ALPHA-STAR is a Phase 1b/2 proof-of-concept clinical trial evaluating STAR-0215 as a potential long-acting treatment for prevention of HAE attacks.
ALPHA-STAR is a clinical trial for people living with HAE types I and II that is evaluating STAR-0215 as a potential long-acting treatment for prevention of HAE attacks. STAR-0215 is an investigational drug, which has not yet been authorized by government authorities for use other than in clinical trials.
The goals of the ALPHA-STAR trial are to evaluate the safety and tolerability of subcutaneous administration of STAR-0215 in people with HAE, assess the effect of STAR-0215 on HAE attacks and quality of life, and study how STAR-0215 works in the body.
The trial is taking place at sites across the globe. All qualifying participants will receive one or two doses of STAR-0215.
Are 18 years or older
Are not on preventative therapy
Individuals currently on preventative therapy and interested in participating should consult with their physician to discuss the risks and benefits before discontinuing medication
Have a confirmed diagnosis of
HAE type I or II
Note: If a participant experiences HAE attacks during the trial, they will be able to use standard-of-care on-demand treatment as prescribed by their physician
Access to an investigational drug
Trial-related support and monitoring by a healthcare team
Reimbursement for reasonable
trial-related travel expenses
Contact 201Study_general@astriatx.com for more information and check out our trial site locations below.
To be connected to your closest site, email:
201Study_general@astriatx.com
Hereditary angioedema (HAE) is a rare genetic disorder that causes unpredictable attacks of swelling in the face, limbs, abdomen, and airway. These attacks can be severe, painful, disabling, and potentially life-threatening.
Most cases of HAE are caused by insufficient levels of functional C1-inhibitor, a protein that regulates plasma kallikrein, a critical mediator of bradykinin-induced edema.
STAR-0215 is an investigational drug, which has not yet been authorized by government authorities for use other than in clinical trials.
STAR-0215 is an investigational monoclonal antibody inhibitor of plasma kallikrein with the potential to provide long-acting attack prevention for HAE with subcutaneous dosing (an injection given in the fatty tissue just under your skin using a small needle) once every 3 and 6 months.
Targeted plasma kallikrein inhibition can prevent HAE attacks by suppressing the pathway that generates bradykinin and causes swelling.
STAR-0215 has previously been tested in preclinical studies, as well as evaluated in people who do not have HAE.
“Investigational” means that STAR-0215 is being tested in clinical trials and has not yet been authorized for use other than in clinical trials by the government authorities in your country, such as the Food and Drug Administration in the United States.
Yes, all qualifying participants will receive one or two doses of STAR-0215.
Participation in the trial has three steps:
Screening Visit: The initial trial visit where potential participants are checked to make sure they meet the eligibility criteria for the trial and that it is safe for them to take part.
Run-in: An 8-week period before participants receive the investigational drug when the trial site will contact participants routinely to check if they have had any HAE attack(s).
Treatment Period and Follow-Up: Participants receive the investigational drug and have their health monitored over several months during visits to the trial site.