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Real-world study shows lanadelumab keeps HAE attacks at bay for many patients

NCT ID NCT05147181

Disease control Sponsor: Takeda 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 48 people with hereditary angioedema (HAE) in Poland who were taking lanadelumab as part of a national drug program. Researchers tracked how many participants remained attack-free over 24 months, how many attacks still needed rescue treatment, and the severity and location of any attacks. The goal was to see how well the drug works in real life, not just in controlled trials.

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

48 people

The number who actually took part.

Started

Mar 2022

Finished

Nov 2025

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 HAE are included in this study.

Ages

12 years and older

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 Participant eligibility is determined according to the following criteria prior to entry into the study: * In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. * The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. * HAE participant (aged greater than or equal to \[\>=\] 12 years old.) qualified to treatment with lanadelumab in the NDP and receiving treatment according to the Summary of Product Characteristics for Takhzyro. * Male or female participants, aged \>=12 years old. Exclusion Criteria Any participant who meets any of the following criteria will not qualify for entry into the study: * Currently participates or plans to participate in any interventional clinical trial. * Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study. Participants should be included in the study only once. Data erroneously collected from participants for which written consent is not available, will not be included in or will be deleted from the database.

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Conditions

The condition(s) this trial relates to.

hereditary angioedema hereditary angioedema type 1 hereditary angioedema type 2

As listed by the trial registrant

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

Hereditary angioedema (HAE)

Contacts and locations

Locations

  • Kliniczny Szpital Wojewódzki nr 1 im. Fryderyka Chopina w Rzeszowie

    Rzeszów, Podkarpackie Voivodeship, 35-001, Poland

  • SAMODZIELNY PUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ - Centralny Szpital Kliniczny Uniwersytety Medycznego w Łodzi

    Lodz, Łódź Voivodeship, 92-213, Poland

  • SPSK nr 2 PUM w Szczecinie

    Szczecin, Zachodniopomorske, 70-111, Poland

  • Samodzielny Publiczny Zespół Gruźlicy i Chorób Płuc w Olsztynie

    Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland

  • Szpital Powiatowy w Chmielniku

    Chmielknik, Świętokrzyskie Voivodeship, 26-020, Poland

  • Szpital Uniwersytecki nr 2

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

  • Szpital Uniwersytecki w Krakowie

    Krakow, Lesser Poland Voivodeship, 31-501, Poland

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

  • Uniwersytecki Szpital Kliniczny w Białymstoku

    Bialystok, Podlaskie Voivodeship, 15-276, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-211, Poland

  • Uniwersytet Medyczny w Białymstoku

    Bialystok, Podlaskie Voivodeship, 15-540, Poland

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów/Szpital w Poznaniu

    Poznan, Greater Poland Voivodeship, 60-569, Poland

  • Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

    Lublin, Lublin Voivodeship, 20-718, Poland

  • Wojskowy Instytut Medyczny

    Warsaw, Masovian Voivodeship, 04-141, Poland

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