The AE-QoL questionnaire was a self-administered validated instrument to assess health related (HR) QoL among participants with recurrent angioedema. The AE-QoL consisted of 17 disease-specific quality-of-life items, to produce a total AEQoL score and 4 domain scores (functioning, fatigue/mood, fear/shame, and nutrition) and each of the 17 items has a five point response scale ranging from 0 (Never) to 4 (Very Often). The raw total score (mean of all item scores) was rescaled using linear transformations into final percentage scores ranging 0 to 100. Swelling episodes (SE); Trouble Concentrating (TC); Food and Beverages (F&B); negative effects (NE). |
| Time to First Angioedema Attack After Day 70 Through Day 182 | Day 70 through Day 182 | The time to the first angioedema attack (days) after Day 0 for the efficacy evaluation period of Day 70 through Day 182 was calculated from the date and time of the first dose of lanadelumab for the efficacy evaluation period (Day 70 through Day 182) to the date and time of the first in angioedema attack after the first dose for the efficacy evaluation period of Day 70 through Day 182. Participants with attacks occurring were the events. Participants who discontinue/complete the study prior to having an angioedema attack were censored. The data is reported for baseline angioedema attack rate groups i.e. 1 to \< 2 Attacks/Month and \>=2 Attacks/Month. |
Countries
Canada, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Spain, United States
Participant flow
Recruitment details
Participants took part in the study at 34 investigative sites in Canada, United States, Germany, Hungary, Italy, Spain, France, Japan, Netherlands, and Poland from 04 May 2020 to 20 October 2022.
Pre-assignment details
Participants with a diagnosis of non-histaminergic angioedema were randomized in a 2:1 ratio to receive lanadelumab or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo-matching lanadelumab subcutaneous (SC) injection once every 2 weeks (q2w) for up to 26 weeks. | 27 |
| Lanadelumab 300 mg Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks. | 50 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Lanadelumab 300 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 42.3 years STANDARD_DEVIATION 14.06 | 43.8 years STANDARD_DEVIATION 10.77 | 42.8 years STANDARD_DEVIATION 12.94 |
| Body Mass Index (BMI) | 29.75 kilogram per squared meter STANDARD_DEVIATION 9.127 | 28.88 kilogram per squared meter STANDARD_DEVIATION 7.413 | 29.44 kilogram per squared meter STANDARD_DEVIATION 8.525 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 2 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 24 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Height | 166.09 centimeter STANDARD_DEVIATION 8.232 | 168.32 centimeter STANDARD_DEVIATION 9.779 | 166.87 centimeter STANDARD_DEVIATION 8.807 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 44 Participants | 24 Participants | 68 Participants |
| Region of Enrollment Canada | 4 Participants | 1 Participants | 5 Participants |
| Region of Enrollment France | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Germany | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment Hungary | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment Italy | 6 Participants | 3 Participants | 9 Participants |
| Region of Enrollment Japan | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment Netherlands | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment Poland | 2 Participants | 4 Participants | 6 Participants |
| Region of Enrollment Spain | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 28 Participants | 12 Participants | 40 Participants |
| Sex: Female, Male Female | 43 Participants | 19 Participants | 62 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
| Weight | 82.04 kilogram STANDARD_DEVIATION 25.217 | 82.09 kilogram STANDARD_DEVIATION 22.701 | 82.06 kilogram STANDARD_DEVIATION 24.213 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 50 |
| other Total, other adverse events | 27 / 27 | 49 / 50 |
| serious Total, serious adverse events | 1 / 27 | 7 / 50 |
Outcome results
Primary
Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182
An angioedema attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by the number of days the participant contributed to the specified period multiplied by 28 days. Number of investigator-confirmed angioedema attacks during the treatment period of Day 0 through Day 182 was assessed.
Time frame: Day 0 through Day 182
Population: Full Analysis Set (FAS) included all randomized participants who received any exposure to the investigational product (IP) during the treatment period (Day 0 through Day 182).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | 1.63 attacks/month | Standard Deviation 1.357 |
| Lanadelumab 300 mg | Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | 2.17 attacks/month | Standard Deviation 2.062 |
p-value: =0.89995% CI: [0.71, 1.47]Chi-squared
Secondary
Number of Investigator-Confirmed Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182
An angioedema attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Number of investigator-confirmed angioedema attacks during the presumed steady state period of day 70 through day 182 were assessed. Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by the number of days the participant contributed to the specified period multiplied by 28 days.
Time frame: Day 70 through Day 182
Population: Steady State (SS)-FAS included all randomized participants who received any exposure to the investigational product during the presumed steady state period (Day 70 through Day 182).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Investigator-Confirmed Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 | 1.37 attacks/month | Standard Deviation 1.231 |
| Lanadelumab 300 mg | Number of Investigator-Confirmed Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 | 2.05 attacks/month | Standard Deviation 2.211 |
p-value: =0.6695% CI: [0.72, 1.7]Chi-squared
Secondary
Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182
An angioedema attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by the number of days the participant contributed to the specified period multiplied by 28 days. Number of investigator-confirmed moderate or severe angioedema attacks during the presumed steady state period of day 70 through day 182 were assessed.
