A Phase 3 interventional study of Lanadelumab in Angioedema, sponsored by Shire. Completed at 35 sites in 10 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-06-17.
Sponsored by Shire · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the long-term safety and efficacy of repeated subcutaneous (SC) administration of lanadelumab in adolescents and adults with non-histaminergic angioedema with normal C1-inhibitor who completed study SHP643-303 (NCT04206605).
This study consists of 26-week treatment period (Day 0 to Day 182) and a 2-week follow-up period. Participants who completed the double-blind treatment period at Day 182 of Study SHP643-303 (NCT04206605) will enroll into this extension study.
Exclusion Criteria:
Participants received 300 milligrams (mg) lanadelumab subcutaneous (SC) injection, every 2 weeks (Q2W) for up to 26 weeks with an option to switch to lanadelumab 300 mg every 4 weeks (Q4W) if attacks were well-controlled based on the investigator's discretion and consultation with the sponsor's medical monitor.
Drug: Lanadelumab
Lanadelumab SC injection
Also known as: DX-2930, SHP643, TAK-743
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) During Treatment Period
TEAE: Any event emerging or manifesting at or after initiation of treatment with investigational product (IP) or medicinal product or any existing event that worsens in either intensity or frequency following exposure to IP or medicinal product including clinically meaningful findings in laboratory safety tests, vital signs, weight, and electrocardiogram (ECG) findings. SAE: Any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to IP 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. TEAEs were classified and reported as angioedema attack and non-angioedema attack adverse events in this outcome measure.
Time frame: From Day 0 up to Day 182
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) During Follow-up
TEAE: Any event emerging or manifesting at or after initiation of treatment with investigational product (IP) or medicinal product or any existing event that worsens in either intensity or frequency following exposure to IP or medicinal product including clinically meaningful findings in laboratory safety tests, vital signs, weight, and electrocardiogram (ECG) findings. SAE: Any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to IP 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. TEAEs were classified and reported as angioedema attack and non-angioedema attack adverse events in this outcome measure.
Time frame: From Day 183 up to Day 196
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). Number of investigator-confirmed angioedema attacks during the treatment period of Day 0 through Day 182 was assessed.
Time frame: From Day 0 up to Day 182
Number of Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182
The overall severity of angioedema attack was determined by the site using following definitions: mild (transient or mild discomfort), moderate (mild to moderate limitation in activity), severe (marked limitation in activity). Number of moderate or severe angioedema attacks during the treatment period of Day 0 through Day 182 was assessed.
Time frame: From Day 0 up to Day 182
Number of High-Morbidity Angioedema Attacks During the Treatment Period of Day 0 Through Day 182
A high-morbidity angioedema attack was defined as any attack that has at least one of the following characteristics: severe, results in hospitalization (except hospitalization for observation \<24 hours), hemodynamically significant (systolic blood pressure (BP) \<90 millimetres of mercury (mmHg), requires intravenous hydration, or associated with syncope or near-syncope) or laryngeal.
Time frame: From Day 0 up to Day 182
Pharmacokinetic (PK) Plasma Concentrations of Lanadelumab
The data was partitioned by dosing regimen and reported accordingly to appropriately attribute to each dosing regimen.
Time frame: Predose on Days 0, 84, and 140 and postdose on Day 182
Plasma Kallikrein (pKal) Activity
Plasma kallikrein activity was measured by biomarker cleaved high molecular weight kininogen (cHMWK) with factor XIIa activation level to assess the pharmacodynamics of lanadelumab. The data was partitioned by dosing regimen and reported accordingly to appropriately attribute to each dosing regimen.
Time frame: Predose on Days 0, 84, and 140 and postdose on Day 182
Number of Participants With Neutralizing Antidrug Antibodies (ADA) in Plasma
Number of participants with positive ADA including evaluation of neutralizing antibodies in plasma was assessed. As pre-specified in the statistical analysis plan (SAP), data for this outcome measure was collected and analyzed as a single group irrespective of dosing regimen.
