Phase
Condition
Allergies & Asthma
Urticaria
Allergy
Treatment
Lanadelumab
Clinical Study ID
Ages > 12 All Genders
Study Summary
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
Study Description
Connect with a study center
Ottawa Allergy Research Corporation
Ottawa, Ontario K1H 1E4
CanadaSite Not Available
Clinique Specialisee en Allergie de la Capitale
Québec, Quebec G1V 4W2
CanadaSite Not Available
Hôpital Saint-Antoine
Paris, 75012
FranceSite Not Available
Klinikum rechts der Isar der TU
Muenchen, Bayern 81675
GermanySite Not Available
Klinikum der Johann Wolfgang Goethe-Universitaet pt
Frankfurt, Hessen 60590
GermanySite Not Available
Semmelweis Egyetem
Budapest, 1088
HungarySite Not Available
A.O. Ospedali riuniti Villa Sofia - Cervello,
Palermo, Palermo Palermo 90100
ItalySite Not Available
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milano, 20157
ItalySite Not Available
Azienda Ospedaliera Universitaria "Federico II"
Napoli, 80131
ItalySite Not Available
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno, 84131
ItalySite Not Available
Hiroshima University Hospital
Hiroshima-shi, Hiroshima-Ken 734-8551
JapanSite Not Available
Kobe University Hospital
Kobe-shi, Hyogo-Ken 650-0017
JapanSite Not Available
Clover Hospital
Fujisawa-shi, Kanagawa-Ken 251-0025
JapanSite Not Available
Amsterdam UMC
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
NetherlandsSite Not Available
UMC Utrecht
Utrecht, 3508 GA
NetherlandsSite Not Available
NZOZ Homeo Medicus, Poradnia Alergologiczna
Bialystok, 15-867
PolandSite Not Available
"ALL-MED" Specjalistyczna Opieka Medyczna Filia
Wroclaw, 53-201
PolandSite Not Available
Hospital Universitario Cruces
Barakaldo, Vizcaya 48903
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Clinical Research Center of Alabama
Birmingham, Alabama 35209
United StatesSite Not Available
Medical Research of Arizona
Scottsdale, Arizona 85248
United StatesSite Not Available
Medical Research of Arizona a division of Allergy, Asthma & Immunology Associates, LTD
Scottsdale, Arizona 85251
United StatesSite Not Available
UCSD Angioedema Center
San Diego, California 92122
United StatesSite Not Available
Allergy and Asthma Clinical Research Inc
Walnut Creek, California 94598
United StatesSite Not Available
Asthma and Allergy Associates, PC
Colorado Springs, Colorado 80907
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Kanarek Allergy, Asthma and Immunology
Overland Park, Kansas 66211
United StatesSite Not Available
Institute for Asthma & Allergy, P.C.
Chevy Chase, Maryland 20815
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48106
United StatesSite Not Available
University of Michigan Specialty Allergy Clinic and Food Allergy Clinic
Ann Arbor, Michigan 48106
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University
Saint Louis, Missouri 63141
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63414
United StatesSite Not Available
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio 45236
United StatesSite Not Available
Optimed Research, LTD
Columbus, Ohio 43235
United StatesSite Not Available
Seattle Allergy & Asthma Research Institute
Seattle, Washington 98115
United StatesSite Not Available

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