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New drug TAKHZYRO tracked for Long-Term safety in rare swelling disorder

NCT ID NCT05397431

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 05, 2026 · Updated 3 times

Summary

This study follows 155 people in Japan with hereditary angioedema (HAE) who are taking TAKHZYRO (lanadelumab) injections every two weeks. Researchers will monitor side effects and check if the drug helps control swelling attacks over 12 months. The goal is to see how well TAKHZYRO works in everyday medical practice.

What this could mean

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

Active substance
Lanadelumab (TAKHZYRO)
What this could lead to
If successful, this study could confirm that TAKHZYRO is safe and effective for long-term use in controlling HAE attacks.
What could go wrong
This is an observational survey, not a controlled trial, so results may be less definitive. Side effects are still possible, and the study only includes Japanese participants, so findings may not apply to everyone.

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

155 people

The number who actually took part.

Started

May 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

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

The population of this survey are all participants who meet the inclusion/exclusion criteria.

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 - Participants diagnosed with hereditary angioedema (HAE) and treated with Lanadelumab for the first time. Exclusion Criteria \- None

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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

  • Takeda selected site

    Tokyo, Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.