Active not recruitingPHASE2INTERVENTIONAL

A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema

This important study is investigating STAR-0215, a potential new treatment for Hereditary Angioedema (HAE). The main aim is to gather information on how safe the treatment is and how well it works over a longer period. People taking part will receive STAR-0215 repeatedly for up to five years. This will help doctors understand its long-term benefits and any potential side effects. The study welcomes individuals who have previously participated in a related STAR-0215 study, as well as new participants who have been diagnosed with HAE Type 1 or Type 2. By understanding the long-term effects, researchers hope to improve care for people living with HAE.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Astria Therapeutics, Inc.

Enrolment target

Start

26 Sep 2023

Estimated completion

01 Mar 2031

Hereditary Angioedema

What is this study about?

Hereditary Angioedema (HAE) is a rare genetic condition that causes sudden and unpredictable swelling attacks in various parts of the body, such as the skin, stomach, or airways. These attacks can be painful, debilitating, and sometimes life-threatening. Finding effective and safe long-term treatments is crucial for improving the quality of life for people with HAE.

This study is focusing on a new investigational medication called STAR-0215. The purpose of this research is to learn more about how STAR-0215 works over many years. Doctors want to understand its long-term safety profile – meaning, are there any side effects that appear after taking it for a long time? They also want to see how effective it is at preventing or reducing HAE attacks when used over an extended period.

By carefully observing participants over a period of up to five years, researchers hope to gain valuable insights into the full impact of STAR-0215. This information will help healthcare professionals and patients make informed decisions about HAE treatment in the future. The findings from this study could potentially contribute to better management of HAE and a better quality of life for those affected.

Key takeaways

This study is looking at the long-term effects of STAR-0215 for Hereditary Angioedema.
It aims to understand both the safety and effectiveness of the treatment over several years.
Participants will receive STAR-0215 regularly for up to five years.
Both previous study participants and new HAE patients may be able to join.
Regular medical check-ups will be part of taking part.
Your participation could help improve future treatments for HAE.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with Hereditary Angioedema (HAE). There are two main groups of people who might be able to join.

The first group includes those who have previously taken part in another STAR-0215 study (called STAR-0215-201). This includes people who finished that study, or who started it but didn't quite meet all the requirements for its main treatment part, or those who stopped for reasons not related to safety after spending at least 84 days in that study.

The second group are individuals who have never taken STAR-0215 before and who were not in the earlier study, but who have a confirmed diagnosis of HAE Type 1 or Type 2. However, you would not be able to join if you have other types of swelling conditions that are not HAE, or if you have recently used certain medications like ACE inhibitors, specific hormone-containing medicines (like some birth control or hormone replacement therapies), or certain male hormones. Also, if you’ve recently used other medications specifically for preventing HAE attacks, you might need to wait a certain period before being able to join.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of Hereditary Angioedema (HAE Type 1 or Type 2)?
Have you recently used certain medications like ACE inhibitors, specific hormones, or male hormones? (If yes, you may not be immediately eligible)
Are you currently using other preventative HAE treatments? (If yes, this may affect your eligibility)
Are you comfortable with regular clinic visits and long-term follow-up?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will receive doses of STAR-0215 over a period of up to five years. The exact schedule for taking the medication and for your clinic visits will be provided by the study team. You will have regular appointments where doctors will check your health, monitor for any side effects, and see how the treatment is working. This will likely involve examinations, blood tests, and discussions about any HAE attacks you experience. The study team will explain everything in detail, including the total number of visits and the overall duration of your participation.

Potential risks and benefits

Participating in any clinical study comes with potential benefits and risks. A potential benefit of taking part in this study is receiving a new investigational treatment for HAE, which might help to reduce your attacks – however, this is not guaranteed. You will also receive careful medical monitoring and contribute to valuable research that could help others with HAE in the future. Potential risks might include side effects from the study medication, which the study team will monitor closely. There might also be inconvenience from the study visits. It’s very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (22)

Allervie Clinical Research
Birmingham, United States
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD
Scottsdale, United States
Acuro Research
Little Rock, United States
UC San Diego US HAEA Angioedema Center
San Diego, United States
Raffi Tachdjian MD, Inc
Santa Monica, United States
Allergy & Asthma Clinical Research
Walnut Creek, United States
Institute for Asthma and Allergy, PC
Chevy Chase, United States
Massachusetts General Hospital
Boston, United States
Washington University School of Medicine
St Louis, United States
Optimed Research
Columbus, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, United States
AARA Research Center
Dallas, United States

+10 more sites — see the official record for the full list.

Common questions

What is Hereditary Angioedema (HAE)?

HAE is a rare genetic condition causing sudden and unpredictable swelling in various body parts, which can be painful and serious.

What is STAR-0215?

STAR-0215 is an investigational medication being studied for its potential to treat Hereditary Angioedema.

How long will the study last for each participant?

If you join, you could be taking part in this study for up to five years to assess the long-term effects of STAR-0215.

Can I join if I haven't been in a previous STAR-0215 study?

Yes, new participants who have a confirmed diagnosis of HAE Type 1 or Type 2 and haven't used STAR-0215 before may be eligible.

What if I decide I don't want to continue in the study?

You are free to leave the study at any time, for any reason, without it affecting your regular medical care.