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NCT Number: NCT06842823

A Study of Navenibart in Participants With Hereditary Angioedema

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.

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This study is active but is not currently recruiting participants.

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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 68, Campbelltown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Documented diagnosis of HAE (Type 1 or 2). The following must be met:
  • Documented clinical history consistent with HAE
  • Lab findings consistent with HAE Type 1 or 2
  • Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.

Exclusion criteria

  • Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type 3), idiopathic angioedema, or angioedema associated with urticaria.
  • Use of therapies prescribed for the prevention of HAE attacks may not be used during the trial or within the below time frames prior to the Run-In Period (adult participants may be on these medications at the time of the Screening Visit, but will need to washout prior to entering the Run-In Period).
  • Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In
  • Plasma-derived C1INH for LTP within 14 days prior to Run-In
  • Berotralstat within 21 days prior to Run-In
  • Lanadelumab within 70 days prior to Run-In
  • Garadacimab within 90 days prior to Run-In

Treatment and study plan

navenibart

Drug

Navenibart will be administered as a subcutaneous injection.

Other names: STAR-0215

Placebo

Drug

Placebo will be administered as a subcutaneous injection.

Primary outcomes

  1. Number of time-normalized investigator-confirmed HAE attacks during the 6-month Treatment Period.

    Time frame: Day 1 through Day 181

Secondary outcomes

  1. Number of moderate or severe investigator-confirmed HAE attacks during the 6-month Treatment Period.

    Time frame: Day 1 through Day 181

  2. Number of investigator-confirmed HAE attacks that require on-demand treatment during the 6-month Treatment Period.

    Time frame: Day 1 through Day 181

  3. Percent reduction in monthly investigator-confirmed HAE attacks in the 6-month Treatment Period versus the Run-In Period.

    Time frame: Baseline through Day 181

  4. Time to first investigator-confirmed HAE attack after first and second dose.

    Time frame: Day 1 through Day 181

  5. The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction from the Run-In Period in investigator-confirmed HAE attack rate (for adult participants: compared to placebo during the 6-month Treatment Period).

    Time frame: Baseline through Day 181

  6. Number of participants with no investigator-confirmed HAE attacks during the 6-month Treatment Period.

    Time frame: Day 1 through Day 181

  7. Change from baseline (Day 1) in the Angioedema Quality of Life questionnaire total score.

    Time frame: Day 1 through Day 181

Other outcomes

  1. Incidence of treatment-emergent adverse events.

    Time frame: Day 1 through Day 361

Sponsors and collaborators

Lead sponsor

Astria Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants With Hereditary Angioedema (HAE)

Acronym: ALPHA-ORBIT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 24, 2025
Registry last updated
Jun 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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