Time frame: Day 70 through Day 182
Population: SS-FAS included all randomized participants who received any exposure to the investigational product during the presumed steady state period (Day 70 through Day 182).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 | 0.97 attacks/month | Standard Deviation 1.013 |
| Lanadelumab 300 mg | Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 | 1.35 attacks/month | Standard Deviation 1.764 |
p-value: =0.89695% CI: [0.58, 1.61]Chi-squared
Secondary
Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182
Angioedema attack was defined as symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of tongue, palate, uvula, or larynx). Overall severity of the participant's angioedema attack was determined by site using the following definitions: 1. Mild: Transient or mild discomfort; 2. Moderate: Mild to moderate limitation in activity some assistance needed; 3. Severe: Marked limitation in activity, assistance required. Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by number of days the participant contributed to the specified period multiplied by 28 days.
Time frame: Day 0 Through Day 182
Population: FAS included all randomized participants who receive any exposure to the IP during the treatment period (Day 0 through Day 182).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | 1.10 attacks/month | Standard Deviation 0.984 |
| Lanadelumab 300 mg | Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | 1.45 attacks/month | Standard Deviation 1.711 |
p-value: =0.85295% CI: [0.62, 1.48]Chi-squared
Secondary
Number of Participants Achieving at Least 50 %, 70%, 90% and 100% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks During Each of the Efficacy Evaluation Periods Relative to the Observation Period NNA
The normalized number of investigator-confirmed angioedema attacks (NNA) during each efficacy evaluation period was expressed as a monthly (28 days) angioedema attack rate. Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by the number of days the participant contributed to the specified period multiplied by 28 days. Number of participants achieving at least 50 percent (%), 70%, 90% and 100% reduction in the investigator-confirmed normalized number of attacks per 4 weeks during each of the efficacy evaluation periods relative to the observation period NNA was assessed. The percentage reduction groups are not mutually exclusive, participants may appear in more than one group as applicable based on their percentage reduction.
Time frame: Day 0 Through Day 182
Population: FAS included all randomized participants who receive any exposure to the IP during the treatment period (Day 0 through Day 182). Overall number of participants analyzed are the number of participants achieving at Least 50 %, 70%, 90% and 100% reduction in the investigator-confirmed normalized number of attacks.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Achieving at Least 50 %, 70%, 90% and 100% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks During Each of the Efficacy Evaluation Periods Relative to the Observation Period NNA | >=50% Reduction | 13 Participants |
| Placebo | Number of Participants Achieving at Least 50 %, 70%, 90% and 100% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks During Each of the Efficacy Evaluation Periods Relative to the Observation Period NNA | >=70% Reduction | 9 Participants |
| Placebo | Number of Participants Achieving at Least 50 %, 70%, 90% and 100% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks During Each of the Efficacy Evaluation Periods Relative to the Observation Period NNA | >=90% Reduction | 3 Participants |
| Placebo | Number of Participants Achieving at Least 50 %, 70%, 90% and 100% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks During Each of the Efficacy Evaluation Periods Relative to the Observation Period NNA | 100% Reduction | 1 Participants |
| Lanadelumab 300 mg | Number of Participants Achieving at Least 50 %, 70%, 90% and 100% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks During Each of the Efficacy Evaluation Periods Relative to the Observation Period NNA | 100% Reduction | 2 Participants |
| Lanadelumab 300 mg | Number of Participants Achieving at Least 50 %, 70%, 90% and 100% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks During Each of the Efficacy Evaluation Periods Relative to the Observation Period NNA | >=50% Reduction | 28 Participants |
| Lanadelumab 300 mg | Number of Participants Achieving at Least 50 %, 70%, 90% and 100% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks During Each of the Efficacy Evaluation Periods Relative to the Observation Period NNA | >=90% Reduction | 6 Participants |
| Lanadelumab 300 mg | Number of Participants Achieving at Least 50 %, 70%, 90% and 100% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks During Each of the Efficacy Evaluation Periods Relative to the Observation Period NNA | >=70% Reduction | 12 Participants |
Secondary
Number of Participants Achieving Attack-Free Status During the Presumed Steady State Period of Day 70 Through Day 182
An angioedema attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). A participant was considered as attack free during a time period if the participant has no investigator-confirmed angioedema attacks during that time period. For participants who discontinue the study prior to completion of the analysis period, participants were classified as attack-free or not based on the observed contribution to the analysis period. Number of participants achieving attack-free status during the presumed steady state period of day 70 through day 182 was assessed.
Time frame: Day 70 through Day 182
Population: SS-FAS included all randomized participants who received any exposure to the investigational product during the presumed steady state period (Day 70 through Day 182).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Achieving Attack-Free Status During the Presumed Steady State Period of Day 70 Through Day 182 | 4 Participants |
| Lanadelumab 300 mg | Number of Participants Achieving Attack-Free Status During the Presumed Steady State Period of Day 70 Through Day 182 | 3 Participants |
p-value: =0.2595% CI: [-0.28, 0.063]Cochran-Mantel-Haenszel
Secondary
Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182
An angioedema attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). A participant was considered as attack free during a time period if the participant has no investigator-confirmed angioedema attacks during that time period. For participants who discontinue the study prior to completion of the analysis period, participants were classified as attack-free or not based on the observed contribution to the analysis period. Number of participants achieving attack-free status during the treatment period of day 0 through day 182 was assessed.
