Trial Outcomes & Findings for A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH) (NCT NCT04206605)

NCT ID: NCT04206605

Last Updated: 2023-12-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

77 participants

Primary outcome timeframe

Day 0 through Day 182

Results posted on

2023-12-27

Participant Flow

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.

Participants with a diagnosis of non-histaminergic angioedema were randomized in a 2:1 ratio to receive lanadelumab or placebo.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo-matching lanadelumab subcutaneous (SC) injection once every 2 weeks (q2w) for up to 26 weeks.	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.
Overall Study STARTED	27	50
Overall Study Steady State Full Analysis Set (SS-FAS)	27	49
Overall Study COMPLETED	26	49
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo-matching lanadelumab subcutaneous (SC) injection once every 2 weeks (q2w) for up to 26 weeks.	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.
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once every 2 weeks (q2w) for up to 26 weeks.	Lanadelumab 300 mg n=50 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.	Total n=77 Participants Total of all reporting groups
Age, Continuous	43.8 years STANDARD_DEVIATION 10.77 • n=93 Participants	42.3 years STANDARD_DEVIATION 14.06 • n=4 Participants	42.8 years STANDARD_DEVIATION 12.94 • n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	43 Participants n=4 Participants	62 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	7 Participants n=4 Participants	15 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	7 Participants n=4 Participants	9 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=93 Participants	43 Participants n=4 Participants	67 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) White	24 Participants n=93 Participants	44 Participants n=4 Participants	68 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment Canada	1 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants
Region of Enrollment France	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment Germany	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment Hungary	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment Italy	3 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants
Region of Enrollment Japan	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment Netherlands	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment Poland	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Region of Enrollment Spain	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment United States	12 Participants n=93 Participants	28 Participants n=4 Participants	40 Participants n=27 Participants
Height	168.32 centimeter STANDARD_DEVIATION 9.779 • n=93 Participants	166.09 centimeter STANDARD_DEVIATION 8.232 • n=4 Participants	166.87 centimeter STANDARD_DEVIATION 8.807 • n=27 Participants
Weight	82.09 kilogram STANDARD_DEVIATION 22.701 • n=93 Participants	82.04 kilogram STANDARD_DEVIATION 25.217 • n=4 Participants	82.06 kilogram STANDARD_DEVIATION 24.213 • n=27 Participants
Body Mass Index (BMI)	28.88 kilogram per squared meter STANDARD_DEVIATION 7.413 • n=93 Participants	29.75 kilogram per squared meter STANDARD_DEVIATION 9.127 • n=4 Participants	29.44 kilogram per squared meter STANDARD_DEVIATION 8.525 • n=27 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=50 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182	1.63 attacks/month Standard Deviation 1.357	2.17 attacks/month Standard Deviation 2.062

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=50 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=50 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
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	1.45 attacks/month Standard Deviation 1.711

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=49 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
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	2.05 attacks/month Standard Deviation 2.211

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=49 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
Number of Participants Achieving Attack-Free Status During the Presumed Steady State Period of Day 70 Through Day 182	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=50 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 No Attack	1 Participants	2 Participants
Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 Mild	2 Participants	4 Participants
Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 Moderate	17 Participants	17 Participants
Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 Severe	7 Participants	27 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=49 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
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	1.35 attacks/month Standard Deviation 1.764

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=49 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 No Attack	4 Participants	3 Participants
Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 Mild	5 Participants	5 Participants
Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 Moderate	12 Participants	23 Participants
Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 Severe	6 Participants	18 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=50 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
Time to First Angioedema Attack After Day 0 Through Day 182 1 to <2 Attacks/Month	10.5 days Interval 6.6 to Upper limit of confidence Interval (CI) was not estimable due to insufficient number of participants with events.	81.0 days Interval 6.4 to Upper limit of CI was not estimable due to insufficient number of participants with events.
Time to First Angioedema Attack After Day 0 Through Day 182 >=2 Attacks/Month	6.8 days Interval 1.4 to 11.6	5.9 days Interval 3.7 to 11.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=49 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
Time to First Angioedema Attack After Day 70 Through Day 182 1 to <2 Attacks/Month	12.3 days Interval 10.3 to Upper limit of CI was not estimable due to insufficient number of participants with events.	40.8 days Interval 3.4 to Upper limit of CI was not estimable due to insufficient number of participants with events.
Time to First Angioedema Attack After Day 70 Through Day 182 >=2 Attacks/Month	16.9 days Interval 6.7 to 32.5	10.6 days Interval 5.0 to 15.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=48 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
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	28 Participants
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	12 Participants
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	6 Participants
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	2 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=49 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
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	31 Participants
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	18 Participants
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	5 Participants
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	3 Participants

