Navenibart for Hereditary Angioedema
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the long-term safety and effectiveness of a treatment called navenibart for individuals with hereditary angioedema (HAE), a condition that causes severe swelling. The trial consists of two parts: initially, all participants receive a set dose of navenibart, and later, doses are adjusted based on individual needs. Participants will receive different dosing regimens, such as 300 mg or 600 mg, at varying intervals. This trial is suitable for those who participated in a previous study (STAR-0215-301) and have hereditary angioedema. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially bringing a new treatment to market.
Will I have to stop taking my current medications?
You will need to stop taking any ACE inhibitors or estrogen-containing medications (like certain birth control pills or hormone therapies) at least 30 days before joining the trial. The protocol does not specify other medications, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that navenibart is likely to be safe for humans?
A previous study found navenibart safe for patients, even at doses up to 1200 mg, with most participants experiencing no serious side effects. Research has shown that navenibart remains in the body for an extended period, helping to reduce the frequency and severity of hereditary angioedema (HAE) attacks. Another study compared navenibart to a placebo, examining its safety and effectiveness in preventing HAE attacks. These studies suggest that navenibart is generally safe for individuals with HAE.12345
Why do researchers think this study treatment might be promising for hereditary angioedema?
Navenibart is unique because it offers a new dosing flexibility for treating hereditary angioedema, which could be more convenient for patients. Most current treatments for this condition, like C1 inhibitors or bradykinin receptor antagonists, require more frequent administrations. Navenibart allows for less frequent dosing, with options for either a 3-month or 6-month interval, potentially improving adherence and lifestyle for patients. Additionally, the option to adjust dosing based on age and specific needs could make it more adaptable to individual patient circumstances. Researchers are excited about the potential for Navenibart to simplify treatment regimens and enhance quality of life for patients.
What evidence suggests that this trial's treatments could be effective for hereditary angioedema?
Research has shown that navenibart can significantly reduce the frequency and severity of hereditary angioedema (HAE) attacks. This trial will test different dosing regimens of navenibart, allowing participants to receive it every 3 or 6 months. Studies have found that navenibart helps prevent these attacks for extended periods. The treatment is generally safe and well-tolerated. Participants in those studies experienced fewer HAE attacks and required less emergency medication during attacks. Overall, navenibart offers hope for lasting relief from HAE symptoms.13467
Are You a Good Fit for This Trial?
This clinical trial is for adults and adolescents with hereditary angioedema (HAE) who were previously part of the STAR-0215-301 study. Specific eligibility criteria are not provided, but typically participants must meet certain health standards to be included.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive navenibart in a dose-controlled fashion
Treatment Part 2
Participants receive personalized dosing option (PDO) based on individual needs
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Navenibart
Trial Overview
The trial is testing navenibart's long-term safety and effectiveness in two parts: initially providing a controlled dose to all participants, followed by personalized dosing based on individual needs.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive 600 mg of navenibart every 6 months.
Participants will receive 300 mg of navenibart every 3 months.
Participants will receive 600 mg of navenibart every 3 months.
Participants will receive 300 mg of navenibart every 3 months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Astria Therapeutics, Inc.
Lead Sponsor
Citations
1.
ir.astriatx.com
ir.astriatx.com/news-releases/news-release-details/astria-therapeutics-announces-final-positive-results-allAstria Therapeutics Announces Final Positive Results from ...
These results reinforce the potential of navenibart's profile to provide effective, long-acting prevention from HAE attacks and highlight ...
FINAL RESULTS FROM ALPHA-STAR, A PHASE 1B/2 ...
Navenibart robustly and durably decreased the HAE attack rate with a favorable safety profile. Every 3- and 6-month regimens are currently being investigated in ...
Treatment with Navenibart (STAR-0215) Reduces Attack ...
This interim analysis suggests that navenibart reduces the burden of HAE, assessed by reduction in HAE attack frequency, severity and use of rescue medication.
NCT06842823 | A Study of Navenibart in Participants With ...
The goal of this clinical trial is to evaluate the efficacy and safety of navenibart compared to placebo in preventing HAE attacks in participants with HAE.
Safety and pharmacokinetics of long-acting plasma ...
In this first-in-human study, up to 1200 mg of navenibart was well tolerated and demonstrated an extended half-life with durable plasma kallikrein inhibition.
Navenibart (STAR-0215)
Navenibart is in clinical development for the treatment of hereditary angioedema. ... safety and tolerability profile, reduction in the mean monthly attack ...
7.
ir.astriatx.com
ir.astriatx.com/news-releases/news-release-details/astria-therapeutics-announces-positive-initial-results-alphaAstria Therapeutics Announces Positive Initial Results from ...
Navenibart demonstrated overall attack-freedom of 50% over six months, which is the longest period of follow-up for all 16 patients to date.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.