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Can a new injection tame hereditary swelling attacks?

NCT ID NCT06415448

Disease control Sponsor: Ionis Pharmaceuticals, Inc. 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This program provides access to an investigational drug called donidalorsen for people with hereditary angioedema (HAE), a genetic condition that causes sudden, painful swelling in various body parts. The drug is given as a monthly or every-other-month injection under the skin. It is available to patients who have completed a prior long-term study of donidalorsen, aiming to see if continued use can help manage their condition.

What this could mean

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

Active substance
donidalorsen
What this could lead to
If successful, this program could provide a new treatment option for people with hereditary angioedema, potentially reducing the frequency and severity of swelling attacks.
What could go wrong
This is an expanded access program, not a formal trial, so it provides limited safety and efficacy data. The drug may not work for everyone, and there are risks of side effects, including injection site reactions.

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.

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.

Ages

18 years and older

Sex

Anyone

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: * Patients in the ISIS 721744-CS3 (Open-Label Extension \[OLE\] Study) who have completed 205 weeks of treatment. * Female patients of childbearing potential, and male patients with partners of childbearing potential must be willing to use acceptable contraception, or refrain from sexual activity. Exclusion Criteria: * Any patient who is pregnant or plans to become pregnant. * Any patient who was withdrawn from the ISIS 721744-CS3 OLE study due to a serious adverse event (SAE) related to donidalorsen therapy or who voluntarily withdrew prior to 205 weeks of treatment.

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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

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

More trials for these conditions

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