Time frame: Predose on Days 0, 84, and 140 and postdose on Day 182
Change From Baseline in Total Angioedema Quality of Life (AE-QoL) Questionnaire Total Score at End of Treatment Period
The AE-QoL questionnaire is self-administered validated instrument to assess health related (HR)QoL among participants with recurrent angioedema(including hereditary angioedema\[HAE\]). It consists of 17 disease-specific QOL items, to produce total AE-QoL score \& 4 domain scores(functioning,fatigue/mood,fear/shame,nutrition) each of 17 items had 5-point response scale ranging from 1(Never) to 5(Very Often). It was scored according to developers' guidelines to produce 4 domain scores yielding total score. The raw total score(mean of all item scores) was rescaled using linear transformations into final percentage scores ranging 0-100, based on maximum possible score, where higher score, greater QoL impairment. Negative change from Baseline indicates better QoL. Baseline: Last non-missing value prior to first exposure to study drug(based on date or date/time). As pre-specified in SAP, data for this outcome measure was collected and analyzed as single group irrespective of dosing regimen.
Time frame: Baseline (Day 0) up to end of treatment period (Day 182)
Number of Participants With Any Pause During Injection
An injection report was completed by the participant (or parent/caregiver) following each dose administration of lanadelumab injection used during the treatment period and any kind of pause during injection was captured. Categories with at least one participant with event are reported.
Time frame: Days 0, 14, 28, 42, 56, 70, 84, 98, 112, 126, 140, 154, and 168
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) in Participants Who Switched Dosing Regimen
TEAE: Any event emerging or manifesting at or after initiation of treatment with investigational product (IP) or medicinal product or any existing event that worsens in either intensity or frequency following exposure to IP or medicinal product including clinically meaningful findings in laboratory safety tests, vital signs, weight, and electrocardiogram (ECG) findings. SAE: Any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to IP 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. TEAEs were classified and reported as angioedema attack and non-angioedema attack adverse events in this outcome measure.
Time frame: From Day 0 up to Day 196
Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 in Participants Who Switched Dosing Regimen
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 treatment period of Day 0 through Day 182 was assessed.
Time frame: From Day 0 up to Day 182
Number of Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 in Participants Who Switched Dosing Regimen
The overall severity of angioedema attack was determined by the site using following definitions: mild (transient or mild discomfort), moderate (mild to moderate limitation in activity), severe (marked limitation in activity). Number of moderate or severe angioedema attacks during the treatment period of Day 0 through Day 182 was assessed.
Time frame: From Day 0 up to Day 182
Number of High-Morbidity Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 in Participants Who Switched Dosing Regimen
A high-morbidity angioedema attack was defined as any attack that has at least one of the following characteristics: severe, results in hospitalization (except hospitalization for observation \<24 hours), hemodynamically significant (systolic BP \<90 mmHg, requires intravenous hydration, or associated with syncope or near-syncope) or laryngeal.
Time frame: From Day 0 up to Day 182
A total of 73 participants took part in the study at 34 investigative sites in Canada, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Spain, and the United States from 05 February 2021 to 05 May 2023.
| Milestone | Lanadelumab 300 mg Q2W |
|---|---|
| Started | 73 |
| Reduced-dose safety analysisset(rd-sfas) | 2 |
| Completed | 64 |
| Not completed | 9 |
| Withdrew: Adverse event | 2 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 5 |
TEAE: Any event emerging or manifesting at or after initiation of treatment with investigational product (IP) or medicinal product or any existing event that worsens in either intensity or frequency following exposure to IP or medicinal product including clinically meaningful findings in laboratory safety tests, vital signs, weight, and electrocardiogram (ECG) findings. SAE: Any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to IP 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. TEAEs were classified and reported as angioedema attack and non-angioedema attack adverse events in this outcome measure.
