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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04444895

Public ClinicalTrials.gov record NCT04444895. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 11, 2026, 6:17 PM EST

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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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT04444895
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
73 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 5, 2021 (Actual)
Primary completion
May 5, 2023 (Actual)
Completion
May 5, 2023 (Actual)
Last update posted
Jun 17, 2024

2021 – 2023

United States locations

U.S. sites
15
U.S. states
13
U.S. cities
15
Facility City State ZIP Site status
Clinical Research Center of Alabama Birmingham Alabama 35209 —
Medical Research of Arizona Scottsdale Arizona 85248 —
UCSD Angioedema Center San Diego California 92122 —
Allergy and Asthma Clinical Research Inc Walnut Creek California 94598 —
Asthma and Allergy Associates, PC Colorado Springs Colorado 80907 —
Rush University Medical Center Chicago Illinois 60612 —
Kanarek Allergy, Asthma and Immunology Overland Park Kansas 66211 —
Institute for Asthma & Allergy, P.C. Chevy Chase Maryland 20815 —
Massachusetts General Hospital Boston Massachusetts 02114 —
University of Michigan Ann Arbor Michigan 48106 —
Mayo Clinic Rochester Minnesota 55905 —
Washington University St Louis Missouri 63141 —
Bernstein Clinical Research Center, LLC Cincinnati Ohio 45236 —
Optimed Research, LTD Columbus Ohio 43235 —
Seattle Allergy & Asthma Research Institute Seattle Washington 98115 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04444895, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 17, 2024 · Synced Nov 11, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04444895 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →