New shot could stop dangerous swelling attacks in HAE
NCT ID NCT06842823
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This Phase 3 trial tests whether navenibart, a drug given as a shot under the skin, can prevent attacks in people with hereditary angioedema (HAE). About 145 adults and teens with HAE type 1 or 2 will receive either navenibart or a placebo for 6 months. The main goal is to see if the drug reduces the number of confirmed HAE 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 it works, this could give people with HAE a new option to prevent painful and dangerous swelling attacks.
- What could go wrong
- This is still a controlled trial, so we don't know yet if navenibart works better than placebo. It may not prevent attacks for everyone, and side effects are possible.
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
St Louis, Missouri, 63141, United States
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Site 11
Colorado Springs, Colorado, 80907, United States
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Site 12
Toledo, Ohio, 43617, United States
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Site 13
Detroit, Michigan, 48202, United States
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Site 14
San Diego, California, 92123,, United States
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Site 15
Hummelstown, Pennsylvania, 17036, United States
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Site 16
Cambridge, CB2 0QQ, United Kingdom
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Site 17
London, E1 2ES, United Kingdom
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Site 18
Plymouth, Devon, PL6 8HD, United Kingdom
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Site 19
Bristol, BS10 5N, United Kingdom
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Site 2
Scottsdale, Arizona, 85251, United States
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Site 20
Hong Kong, Hong Kong
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Site 21
Cape Town, 7700, South Africa
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Site 22
Frimley, GU16 7UJ, United Kingdom
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Site 23
Edmonton, AB T6G 2B7, Canada
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Site 24
Hampstead, London, NW3 2QG, United Kingdom
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Site 25
Tampa, Florida, 33613, United States
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Site 26
San Diego, California, 92122, United States
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Site 27
Amsterdam, Netherlands
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Site 28
Sofia, 1680, Bulgaria
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Site 29
Rzeszów, 35-051, Poland
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Site 3
Little Rock, Arkansas, 72205, United States
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Site 30
Fukuoka, Kurume-shi, 830-0011, Japan
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Site 31
Saitama, Soka-shi, 340-0041, Japan
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Site 32
Barcelona, Spain
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Site 33
Skopje, 1000, North Macedonia
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Site 34
Petah Tikva, 4920235, Israel
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Site 35
Petah Tikva, 49100, Israel
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Site 36
Valencia, 46026, Spain
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Site 37
Hradec Králové, 500 05, Czechia
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Site 38
Berlin, 12203, Germany
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Site 39
Prague, 150 06, Czechia
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Site 4
Santa Monica, California, 90404, United States
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Site 40
San Donato Milanese, 20097, Italy
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Site 41
Torino, 10128, Italy
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Site 42
Milan, 20138, Italy
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Site 44
Frankfurt, D-60590, Germany
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Site 45
Santo André, 09060870, Brazil
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Site 46
La Tronche, 38700, France
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Site 47
Saga, 849-8501, Japan
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Site 48
Seville, 41013, Spain
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Site 49
Haifa, 3104802, Israel
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Site 5
Ottawa, Ontario, K1H 1E4, Canada
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Site 50
Hiroshima, 734-8551, Japan
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Site 51
Monserrato, 09042, Italy
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Site 51
Monserrato, CA 09042, Italy
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Site 52
Paris, 75012, France
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Site 53
Tel Aviv, 6423906, Israel
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Site 54
Lille, 59037, France
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Site 55
Ashkelon, 7830604, Israel
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Site 56
Tsu, Mei, 514-8507, Japan
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Site 57
Hiroshima, 730-8518, Japan
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Site 58
Kawasaki, 216-8511, Japan
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Site 59
San Juan, 00918, Puerto Rico
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Site 6
Wheaton, Maryland, 20902, United States
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Site 60
Yangcheon, Seoul, South Korea
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Site 61
Kawagoe, Saitama, 350-8550, Japan
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Site 62
Seoul, Jongno, South Korea
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Site 63
Madrid, 28007, Spain
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Site 64
Budapest, 1088, Hungary
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Site 65
Marseille, 13005, France
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Site 66
Padova, 35128, Italy
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Site 67
Boston, Massachusetts, 02114, United States
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Site 68
Campbelltown, New South Wales, 2560, Australia
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Site 69
Weston, Florida, 33331, United States
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Site 7
Cincinnati, Ohio, 45236, United States
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Site 70
Hanover, 30625, Germany
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Site 71
Krakow, 31-503, Poland
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Site 72
Nice, 06202, France
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Site 73
Tokyo, 173-0032, Japan
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Site 74
Murdoch, WA 6150, Australia
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Site 75
Auckland, New Zealand
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Site 76
Melbourne, Victoria, Australia
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Site 77
Seongnam-si, South Korea
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Site 78
Lodz, 92-213, Poland
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Site 79
Warsaw, 04-141, Poland
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Site 8
Centennial, Colorado, 80112, United States
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Site 80
Nagasaki, 852-8501, Japan
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Site 81
Coimbra, 3004-561, Portugal
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Site 82
Lisbon, 1649-028, Portugal
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Site 83
Vienna, 1090, Austria
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Site 84
Santa Cruz de Tenerife, 38010, Spain
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Site 85
Milan, 20157, Italy
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Site 86
Dallas, Texas, 75231, United States
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Site 9
Birmingham, Alabama, 35209, 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
- Smartphone study reveals hidden toll of hereditary angioedema
- New RNA drug shows promise in preventing HAE attacks in ongoing study