| Participants | Lanadelumab 300 mg Q2W | Lanadelumab 300 mg Q4W |
|---|---|---|
| Any TEAEs: Non-Angioedema Attack | 55 | 1 |
| Any TEAEs: Angioedema Attack | 61 | 1 |
| AESI: Non-Angioedema Attack | 1 | 0 |
| AESI: Angioedema Attack | 0 | 0 |
| Any SAEs: Non-Angioedema Attack | 5 | 1 |
| Any SAEs: Angioedema Attack | 3 | 0 |
TEAE: Any event emerging or manifesting at or after initiation of treatment with investigational product (IP) or medicinal product or any existing event that worsens in either intensity or frequency following exposure to IP or medicinal product including clinically meaningful findings in laboratory safety tests, vital signs, weight, and electrocardiogram (ECG) findings. SAE: Any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to IP 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. TEAEs were classified and reported as angioedema attack and non-angioedema attack adverse events in this outcome measure.
| Participants | Lanadelumab 300 mg Q2W | Lanadelumab 300 mg Q4W |
|---|---|---|
| Any TEAEs: Non-Angioedema Attack | 4 | 0 |
| Any TEAEs: Angioedema Attack | 19 | 0 |
| AESI: Non-Angioedema Attack | 0 | 0 |
| AESI: Angioedema Attack | 0 | 0 |
| Any SAEs: Non-Angioedema Attack | 0 | 0 |
| Any SAEs: Angioedema Attack | 0 | 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). Number of investigator-confirmed angioedema attacks during the treatment period of Day 0 through Day 182 was assessed.
| angioedema attacks | Lanadelumab 300 mg Q2W | Lanadelumab 300 mg Q4W |
|---|---|---|
| Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | 595 | 2 |
The overall severity of angioedema attack was determined by the site using following definitions: mild (transient or mild discomfort), moderate (mild to moderate limitation in activity), severe (marked limitation in activity). Number of moderate or severe angioedema attacks during the treatment period of Day 0 through Day 182 was assessed.
| angioedema attacks | Lanadelumab 300 mg Q2W | Lanadelumab 300 mg Q4W |
|---|---|---|
| Number of Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | 391 | 2 |
A high-morbidity angioedema attack was defined as any attack that has at least one of the following characteristics: severe, results in hospitalization (except hospitalization for observation \<24 hours), hemodynamically significant (systolic blood pressure (BP) \<90 millimetres of mercury (mmHg), requires intravenous hydration, or associated with syncope or near-syncope) or laryngeal.
| angioedema attacks | Lanadelumab 300 mg Q2W | Lanadelumab 300 mg Q4W |
|---|---|---|
| Number of High-Morbidity Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | 232 | 1 |
The data was partitioned by dosing regimen and reported accordingly to appropriately attribute to each dosing regimen.
| nanograms per milliliter (ng/mL) | Lanadelumab 300 mg Q2W | Lanadelumab 300 mg Q4W |
|---|---|---|
| Day 0 | 14419.068 ± 13208.1952 | NA ± NA |
| Day 84 | 17021.002 ± 10116.5279 | 7047.860 ± NA |
| Day 140 | 21138.057 ± 12076.9186 | 4944.010 ± NA |
| Day 182 | 18799.596 ± 12054.1105 | 14573.340 ± NA |
Plasma kallikrein activity was measured by biomarker cleaved high molecular weight kininogen (cHMWK) with factor XIIa activation level to assess the pharmacodynamics of lanadelumab. The data was partitioned by dosing regimen and reported accordingly to appropriately attribute to each dosing regimen.
| percentage of cHMWK | Lanadelumab 300 mg Q2W | Lanadelumab 300 mg Q4W |
|---|---|---|
| Day 0 | 15.306 ± 15.2413 | NA ± NA |
| Day 84 | 17.586 ± 9.2437 | 21.600 ± NA |
| Day 140 | 17.238 ± 9.1590 | 44.700 ± NA |
| Day 182 | 15.515 ± 9.2074 | 37.100 ± NA |
Number of participants with positive ADA including evaluation of neutralizing antibodies in plasma was assessed. As pre-specified in the statistical analysis plan (SAP), data for this outcome measure was collected and analyzed as a single group irrespective of dosing regimen.
