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A trial to learn about a study drug (STAR-0215) in adults with hereditary angioedema
EU CTIS ID: 2022-502953-32-01
What this study is testing
To assess the safety and tolerability of subcutaneous (SC) administration of single and multiple doses of STAR-0215 in participants with Type I or Type II hereditary angioedema (HAE)
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- At least 18 years of age at the time of Screening.
- Willing and able to read, understand, and sign the IRB/IEC/REC approved informed consent form (ICF).
- Documented diagnosis of HAE (Type I or II). All of the following must be met: a. Documented clinical history consistent with HAE (e.g. SC or mucosal, nonpruritic swelling episodes without accompanying urticaria); c. Age at reported onset of first angioedema symptoms 30 years of age or younger, or a family history consistent with HAE Type I or II.
- Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.
You likely can't join if
- Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1inhibitor deficiency, HAE with normal C1-INH (also known as HAE Type III), idiopathic angioedema, or angioedema associated with urticaria.
- Use of therapies prescribed for the prevention of HAE attacks prior to Screening: a.lanadelumab within 90 days; b.berotralstat within 21 days; c.all other prophylactic therapies, within 7 days.
- Any exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy [HRT]) within 28 days prior to Screening.
- Any exposure to androgens (e.g. stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.