New hope for HAE: Long-Term trial of navenibart launches

NCT ID NCT07204938

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests the long-term safety and effectiveness of navenibart, an injectable drug, in 145 adults and teens with hereditary angioedema (HAE) who were in a previous study. The trial has two parts: first, everyone gets a fixed dose; then, some may switch to a personalized dose based on their needs. Researchers will track side effects and how well the drug prevents swelling attacks.

What this could mean

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

Active substance

navenibart (also called STAR-0215), given as a shot under the skin

What this could lead to

If successful, this could provide a long-term treatment option to prevent swelling attacks in people with hereditary angioedema, potentially improving quality of life.

What could go wrong

This is an extension study, so participants already know the drug is safe enough to continue. However, long-term side effects are still being tracked, and the personalized dosing part is new, so its benefits are not yet proven.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

angioedema hereditary angioedema

As listed by the trial registrant

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

Contacts and locations

Locations

  • Site 1

    Walnut Creek, California, 94598, United States

  • Site 10

    Hong Kong, Hong Kong

  • Site 11

    Cape Town, South Africa

  • Site 12

    Bristol, BS10 5N, United Kingdom

  • Site 13

    London, E1 2ES, United Kingdom

  • Site 14

    Frimley, GU16 7UJ, United Kingdom

  • Site 14

    Plymouth, PL6 8HD, United Kingdom

  • Site 15

    Hampstead, NW3 2QG, United Kingdom

  • Site 16

    Rzeszów, 35-051, Poland

  • Site 17

    Amsterdam, Netherlands

  • Site 18

    Skopje, 1000, North Macedonia

  • Site 19

    Colorado Springs, Colorado, 80907, United States

  • Site 2

    Scottsdale, Arizona, 85251, United States

  • Site 20

    Sofia, 1680, Bulgaria

  • Site 21

    Wheaton, Maryland, 20902, United States

  • Site 22

    Santo André, 09060870, Brazil

  • Site 23

    Edmonton, AB T6G 2B7, Canada

  • Site 24

    Petah Tikva, 4920235, Israel

  • Site 25

    Frankfurt, D-60590, Germany

  • Site 26

    Valencia, 46026, Spain

  • Site 27

    Fukuoka, 830-0011, Japan

  • Site 3

    Little Rock, Arkansas, 72205, United States

  • Site 4

    Santa Monica, California, 90404, United States

  • Site 5

    Centennial, Colorado, 80112, United States

  • Site 6

    Cincinnati, Ohio, 45236, United States

  • Site 7

    San Diego, California, 92122, United States

  • Site 8

    Cambridge, CB2 0QQ, United Kingdom

  • Site 9

    Hershey, Pennsylvania, 17033, United States