A Phase 3 interventional study of Placebo and Lanadelumab in Angioedema, sponsored by Takeda. Completed at 45 sites in 10 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-12-27.
Sponsored by Takeda · Phase 3, Interventional, and Treatment
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.
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).
69 studies on the registry are indexed under Angioedema; 16 are open to participants now.
This study's enrollment of 77 is above the median of 45 across 44 interventional studies indexed under Angioedema.
Browse Angioedema studies →Takeda is the lead sponsor of 1,026 studies on the registry; 89 are open to participants now.
Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The Participant will not be considered eligible for the study without meeting all of the applicable population criteria below.
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:
OR
Exclusion Criteria
The participant will be excluded from the study if any of the following exclusion criteria are met.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received placebo-matching lanadelumab subcutaneous (SC) injection once every 2 weeks (q2w) for up to 7 months.
Other: Placebo
Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once (q2w) for up to 6 months.
Drug: Lanadelumab
Placebo-matching lanadelumab SC injection.
Lanadelumab solution in a PFS for injection.
Also known as: SHP643, DX-2930, TAK-743
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
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
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
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
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
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
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
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
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
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
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
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
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)
Plasma Concentrations of Lanadelumab
Time frame: Pre-dose and post-dose at Days 0, 4, 14, 28, 56, 84, 112, 140, 168 and 182
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
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
Number 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
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.
| Milestone | Placebo | Lanadelumab 300 mg |
|---|---|---|
| Started | 27 | 50 |
| Steady state full analysis set (ss-fas) | 27 | 49 |
| Completed | 26 | 49 |
| Not completed | 1 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| attacks/month | Placebo | Lanadelumab 300 mg |
|---|---|---|
| Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | 1.63 ± 1.357 | 2.17 ± 2.062 |
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.
| Participants | Placebo | Lanadelumab 300 mg |
|---|---|---|
| Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182 | 1 | 2 |
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.
| attacks/month | Placebo | Lanadelumab 300 mg |
|---|---|---|
| Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | 1.10 ± 0.984 | 1.45 ± 1.711 |
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.
| attacks/month | Placebo | Lanadelumab 300 mg |
|---|---|---|
| Number of Investigator-Confirmed Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 | 1.37 ± 1.231 | 2.05 ± 2.211 |
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.
| Participants | Placebo | Lanadelumab 300 mg |
|---|---|---|
| Number of Participants Achieving Attack-Free Status During the Presumed Steady State Period of Day 70 Through Day 182 | 4 | 3 |
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.
| Participants | Placebo | Lanadelumab 300 mg |
|---|---|---|
| No Attack | 1 | 2 |
| Mild | 2 | 4 |
| Moderate | 17 | 17 |
| Severe | 7 | 27 |
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.
| attacks/month | Placebo | Lanadelumab 300 mg |
|---|---|---|
| Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 | 0.97 ± 1.013 | 1.35 ± 1.764 |
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.
| Participants | Placebo | Lanadelumab 300 mg |
|---|---|---|
| No Attack | 4 | 3 |
| Mild | 5 | 5 |
| Moderate | 12 | 23 |
| Severe | 6 | 18 |
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.
| days | Placebo | Lanadelumab 300 mg |
|---|---|---|
| 1 to <2 Attacks/Month | 10.5 (6.6 to NA) | 81.0 (6.4 to NA) |
| >=2 Attacks/Month | 6.8 (1.4 to 11.6) | 5.9 (3.7 to 11.6) |
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.
| days | Placebo | Lanadelumab 300 mg |
|---|---|---|
| 1 to <2 Attacks/Month | 12.3 (10.3 to NA) | 40.8 (3.4 to NA) |
| >=2 Attacks/Month | 16.9 (6.7 to 32.5) | 10.6 (5.0 to 15.9) |
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.
| Participants | Placebo | Lanadelumab 300 mg |
|---|---|---|
| >=50% Reduction | 13 | 28 |
| >=70% Reduction | 9 | 12 |
| >=90% Reduction | 3 | 6 |
| 100% Reduction | 1 | 2 |
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.
| Participants | Placebo | Lanadelumab 300 mg |
|---|---|---|
| >=50% Reduction | 14 | 31 |
| >=70% Reduction | 12 | 18 |
| >=90% Reduction | 5 | 5 |
| 100% Reduction | 4 | 3 |
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.