| Participants | Lanadelumab 300 mg Q2W |
|---|---|
| Day 0 | 2 |
| Day 84 | 2 |
| Day 140 | 3 |
| Day 182 | 4 |
The AE-QoL questionnaire is self-administered validated instrument to assess health related (HR)QoL among participants with recurrent angioedema(including hereditary angioedema\[HAE\]). It consists of 17 disease-specific QOL items, to produce total AE-QoL score \& 4 domain scores(functioning,fatigue/mood,fear/shame,nutrition) each of 17 items had 5-point response scale ranging from 1(Never) to 5(Very Often). It was scored according to developers' guidelines to produce 4 domain scores yielding total score. The raw total score(mean of all item scores) was rescaled using linear transformations into final percentage scores ranging 0-100, based on maximum possible score, where higher score, greater QoL impairment. Negative change from Baseline indicates better QoL. Baseline: Last non-missing value prior to first exposure to study drug(based on date or date/time). As pre-specified in SAP, data for this outcome measure was collected and analyzed as single group irrespective of dosing regimen.
| score on a scale | Lanadelumab 300 mg Q2W |
|---|---|
| Change From Baseline in Total Angioedema Quality of Life (AE-QoL) Questionnaire Total Score at End of Treatment Period | -12.73 ± 20.696 |
An injection report was completed by the participant (or parent/caregiver) following each dose administration of lanadelumab injection used during the treatment period and any kind of pause during injection was captured. Categories with at least one participant with event are reported.
| Participants | Lanadelumab 300 mg Q2W | Lanadelumab 300 mg Q4W |
|---|---|---|
| Day 0 | 3 | 0 |
| Day 14 | 5 | 0 |
| Day 28 | 5 | 0 |
| Day 42 | 3 | 0 |
| Day 56 | 3 | 0 |
| Day 70 | 4 | 0 |
| Day 84 | 4 | 0 |
| Day 98 | 1 | 0 |
| Day 112 | 2 | 1 |
| Day 126 | 2 | 0 |
| Day 140 | 3 | 0 |
| Day 154 | 2 | 0 |
| Day 168 | 1 | 0 |
TEAE: Any event emerging or manifesting at or after initiation of treatment with investigational product (IP) or medicinal product or any existing event that worsens in either intensity or frequency following exposure to IP or medicinal product including clinically meaningful findings in laboratory safety tests, vital signs, weight, and electrocardiogram (ECG) findings. SAE: Any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to IP 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. TEAEs were classified and reported as angioedema attack and non-angioedema attack adverse events in this outcome measure.
| Participants | Lanadelumab 300 mg Q2W | Lanadelumab 300 mg Q4W |
|---|---|---|
| Any TEAEs: Non-Angioedema Attack | 2 | 1 |
| Any TEAEs: Angioedema Attack | 0 | 1 |
| AESI: Non-Angioedema Attack | 0 | 0 |
| AESI: Angioedema Attack | 0 | 0 |
| Any SAEs: Non-Angioedema Attack | 0 | 1 |
| Any SAEs: Angioedema Attack | 0 | 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). Number of investigator-confirmed angioedema attacks during the treatment period of Day 0 through Day 182 was assessed.
| angioedema attacks | Lanadelumab 300 mg Q2W | Lanadelumab 300 mg Q4W |
|---|---|---|
| Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 in Participants Who Switched Dosing Regimen | 0 | 2 |
The overall severity of angioedema attack was determined by the site using following definitions: mild (transient or mild discomfort), moderate (mild to moderate limitation in activity), severe (marked limitation in activity). Number of moderate or severe angioedema attacks during the treatment period of Day 0 through Day 182 was assessed.
| angioedema attacks | Lanadelumab 300 mg Q2W | Lanadelumab 300 mg Q4W |
|---|---|---|
| Number of Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 in Participants Who Switched Dosing Regimen | 0 | 2 |
A high-morbidity angioedema attack was defined as any attack that has at least one of the following characteristics: severe, results in hospitalization (except hospitalization for observation \<24 hours), hemodynamically significant (systolic BP \<90 mmHg, requires intravenous hydration, or associated with syncope or near-syncope) or laryngeal.