SECONDARY outcome

Timeframe: From the first study drug administration up to follow-up (Day 196)

Population: SAS included all participants who received any exposure to the IP.

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.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=50 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
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	46 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) AESI	0 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) SAE	1 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=49 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
Plasma Concentrations of Lanadelumab Baseline	661.573 nanogram/milliliter (ng/mL) Standard Deviation 2991.1363	1.665 nanogram/milliliter (ng/mL) Standard Deviation 7.8812
Plasma Concentrations of Lanadelumab Day 0	—	0.000 nanogram/milliliter (ng/mL) Standard Deviation NA The standard deviation (SD) was not estimable for a single participant.
Plasma Concentrations of Lanadelumab Day 4	42.749 nanogram/milliliter (ng/mL) Standard Deviation 113.1021	16895.996 nanogram/milliliter (ng/mL) Standard Deviation 8136.5164
Plasma Concentrations of Lanadelumab Day 14	5.366 nanogram/milliliter (ng/mL) Standard Deviation 21.4650	11030.519 nanogram/milliliter (ng/mL) Standard Deviation 4632.9383
Plasma Concentrations of Lanadelumab Day 28	6.188 nanogram/milliliter (ng/mL) Standard Deviation 17.9944	15969.813 nanogram/milliliter (ng/mL) Standard Deviation 7210.5963
Plasma Concentrations of Lanadelumab Day 56	16.820 nanogram/milliliter (ng/mL) Standard Deviation 61.3021	20722.131 nanogram/milliliter (ng/mL) Standard Deviation 8396.5980
Plasma Concentrations of Lanadelumab Day 84	7.335 nanogram/milliliter (ng/mL) Standard Deviation 30.0848	22698.616 nanogram/milliliter (ng/mL) Standard Deviation 8953.3488
Plasma Concentrations of Lanadelumab Day 112	5.604 nanogram/milliliter (ng/mL) Standard Deviation 22.1843	22938.312 nanogram/milliliter (ng/mL) Standard Deviation 10021.8340
Plasma Concentrations of Lanadelumab Day 140	3.200 nanogram/milliliter (ng/mL) Standard Deviation 16.3188	22778.286 nanogram/milliliter (ng/mL) Standard Deviation 9680.4686
Plasma Concentrations of Lanadelumab Day 168	9.260 nanogram/milliliter (ng/mL) Standard Deviation 23.0763	21369.818 nanogram/milliliter (ng/mL) Standard Deviation 11072.0806
Plasma Concentrations of Lanadelumab Day 182	4.733 nanogram/milliliter (ng/mL) Standard Deviation 18.7014	20496.158 nanogram/milliliter (ng/mL) Standard Deviation 10774.2169

SECONDARY outcome

Timeframe: 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.

