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

Completed · Phase 3

Conditions studied: Angioedema

In brief

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).

Key facts

Study ID

NCT04444895

Run by

Shire

People needed

73

Starts

2021-02-05

Expected to finish

2023-05-05

Last updated by the study team

2024-06-17

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, 12 years of age and older diagnosed with non-histaminergic normal C1-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) of Study SHP643-303 (NCT04206605) without reporting a clinically significant TEAE that would preclude subsequent exposure to lanadelumab.
• Agree to adhere to the protocol-defined schedule of treatments, assessments, and procedures.
• Males, or non-pregnant, non-lactating females who are of child-bearing potential and who agree to be abstinent or agree to comply with the applicable contraceptive requirements of this protocol for the duration of the study; or females of non-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) has provided written informed consent approved by the institutional review board/research ethics board/ethics committee (IRB/REB/EC) at any time prior to study start. If the participant is a minor (i.e. lesser then (<) 18 years of age), have a parent/legal guardian who is informed of the nature of the study provide written informed consent (i.e. permission) for the minor to participate in the study before any study-specific procedures are performed. Assent will be obtained from minor participants.

You may not qualify if…

• 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 antecedent Study SHP643-303 [NCT04206605]) or exposure to an investigational device within 4 weeks prior to Day 0.
• Participants has a known hypersensitivity to the investigational product or its components.
• Have any condition (surgical or medical) that, in the opinion of the investigator or sponsor, may compromise their safety or compliance, preclude the successful conduct of the study, or interfere with interpretation of the results (e.g. significant pre-existing illness or other major comorbidities that the investigator considers may confound the interpretation of study results).

Where it is running

• Clinical Research Center of Alabama — Birmingham, Alabama, United States
• Medical Research of Arizona — Scottsdale, Arizona, United States
• UCSD Angioedema Center — San Diego, California, United States
• Allergy and Asthma Clinical Research Inc — Walnut Creek, California, United States
• Asthma and Allergy Associates, PC — Colorado Springs, Colorado, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Kanarek Allergy, Asthma and Immunology — Overland Park, Kansas, United States
• Institute for Asthma & Allergy, P.C. — Chevy Chase, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Bernstein Clinical Research Center, LLC — Cincinnati, Ohio, United States
• Optimed Research, LTD — Columbus, Ohio, United States
• Seattle Allergy & Asthma Research Institute — Seattle, Washington, United States
• Ottawa Allergy Research Corporation — Ottawa, Ontario, Canada
• Clinique Specialisee en Allergie de la Capitale — Québec, Quebec, Canada
• Hôpital Saint-Antoine — Paris, France
• Klinikum rechts der Isar der TU — Munich, Bavaria, Germany
• Klinikum der Johann Wolfgang Goethe-Universitaet pt — Frankfurt am Main, Hesse, Germany
• Semmelweis Egyetem — Budapest, Hungary
• A.O. Ospedali riuniti Villa Sofia - Cervello, — Palermo, Palermo Palermo, Italy
• Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco) — Milan, Italy
• Azienda Ospedaliera Universitaria "Federico II" — Naples, Italy
• Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona — Salerno, Italy

Full record on ClinicalTrials.gov

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