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Study on the Safety and Effects of STAR-0215 for Adults with Hereditary Angioedema

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What is this study about?

This clinical trial is focused on studying a condition known as Hereditary Angioedema (HAE), which is a rare genetic disorder that causes sudden and severe swelling in various parts of the body. The study is investigating a new treatment called STAR-0215, which is administered as a sterile solution through a small injection under the skin, known as subcutaneous use. The main goal of the study is to evaluate the safety and tolerability of this treatment in adults with Type I or Type II HAE.

Participants in the trial will receive either a single dose or multiple doses of STAR-0215. Throughout the study, researchers will monitor participants for any side effects and changes in their health, such as vital signs and laboratory test results. The study will also look at how often HAE attacks occur, how severe they are, and how long they last. Additionally, the study will measure the levels of STAR-0215 in the blood and check for any immune response to the treatment.

The trial is expected to continue until October 2024, with recruitment having started in September 2023. This research aims to provide valuable information about the potential of STAR-0215 as a treatment option for people living with Hereditary Angioedema, potentially improving their quality of life by reducing the frequency and severity of swelling episodes.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a documented diagnosis of hereditary angioedema (HAE) and ensuring the participant is at least 18 years old.

The participant must have experienced at least two HAE attacks during the run-in period, as confirmed by an investigator.

2 informed consent

The participant is required to read, understand, and sign an informed consent form. This document outlines the study’s purpose, procedures, and potential risks.

3 medication administration

The study involves the administration of STAR-0215, a sterile solution, through subcutaneous injection. This means the medication is injected under the skin.

The study includes both single and multiple dose phases to assess the safety and tolerability of the medication.

4 monitoring and evaluation

Throughout the trial, the participant’s health is closely monitored. This includes tracking any adverse events, changes in vital signs, and results from physical examinations and laboratory tests.

The study also evaluates the frequency and severity of HAE attacks, as well as the duration of these attacks.

5 end of trial

The trial is expected to conclude by October 20, 2024. At the end of the study, a final assessment is conducted to evaluate the overall impact of STAR-0215 on the participant’s condition.

Who Can Join the Study?

  • Must be at least 18 years old at the time of screening.
  • Must be willing and able to read, understand, and sign the approved informed consent form. This is a document that explains the study and what participation involves.
  • Must have a documented diagnosis of Hereditary Angioedema (HAE), which is a condition that causes episodes of swelling. This includes:
    • A clinical history that matches HAE, such as swelling episodes that occur under the skin or in mucous areas, without itching or hives.
    • First symptoms of swelling started at age 30 or younger, or there is a family history of HAE Type I or II.
  • Must have experienced at least 2 HAE attacks during the initial period of the study, as confirmed by a study investigator. An HAE attack is a period when the swelling symptoms occur.

Who Cannot Join the Study?

  • Participants who have any other serious health conditions that could interfere with the study.
  • Individuals who are currently participating in another clinical trial.
  • People who have had a recent surgery or are planning to have surgery during the study period.
  • Participants who are pregnant or breastfeeding.
  • Individuals with a history of drug or alcohol abuse.
  • People who have an allergy to the study medication or its ingredients.
  • Participants who are unable to comply with the study procedures or follow-up visits.
  • Individuals who have received certain medications that could affect the study results.
  • People with a history of certain heart conditions.
  • Participants who have uncontrolled high blood pressure.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Universitaetsklinikum Ulm AöR Ulm Germany
Gmkjdm Ujconyptgm Fjkypinad Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
29.09.2023
Czechia Czechia
Not recruiting
29.09.2023
Germany Germany
Not recruiting
29.09.2023
Poland Poland
Not recruiting
29.09.2023

Trial locations

Investigated drugs:

STAR-0215 is a medication being studied for its safety and tolerability in people with hereditary angioedema, a condition that causes sudden swelling. The trial is investigating how the body processes and responds to this medication when given in single and multiple doses under the skin. The study aims to understand how well the medication works and if it causes any side effects.

Investigated diseases:

Hereditary Angioedema – Hereditary Angioedema (HAE) is a rare 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, as well as the intestinal walls, leading to abdominal pain. The condition is caused by a deficiency or dysfunction of a protein called C1 inhibitor, which helps regulate blood vessel permeability. During an attack, the lack of this protein leads to an overproduction of bradykinin, a peptide that increases blood vessel permeability, resulting in swelling. The frequency and severity of attacks can vary greatly among individuals, with some experiencing frequent and severe episodes, while others have milder symptoms. Swelling episodes can last from several hours to a few days and can be triggered by stress, trauma, or hormonal changes.

Trial ID:
2022-502953-32-01
Protocol code:
STAR-0215-201
NCT ID:
NCT05695248
Trial Phase:
Human Pharmacology (Phase I) – Other

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