<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04444895</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-743-3001</org_study_id>
    <secondary_id>2019-004823-20</secondary_id>
    <secondary_id>jRCT2051220001</secondary_id>
    <nct_id>NCT04444895</nct_id>
  </id_info>
  <brief_title>A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor</brief_title>
  <official_title>An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shire</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Takeda Development Center Americas, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the long-term safety and efficacy of repeated&#xD;
      subcutaneous (SC) administration of lanadelumab in adolescents and adults with&#xD;
      non-histaminergic angioedema with normal C1-inhibitor who completed study SHP643-303&#xD;
      (NCT04206605).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consists of 26-week treatment period (Day 0 to Day 182) and a 2-week follow-up&#xD;
      period. Participants who completed the double-blind treatment period at Day 182 of Study&#xD;
      SHP643-303 (NCT04206605) will enroll into this extension study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2021</start_date>
  <completion_date type="Actual">May 5, 2023</completion_date>
  <primary_completion_date type="Actual">May 5, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Treatment Emergent Adverse Events (TEAEs)</measure>
    <time_frame>From start of the study up to follow-up (Day 196)</time_frame>
    <description>A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the investigational product or medicinal product. A SAE is any 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 will include hypersensitivity reactions, events of disordered coagulation such as bleeding AESI, hypercoagulable AESI. Number of participants with TEAEs including AESI and SAE will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182</measure>
    <time_frame>Day 0 through Day 182</time_frame>
    <description>An angioedema attack is 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 will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182</measure>
    <time_frame>Day 0 through Day 182</time_frame>
    <description>The overall severity of angioedema attack will be 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 will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of High-Morbidity Angioedema Attacks During the Treatment Period of Day 0 Through Day 182</measure>
    <time_frame>Day 0 through Day 182</time_frame>
    <description>A high morbidity angioedema attack is defined as any attack that has at least 1 of the following characteristics: severe, results in hospitalization (except hospitalization for observation less than (&lt;) 24 hours), hemodynamically significant (systolic blood pressure less than &lt; 90, requires intravenous (IV) hydration, or associated with syncope or near syncope) or laryngeal. Number of high-morbidity angioedema attacks during the treatment period of Day 0 through Day 182 will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) Plasma Concentrations of Lanadelumab</measure>
    <time_frame>Day 0, 84, 140 and 182</time_frame>
    <description>Pharmacokinetic plasma concentrations of lanadelumab will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Kallikrein (pKal) Activity</measure>
    <time_frame>Day 0, 84, 140 and 182</time_frame>
    <description>Plasma Kallikrein activity will be measured by biomarker cleaved high molecular weight kininogen (cHMWK ) with factor XIIa activation level to assess pharmacodynamics of lanadelumab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Positive Antidrug Antibodies (ADA) in Plasma</measure>
    <time_frame>Day 0, 84, 140 and 182</time_frame>
    <description>Number of participants with positive ADA including evaluation of neutralizing antibodies in plasma will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angioedema Quality of life (AE-QoL) Questionnaire</measure>
    <time_frame>Day 0, 28, 84, 140 and 182</time_frame>
    <description>The AE-QoL questionnaire is a self-administered validated instrument to assess health related (HR)QoL among participants with recurrent angioedema (including HAE). The AE-QoL consists of 17 disease-specific quality-of-life items, to produce a total AE-QoL 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 1 (Never) to 5 (Very Often).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lanadelumab Injection Report During the Treatment Period of Day 0 Through Day 168</measure>
    <time_frame>Day 0 through Day 168</time_frame>
    <description>An injection report will be completed by the participant (or parent/caregiver) following each dose administration of lanadelumab injection used during the treatment period of Day 0 through Day 168 will be assessed.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Angioedema</condition>
  <arm_group>
    <arm_group_label>Lanadelumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rollover participants from SHP643-303 (NCT04206605) will receive 300 milligram (mg) of lanadelumab solution in prefilled syringe subcutaneously (SC) for 26 weeks once every 2 weeks (Q2W) or once every 4 weeks (Q4W) if well controlled during SHP643-303 (NCT04206605) with up to 13 doses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lanadelumab</intervention_name>
    <description>Rollover participants will receive 300 mg of lanadelumab solution in a PFS SC injection once Q2W or Q4W for 26 consecutive weeks.</description>
    <arm_group_label>Lanadelumab</arm_group_label>
    <other_name>DX-2930</other_name>
    <other_name>SHP643</other_name>
    <other_name>TAK-743</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females, 12 years of age and older diagnosed with non-histaminergic normal&#xD;
             C1-INH angioedema at the time of enrollment into the antecedent Study SHP643-303&#xD;
             (NCT04206605).&#xD;
&#xD;
          -  Participants must have completed the treatment period (through Visit 26/Day 182) of&#xD;
             Study SHP643-303 (NCT04206605) without reporting a clinically significant TEAE that&#xD;
             would preclude subsequent exposure to lanadelumab.&#xD;
&#xD;
          -  Agree to adhere to the protocol-defined schedule of treatments, assessments, and&#xD;
             procedures.&#xD;
&#xD;
          -  Males, or non-pregnant, non-lactating females who are of child-bearing potential and&#xD;
             who agree to be abstinent or agree to comply with the applicable contraceptive&#xD;
             requirements of this protocol for the duration of the study; or females of&#xD;
