A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor

Last updated: June 14, 2024
Sponsor: Shire
Overall Status: Completed

Phase

3

Condition

Allergies & Asthma

Urticaria

Allergy

Treatment

Lanadelumab

Clinical Study ID

NCT04444895
TAK-743-3001
jRCT2051220001
2019-004823-20
  • Ages > 12
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and females, 12 years of age and older diagnosed with non-histaminergic normalC1-INH angioedema at the time of enrollment into the antecedent Study SHP643-303 (NCT04206605).

  • Participants must have completed the treatment period (through Visit 26/Day 182) ofStudy SHP643-303 (NCT04206605) without reporting a clinically significant TEAE thatwould preclude subsequent exposure to lanadelumab.

  • Agree to adhere to the protocol-defined schedule of treatments, assessments, andprocedures.

  • Males, or non-pregnant, non-lactating females who are of child-bearing potential andwho agree to be abstinent or agree to comply with the applicable contraceptiverequirements of this protocol for the duration of the study; or females ofnon-childbearing potential, defined as surgically sterile (status post hysterectomy,bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months.

  • The participant (or the participant's parent/legal guardian, if applicable) hasprovided written informed consent approved by the institutional reviewboard/research ethics board/ethics committee (IRB/REB/EC) at any time prior to studystart. If the participant is a minor (i.e. lesser then (<) 18 years of age), have aparent/legal guardian who is informed of the nature of the study provide writteninformed consent (i.e. permission) for the minor to participate in the study beforeany study-specific procedures are performed. Assent will be obtained from minorparticipants.

Exclusion

Exclusion Criteria:

  • Discontinued from Study SHP643-303 (NCT04206605) after enrollment but before Visit 26 for any reason.

  • Presence of important safety concerns identified in Study SHP643-303 (NCT04206605)that would preclude participation in this study.

  • Dosing with an investigational product (IP, not including IP defined in antecedentStudy SHP643-303 [NCT04206605]) or exposure to an investigational device within 4weeks prior to Day 0.

  • Participants has a known hypersensitivity to the investigational product or itscomponents.

  • Have any condition (surgical or medical) that, in the opinion of the investigator orsponsor, may compromise their safety or compliance, preclude the successful conductof the study, or interfere with interpretation of the results (e.g. significantpre-existing illness or other major comorbidities that the investigator considersmay confound the interpretation of study results).

Study Design

Total Participants: 73
Treatment Group(s): 1
Primary Treatment: Lanadelumab
Phase: 3
Study Start date:
February 05, 2021
Estimated Completion Date:
May 05, 2023

Study Description

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.

Connect with a study center

  • Ottawa Allergy Research Corporation

    Ottawa, Ontario K1H 1E4
    Canada

    Site Not Available

  • Clinique Specialisee en Allergie de la Capitale

    Québec, Quebec G1V 4W2
    Canada

    Site Not Available

  • Hôpital Saint-Antoine

    Paris, 75012
    France

    Site Not Available

  • Klinikum rechts der Isar der TU

    Muenchen, Bayern 81675
    Germany

    Site Not Available

  • Klinikum der Johann Wolfgang Goethe-Universitaet pt

    Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1088
    Hungary

    Site Not Available

  • A.O. Ospedali riuniti Villa Sofia - Cervello,

    Palermo, Palermo Palermo 90100
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

    Milano, 20157
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria "Federico II"

    Napoli, 80131
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

    Salerno, 84131
    Italy

    Site Not Available

  • Hiroshima University Hospital

    Hiroshima-shi, Hiroshima-Ken 734-8551
    Japan

    Site Not Available

  • Kobe University Hospital

    Kobe-shi, Hyogo-Ken 650-0017
    Japan

    Site Not Available

  • Clover Hospital

    Fujisawa-shi, Kanagawa-Ken 251-0025
    Japan

    Site Not Available

  • Amsterdam UMC

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • UMC Utrecht

    Utrecht, 3508 GA
    Netherlands

    Site Not Available

  • NZOZ Homeo Medicus, Poradnia Alergologiczna

    Bialystok, 15-867
    Poland

    Site Not Available

  • "ALL-MED" Specjalistyczna Opieka Medyczna Filia

    Wroclaw, 53-201
    Poland

    Site Not Available

  • Hospital Universitario Cruces

    Barakaldo, Vizcaya 48903
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Clinical Research Center of Alabama

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Medical Research of Arizona

    Scottsdale, Arizona 85248
    United States

    Site Not Available

  • Medical Research of Arizona a division of Allergy, Asthma & Immunology Associates, LTD

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • UCSD Angioedema Center

    San Diego, California 92122
    United States

    Site Not Available

  • Allergy and Asthma Clinical Research Inc

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Asthma and Allergy Associates, PC

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Kanarek Allergy, Asthma and Immunology

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Institute for Asthma & Allergy, P.C.

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • University of Michigan Specialty Allergy Clinic and Food Allergy Clinic

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63414
    United States

    Site Not Available

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Optimed Research, LTD

    Columbus, Ohio 43235
    United States

    Site Not Available

  • Seattle Allergy & Asthma Research Institute

    Seattle, Washington 98115
    United States

    Site Not Available

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