| Participants | Placebo | Lanadelumab 300 mg |
|---|---|---|
| Any TEAE | 23 | 46 |
| AESI | 0 | 1 |
| SAE | 1 | 7 |
| nanogram/milliliter (ng/mL) | Placebo | Lanadelumab 300 mg |
|---|---|---|
| Baseline | 661.573 ± 2991.1363 | 1.665 ± 7.8812 |
| Day 0 | — | 0.000 ± NA |
| Day 4 | 42.749 ± 113.1021 | 16895.996 ± 8136.5164 |
| Day 14 | 5.366 ± 21.4650 | 11030.519 ± 4632.9383 |
| Day 28 | 6.188 ± 17.9944 | 15969.813 ± 7210.5963 |
| Day 56 | 16.820 ± 61.3021 | 20722.131 ± 8396.5980 |
| Day 84 | 7.335 ± 30.0848 | 22698.616 ± 8953.3488 |
| Day 112 | 5.604 ± 22.1843 | 22938.312 ± 10021.8340 |
| Day 140 | 3.200 ± 16.3188 | 22778.286 ± 9680.4686 |
| Day 168 | 9.260 ± 23.0763 | 21369.818 ± 11072.0806 |
| Day 182 | 4.733 ± 18.7014 | 20496.158 ± 10774.2169 |
Plasma Kallikrein activity was measured by biomarker cleaved high molecular weight kininogen (cHMWK ) level to assess pharmacodynamics of lanadelumab.
| % cHMWK | Placebo | Lanadelumab 300 mg |
|---|---|---|
| Baseline | 20.30 ± 14.927 | 18.69 ± 11.854 |
| Day 4 | 25.94 ± 33.285 | 20.20 ± 20.333 |
| Day 14 | 17.23 ± 9.801 | 12.83 ± 13.136 |
| Day 28 | 16.16 ± 12.458 | 14.24 ± 13.472 |
| Day 56 | 17.83 ± 12.169 | 15.88 ± 15.618 |
| Day 84 | 17.00 ± 15.508 | 16.76 ± 15.941 |
| Day 112 | 15.88 ± 11.109 | 16.12 ± 17.242 |
| Day 140 | 17.40 ± 15.413 | 14.91 ± 14.656 |
| Day 168 | 20.90 ± 16.588 | 15.07 ± 15.061 |
| Day 182 | 18.08 ± 20.384 | 15.39 ± 15.333 |
Number of participants with neutralizing or non-neutralizing antidrug antibodies in plasma was assessed.
| Participants | Placebo | Lanadelumab 300 mg |
|---|---|---|
| Baseline | 0 | 0 |
| Day 28 | 0 | 0 |
| Day 56 | 0 | 0 |
| Day 84 | 0 | 0 |
| Day 112 | 0 | 1 |
| Day 140 | 0 | 1 |
| Day 168 | 0 | 0 |
| Day 182 | 0 | 2 |
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).
| Participants | Placebo | Lanadelumab 300 mg |
|---|---|---|
| Baseline: Work - Never | 7 | 6 |
| Baseline: Work - Rarely | 4 | 8 |
| Baseline: Work - Occasionally | 6 | 14 |
| Baseline: Work - Often | 7 | 10 |
| Baseline: Work - Very Often | 2 | 10 |
| Baseline: Physical activity - Never | 1 | 4 |
| Baseline: Physical activity - Rarely | 1 | 7 |
| Baseline: Physical activity - Occasionally | 16 | 15 |
| Baseline: Physical activity - Often | 4 | 12 |
| Baseline: Physical activity - Very Often | 4 | 11 |
| Baseline: Leisure time - Never | 1 | 4 |
| Baseline: Leisure time - Rarely | 5 | 9 |
| Baseline: Leisure time - Occasionally | 12 | 17 |
| Baseline: Leisure time - Often | 5 | 15 |
| Baseline: Leisure time - Very Often | 3 | 4 |
| Baseline: Social relations - Never | 2 | 4 |
| Baseline: Social relations - Rarely | 4 | 9 |
| Baseline: Social relations - Occasionally | 12 | 16 |
| Baseline: Social relations - Often | 7 | 16 |
| Baseline: Social relations - Very Often | 1 | 4 |
| Baseline: Eating and drinking - Never | 3 | 8 |
| Baseline: Eating and drinking - Rarely | 6 | 10 |
| Baseline: Eating and drinking - Occasionally | 9 | 16 |
| Baseline: Eating and drinking - Often | 6 | 13 |
| Baseline: Eating and drinking - Very often | 2 | 2 |
| Baseline: Difficulty falling asleep - Never | 3 | 7 |
| Baseline: Difficulty falling asleep - Rarely | 3 | 7 |
| Baseline: Difficulty falling asleep - Occasionally | 11 | 17 |
| Baseline: Difficulty falling asleep - Often | 5 | 8 |
| Baseline: Difficulty falling asleep - Very often | 4 | 10 |
| Baseline: Wake up during the night - Never | 2 | 2 |
| Baseline: Wake up during the night - Rarely | 7 | 11 |
| Baseline: Wake up during the night - Occasionally | 5 | 12 |
| Baseline: Wake up during the night - Often | 6 | 10 |
| Baseline: Wake up during the night - Very often | 6 | 14 |
| Baseline: Tired during the day - Never | 1 | 3 |
