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Active, Not Recruiting

NCT Number: NCT06007677

A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema

The goal of this trial is to enable the collection of information about long-term safety and clinical activity of STAR-0215 in participants with hereditary angioedema (HAE). Participants will receive repeat doses of STAR-0215 for up to 5 years.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hereditary Angioedema 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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Diagnostic Consultative Center Convex Ltd., Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following conditions:
  • Completed STAR-0215-201 (follow up through 6 months after their last dose);
  • Eligible for STAR-0215-201 and entered the Run-In period but did not qualify for the Treatment Period because they did not meet the criterion for the minimum number of HAE attacks;
  • Eligible for STAR-0215-201 and entered the Run-In period but did not complete it for reasons other than not meeting the criterion for the minimum number of HAE attacks (eligibility requires consultation with the Medical Monitor); or
  • Discontinued STAR-0215-201 (for reasons other than safety) after having completed at least 84 days of trial follow-up since their last dose of STAR-0215 (eligibility requires consultation with the Medical Monitor).
  • Open to participants who are STAR-0215 naïve and were not enrolled in STAR-0215-201 (NCT05695248), have a documented diagnosis of HAE (Type 1 or Type 2).

Exclusion criteria

  • Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-esterase inhibitor protein (also known as HAE Type III), idiopathic angioedema, or angioedema associated with urticaria.
  • Any exposure to angiotensin-converting enzyme inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening
  • Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.
  • Use of therapies prescribed for the prevention of HAE attacks prior to Screening:
  • lanadelumab within 90 days
  • berotralstat within 21 days
  • all other prophylactic therapies, discuss with the Medical Monitor

Note: Other inclusion and exclusion criteria may apply.

Treatment and study plan

STAR-0215

Drug

STAR-0215 will be administered as a subcutaneous injection.

Primary outcomes

  1. Number of Participants Experiencing Treatment-emergent Adverse Events

    Time frame: Day 1 through study completion, an average of 6 years

Secondary outcomes

  1. Change From Baseline in Monthly HAE Attack Rate

    Time frame: Day 1, up to 5 years

  2. Severity of HAE Attacks Experienced by Participants

    Time frame: Day 1 through up to 5 years

    All HAE attacks will be classified according to severity (mild, moderate, and severe).

  3. Duration of HAE Attacks

    Time frame: Day 1 through up to 5 years

    Duration will be reported as shorter than 12 hours, 12 to 24 hours, 24 to 48 hours, and longer than 48 hours.

  4. Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy

    Time frame: Day 1 through up to 5 years

  5. Time to First HAE Attack After Each Dose

    Time frame: Day 1 through up to 5 years

  6. Number of HAE Attack-free Days

    Time frame: Day 1 through up to 5 years

  7. Number of Participants Experiencing Zero HAE Attacks

    Time frame: Day 1 through up to 5 years

  8. Serum Concentration of STAR-0215

    Time frame: Every 3 months for first 2 years, Every 6 months for next 3 years

    Blood samples will be collected on dosing days to measure the serum concentration of STAR-0215.

  9. Plasma Levels of Cleaved High-molecular-weight Kininogen

    Time frame: Every 3 months for first 2 years, Every 6 months for next 3 years

    Blood samples will be collected on dosing days to measure the plasma levels of cleaved high-molecular-weight kininogen (a measure of plasma kallikrein activity).

  10. Number of Participants with Anti-drug Antibodies to STAR-0215

    Time frame: Every 3 months for first 2 years, Every 6 months for next 3 years

    Blood samples will be collected on dosing days to assess the formation of STAR-0215 anti-drug antibodies in serum.

Sponsors and collaborators

Lead sponsor

Astria Therapeutics, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Aug 23, 2023
Registry last updated
Jul 23, 2025

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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