Time frame: Day 0 through Day 182
Population: FAS included all randomized participants who receive any exposure to the IP during the treatment period (Day 0 through Day 182).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182 | 1 Participants |
| Lanadelumab 300 mg | Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182 | 2 Participants |
p-value: =195% CI: [-0.153, 0.114]Cochran-Mantel-Haenszel
Secondary
Number of Participants Achieving Normalized Number of Attacks (NNA) Less Than (<)1.0 Per 4 Weeks During Each of the Efficacy Evaluation Periods
The normalized number of investigator-confirmed angioedema attacks (NNA) during each efficacy evaluation period was expressed as a monthly (28 days) angioedema attack rate. Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by the number of days the participant contributed to the specified period multiplied by 28 days. Number of participants achieving normalized number of attacks \< 1.0 per 4 weeks during each of the efficacy evaluation periods was assessed. The percentage reduction groups are not mutually exclusive, participants may appear in more than one group as applicable based on their percentage reduction.
Time frame: Day 0 through Day 182, Day 70 through Day 182
Population: SS-FAS included all randomized participants who received any exposure to the investigational product during the presumed steady state period (Day 70 through Day 182).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Achieving Normalized Number of Attacks (NNA) Less Than (<)1.0 Per 4 Weeks During Each of the Efficacy Evaluation Periods | >=50% Reduction | 14 Participants |
| Placebo | Number of Participants Achieving Normalized Number of Attacks (NNA) Less Than (<)1.0 Per 4 Weeks During Each of the Efficacy Evaluation Periods | >=70% Reduction | 12 Participants |
| Placebo | Number of Participants Achieving Normalized Number of Attacks (NNA) Less Than (<)1.0 Per 4 Weeks During Each of the Efficacy Evaluation Periods | >=90% Reduction | 5 Participants |
| Placebo | Number of Participants Achieving Normalized Number of Attacks (NNA) Less Than (<)1.0 Per 4 Weeks During Each of the Efficacy Evaluation Periods | 100% Reduction | 4 Participants |
| Lanadelumab 300 mg | Number of Participants Achieving Normalized Number of Attacks (NNA) Less Than (<)1.0 Per 4 Weeks During Each of the Efficacy Evaluation Periods | 100% Reduction | 3 Participants |
| Lanadelumab 300 mg | Number of Participants Achieving Normalized Number of Attacks (NNA) Less Than (<)1.0 Per 4 Weeks During Each of the Efficacy Evaluation Periods | >=50% Reduction | 31 Participants |
| Lanadelumab 300 mg | Number of Participants Achieving Normalized Number of Attacks (NNA) Less Than (<)1.0 Per 4 Weeks During Each of the Efficacy Evaluation Periods | >=90% Reduction | 5 Participants |
| Lanadelumab 300 mg | Number of Participants Achieving Normalized Number of Attacks (NNA) Less Than (<)1.0 Per 4 Weeks During Each of the Efficacy Evaluation Periods | >=70% Reduction | 18 Participants |
Secondary
Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182
The AE-QoL questionnaire was a self-administered validated instrument to assess health related (HR) QoL among participants with recurrent angioedema. The AE-QoL consisted of 17 disease-specific quality-of-life items, to produce a total AEQoL score and 4 domain scores (functioning, fatigue/mood, fear/shame, and nutrition) and each of the 17 items has a five point response scale ranging from 0 (Never) to 4 (Very Often). The raw total score (mean of all item scores) was rescaled using linear transformations into final percentage scores ranging 0 to 100. Swelling episodes (SE); Trouble Concentrating (TC); Food and Beverages (F&B); negative effects (NE).
Time frame: Baseline through Day 182
Population: SAS included all participants who receive any exposure to the IP. Overall number of participants analyzed are the number of participants with data available for analyses. Number analyzed is the number of participants available for analyses in the specific category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Trouble concentrating - Occasionally | 10 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Work - Rarely | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Work - Occasionally | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Work - Often | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Work - Very Often | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Physical activity - Never | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Physical activity - Rarely | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Physical activity - Occasionally | 16 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Physical activity - Often | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Physical activity - Very Often | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Leisure time - Never | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Leisure time - Rarely | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Leisure time - Occasionally | 12 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Leisure time - Often | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Leisure time - Very Often | 3 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Social relations - Never | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Social relations - Rarely | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Social relations - Occasionally | 12 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Social relations - Often | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Social relations - Very Often | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Eating and drinking - Never | 3 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Eating and drinking - Rarely | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Eating and drinking - Occasionally | 9 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Eating and drinking - Often | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Eating and drinking - Very often | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Difficulty falling asleep - Never | 3 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Difficulty falling asleep - Rarely | 3 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Difficulty falling asleep - Occasionally | 11 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Difficulty falling asleep - Often | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Difficulty falling asleep - Very often | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Wake up during the night - Never | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Wake up during the night - Rarely | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Wake up during the night - Occasionally | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Wake up during the night - Often | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Wake up during the night - Very often | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Tired during the day - Never | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Tired during the day - Rarely | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Tired during the day - Occasionally | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Tired during the day - Often | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Tired during the day - Very often | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Trouble concentrating - Never | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Trouble concentrating - Rarely | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Work - Never | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Trouble concentrating - Often | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Trouble concentrating - Very often | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Feel depressed - Never | 9 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Feel depressed - Rarely | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Feel depressed - Occasionally | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Feel depressed - Often | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Feel depressed - Very often | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Limit your choices of food or beverages - Never | 10 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Limit your choices of food or beverages - Rarely | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Limit your choices of food or beverages - Occasionally | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Limit your choices of food or beverages - Often | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Limit your choices of food or beverages - Very often | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes place a burden on you - Never | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes place a burden on you - Rarely | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes place a burden on you - Occasionally | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes place a burden on you - Often | 10 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes place a burden on you - Very often | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episode could occur suddenly - Never | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episode could occur suddenly - Rarely | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episode could occur suddenly - Occasionally | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episode could occur suddenly - Often | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episode could occur suddenly - Very often | 11 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Freq of swelling episodes might increase - Never | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Freq of swelling episodes might increase - Rarely | 3 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Freq of swelling episodes might increase - Occasionally | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Freq of swelling episodes might increase - Often | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Freq of swelling episodes might increase - Very often | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Ashamed to go out due to swell episodes - Never | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Ashamed to go out due to swell episodes - Rarely | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Ashamed to go out due to swell episodes - Occasionally | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Ashamed to go out due to swell episodes - Often | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Ashamed to go out due to swell episodes - Very often | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes make you embarrassed - Never | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes make you embarrassed - Rarely | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes make you embarrassed - Occasionally | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes make you embarrassed - Often | 3 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes make you embarrassed - Very often | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Afraid of long term negative effects - Never | 3 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Afraid of long term negative effects - Rarely | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Afraid of long term negative effects - Occasionally | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Afraid of long term negative effects - Often | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Afraid of long term negative effects - Very often | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Work - Never | 3 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Work - Rarely | 10 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Work - Occasionally | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Work - Often | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Work - Very Often | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Physical activity - Never | 3 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Physical activity - Rarely | 10 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Physical activity - Occasionally | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Physical activity - Often | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Physical activity - Very often | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Leisure time - Never | 3 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Leisure time - Rarely | 12 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Leisure time - Occasionally | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Leisure time - Often | 3 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Leisure time - Very often | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Social relations - Never | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Social relations - Rarely | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Social relations - Occasionally | 9 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Social relations - Often | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Social relations - Very often | 3 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Eating and drinking - Never | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Eating and drinking - Rarely | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Eating and drinking - Occasionally | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Eating and drinking - Often | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Eating and drinking - Very often | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Difficulty falling asleep - Never | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Difficulty falling asleep - Rarely | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Difficulty falling asleep - Occasionally | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Difficulty falling asleep - Often | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Difficulty falling asleep - Very often | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Wake up during the night - Never | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Wake up during the night - Rarely | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Wake up during the night - Occasionally | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Wake up during the night - Often | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Wake up during the night - Very often | 3 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Tired during the day - Never | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Tired during the day - Rarely | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Tired during the day - Occasionally | 11 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Tired during the day - Often | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Tired during the day - Very often | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Trouble concentrating - Never | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Trouble concentrating - Rarely | 17 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Trouble concentrating - Occasionally | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Trouble concentrating - Often | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Trouble concentrating - Very often | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Feel depressed - Never | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Feel depressed - Rarely | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Feel depressed - Occasionally | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Feel depressed - Often | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Feel depressed - Very often | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Limit your choices of food or beverages - Never | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Limit your choices of food or beverages - Rarely | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Limit your choices of food or beverages - Occasionally | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Limit your choices of food or beverages - Often | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Visit 26: Limit your choices of food or beverages - Very often | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes place a burden on you - Never | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes place a burden on you - Rarely | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes place a burden on you - Occasionally | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes place a burden on you - Often | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes place a burden on you - Very often | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episode could occur suddenly - Never | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episode could occur suddenly - Rarely | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episode could occur suddenly - Occasionally | 9 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episode could occur suddenly - Often | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episode could occur suddenly - Very often | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Freq of swelling episodes might increase - Never | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Freq of swelling episodes might increase - Rarely | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Freq of swelling episodes might increase - Occasionally | 9 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Freq of swelling episodes might increase - Often | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Freq of swelling episodes might increase - Very often | 3 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Ashamed to go out due to swell episodes - Never | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Ashamed to go out due to swell episodes - Rarely | 8 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Ashamed to go out due to swell episodes - Occasionally | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Ashamed to go out due to swell episodes - Often | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Ashamed to go out due to swell episodes - Very often | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes make you embarrassed - Never | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes make you embarrassed - Rarely | 5 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes make you embarrassed - Occasionally | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes make you embarrassed - Often | 6 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes make you embarrassed - Very often | 2 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Afraid of long term negative effects - Never | 4 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Afraid of long term negative effects - Rarely | 10 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Afraid of long term negative effects - Occasionally | 7 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Afraid of long term negative effects - Often | 1 Participants |
