Navenibart for Angioedema
(ALPHA-ORBIT Trial)

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Astria Therapeutics, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2 hereditary angioedema (HAE). 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.

Eligibility Criteria

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

I have a documented history of hereditary angioedema.

My lab results show I have Hereditary Angioedema Type 1 or 2.

I have had at least 2 HAE attacks recently.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous administration of navenibart or placebo to evaluate efficacy and safety in preventing HAE attacks

12 months

Every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The trial is testing navenibart, administered subcutaneously, against a placebo to see if it can prevent attacks in people with hereditary angioedema. It's a phase 3 study where participants are randomly assigned to either the drug or placebo group without knowing which one they receive.

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Adult Navenibart Dosing Regimen 3Experimental Treatment1 Intervention

Participants will receive 600 mg of navenibart every 6 months.

Group II: Adult Navenibart Dosing Regimen 2Experimental Treatment1 Intervention

Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.

Group III: Adult Navenibart Dosing Regimen 1Experimental Treatment1 Intervention

Participants will receive 600 mg of navenibart every 3 months.

Group IV: Adolescent Navenibart Dosing Regimen 1Experimental Treatment1 Intervention

Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.

Group V: Placebo (adult)Placebo Group1 Intervention