Navenibart for Angioedema

(ALPHA-ORBIT Trial)

Recruiting at 11 trial locations

Overseen By Claire VanEenwyk, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Astria Therapeutics, Inc.

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 months

145 Participants Needed

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.

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

Treatment Details

Interventions

• Navenibart

Trial Overview 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.

Participant Groups

Group I: Adult Navenibart Dosing Regimen 3 Experimental Treatment 1 Intervention

Participants will receive 600 mg of navenibart every 6 months.

Group II: Adult Navenibart Dosing Regimen 2 Experimental Treatment 1 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 1 Experimental Treatment 1 Intervention

Participants will receive 600 mg of navenibart every 3 months.

Group IV: Adolescent Navenibart Dosing Regimen 1 Experimental Treatment 1 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 Group 1 Intervention

Participants will receive placebo every 3 months.

Who Is Running the Clinical Trial?

Astria Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

310+