Navenibart for Angioedema
(ALPHA-ORBIT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called navenibart for individuals with hereditary angioedema (HAE), a condition causing sudden swelling attacks. The goal is to determine if navenibart can safely and effectively prevent these attacks better than a placebo. Participants may receive varying doses of navenibart or a placebo for comparison. Ideal candidates have type 1 or type 2 HAE and have experienced at least two recent swelling attacks. This trial could provide a new option for managing HAE and reducing the impact of these attacks on daily life. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for HAE.
Do I have to stop taking my current medications for the trial?
Yes, if you are taking certain medications to prevent HAE attacks, you will need to stop them before joining the trial. There are specific time frames for stopping each medication, ranging from 3 to 90 days before the trial's Run-In period.
Is there any evidence suggesting that navenibart is likely to be safe for humans?
A previous study found that navenibart was well tolerated by participants. Researchers tested doses up to 1200 mg in humans, and the treatment showed a favorable safety profile, meaning most people did not experience severe side effects. It also proved effective over time, aiding in extended symptom control. Research indicates that it reduces the frequency of HAE attacks, a promising sign for those considering this treatment. Overall, the safety data suggests that navenibart is generally safe for use in humans.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about Navenibart for angioedema because it offers a potentially novel approach compared to existing treatments like antihistamines, corticosteroids, and C1 inhibitors. Unlike these standard therapies, Navenibart may work with a different mechanism, potentially targeting pathways that are not addressed by current options. With several dosing regimens being tested, including both every three months and every six months, Navenibart could provide more flexible and less frequent treatment schedules. This could mean fewer disruptions for patients and better management of symptoms, which is a big step forward in treating angioedema.
What evidence suggests that navenibart might be an effective treatment for hereditary angioedema?
Studies have shown that navenibart can significantly reduce the frequency and severity of hereditary angioedema (HAE) attacks. Research indicates that individuals taking navenibart experience fewer attacks and require less emergency medication. Additionally, patients reported improved quality of life with navenibart. The treatment blocks plasma kallikrein, a substance in the blood involved in HAE attacks, providing long-lasting protection. Overall, evidence supports navenibart as a promising option for preventing HAE attacks. Participants in this trial will receive one of several dosing regimens of navenibart or a placebo to further evaluate its effectiveness.34567
Are You a Good Fit for This Trial?
Adults and adolescents with a documented history of hereditary angioedema (HAE) types 1 or 2, who have had at least two HAE attacks during the run-in period. Participants must meet specific lab criteria for HAE.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous administration of navenibart or placebo to evaluate efficacy and safety in preventing HAE attacks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Navenibart
Find a Clinic Near You
Who Is Running the Clinical Trial?
Astria Therapeutics, Inc.
Lead Sponsor