New hope for HAE: Long-Term trial of navenibart launches
NCT ID NCT07204938
First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times
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.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Site 1
Walnut Creek, California, 94598, United States
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Site 10
Hong Kong, Hong Kong
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Site 11
Cape Town, South Africa
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Site 12
Bristol, BS10 5N, United Kingdom
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Site 13
London, E1 2ES, United Kingdom
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Site 14
Plymouth, PL6 8HD, United Kingdom
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Site 15
Hampstead, NW3 2QG, United Kingdom
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Site 16
Rzeszów, 35-051, Poland
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Site 17
Amsterdam, Netherlands
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Site 18
Skopje, 1000, North Macedonia
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Site 19
Colorado Springs, Colorado, 80907, United States
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Site 2
Scottsdale, Arizona, 85251, United States
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Site 20
Sofia, 1680, Bulgaria
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Site 21
Wheaton, Maryland, 20902, United States
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Site 22
Santo André, 09060870, Brazil
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Site 23
Edmonton, AB T6G 2B7, Canada
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Site 24
Petah Tikva, 4920235, Israel
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Site 25
Frankfurt, D-60590, Germany
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Site 26
Valencia, 46026, Spain
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Site 27
Fukuoka, 830-0011, Japan
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Site 28
Frimley, GU16 7UJ, United Kingdom
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Site 29
Ashkelon, 783604, Israel
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Site 3
Little Rock, Arkansas, 72205, United States
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Site 30
Haifa, 3104802, Israel
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Site 31
Petah Tikva, 49100, Israel
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Site 32
San Juan, 00918, Puerto Rico
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Site 33
Kawasaki, 216-8511, Japan
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Site 34
Madrid, 28007, Spain
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Site 35
Krakow, 31-503, Poland
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Site 36
Prague, 150 06, Czechia
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Site 37
Milan, 20157, Italy
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Site 38
Monserrato, 09042, Italy
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Site 39
Paris, 75012, France
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Site 4
Santa Monica, California, 90404, United States
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Site 40
Kawagoe, Saitama, 350-0844, Japan
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Site 5
Centennial, Colorado, 80112, United States
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Site 6
Cincinnati, Ohio, 45236, United States
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Site 7
San Diego, California, 92122, United States
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Site 8
Cambridge, CB2 0QQ, United Kingdom
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Site 9
Hershey, Pennsylvania, 17033, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- HAE patients and caregivers speak out: the hidden costs of On-Demand treatment
- Real-world study shows lanadelumab keeps HAE attacks at bay for many patients
- Takhzyro under the microscope: Real-World safety check for rare swelling disease
- New hope for HAE patients: experimental drug aims to slash attack rate
- New RNA drug shows promise in preventing HAE attacks in ongoing study
- New drug TAKHZYRO tracked for Long-Term safety in rare swelling disorder