| Placebo | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Afraid of long term negative effects - Very often | 4 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Trouble concentrating - Occasionally | 14 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Work - Never | 6 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Work - Never | 17 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Work - Rarely | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Ashamed to go out due to swell episodes - Very often | 6 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Work - Occasionally | 14 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Work - Rarely | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Work - Often | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Trouble concentrating - Often | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Work - Very Often | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Work - Occasionally | 12 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Physical activity - Never | 4 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episode could occur suddenly - Very often | 12 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Physical activity - Rarely | 7 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Work - Often | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Physical activity - Occasionally | 15 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Trouble concentrating - Very often | 3 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Physical activity - Often | 12 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Work - Very Often | 3 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Physical activity - Very Often | 11 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Afraid of long term negative effects - Occasionally | 11 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Leisure time - Never | 4 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Physical activity - Never | 13 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Leisure time - Rarely | 9 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Feel depressed - Never | 18 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Leisure time - Occasionally | 17 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Physical activity - Rarely | 12 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Leisure time - Often | 15 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Freq of swelling episodes might increase - Never | 7 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Leisure time - Very Often | 4 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Physical activity - Occasionally | 13 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Social relations - Never | 4 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Feel depressed - Rarely | 18 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Social relations - Rarely | 9 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Physical activity - Often | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Social relations - Occasionally | 16 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes make you embarrassed - Never | 14 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Social relations - Often | 16 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Physical activity - Very often | 4 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Social relations - Very Often | 4 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Feel depressed - Occasionally | 7 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Eating and drinking - Never | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Leisure time - Never | 14 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Eating and drinking - Rarely | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Freq of swelling episodes might increase - Rarely | 12 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Eating and drinking - Occasionally | 16 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Leisure time - Rarely | 15 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Eating and drinking - Often | 13 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Feel depressed - Often | 5 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Eating and drinking - Very often | 2 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Leisure time - Occasionally | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Difficulty falling asleep - Never | 7 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Afraid of long term negative effects - Never | 15 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Difficulty falling asleep - Rarely | 7 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Leisure time - Often | 7 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Difficulty falling asleep - Occasionally | 17 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Feel depressed - Very often | 2 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Difficulty falling asleep - Often | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Leisure time - Very often | 4 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Difficulty falling asleep - Very often | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Freq of swelling episodes might increase - Occasionally | 13 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Wake up during the night - Never | 2 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Social relations - Never | 15 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Wake up during the night - Rarely | 11 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Limit your choices of food or beverages - Never | 19 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Wake up during the night - Occasionally | 12 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Social relations - Rarely | 11 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Wake up during the night - Often | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes make you embarrassed - Rarely | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Wake up during the night - Very often | 14 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Social relations - Occasionally | 13 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Tired during the day - Never | 3 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Limit your choices of food or beverages - Rarely | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Tired during the day - Rarely | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Social relations - Often | 6 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Tired during the day - Occasionally | 16 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Freq of swelling episodes might increase - Often | 6 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Tired during the day - Often | 9 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Social relations - Very often | 5 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Tired during the day - Very often | 13 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Limit your choices of food or beverages - Occasionally | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Trouble concentrating - Never | 3 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Eating and drinking - Never | 18 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Trouble concentrating - Rarely | 14 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Afraid of long term negative effects - Very often | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Trouble concentrating - Occasionally | 14 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Eating and drinking - Rarely | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Trouble concentrating - Often | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Limit your choices of food or beverages - Often | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Trouble concentrating - Very often | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Eating and drinking - Occasionally | 9 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Feel depressed - Never | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Freq of swelling episodes might increase - Very often | 12 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Feel depressed - Rarely | 18 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Eating and drinking - Often | 14 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Feel depressed - Occasionally | 11 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Visit 26: Limit your choices of food or beverages - Very often | 5 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Feel depressed - Often | 7 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Eating and drinking - Very often | 1 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Feel depressed - Very often | 3 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes make you embarrassed - Occasionally | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Limit your choices of food or beverages - Never | 17 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Difficulty falling asleep - Never | 9 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Limit your choices of food or beverages - Rarely | 4 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes place a burden on you - Never | 6 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Limit your choices of food or beverages - Occasionally | 13 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Difficulty falling asleep - Rarely | 15 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Limit your choices of food or beverages - Often | 7 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Ashamed to go out due to swell episodes - Never | 15 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Limit your choices of food or beverages - Very often | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Difficulty falling asleep - Occasionally | 12 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes place a burden on you - Never | 1 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes place a burden on you - Rarely | 9 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes place a burden on you - Rarely | 0 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Difficulty falling asleep - Often | 9 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes place a burden on you - Occasionally | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Afraid of long term negative effects - Rarely | 13 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes place a burden on you - Often | 24 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Difficulty falling asleep - Very often | 5 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes place a burden on you - Very often | 16 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes place a burden on you - Occasionally | 17 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episode could occur suddenly - Never | 2 