A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children
Public ClinicalTrials.gov record NCT04070326. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
SPRING STUDY: An Open-Label, Multicenter, Phase 3 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab for Prevention Against Acute Attacks of Hereditary Angioedema (HAE) in Pediatric Subjects 2 to <12 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main aims of this study are to learn how lanadelumab moves through a child's body and if the children have any medical problems from lanadelumab. Other aims are to learn if prophylactic treatment with lanadelumab reduces the number and severity of HAE attacks in children, how lanadelumab affects the child's body, and if the children develop antibodies to lanadelumab. The study doctors will treat acute HAE attacks according to their standard practice. Participants will receive lanadelumab for up to 52 weeks. When they start treatment, participants will visit their clinic every week for the first 4 weeks. Then, they will visit their clinic every 4 weeks during treatment.
Study identification
- NCT ID
- NCT04070326
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 21 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 11 Years
- 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
- Aug 18, 2019
- Primary completion
- Oct 29, 2021
- Completion
- Oct 29, 2021
- Last update posted
- May 25, 2022
2019 – 2021
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AIRE Medical of Los Angeles | Santa Monica | California | 90404 | — |
| Allergy & Asthma Clinical Research | Walnut Creek | California | 94598 | — |
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | — |
| Institute Asthma and Allergy | Chevy Chase | Maryland | 20815 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Hudson-Essex Allergy | Belleville | New Jersey | 07109 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Clinical Research Center of Charlotte | Charlotte | North Carolina | 28277 | — |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | — |
| Toledo Institute of Clinical Research Asthma & Allergy Center | Toledo | Ohio | 43617 | — |
| AARA Research Center | Dallas | Texas | 75231 | — |
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 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04070326, 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 May 25, 2022 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04070326 live on ClinicalTrials.gov.