| angioedema attacks | Lanadelumab 300 mg Q2W | Lanadelumab 300 mg Q4W |
|---|---|---|
| Number of High-Morbidity Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 in Participants Who Switched Dosing Regimen | 0 | 1 |
Collected over From the first study drug administration up to follow-up (Day 196). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lanadelumab 300 mg Every 2 Weeks | 0/73 (0%) | 7/73 (9.6%) | 65/73 (89%) |
| Lanadelumab 300 mg Every 4 Weeks | 0/2 (0%) | 1/2 (50%) | 1/2 (50%) |
| Event | Lanadelumab 300 mg Every 2 Weeks | Lanadelumab 300 mg Every 4 Weeks |
|---|---|---|
| Abdominal pain upperGastrointestinal disorders | 0/73 | 1/2 |
| AngioedemaSkin and subcutaneous tissue disorders | 3/73 | 0/2 |
| Acute myocardial infarctionCardiac disorders | 1/73 | 0/2 |
| Arthritis viralInfections and infestations | 1/73 | 0/2 |
| CellulitisInfections and infestations | 1/73 | 0/2 |
| Deep vein thrombosisVascular disorders | 1/73 | 0/2 |
| Device related sepsisInfections and infestations | 1/73 | 0/2 |
| Lactic acidosisMetabolism and nutrition disorders | 1/73 | 0/2 |
| Suicide attemptPsychiatric disorders | 1/73 | 0/2 |
| Event | Lanadelumab 300 mg Every 2 Weeks | Lanadelumab 300 mg Every 4 Weeks |
|---|---|---|
| AngioedemaSkin and subcutaneous tissue disorders | 61/73 | 1/2 |
| Eye swellingEye disorders | 0/73 | 1/2 |
| FatigueGeneral disorders | 1/73 | 1/2 |
| HeadacheNervous system disorders | 10/73 | 1/2 |
| MalaiseGeneral disorders | 1/73 | 1/2 |
| COVID-19Infections and infestations | 17/73 | 0/2 |
| Injection site painGeneral disorders | 8/73 | 0/2 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 7/73 | 0/2 |
| NauseaGastrointestinal disorders | 6/73 | 0/2 |
| Upper respiratory tract infectionInfections and infestations | 6/73 | 0/2 |
The SFAS included all participants who received any study drug after entering this study (i.e., any exposure to open-label lanadelumab).
| Age, Continuous(years) | Lanadelumab 300 mg Q2W |
|---|---|
| Mean | 43.7 ± 12.63 |
| Sex: Female, Male(Participants) | Lanadelumab 300 mg Q2W |
|---|---|
| Female | 59 |
| Male | 14 |
| Ethnicity (NIH/OMB)(Participants) | Lanadelumab 300 mg Q2W |
|---|---|
| Hispanic or Latino | 9 |
| Not Hispanic or Latino | 63 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Lanadelumab 300 mg Q2W |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 64 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Lanadelumab 300 mg Q2W |
|---|---|
| Canada | 5 |
| France | 1 |
| Germany | 3 |
| Hungary | 2 |
| Italy | 7 |
| Japan | 4 |
| Netherlands | 3 |
| Poland | 6 |
| Spain | 3 |
| United States | 39 |
| Weight(kilograms (kg)) | Lanadelumab 300 mg Q2W |
|---|---|
| Mean | 81.52 ± 23.129 |
| Height(centimeters (cm)) | Lanadelumab 300 mg Q2W |
|---|---|
| Mean | 166.75 ± 8.938 |
| Body Mass Index (BMI)(kilogram per square meter (kg/m^2)) | Lanadelumab 300 mg Q2W |
|---|---|
| Mean | 29.23 ± 7.972 |
Documents are hosted by the registry — open the source record to download them.
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, Sap, Icf, Csr
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shire