             non-childbearing potential, defined as surgically sterile (status post hysterectomy,&#xD;
             bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least&#xD;
             12 months.&#xD;
&#xD;
          -  The participant (or the participant's parent/legal guardian, if applicable) has&#xD;
             provided written informed consent approved by the institutional review board/research&#xD;
             ethics board/ethics committee (IRB/REB/EC) at any time prior to study start. If the&#xD;
             participant is a minor (i.e. lesser then (&lt;) 18 years of age), have a parent/legal&#xD;
             guardian who is informed of the nature of the study provide written informed consent&#xD;
             (i.e. permission) for the minor to participate in the study before any study-specific&#xD;
             procedures are performed. Assent will be obtained from minor participants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Discontinued from Study SHP643-303 (NCT04206605) after enrollment but before Visit 26&#xD;
             for any reason.&#xD;
&#xD;
          -  Presence of important safety concerns identified in Study SHP643-303 (NCT04206605)&#xD;
             that would preclude participation in this study.&#xD;
&#xD;
          -  Dosing with an investigational product (IP, not including IP defined in antecedent&#xD;
             Study SHP643-303 [NCT04206605]) or exposure to an investigational device within 4&#xD;
             weeks prior to Day 0.&#xD;
&#xD;
          -  Participants has a known hypersensitivity to the investigational product or its&#xD;
             components.&#xD;
&#xD;
          -  Have any condition (surgical or medical) that, in the opinion of the investigator or&#xD;
             sponsor, may compromise their safety or compliance, preclude the successful conduct of&#xD;
             the study, or interfere with interpretation of the results (e.g. significant&#xD;
             pre-existing illness or other major comorbidities that the investigator considers may&#xD;
             confound the interpretation of study results).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda Development Center Americas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Center of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research of Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85248</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSD Angioedema Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy and Asthma Clinical Research Inc</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asthma and Allergy Associates, PC</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanarek Allergy, Asthma and Immunology</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Asthma &amp; Allergy, P.C.</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bernstein Clinical Research Center, LLC</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimed Research, LTD</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Allergy &amp; Asthma Research Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Allergy Research Corporation</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 1E4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Specialisee en Allergie de la Capitale</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1V 4W2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar der TU</name>
      <address>
        <city>Muenchen</city>
        <state>Bayern</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Johann Wolfgang Goethe-Universitaet pt</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem</name>
      <address>
        <city>Budapest</city>
        <zip>1088</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Ospedali riuniti Villa Sofia - Cervello,</name>
      <address>
        <city>Palermo</city>
        <state>Palermo Palermo</state>
        <zip>90100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)</name>
      <address>
        <city>Milano</city>
        <zip>20157</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria &quot;Federico II&quot;</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona</name>
      <address>
        <city>Salerno</city>
        <zip>84131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima University Hospital</name>
      <address>
        <city>Hiroshima-shi</city>
        <state>Hiroshima-Ken</state>
        <zip>734-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe University Hospital</name>
      <address>
        <city>Kobe-shi</city>
        <state>Hyogo-Ken</state>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clover Hospital</name>
      <address>
        <city>Fujisawa-shi</city>
        <state>Kanagawa-Ken</state>
        <zip>251-0025</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3508 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Homeo Medicus, Poradnia Alergologiczna</name>
      <address>
        <city>Bialystok</city>
        <zip>15-867</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;ALL-MED&quot; Specjalistyczna Opieka Medyczna Filia</name>
      <address>
        <city>Wroclaw</city>
        <zip>53-201</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Cruces</name>
      <address>
        <city>Barakaldo</city>
        <state>Vizcaya</state>
        <zip>48903</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5f6b600d4db2bf003ab48cf1?idFilter=%5B%22TAK-743-3001%22%5D</url>
    <description>To obtain more information on the study, click here/on this link</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 15, 2023</last_update_submitted>
  <last_update_submitted_qc>June 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angioedema</mesh_term>
    <mesh_term>Angioedemas, Hereditary</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>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.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_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.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04444895
org study id: TAK-743-3001
secondary id: 2019-004823-20
secondary id: jRCT2051220001
nct id: NCT04444895
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
time frame: From start of the study up to follow-up (Day 196)
description: A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the investigational product or medicinal product. A SAE is any 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 will include hypersensitivity reactions, events of disordered coagulation such as bleeding AESI, hypercoagulable AESI. Number of participants with TEAEs including AESI and SAE will be assessed.