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Wake up during the night - Never | 9 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episode could occur suddenly - Rarely | 1 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Ashamed to go out due to swell episodes - Rarely | 11 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episode could occur suddenly - Occasionally | 12 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Wake up during the night - Rarely | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episode could occur suddenly - Often | 16 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes place a burden on you - Often | 7 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episode could occur suddenly - Very often | 18 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Wake up during the night - Occasionally | 15 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Freq of swelling episodes might increase - Never | 1 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes make you embarrassed - Often | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Freq of swelling episodes might increase - Rarely | 3 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Wake up during the night - Often | 9 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Freq of swelling episodes might increase - Occasionally | 7 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes place a burden on you - Very often | 11 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Freq of swelling episodes might increase - Often | 21 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Wake up during the night - Very often | 7 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Freq of swelling episodes might increase - Very often | 17 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Ashamed to go out due to swell episodes - Occasionally | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Ashamed to go out due to swell episodes - Never | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Tired during the day - Never | 9 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Ashamed to go out due to swell episodes - Rarely | 7 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episode could occur suddenly - Never | 7 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Ashamed to go out due to swell episodes - Occasionally | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Tired during the day - Rarely | 15 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Ashamed to go out due to swell episodes - Often | 11 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Afraid of long term negative effects - Often | 3 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Ashamed to go out due to swell episodes - Very often | 11 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Tired during the day - Occasionally | 12 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes make you embarrassed - Never | 9 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episode could occur suddenly - Rarely | 14 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes make you embarrassed - Rarely | 5 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Tired during the day - Often | 9 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes make you embarrassed - Occasionally | 13 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Ashamed to go out due to swell episodes - Often | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes make you embarrassed - Often | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Tired during the day - Very often | 5 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Swelling episodes make you embarrassed - Very often | 14 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episode could occur suddenly - Occasionally | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Afraid of long term negative effects - Never | 9 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Trouble concentrating - Never | 13 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Afraid of long term negative effects - Rarely | 15 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episodes make you embarrassed - Very often | 8 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Afraid of long term negative effects - Occasionally | 4 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Trouble concentrating - Rarely | 10 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Afraid of long term negative effects - Often | 12 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Day 182: Swelling episode could occur suddenly - Often | 7 Participants |
| Lanadelumab 300 mg | Number of Participants With Change in Total Angioedema Quality of Life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 | Baseline: Afraid of long term negative effects - Very often | 9 Participants |
Secondary
Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182
An angioedema attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Number of participants with maximum attack severity during the presumed steady state period of day 70 through day 182 was assessed. Angioedema attack severity was calculated per participant based on the severity categories as follows: No attack, Mild, Moderate, and Severe.
Time frame: Day 70 through Day 182
Population: SS-FAS included all randomized participants who received any exposure to the investigational product during the presumed steady state period (Day 70 through Day 182).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 | No Attack | 4 Participants |
| Placebo | Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 | Mild | 5 Participants |
| Placebo | Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 | Moderate | 12 Participants |
| Placebo | Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 | Severe | 6 Participants |
| Lanadelumab 300 mg | Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 | Severe | 18 Participants |
| Lanadelumab 300 mg | Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 | No Attack | 3 Participants |
| Lanadelumab 300 mg | Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 | Moderate | 23 Participants |
| Lanadelumab 300 mg | Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 | Mild | 5 Participants |
Secondary
Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182
An angioedema attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Number of participants with maximum attack severity during treatment period of day 0 through day 182 was assessed. Angioedema attack severity was calculated per participant based on the severity categories as follows: No attack, Mild, Moderate, and Severe.
Time frame: Day 0 through Day 182
Population: FAS included all randomized participants who receive any exposure to the IP during the treatment period (Day 0 through Day 182).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 | No Attack | 1 Participants |
| Placebo | Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 | Mild | 2 Participants |
| Placebo | Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 | Moderate | 17 Participants |
| Placebo | Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 | Severe | 7 Participants |
| Lanadelumab 300 mg | Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 | Severe | 27 Participants |
| Lanadelumab 300 mg | Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 | No Attack | 2 Participants |
| Lanadelumab 300 mg | Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 | Moderate | 17 Participants |
| Lanadelumab 300 mg | Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 | Mild | 4 Participants |
Secondary
Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma
Number of participants with neutralizing or non-neutralizing antidrug antibodies in plasma was assessed.
Time frame: Pre-dose and post-dose at Days 28, 56, 84, 112, 140, 168 and 182
Population: FAS included all randomized participants who receive any exposure to the IP during the treatment period (Day 0 through Day 182). Number analyzed is the number of participants available for analyses at the given timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Day 140 | 0 Participants |
| Placebo | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Baseline | 0 Participants |
| Placebo | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Day 28 | 0 Participants |
| Placebo | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Day 56 | 0 Participants |
| Placebo | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Day 84 | 0 Participants |
| Placebo | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Day 112 | 0 Participants |
| Placebo | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Day 168 | 0 Participants |
| Placebo | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Day 182 | 0 Participants |
| Lanadelumab 300 mg | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Day 182 | 2 Participants |
| Lanadelumab 300 mg | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Day 140 | 1 Participants |
| Lanadelumab 300 mg | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Day 84 | 0 Participants |
| Lanadelumab 300 mg | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Baseline | 0 Participants |
| Lanadelumab 300 mg | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Day 168 | 0 Participants |
| Lanadelumab 300 mg | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Day 28 | 0 Participants |
| Lanadelumab 300 mg | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Day 112 | 1 Participants |
| Lanadelumab 300 mg | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Day 56 | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs)
TEAE was defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product (IP) or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. SAE=untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not and at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, congenital abnormality/birth defect, an important medical event. AESI included hypersensitivity reactions, events of disordered coagulation such as bleeding AESI, hypercoagulable AESI.
