Study on the Long-Term Safety of STAR-0215 for Adults with Hereditary Angioedema

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What is this study about?

This clinical trial is focused on studying hereditary angioedema, a rare genetic condition that causes sudden swelling in various parts of the body, such as the face, hands, and feet. The study will use a treatment called STAR-0215, which is administered as a sterile solution through subcutaneous use, meaning it is injected under the skin. The purpose of the study is to assess the long-term safety and tolerability of this treatment in adults with hereditary angioedema.

Participants in the trial will receive repeat doses of STAR-0215 over a period of time. The study will monitor the occurrence of any adverse events, which are unexpected medical problems that may happen during the trial. Additionally, the study will observe changes in the frequency and severity of hereditary angioedema attacks, as well as the duration of these attacks. The trial will also look at how long it takes for an attack to occur after each dose and the number of days participants remain free from attacks.

Throughout the study, researchers will measure the concentration of STAR-0215 in the body and any changes in plasma kallikrein activity, which is a protein involved in the swelling process. The formation of antibodies against the drug will also be monitored. This trial aims to provide valuable information on the effectiveness and safety of STAR-0215 for individuals living with hereditary angioedema.

1 initial assessment

Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and confirming a diagnosis of hereditary angioedema (HAE).

Eligibility is based on specific criteria, such as age and previous participation in related studies. For those new to STAR-0215, a documented history of HAE and specific laboratory tests are required.

2 baseline evaluation

A baseline evaluation is performed to establish a starting point for the trial. This involves measuring the frequency and severity of HAE attacks before starting the treatment.

The evaluation helps in comparing changes during the trial period.

3 treatment administration

The study drug, STAR-0215, is administered as a sterile solution through subcutaneous use. The dosage and frequency are determined by the study protocol.

The primary goal is to assess the long-term safety and tolerability of the drug in managing HAE.

4 monitoring and follow-up

Regular monitoring is conducted to track the incidence of adverse events and changes in the frequency and severity of HAE attacks.

Participants are observed for any side effects and the effectiveness of the treatment in reducing HAE attacks.

5 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation is performed to assess the overall impact of the drug.

This includes measuring the number of HAE attack-free days and any changes in plasma kallikrein activity.

6 final assessment

A final assessment is conducted to determine the formation of any anti-drug antibodies and to evaluate the long-term safety of the treatment.

The trial aims to conclude by March 31, 2031, with ongoing assessments throughout the study period.

Who Can Join the Study?

Must be at least 18 years old at the time of screening.
If previously participated in the STAR-0215-201 study, must have completed all visits through 6 months after the last dose, or met specific criteria related to participation and consultation with the Medical Monitor.
If new to the STAR-0215 study and not enrolled in STAR-0215-201, must have a documented diagnosis of Hereditary Angioedema (HAE), which is a condition causing episodes of swelling.
Must have a clinical history consistent with HAE, such as swelling episodes without itching.
Must have experienced the first symptoms of angioedema at age 30 or younger, or have a family history of HAE.
Must have specific levels of a protein called C1-esterase inhibitor (C1-INH), which is involved in controlling swelling. These levels will be tested during screening.
If new to the STAR-0215 study, must have had at least 2 HAE attacks during the Run-In Period, confirmed by a study investigator.

Who Cannot Join the Study?

Individuals who do not have a diagnosis of Hereditary Angioedema. This is a rare genetic condition that causes sudden swelling in different parts of the body.
Participants who are not within the specified age range for the study.
Individuals who are part of a vulnerable population, which means they might need special protection or care.
Participants who do not meet other specific health criteria set by the study.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Diagnostics And Consultation Center Convex Ltd.	Sofia	Bulgaria
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	01.12.2024
Czechia	Not recruiting	01.12.2024
Germany	Not recruiting	01.12.2024
Poland	Not recruiting	01.12.2024

Trial locations

Investigated drugs:

NAVENIBART

STAR-0215 is a medication being studied for its safety and effectiveness in treating hereditary angioedema, a condition that causes sudden swelling in different parts of the body. This trial is focused on understanding how well patients tolerate the medication over a long period and whether it helps in managing the symptoms of hereditary angioedema.

Investigated diseases:

Hereditary angioedema

Hereditary Angioedema – Hereditary Angioedema is a genetic disorder characterized by recurrent episodes of severe swelling. This swelling can occur in various parts of the body, including the hands, feet, face, and airway. The condition is caused by a deficiency or dysfunction of a protein called C1 inhibitor, which leads to an overproduction of bradykinin, a peptide that increases blood vessel permeability. Swelling episodes can be triggered by stress, trauma, or hormonal changes, but they often occur without a clear cause. The frequency and severity of attacks can vary widely among individuals. Swelling in the airway can be particularly dangerous, requiring immediate medical attention.

Trial ID:

2023-506540-16-01

Protocol code:

STAR-0215-202

NCT ID:

NCT06007677

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Long-Term Safety of STAR-0215 for Adults with Hereditary Angioedema

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