measure: Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182
time frame: Day 0 through Day 182
description: An angioedema attack is 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 will be assessed.
measure: Number of Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182
time frame: Day 0 through Day 182
description: The overall severity of angioedema attack will be 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 will be assessed.
measure: Number of High-Morbidity Angioedema Attacks During the Treatment Period of Day 0 Through Day 182
time frame: Day 0 through Day 182
description: A high morbidity angioedema attack is defined as any attack that has at least 1 of the following characteristics: severe, results in hospitalization (except hospitalization for observation less than (<) 24 hours), hemodynamically significant (systolic blood pressure less than < 90, requires intravenous (IV) hydration, or associated with syncope or near syncope) or laryngeal. Number of high-morbidity angioedema attacks during the treatment period of Day 0 through Day 182 will be assessed.
measure: Pharmacokinetic (PK) Plasma Concentrations of Lanadelumab
time frame: Day 0, 84, 140 and 182
description: Pharmacokinetic plasma concentrations of lanadelumab will be assessed.
measure: Plasma Kallikrein (pKal) Activity
time frame: Day 0, 84, 140 and 182
description: Plasma Kallikrein activity will be measured by biomarker cleaved high molecular weight kininogen (cHMWK ) with factor XIIa activation level to assess pharmacodynamics of lanadelumab.
measure: Number of Participants With Positive Antidrug Antibodies (ADA) in Plasma
time frame: Day 0, 84, 140 and 182
description: Number of participants with positive ADA including evaluation of neutralizing antibodies in plasma will be assessed.
measure: Angioedema Quality of life (AE-QoL) Questionnaire
time frame: Day 0, 28, 84, 140 and 182
description: The AE-QoL questionnaire is a self-administered validated instrument to assess health related (HR)QoL among participants with recurrent angioedema (including HAE). The AE-QoL consists of 17 disease-specific quality-of-life items, to produce a total AE-QoL 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 1 (Never) to 5 (Very Often).
measure: Lanadelumab Injection Report During the Treatment Period of Day 0 Through Day 168
time frame: Day 0 through Day 168
description: An injection report will be completed by the participant (or parent/caregiver) following each dose administration of lanadelumab injection used during the treatment period of Day 0 through Day 168 will be assessed.
arm group label: Lanadelumab
arm group type: Experimental
description: Rollover participants from SHP643-303 (NCT04206605) will receive 300 milligram (mg) of lanadelumab solution in prefilled syringe subcutaneously (SC) for 26 weeks once every 2 weeks (Q2W) or once every 4 weeks (Q4W) if well controlled during SHP643-303 (NCT04206605) with up to 13 doses.
intervention type: Drug
intervention name: Lanadelumab
description: Rollover participants will receive 300 mg of lanadelumab solution in a PFS SC injection once Q2W or Q4W for 26 consecutive weeks.
arm group label: Lanadelumab
other name: DX-2930
other name: SHP643
other name: TAK-743
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Takeda Development Center Americas
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country: Canada
country: France
country: Germany
country: Hungary
country: Italy
country: Japan
country: Netherlands
country: Poland
country: Spain
country: United States
url: https://clinicaltrials.takeda.com/study-detail/5f6b600d4db2bf003ab48cf1?idFilter=%5B%22TAK-743-3001%22%5D
description: To obtain more information on the study, click here/on this link
responsible party type: Sponsor
mesh term: Angioedema
mesh term: Angioedemas, Hereditary
sharing ipd: Yes
ipd description: 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.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd 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.
ipd url: https://vivli.org/ourmember/takeda/