Plasma Kallikrein activity was measured by biomarker cleaved high molecular weight kininogen (cHMWK ) level to assess pharmacodynamics of lanadelumab.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=50 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
Plasma Kallikrein (pKal) Activity Baseline	20.30 % cHMWK Standard Deviation 14.927	18.69 % cHMWK Standard Deviation 11.854
Plasma Kallikrein (pKal) Activity Day 4	25.94 % cHMWK Standard Deviation 33.285	20.20 % cHMWK Standard Deviation 20.333
Plasma Kallikrein (pKal) Activity Day 14	17.23 % cHMWK Standard Deviation 9.801	12.83 % cHMWK Standard Deviation 13.136
Plasma Kallikrein (pKal) Activity Day 28	16.16 % cHMWK Standard Deviation 12.458	14.24 % cHMWK Standard Deviation 13.472
Plasma Kallikrein (pKal) Activity Day 56	17.83 % cHMWK Standard Deviation 12.169	15.88 % cHMWK Standard Deviation 15.618
Plasma Kallikrein (pKal) Activity Day 84	17.00 % cHMWK Standard Deviation 15.508	16.76 % cHMWK Standard Deviation 15.941
Plasma Kallikrein (pKal) Activity Day 112	15.88 % cHMWK Standard Deviation 11.109	16.12 % cHMWK Standard Deviation 17.242
Plasma Kallikrein (pKal) Activity Day 140	17.40 % cHMWK Standard Deviation 15.413	14.91 % cHMWK Standard Deviation 14.656
Plasma Kallikrein (pKal) Activity Day 168	20.90 % cHMWK Standard Deviation 16.588	15.07 % cHMWK Standard Deviation 15.061
Plasma Kallikrein (pKal) Activity Day 182	18.08 % cHMWK Standard Deviation 20.384	15.39 % cHMWK Standard Deviation 15.333

SECONDARY outcome

Timeframe: 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.

Number of participants with neutralizing or non-neutralizing antidrug antibodies in plasma was assessed.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=50 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma Day 28	0 Participants	0 Participants
Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma Day 56	0 Participants	0 Participants
Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma Baseline	0 Participants	0 Participants
Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma Day 84	0 Participants	0 Participants
Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma Day 112	0 Participants	1 Participants
Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma Day 140	0 Participants	1 Participants
Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma Day 168	0 Participants	0 Participants
Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma Day 182	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks.	Lanadelumab 300 mg n=50 Participants Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
Number 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	18 Participants
Number 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	11 Participants
Number 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	7 Participants
Number 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	3 Participants
Number 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	17 Participants
Number 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	4 Participants
Number 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	13 Participants
Number 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	7 Participants
Number 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	8 Participants
Number 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	1 Participants
Number 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	0 Participants
Number 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	8 Participants
Number 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	24 Participants
Number 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	16 Participants
Number 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	2 Participants
Number 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	1 Participants
Number 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	12 Participants
Number 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	16 Participants
Number 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	18 Participants
Number 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	1 Participants
Number 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	3 Participants
Number 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	7 Participants
Number 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	21 Participants
Number 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	17 Participants
Number 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	10 Participants
Number 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	7 Participants
Number 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	10 Participants
Number 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	11 Participants
Number 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	11 Participants
Number 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	9 Participants
Number 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	5 Participants
Number 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	13 Participants
Number 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	8 Participants
Number 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	14 Participants
Number 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	9 Participants
Number 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	15 Participants
Number 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	4 Participants
Number 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	12 Participants
Number 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	9 Participants
Number 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	17 Participants
Number 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	8 Participants
Number 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	12 Participants
Number 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	10 Participants
Number 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	3 Participants
Number 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	13 Participants
Number 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	12 Participants
Number 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	13 Participants
Number 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	8 Participants
Number 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	4 Participants
Number 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	14 Participants
Number 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	15 Participants
Number 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	10 Participants
Number 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	7 Participants
Number 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	4 Participants
Number 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	15 Participants
Number 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	11 Participants
Number 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	13 Participants
Number 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	6 Participants
Number 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	5 Participants
Number 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	18 Participants
Number 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	8 Participants
Number 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	9 Participants
Number 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	14 Participants
Number 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	1 Participants
Number 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	9 Participants
Number 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	15 Participants
Number 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	12 Participants
Number 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	9 Participants