| Baseline: Tired during the day - Rarely | 7 | 8 |
| Baseline: Tired during the day - Occasionally | 6 | 16 |
| Baseline: Tired during the day - Often | 7 | 9 |
| Baseline: Tired during the day - Very often | 5 | 13 |
| Baseline: Trouble concentrating - Never | 2 | 3 |
| Baseline: Trouble concentrating - Rarely | 8 | 14 |
| Baseline: Trouble concentrating - Occasionally | 10 | 14 |
| Baseline: Trouble concentrating - Often | 4 | 10 |
| Baseline: Trouble concentrating - Very often | 2 | 8 |
| Baseline: Feel depressed - Never | 9 | 10 |
| Baseline: Feel depressed - Rarely | 5 | 18 |
| Baseline: Feel depressed - Occasionally | 5 | 11 |
| Baseline: Feel depressed - Often | 6 | 7 |
| Baseline: Feel depressed - Very often | 1 | 3 |
| Baseline: Limit your choices of food or beverages - Never | 10 | 17 |
| Baseline: Limit your choices of food or beverages - Rarely | 1 | 4 |
| Baseline: Limit your choices of food or beverages - Occasionally | 2 | 13 |
| Baseline: Limit your choices of food or beverages - Often | 8 | 7 |
| Baseline: Limit your choices of food or beverages - Very often | 5 | 8 |
| Baseline: Swelling episodes place a burden on you - Never | 1 | 1 |
| Baseline: Swelling episodes place a burden on you - Rarely | 1 | 0 |
| Baseline: Swelling episodes place a burden on you - Occasionally | 7 | 8 |
| Baseline: Swelling episodes place a burden on you - Often | 10 | 24 |
| Baseline: Swelling episodes place a burden on you - Very often | 7 | 16 |
| Baseline: Swelling episode could occur suddenly - Never | 1 | 2 |
| Baseline: Swelling episode could occur suddenly - Rarely | 4 | 1 |
| Baseline: Swelling episode could occur suddenly - Occasionally | 4 | 12 |
| Baseline: Swelling episode could occur suddenly - Often | 6 | 16 |
| Baseline: Swelling episode could occur suddenly - Very often | 11 | 18 |
| Baseline: Freq of swelling episodes might increase - Never | 2 | 1 |
| Baseline: Freq of swelling episodes might increase - Rarely | 3 | 3 |
| Baseline: Freq of swelling episodes might increase - Occasionally | 5 | 7 |
| Baseline: Freq of swelling episodes might increase - Often | 8 | 21 |
| Baseline: Freq of swelling episodes might increase - Very often | 8 | 17 |
| Baseline: Ashamed to go out due to swell episodes - Never | 6 | 10 |
| Baseline: Ashamed to go out due to swell episodes - Rarely | 1 | 7 |
| Baseline: Ashamed to go out due to swell episodes - Occasionally | 8 | 10 |
| Baseline: Ashamed to go out due to swell episodes - Often | 4 | 11 |
| Baseline: Ashamed to go out due to swell episodes - Very often | 7 | 11 |
| Baseline: Swelling episodes make you embarrassed - Never | 5 | 9 |
| Baseline: Swelling episodes make you embarrassed - Rarely | 4 | 5 |
| Baseline: Swelling episodes make you embarrassed - Occasionally | 6 | 13 |
| Baseline: Swelling episodes make you embarrassed - Often | 3 | 8 |
| Baseline: Swelling episodes make you embarrassed - Very often | 8 | 14 |
| Baseline: Afraid of long term negative effects - Never | 3 | 9 |
| Baseline: Afraid of long term negative effects - Rarely | 6 | 15 |
| Baseline: Afraid of long term negative effects - Occasionally | 6 | 4 |
| Baseline: Afraid of long term negative effects - Often | 6 | 12 |
| Baseline: Afraid of long term negative effects - Very often | 5 | 9 |
| Day 182: Work - Never | 3 | 17 |
| Day 182: Work - Rarely | 10 | 8 |
| Day 182: Work - Occasionally | 8 | 12 |
| Day 182: Work - Often | 4 | 10 |
| Day 182: Work - Very Often | 1 | 3 |
| Day 182: Physical activity - Never | 3 | 13 |
| Day 182: Physical activity - Rarely | 10 | 12 |
| Day 182: Physical activity - Occasionally | 8 | 13 |
| Day 182: Physical activity - Often | 4 | 8 |
| Day 182: Physical activity - Very often | 1 | 4 |
| Day 182: Leisure time - Never | 3 | 14 |
| Day 182: Leisure time - Rarely | 12 | 15 |
| Day 182: Leisure time - Occasionally | 7 | 10 |
| Day 182: Leisure time - Often | 3 | 7 |
| Day 182: Leisure time - Very often | 1 | 4 |
| Day 182: Social relations - Never | 4 | 15 |
| Day 182: Social relations - Rarely | 8 | 11 |
| Day 182: Social relations - Occasionally | 9 | 13 |
| Day 182: Social relations - Often | 2 | 6 |
| Day 182: Social relations - Very often | 3 | 5 |
| Day 182: Eating and drinking - Never | 5 | 18 |
| Day 182: Eating and drinking - Rarely | 8 | 8 |
| Day 182: Eating and drinking - Occasionally | 8 | 9 |
| Day 182: Eating and drinking - Often | 4 | 14 |
| Day 182: Eating and drinking - Very often | 1 | 1 |
| Day 182: Difficulty falling asleep - Never | 4 | 9 |
| Day 182: Difficulty falling asleep - Rarely | 7 | 15 |
| Day 182: Difficulty falling asleep - Occasionally | 8 | 12 |
| Day 182: Difficulty falling asleep - Often | 6 | 9 |
| Day 182: Difficulty falling asleep - Very often | 1 | 5 |
| Day 182: Wake up during the night - Never | 1 | 9 |
| Day 182: Wake up during the night - Rarely | 7 | 10 |
| Day 182: Wake up during the night - Occasionally | 8 | 15 |
| Day 182: Wake up during the night - Often | 7 | 9 |
| Day 182: Wake up during the night - Very often | 3 | 7 |
| Day 182: Tired during the day - Never | 2 | 9 |
| Day 182: Tired during the day - Rarely | 6 | 15 |
| Day 182: Tired during the day - Occasionally | 11 | 12 |
| Day 182: Tired during the day - Often | 6 | 9 |
| Day 182: Tired during the day - Very often | 1 | 5 |
| Day 182: Trouble concentrating - Never | 2 | 13 |
| Day 182: Trouble concentrating - Rarely | 17 | 10 |
| Day 182: Trouble concentrating - Occasionally | 5 | 14 |
| Day 182: Trouble concentrating - Often | 1 | 10 |
| Day 182: Trouble concentrating - Very often | 1 | 3 |
| Day 182: Feel depressed - Never | 8 | 18 |
| Day 182: Feel depressed - Rarely | 8 | 18 |
| Day 182: Feel depressed - Occasionally | 5 | 7 |
| Day 182: Feel depressed - Often | 4 | 5 |
| Day 182: Feel depressed - Very often | 1 | 2 |
| Day 182: Limit your choices of food or beverages - Never | 7 | 19 |
| Day 182: Limit your choices of food or beverages - Rarely | 6 | 8 |
| Day 182: Limit your choices of food or beverages - Occasionally | 6 | 10 |
| Day 182: Limit your choices of food or beverages - Often | 5 | 8 |
| Visit 26: Limit your choices of food or beverages - Very often | 2 | 5 |
| Day 182: Swelling episodes place a burden on you - Never | 2 | 6 |
| Day 182: Swelling episodes place a burden on you - Rarely | 7 | 9 |
| Day 182: Swelling episodes place a burden on you - Occasionally | 8 | 17 |
| Day 182: Swelling episodes place a burden on you - Often | 7 | 7 |
| Day 182: Swelling episodes place a burden on you - Very often | 2 | 11 |
| Day 182: Swelling episode could occur suddenly - Never | 2 | 7 |
| Day 182: Swelling episode could occur suddenly - Rarely | 6 | 14 |
| Day 182: Swelling episode could occur suddenly - Occasionally | 9 | 10 |
| Day 182: Swelling episode could occur suddenly - Often | 5 | 7 |
| Day 182: Swelling episode could occur suddenly - Very often | 4 | 12 |
| Day 182: Freq of swelling episodes might increase - Never | 2 | 7 |
| Day 182: Freq of swelling episodes might increase - Rarely | 7 | 12 |
| Day 182: Freq of swelling episodes might increase - Occasionally | 9 | 13 |
| Day 182: Freq of swelling episodes might increase - Often | 5 | 6 |
| Day 182: Freq of swelling episodes might increase - Very often | 3 | 12 |
| Day 182: Ashamed to go out due to swell episodes - Never | 5 | 15 |
| Day 182: Ashamed to go out due to swell episodes - Rarely | 8 | 11 |
