Study of Navenibart to prevent attacks in adults and adolescents with Hereditary Angioedema

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What is this study about?

This study focuses on people with Hereditary Angioedema (HAE), a rare genetic condition that causes unexpected episodes of severe swelling in various parts of the body. The research evaluates a new medication called Navenibart (also known as STAR-0215), which is being tested to see if it can prevent HAE attacks from occurring.

The study compares Navenibart against placebo to determine how effective it is in reducing the frequency of HAE attacks. During the study, participants will receive either Navenibart or placebo as a subcutaneous (under the skin) injection. The treatment period lasts for 6 months, during which participants will be monitored for any HAE attacks and their severity.

Throughout the study, researchers will track how many HAE attacks occur and how severe they are. They will also monitor the overall well-being of participants and any changes in their quality of life. The medication will be tested in both adults and adolescents with HAE to evaluate its safety and effectiveness in preventing attacks.

1 Initial period – Run-in phase

Your hereditary angioedema (HAE) attacks will be monitored to establish your baseline attack frequency.

You need to experience at least 2 HAE attacks during this period to continue in the study.

2 Treatment assignment

You will be randomly assigned to receive either Navenibart or a matching placebo.

Neither you nor your doctor will know which treatment you are receiving.

3 Treatment period – 6 months

You will receive subcutaneous injections (under the skin) of the study medication.

Your HAE attacks will be monitored and confirmed by the study doctor.

You may receive additional treatment if needed for any HAE attacks that occur.

Your quality of life will be assessed using a questionnaire.

Any side effects will be monitored and recorded.

4 Evaluation points

The study will track:

– Number of HAE attacks during the 6-month period

– Severity of attacks (moderate or severe)

– Number of attacks requiring additional treatment

– Time between receiving medication and first attack

– Changes in your quality of life

– Any side effects you may experience

5 Study completion

The treatment period ends after 6 months.

Final assessments will be conducted to evaluate the medication’s effectiveness and safety.

Who Can Join the Study?

Must have a confirmed diagnosis of Hereditary Angioedema (HAE) Type 1 or Type 2, supported by:
- Medical history showing typical HAE symptoms
- Laboratory test results confirming the condition
Must have experienced at least 2 HAE attacks during the initial observation period (Run-In period), which need to be verified by the study doctor
Can be either male or female
Must be an adolescent or adult (12 years and older)
Must be able to have their HAE attacks confirmed according to the study’s specific definition
Must be willing to participate in the study’s observation period before receiving treatment

Who Cannot Join the Study?

History of severe allergic reactions to any medications
Active liver disease (problems with liver function)
Pregnant or breastfeeding women
Participation in another clinical trial within the past 30 days
Major surgery planned during the study period
Uncontrolled high blood pressure (blood pressure that remains high despite treatment)
History of blood clotting disorders (conditions that affect blood’s ability to form clots)
Severe kidney problems (poor kidney function)
Active cancer or ongoing cancer treatment
History of drug or alcohol abuse within the past year
Severe mental health conditions that could affect participation
Taking medications that could interfere with the study drug
Unable to follow study procedures or attend scheduled visits
Any condition that, in the investigator’s opinion, makes participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Medical University Of Vienna	Vienna	Austria
Centre Hospitalier Universitaire De Lille	Lille	France
Medical University Of Graz	Graz	Austria
CHU Grenoble Alpes	La Tronche	France
Hospitais da Universidade de Coimbra	Coimbra	Portugal
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Diagnostics And Consultation Center Convex Ltd.	Sofia	Bulgaria
ASST Fatebenefratelli Sacco	Milan	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Azienda Ospedaliera di Padova	Padua	Italy
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Hospital Universitario Nuestra Senora De Candelaria	Santa Cruz De Tenerife	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
IRCCS Policlinico San Donato	San Donato Milanese	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Semmelweis University	Budapest	Hungary
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Centre Hospitalier Universitaire De Nice	Nice	France
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Hopital Beaujon	Clichy	France
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Ujbt Crilafcq Tdfziz Str z onwj	Lodz	Poland
Piuvowdkbjsb Mpkyvbanlv Pwlzhigg Gpzbvqs Lhhuqoyy	Rzeszow	Poland
Fpgcrgcz nampxdxhs Mfeyj a Hbjidhx	Prague	Czechia
Adhvjsrpz Uvh	Amsterdam	The Netherlands
Atlyyhvlma Ppeyjgre Hwpedfwm Dq Modklsvfs	Marseille	France
Gmyjfj Uvwdypcejl Fxsgpkdjq	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	30.08.2025
Bulgaria	Recruiting	30.08.2025
Czechia	Recruiting	30.08.2025
France	Recruiting	30.08.2025
Germany	Recruiting	30.08.2025
Hungary	Recruiting	30.08.2025
Italy	Recruiting	30.08.2025
Poland	Recruiting	30.08.2025
Portugal	Recruiting	30.08.2025
Spain	Recruiting	30.08.2025
The Netherlands	Recruiting	30.08.2025

Trial locations

Investigated drugs:

NAVENIBART

Navenibart is an investigational medication being studied for preventing attacks in people with Hereditary Angioedema (HAE). HAE is a rare genetic condition that causes sudden episodes of swelling in various parts of the body. This medication is being tested to see if it can reduce the frequency of these swelling attacks and help manage the condition in both adults and adolescents.

Investigated diseases:

Hereditary angioedema

Hereditary Angioedema – A rare genetic condition that causes recurring episodes of severe swelling in various parts of the body. The swelling can affect the hands, feet, face, intestinal walls, and airways. Episodes of swelling develop over 24 hours and typically last for 2-3 days without treatment. The condition is caused by a deficiency or dysfunction of certain blood proteins that help regulate swelling. Between episodes, patients may have no visible symptoms. The frequency of attacks varies greatly among individuals, with some experiencing weekly episodes while others have them only occasionally.

Trial ID:

2025-521660-35-00

Protocol code:

STAR-0215-301

NCT ID:

NCT06842823

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Navenibart to prevent attacks in adults and adolescents with Hereditary Angioedema

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