Number 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	5 Participants
Number 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	9 Participants
Number 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	10 Participants
Number 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	15 Participants
Number 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	9 Participants
Number 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	7 Participants
Number 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	9 Participants
Number 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	15 Participants
Number 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	12 Participants
Number 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	9 Participants
Number 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	5 Participants
Number 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	13 Participants
Number 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	10 Participants
Number 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	14 Participants
Number 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	10 Participants
Number 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	3 Participants
Number 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	18 Participants
Number 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	18 Participants
Number 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	7 Participants
Number 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	5 Participants
Number 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	2 Participants
Number 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	19 Participants
Number 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	8 Participants
Number 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	10 Participants
Number 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	8 Participants
Number 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	5 Participants
Number 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	6 Participants
Number 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	9 Participants
Number 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	17 Participants
Number 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	7 Participants
Number 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	11 Participants
Number 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	7 Participants
Number 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	14 Participants
Number 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	10 Participants
Number 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	7 Participants
Number 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	12 Participants
Number 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	7 Participants
Number 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	12 Participants
Number 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	13 Participants
Number 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	6 Participants
Number 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	12 Participants
Number 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	15 Participants
Number 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	11 Participants
Number 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	10 Participants
Number 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	8 Participants
Number 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	6 Participants
Number 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	14 Participants
Number 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	10 Participants
Number 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	10 Participants
Number 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	8 Participants
Number 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	8 Participants
Number 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	15 Participants
Number 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	13 Participants
Number 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	11 Participants
Number 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	3 Participants
Number 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	8 Participants
Number 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	6 Participants
Number 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	8 Participants
Number 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	14 Participants
Number 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	10 Participants
Number 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	10 Participants
Number 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	4 Participants
Number 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	7 Participants
Number 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	15 Participants
Number 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	12 Participants
Number 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	11 Participants
Number 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	4 Participants
Number 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	9 Participants
Number 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	17 Participants
Number 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	15 Participants
Number 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	4 Participants
Number 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	4 Participants
Number 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	9 Participants
Number 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	16 Participants
Number 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	16 Participants
Number 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	4 Participants
Number 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	8 Participants
Number 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	10 Participants
Number 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	16 Participants
Number 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	13 Participants
Number 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	2 Participants
Number 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	7 Participants
Number 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	7 Participants
Number 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	17 Participants
Number 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	8 Participants
Number 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	10 Participants
Number 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	2 Participants
Number 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	11 Participants
Number 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	12 Participants
Number 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	10 Participants
Number 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	14 Participants
Number 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	3 Participants
Number 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	8 Participants
Number 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	16 Participants
Number 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	9 Participants
Number 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	13 Participants
Number 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	3 Participants
Number 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	14 Participants
Number 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	14 Participants
Number 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	10 Participants
Number 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	8 Participants
Number 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	10 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Lanadelumab 300 mg

