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A study of Navenibart in Participants with Hereditary Angioedema
EU CTIS ID: 2025-521660-35-00
What this study is testing
1) For adults - To assess the superiority of navenibart compared to placebo in preventing HAE attacks in participants with Hereditary Angioedema (HAE). 2) For adolescents - To assess the efficacy of navenibart in preventing HAE attacks in participants with HAE 3) For adolescents - to assess the safety and tolerability of navenibart as a preventive treatment in participants with HAE.
- Therapeutic confirmatory (Phase III)
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
- Documented diagnosis of HAE (Type 1 or 2). The following must be met: a. Documented clinical history consistent with HAE b. Lab findings consistent with HAE Type 1 or 2
- 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 C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type 3), idiopathic angioedema, or angioedema associated with urticaria
- Use of therapies prescribed for the prevention of HAE attacks may not be used during the trial or within the below time frames prior to the Run-In Period (adult participants may be on these medications at the time of the Screening Visit, but will need to washout prior to entering the Run-In Period): a. Lanadelumab within 70 days prior to Run-In b. Berotralstat within 21 days prior to Run-In c. Garadacimab within 90 days prior to Run-In d. Plasma-derived C1INH for LTP within 14 days prior to Run-In e. Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In f. All other prophylactic therapies, including investigational drugs, require consultation with the Medical Monitor
- Any exposure to angiotensin-converting enzyme inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 30 days before Screening.
The study team makes the final eligibility decision.
Where it's taking place
- South Africa
- New Zealand
- United States
- Brazil
- Australia
- Japan
- Israel
- Korea, Republic of
- Canada
- North Macedonia
- United Kingdom
- Hong Kong
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, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South Africa; New Zealand; United States; Brazil; Australia; Japan and 6 more location(s). 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.