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NCT04206605 · ClinicalTrials.gov registry record · Phase 3

A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)

A Phase 3 study, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
77
Enrollment target

NCT04206605 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 77 participants.

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The verdict

NCT04206605, a Phase 3 study, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
77 participants
Enrollment target

Study Summary

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.

Interventions

  • OTHER Placebo
  • DRUG Lanadelumab

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2020-05-04
Est. Completion 2022-10-20
Phase Phase 3

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT04206605

The ClinicalTrials.gov registry entry for NCT04206605 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04206605 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04206605 about?

NCT04206605 is a clinical study titled "A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)". 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 ...

What is the current status of trial NCT04206605?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2020-05-04. Estimated completion is 2022-10-20.

What interventions are being tested in trial NCT04206605?

The interventions under investigation include: Placebo (OTHER), Lanadelumab (DRUG).

Who is sponsoring clinical trial NCT04206605?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.