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Enrolling by Invitation

NCT Number: NCT07204938

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

This is a Phase 3 multicenter trial in 2 parts to evaluate the long-term safety and efficacy of navenibart in adult and adolescent participants with hereditary angioedema (HAE) who participated in STAR-0215-301 (NCT06842823; ALPHA-ORBIT). Part 1 provides all participants with navenibart in a dose-controlled fashion; Part 2 introduces a personalized dosing option (PDO) for participants based on individual needs.

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Key information

Conditions

Hereditary Angioedema (HAE) Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 22, Santo André, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants from STAR-0215-301 who met one of the following conditions:
  • Completed STAR-0215-301 through the Day 181 visit
  • Withdrew from STAR-0215-301 but met the following criteria:

i. Received 2 doses of IP ii. completed ≥ 2 months of trial follow-up after the second dose of IP iii. Met other eligibility criteria as assessed by Investigator

Exclusion criteria

  • Participation in an investigational clinical trial other than STAR-0215- 301 in the 30 days or any exposure to an investigational drug (other than navenibart in STAR-0215-301) within 5 half-lives before informed consent/assent
  • Any exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 30 days before Screening.
  • Known sensitivity to the ingredients in the formulation of IP

Treatment and study plan

navenibart

Drug

Navenibart will be administered as a subcutaneous injection.

Other names: STAR-0215

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Day 1 through Month 48

Secondary outcomes

  1. Number of time-normalized investigator-confirmed HAE attacks

    Time frame: Day 1 through Month 48

  2. Number of moderate or severe investigator-confirmed HAE attacks

    Time frame: Day 1 through Month 48

  3. Number of investigator-confirmed HAE attacks that require on-demand treatment

    Time frame: Day 1 through Month 48

  4. Percent reduction in monthly investigator-confirmed HAE attacks

    Time frame: Day 1 through Month 48

  5. Time to first investigator-confirmed HAE attack after first dose

    Time frame: Day 1 through Month 48

  6. The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction in investigator-confirmed HAE attack rate

    Time frame: Day 1 through Month 48

  7. Number of participants with no investigator-confirmed HAE attacks

    Time frame: Day 1 through Month 48

  8. Angioedema Quality of Life questionnaire total score

    Time frame: Day 1 through Month 48

    The Angioedema Quality of Life Questionnaire (AE-QoL) consists of 17 questions divided into four domains: functioning (4 questions), fatigue/mood (5), fears/shame (6), and food/nutrition (2). Each question is answered on a 5-point scale from "never" to "very often." Scores are calculated for each domain and then normalized to a scale from 0 to 100, where 0 represents the best possible quality of life and 100 the worst.

Sponsors and collaborators

Lead sponsor

Astria Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Oct 3, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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