Time frame: From the first study drug administration up to follow-up (Day 196)
Population: SAS included all participants who received any exposure to the IP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) | Any TEAE | 23 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) | AESI | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) | SAE | 1 Participants |
| Lanadelumab 300 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) | Any TEAE | 46 Participants |
| Lanadelumab 300 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) | AESI | 1 Participants |
| Lanadelumab 300 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) | SAE | 7 Participants |
Secondary
Plasma Concentrations of Lanadelumab
Time frame: Pre-dose and post-dose at Days 0, 4, 14, 28, 56, 84, 112, 140, 168 and 182
Population: Pharmacokinetic Set (PK Set) included all participants in the SAS who had at least 1 evaluable postdose PK concentration value. Overall number of participants analyzed is the number of participants available with data for analyses. Number analyzed is the number of participants available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Plasma Concentrations of Lanadelumab | Day 84 | 7.335 nanogram/milliliter (ng/mL) | Standard Deviation 30.0848 |
| Placebo | Plasma Concentrations of Lanadelumab | Day 28 | 6.188 nanogram/milliliter (ng/mL) | Standard Deviation 17.9944 |
| Placebo | Plasma Concentrations of Lanadelumab | Day 112 | 5.604 nanogram/milliliter (ng/mL) | Standard Deviation 22.1843 |
| Placebo | Plasma Concentrations of Lanadelumab | Day 14 | 5.366 nanogram/milliliter (ng/mL) | Standard Deviation 21.465 |
| Placebo | Plasma Concentrations of Lanadelumab | Day 140 | 3.200 nanogram/milliliter (ng/mL) | Standard Deviation 16.3188 |
| Placebo | Plasma Concentrations of Lanadelumab | Day 56 | 16.820 nanogram/milliliter (ng/mL) | Standard Deviation 61.3021 |
| Placebo | Plasma Concentrations of Lanadelumab | Day 168 | 9.260 nanogram/milliliter (ng/mL) | Standard Deviation 23.0763 |
| Placebo | Plasma Concentrations of Lanadelumab | Day 4 | 42.749 nanogram/milliliter (ng/mL) | Standard Deviation 113.1021 |
| Placebo | Plasma Concentrations of Lanadelumab | Day 182 | 4.733 nanogram/milliliter (ng/mL) | Standard Deviation 18.7014 |
| Placebo | Plasma Concentrations of Lanadelumab | Baseline | 661.573 nanogram/milliliter (ng/mL) | Standard Deviation 2991.1363 |
| Lanadelumab 300 mg | Plasma Concentrations of Lanadelumab | Day 168 | 21369.818 nanogram/milliliter (ng/mL) | Standard Deviation 11072.0806 |
| Lanadelumab 300 mg | Plasma Concentrations of Lanadelumab | Day 182 | 20496.158 nanogram/milliliter (ng/mL) | Standard Deviation 10774.2169 |
| Lanadelumab 300 mg | Plasma Concentrations of Lanadelumab | Baseline | 1.665 nanogram/milliliter (ng/mL) | Standard Deviation 7.8812 |
| Lanadelumab 300 mg | Plasma Concentrations of Lanadelumab | Day 0 | 0.000 nanogram/milliliter (ng/mL) | — |
| Lanadelumab 300 mg | Plasma Concentrations of Lanadelumab | Day 4 | 16895.996 nanogram/milliliter (ng/mL) | Standard Deviation 8136.5164 |
| Lanadelumab 300 mg | Plasma Concentrations of Lanadelumab | Day 14 | 11030.519 nanogram/milliliter (ng/mL) | Standard Deviation 4632.9383 |
| Lanadelumab 300 mg | Plasma Concentrations of Lanadelumab | Day 28 | 15969.813 nanogram/milliliter (ng/mL) | Standard Deviation 7210.5963 |
| Lanadelumab 300 mg | Plasma Concentrations of Lanadelumab | Day 56 | 20722.131 nanogram/milliliter (ng/mL) | Standard Deviation 8396.598 |
| Lanadelumab 300 mg | Plasma Concentrations of Lanadelumab | Day 84 | 22698.616 nanogram/milliliter (ng/mL) | Standard Deviation 8953.3488 |
| Lanadelumab 300 mg | Plasma Concentrations of Lanadelumab | Day 112 | 22938.312 nanogram/milliliter (ng/mL) | Standard Deviation 10021.834 |
| Lanadelumab 300 mg | Plasma Concentrations of Lanadelumab | Day 140 | 22778.286 nanogram/milliliter (ng/mL) | Standard Deviation 9680.4686 |
Secondary
Plasma Kallikrein (pKal) Activity
Plasma Kallikrein activity was measured by biomarker cleaved high molecular weight kininogen (cHMWK ) level to assess pharmacodynamics of lanadelumab.
