A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)
Public ClinicalTrials.gov record NCT04206605. 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.
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Official title
A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety 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 main aim of this study is to check if repeated subcutaneous (SC) injections of lanadelumab can prevent angioedema attacks in teenagers and adults with non-histaminergic angioedema with normal C1-INH. Another aim is to check if they tolerate the repeated SC injections. Participants will receive a SC injection of lanadelumab every two weeks for 26 weeks. The first two doses of lanadelumab will be given at the study clinic. Once a participant (and/or parent/caregiver) has been appropriately trained, lanadelumab can be self-injected. Visits to the study clinic are planned for the first, third and fourth week and then every 4 weeks.
Study identification
- NCT ID
- NCT04206605
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 77 participants
Conditions and interventions
Conditions
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
- May 4, 2020 (Actual)
- Primary completion
- Oct 20, 2022 (Actual)
- Completion
- Oct 20, 2022 (Actual)
- Last update posted
- Dec 27, 2023
2020 – 2022
United States locations
- U.S. sites
- 20
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Center of Alabama | Birmingham | Alabama | 35209 | — |
| Medical Research of Arizona | Scottsdale | Arizona | 85248 | — |
| University of California San Diego | San Diego | California | 92122 | — |
| AIRE Medical of Los Angeles | Santa Monica | California | 90404 | — |
| Allergy and Asthma Clinical Research Inc | Walnut Creek | California | 94598 | — |
| Asthma and Allergy Associates, PC | Colorado Springs | Colorado | 80907 | — |
| University of South Florida Asthma, Allergy & Immunology | Tampa | Florida | 33613 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Kanarek Allergy, Asthma and Immunology | Overland Park | Kansas | 66211 | — |
| Institute for Asthma & Allergy - Chevy Chase | Chevy Chase | Maryland | 20815 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02421 | — |
| University of Michigan | Ann Arbor | Michigan | 48106 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| Washington University | St Louis | Missouri | 63141 | — |
| Jay M Kashkin, MD Allergy, Asthma and Immunology | Fair Lawn | New Jersey | 07410 | — |
| Clinical Research of Charlotte | Charlotte | North Carolina | 28277 | — |
| Bernstein Clinical Research Center, LLC | Cincinnati | Ohio | 45231 | — |
| Optimed Research, LTD | Columbus | Ohio | 43235 | — |
| Tanner Clinic | Layton | Utah | 84041 | — |
| 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 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04206605, 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 Dec 27, 2023 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04206605 live on ClinicalTrials.gov.