| Day 182: Ashamed to go out due to swell episodes - Occasionally | 4 | 10 |
| Day 182: Ashamed to go out due to swell episodes - Often | 7 | 8 |
| Day 182: Ashamed to go out due to swell episodes - Very often | 2 | 6 |
| Day 182: Swelling episodes make you embarrassed - Never | 7 | 14 |
| Day 182: Swelling episodes make you embarrassed - Rarely | 5 | 10 |
| Day 182: Swelling episodes make you embarrassed - Occasionally | 6 | 10 |
| Day 182: Swelling episodes make you embarrassed - Often | 6 | 8 |
| Day 182: Swelling episodes make you embarrassed - Very often | 2 | 8 |
| Day 182: Afraid of long term negative effects - Never | 4 | 15 |
| Day 182: Afraid of long term negative effects - Rarely | 10 | 13 |
| Day 182: Afraid of long term negative effects - Occasionally | 7 | 11 |
| Day 182: Afraid of long term negative effects - Often | 1 | 3 |
| Day 182: Afraid of long term negative effects - Very often | 4 | 8 |
Collected over From start of the study up to follow up (Day 196). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/27 (0%) | 1/27 (3.7%) | 27/27 (100%) |
| Lanadelumab 300 mg | 0/50 (0%) | 7/50 (14%) | 49/50 (98%) |
| Event | Placebo | Lanadelumab 300 mg |
|---|---|---|
| AngioedemaSkin and subcutaneous tissue disorders | 1/27 | 6/50 |
| Cellulitis staphylococcalInfections and infestations | 0/27 | 1/50 |
| LymphoedemaVascular disorders | 0/27 | 1/50 |
| Event | Placebo | Lanadelumab 300 mg |
|---|---|---|
| AngioedemaSkin and subcutaneous tissue disorders | 26/27 | 48/50 |
| Injection site painGeneral disorders | 7/27 | 15/50 |
| HeadacheNervous system disorders | 6/27 | 6/50 |
| COVID-19Infections and infestations | 4/27 | 3/50 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/27 | 7/50 |
| NauseaGastrointestinal disorders | 3/27 | 4/50 |
| Injection site erythemaGeneral disorders | 3/27 | 3/50 |
| Upper respiratory tract infectionInfections and infestations | 3/27 | 3/50 |
| InsomniaPsychiatric disorders | 3/27 | 1/50 |
| FatigueGeneral disorders | 2/27 | 4/50 |
Safety analysis set (SAS) included all participants who received any exposure to the investigational product.
| Age, Continuous(years) | Placebo | Lanadelumab 300 mg | Total |
|---|---|---|---|
| Mean | 43.8 ± 10.77 | 42.3 ± 14.06 | 42.8 ± 12.94 |
| Sex: Female, Male(Participants) | Placebo | Lanadelumab 300 mg | Total |
|---|---|---|---|
| Female | 19 | 43 | 62 |
| Male | 8 | 7 | 15 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Lanadelumab 300 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 7 | 9 |
| Not Hispanic or Latino | 24 | 43 | 67 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Placebo | Lanadelumab 300 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 4 | 4 |
| White | 24 | 44 | 68 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Placebo | Lanadelumab 300 mg | Total |
|---|---|---|---|
| Canada | 1 | 4 | 5 |
| France | 0 | 1 | 1 |
| Germany | 1 | 2 | 3 |
| Hungary | 1 | 1 | 2 |
| Italy | 3 | 6 | 9 |
| Japan | 2 | 2 | 4 |
| Netherlands | 2 | 2 | 4 |
| Poland | 4 | 2 | 6 |
| Spain | 1 | 2 | 3 |
| United States | 12 | 28 | 40 |
| Height(centimeter) | Placebo | Lanadelumab 300 mg | Total |
|---|---|---|---|
| Mean | 168.32 ± 9.779 | 166.09 ± 8.232 | 166.87 ± 8.807 |
| Weight(kilogram) | Placebo | Lanadelumab 300 mg | Total |
|---|---|---|---|
| Mean | 82.09 ± 22.701 | 82.04 ± 25.217 | 82.06 ± 24.213 |
| Body Mass Index (BMI)(kilogram per squared meter) | Placebo | Lanadelumab 300 mg | Total |
|---|---|---|---|
| Mean | 28.88 ± 7.413 | 29.75 ± 9.127 | 29.44 ± 8.525 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
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Studies of the drug tested here: Lanadelumab