Time frame: Pre-dose and post-dose at Days 4, 14, 28, 56, 84, 112, 140, 168 and 182
Population: The Pharmacodynamic Set (PD Set) included all participants in the SAS who had at least 1 evaluable PD concentration value. Overall number of participants analyzed are the number of participants with data available for analyses. Number analyzed is the number of participants available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Plasma Kallikrein (pKal) Activity | Day 4 | 25.94 % cHMWK | Standard Deviation 33.285 |
| Placebo | Plasma Kallikrein (pKal) Activity | Day 56 | 17.83 % cHMWK | Standard Deviation 12.169 |
| Placebo | Plasma Kallikrein (pKal) Activity | Baseline | 20.30 % cHMWK | Standard Deviation 14.927 |
| Placebo | Plasma Kallikrein (pKal) Activity | Day 14 | 17.23 % cHMWK | Standard Deviation 9.801 |
| Placebo | Plasma Kallikrein (pKal) Activity | Day 140 | 17.40 % cHMWK | Standard Deviation 15.413 |
| Placebo | Plasma Kallikrein (pKal) Activity | Day 112 | 15.88 % cHMWK | Standard Deviation 11.109 |
| Placebo | Plasma Kallikrein (pKal) Activity | Day 168 | 20.90 % cHMWK | Standard Deviation 16.588 |
| Placebo | Plasma Kallikrein (pKal) Activity | Day 28 | 16.16 % cHMWK | Standard Deviation 12.458 |
| Placebo | Plasma Kallikrein (pKal) Activity | Day 182 | 18.08 % cHMWK | Standard Deviation 20.384 |
| Placebo | Plasma Kallikrein (pKal) Activity | Day 84 | 17.00 % cHMWK | Standard Deviation 15.508 |
| Lanadelumab 300 mg | Plasma Kallikrein (pKal) Activity | Day 182 | 15.39 % cHMWK | Standard Deviation 15.333 |
| Lanadelumab 300 mg | Plasma Kallikrein (pKal) Activity | Day 84 | 16.76 % cHMWK | Standard Deviation 15.941 |
| Lanadelumab 300 mg | Plasma Kallikrein (pKal) Activity | Baseline | 18.69 % cHMWK | Standard Deviation 11.854 |
| Lanadelumab 300 mg | Plasma Kallikrein (pKal) Activity | Day 4 | 20.20 % cHMWK | Standard Deviation 20.333 |
| Lanadelumab 300 mg | Plasma Kallikrein (pKal) Activity | Day 14 | 12.83 % cHMWK | Standard Deviation 13.136 |
| Lanadelumab 300 mg | Plasma Kallikrein (pKal) Activity | Day 28 | 14.24 % cHMWK | Standard Deviation 13.472 |
| Lanadelumab 300 mg | Plasma Kallikrein (pKal) Activity | Day 56 | 15.88 % cHMWK | Standard Deviation 15.618 |
| Lanadelumab 300 mg | Plasma Kallikrein (pKal) Activity | Day 112 | 16.12 % cHMWK | Standard Deviation 17.242 |
| Lanadelumab 300 mg | Plasma Kallikrein (pKal) Activity | Day 140 | 14.91 % cHMWK | Standard Deviation 14.656 |
| Lanadelumab 300 mg | Plasma Kallikrein (pKal) Activity | Day 168 | 15.07 % cHMWK | Standard Deviation 15.061 |
Secondary
Time to First Angioedema Attack After Day 0 Through Day 182
The time to the first angioedema attack (days) after Day 0 for the efficacy evaluation period of Day 0 through Day 182 was calculated from the date and time of the first dose of lanadelumab for the efficacy evaluation period (Day 0 through Day 182) to the date and time of the first in angioedema attack after the first dose for the efficacy evaluation period of Day 0 through Day 182. Participants with attacks occurring were the events. Participants who discontinue/complete the study prior to having an angioedema attack were censored. The data is reported for baseline angioedema attack rate groups i.e. 1 to \< 2 Attacks/Month and \>=2 Attacks/Month.
Time frame: Day 0 Through Day 182
Population: FAS included all randomized participants who receive any exposure to the IP during the treatment period (Day 0 through Day 182). Number analyzed are the number of participants with attacks occurring as events.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time to First Angioedema Attack After Day 0 Through Day 182 | 1 to <2 Attacks/Month | 10.5 days |
| Placebo | Time to First Angioedema Attack After Day 0 Through Day 182 | >=2 Attacks/Month | 6.8 days |
| Lanadelumab 300 mg | Time to First Angioedema Attack After Day 0 Through Day 182 | 1 to <2 Attacks/Month | 81.0 days |
| Lanadelumab 300 mg | Time to First Angioedema Attack After Day 0 Through Day 182 | >=2 Attacks/Month | 5.9 days |
p-value: =0.498Log Rank
Secondary
Time to First Angioedema Attack After Day 70 Through Day 182
The time to the first angioedema attack (days) after Day 0 for the efficacy evaluation period of Day 70 through Day 182 was calculated from the date and time of the first dose of lanadelumab for the efficacy evaluation period (Day 70 through Day 182) to the date and time of the first in angioedema attack after the first dose for the efficacy evaluation period of Day 70 through Day 182. Participants with attacks occurring were the events. Participants who discontinue/complete the study prior to having an angioedema attack were censored. The data is reported for baseline angioedema attack rate groups i.e. 1 to \< 2 Attacks/Month and \>=2 Attacks/Month.
Time frame: Day 70 through Day 182
Population: SS-FAS included all randomized participants who received any exposure to the investigational product during the presumed steady state period (Day 70 through Day 182). Number analyzed are the number of participants with attacks occurring as events.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time to First Angioedema Attack After Day 70 Through Day 182 | 1 to <2 Attacks/Month | 12.3 days |
| Placebo | Time to First Angioedema Attack After Day 70 Through Day 182 | >=2 Attacks/Month | 16.9 days |
| Lanadelumab 300 mg | Time to First Angioedema Attack After Day 70 Through Day 182 | 1 to <2 Attacks/Month | 40.8 days |
| Lanadelumab 300 mg | Time to First Angioedema Attack After Day 70 Through Day 182 | >=2 Attacks/Month | 10.6 days |
p-value: =0.184Log Rank