Navenibart

DRUG6 trials

Sponsors

Astria Therapeutics Inc., Astria Therapeutics, Inc.

Conditions

Hereditary AngioedemaHereditary Angioedema (HAE)

Phase 1

A Study of Navenibart (STAR-0215) in Participants With Hereditary Angioedema

CompletedNCT05695248

Astria Therapeutics, Inc.Hereditary Angioedema

Start: 2023-02-21End: 2025-03-13Updated: 2026-05-08

Phase 2

A Phase 2 Long-Term Open-Label Trial to Assess the Safety and Efficacy of Repeat Dosing of STAR-0215 in Adult Patients with Hereditary Angioedema (The ALPHA-SOLAR Trial)

Active, not recruitingCTIS2023-506540-16-01

Astria Therapeutics Inc.Hereditary Angioedema

Start: 2025-01-20Target: 26Updated: 2026-01-27

Phase 3

A Study of Navenibart in Participants With Hereditary Angioedema

Active, not recruitingNCT06842823

Astria Therapeutics, Inc.Hereditary Angioedema (HAE)

Start: 2025-03-20End: 2027-06-01Updated: 2026-06-30

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants with Hereditary Angioedema - ALPHA-ORBIT

RecruitingCTIS2025-521660-35-00

Astria Therapeutics Inc.Hereditary Angioedema

Start: 2025-09-11Target: 53Updated: 2026-01-26

A Long-Term Study of Navenibart in Participants With Hereditary Angioedema

Enrolling by invitationNCT07204938

Astria Therapeutics, Inc.Hereditary Angioedema (HAE)

Start: 2025-10-01End: 2031-12-01Target: 145Updated: 2026-07-30

A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants with Hereditary Angioedema – ORBIT-EXPANSE

Not yet recruitingCTIS2025-521142-22-00

Astria Therapeutics Inc.Hereditary Angioedema

Target: 17Updated: 2026-02-10