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Real-World data shows lanadelumab cuts HAE attacks over three years

NCT ID NCT04130191

Disease control Sponsor: Shire Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study followed 140 people with hereditary angioedema (HAE) who were already taking lanadelumab. Researchers compared the number of swelling attacks during treatment to the number before starting the drug. Participants reported their symptoms via a smartphone app and during clinic visits for up to three years. The goal was to see how well lanadelumab works in everyday life, not just in controlled trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lanadelumab
What this could lead to
If successful, this study could confirm that lanadelumab effectively reduces HAE attacks in everyday use, supporting its long-term role in managing the condition.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient selection or reporting bias. It does not test new treatments or cures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

140 people

The number who actually took part.

Started

Dec 2019

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants with type 1 or type 2 HAE who initiate treatment with lanadelumab according to the current product labelling.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Voluntarily provision of written, signed, and dated (personally or via a legally authorized representative) informed consent to participate in the study. * Initiation of treatment with lanadelumab in accordance with current product labelling. Decision to start treatment with lanadelumab must be made before and be independent from enrollment in the study. * Availability of information for HAE attack-related variables assessed at study enrollment for the previous three months. * Ability to use a smartphone for data collection in this study. Exclusion Criteria: * Inability to provide written, signed, and dated informed consent. * Participation in the study not considered appropriate by the treating physician/investigator. * Contraindication to treatment with lanadelumab according to current product labelling. * Pregnant or breastfeeding. * Concomitant exposure to any investigational therapy (including medications not used for HAE). * Current or planned participation in other interventional studies.

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Conditions

The condition(s) this trial relates to.

hereditary angioedema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hereditary angioedema (HAE)

Contacts and locations

Locations

  • ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

    Milan, 20157, Italy

  • Al-Rashed Allergy Center

    Kuwait City, 90806, Kuwait

  • Azienda Ospedale Università Padova

    Padova, 35128, Italy

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Campania, 80131, Italy

  • Bnai Zion Medical Center

    Haifa, 31048, Israel

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035, Spain

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hämophilie Zentrum Rhein Main GmbH

    Mörfelden-Walldorf, 64546, Germany

  • Klinikum der Johann-Wolfgang Goethe-Universitat

    Frankfurt am Main, Hesse, 60590, Germany

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675, Germany

  • Luzerner Kantonsspital LUKS

    Lucerne, 6000, Switzerland

  • Medical University of Vienna

    Vienna, 1090, Austria

  • Sheba Medical Center - PPDS

    Ramat Gan, 52621, Israel

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225, Germany

  • Universitatsklinikum Schleswig-Holstein

    Lübeck, 23538, Germany

  • Universitätsklinikum Münster

    Münster, 48149, Germany

  • Universitätsklinikum Ulm

    Ulm, 89075, Germany

  • Universitätsspital Basel

    Basel, 4031, Switzerland

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