Serious events: 7 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=27 participants at risk Participants received placebo-matching lanadelumab subcutaneous (SC) injection once every 2 weeks (q2w) for up to 26 weeks.	Lanadelumab 300 mg n=50 participants at risk Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
Infections and infestations Cellulitis staphylococcal	0.00% 0/27 • From start of the study up to follow up (Day 196)	2.0% 1/50 • Number of events 1 • From start of the study up to follow up (Day 196)
Skin and subcutaneous tissue disorders Angioedema	3.7% 1/27 • Number of events 1 • From start of the study up to follow up (Day 196)	12.0% 6/50 • Number of events 8 • From start of the study up to follow up (Day 196)
Vascular disorders Lymphoedema	0.00% 0/27 • From start of the study up to follow up (Day 196)	2.0% 1/50 • Number of events 1 • From start of the study up to follow up (Day 196)

Other adverse events

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=27 participants at risk Participants received placebo-matching lanadelumab subcutaneous (SC) injection once every 2 weeks (q2w) for up to 26 weeks.	Lanadelumab 300 mg n=50 participants at risk Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks.
Blood and lymphatic system disorders Lymphadenopathy	7.4% 2/27 • Number of events 2 • From start of the study up to follow up (Day 196)	2.0% 1/50 • Number of events 1 • From start of the study up to follow up (Day 196)
Gastrointestinal disorders Constipation	7.4% 2/27 • Number of events 3 • From start of the study up to follow up (Day 196)	2.0% 1/50 • Number of events 1 • From start of the study up to follow up (Day 196)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/27 • From start of the study up to follow up (Day 196)	6.0% 3/50 • Number of events 3 • From start of the study up to follow up (Day 196)
Gastrointestinal disorders Nausea	11.1% 3/27 • Number of events 8 • From start of the study up to follow up (Day 196)	8.0% 4/50 • Number of events 4 • From start of the study up to follow up (Day 196)
General disorders Fatigue	7.4% 2/27 • Number of events 9 • From start of the study up to follow up (Day 196)	8.0% 4/50 • Number of events 13 • From start of the study up to follow up (Day 196)
General disorders Injection site erythema	11.1% 3/27 • Number of events 6 • From start of the study up to follow up (Day 196)	6.0% 3/50 • Number of events 22 • From start of the study up to follow up (Day 196)
General disorders Injection site pain	25.9% 7/27 • Number of events 9 • From start of the study up to follow up (Day 196)	30.0% 15/50 • Number of events 61 • From start of the study up to follow up (Day 196)
General disorders Pyrexia	7.4% 2/27 • Number of events 2 • From start of the study up to follow up (Day 196)	6.0% 3/50 • Number of events 3 • From start of the study up to follow up (Day 196)
Infections and infestations COVID-19	14.8% 4/27 • Number of events 4 • From start of the study up to follow up (Day 196)	6.0% 3/50 • Number of events 3 • From start of the study up to follow up (Day 196)
Infections and infestations Nasopharyngitis	7.4% 2/27 • Number of events 2 • From start of the study up to follow up (Day 196)	6.0% 3/50 • Number of events 5 • From start of the study up to follow up (Day 196)
Infections and infestations Upper respiratory tract infection	11.1% 3/27 • Number of events 3 • From start of the study up to follow up (Day 196)	6.0% 3/50 • Number of events 5 • From start of the study up to follow up (Day 196)
Infections and infestations Urinary tract infection	3.7% 1/27 • Number of events 1 • From start of the study up to follow up (Day 196)	8.0% 4/50 • Number of events 6 • From start of the study up to follow up (Day 196)
Injury, poisoning and procedural complications Ligament sprain	7.4% 2/27 • Number of events 2 • From start of the study up to follow up (Day 196)	0.00% 0/50 • From start of the study up to follow up (Day 196)
Musculoskeletal and connective tissue disorders Arthralgia	7.4% 2/27 • Number of events 2 • From start of the study up to follow up (Day 196)	14.0% 7/50 • Number of events 8 • From start of the study up to follow up (Day 196)
Musculoskeletal and connective tissue disorders Back pain	7.4% 2/27 • Number of events 2 • From start of the study up to follow up (Day 196)	0.00% 0/50 • From start of the study up to follow up (Day 196)
Musculoskeletal and connective tissue disorders Myalgia	3.7% 1/27 • Number of events 2 • From start of the study up to follow up (Day 196)	8.0% 4/50 • Number of events 4 • From start of the study up to follow up (Day 196)
Nervous system disorders Headache	22.2% 6/27 • Number of events 13 • From start of the study up to follow up (Day 196)	12.0% 6/50 • Number of events 13 • From start of the study up to follow up (Day 196)
Nervous system disorders Migraine	3.7% 1/27 • Number of events 1 • From start of the study up to follow up (Day 196)	6.0% 3/50 • Number of events 3 • From start of the study up to follow up (Day 196)
Psychiatric disorders Insomnia	11.1% 3/27 • Number of events 3 • From start of the study up to follow up (Day 196)	2.0% 1/50 • Number of events 1 • From start of the study up to follow up (Day 196)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/27 • From start of the study up to follow up (Day 196)	6.0% 3/50 • Number of events 3 • From start of the study up to follow up (Day 196)
Skin and subcutaneous tissue disorders Angioedema	96.3% 26/27 • Number of events 305 • From start of the study up to follow up (Day 196)	96.0% 48/50 • Number of events 740 • From start of the study up to follow up (Day 196)
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/27 • From start of the study up to follow up (Day 196)	6.0% 3/50 • Number of events 5 • From start of the study up to follow up (Day 196)