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

July 21, 2025 updated by: Astria Therapeutics, Inc.

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1680
        • Diagnostic Consultative Center Convex Ltd.
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R3
        • University of Alberta
    • Ontario
      • Ottawa, Ontario, Canada, K1H 1E4
        • Ottawa Allergy Research Corporation
  • Czechia
      • Hradec Králové, Czechia, 550 05
        • Institute of Clinical Immunology/Allergology, Faculty Hospital, Hradec Kralove
  • Germany
      • Berlin, Germany, 12203
        • Charité Universitätsmedizin Berlin
      • Frankfurt, Germany, 60596
        • Johann Wolfgang Goethe-Universität Frankfurt
      • Ulm, Germany, 89075
        • Universitätsklinikum Ulm
  • Poland
      • Kraków, Poland, 31-503
        • Szpital Uniwersytecki w Krakowie
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
      • Leeds, United Kingdom, LS9 7TF
        • St. James's Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • AllerVie Clinical Research
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Acuro Research
    • California
      • San Diego, California, United States, 92122
        • UC San Diego US HAEA Angioedema Center
      • Santa Monica, California, United States, 90404
        • Raffi Tachdjian MD, Inc
      • Walnut Creek, California, United States, 94598
        • Allergy & Asthma Clinical Research
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Institute for Asthma and Allergy, PC
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Ohio
      • Columbus, Ohio, United States, 43235
        • Optimed Research
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Health Milton S. Hershey Medical Center
    • Texas
      • Dallas, Texas, United States, 75231
        • AARA Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Regimen 1 (Arm A): STAR-0215
Participants will receive STAR-0215 every 3 months.
Drug: STAR-0215
STAR-0215 will be administered as a subcutaneous injection.
Experimental: Dose Regimen 2 (Arm B): STAR-0215
Participants will receive STAR-0215 every 6 months.
Drug: STAR-0215
STAR-0215 will be administered as a subcutaneous injection.
Experimental: Dose Regimen 1 (Arm C): STAR-0215
STAR-0215 will be administered as a subcutaneous injection.
Drug: STAR-0215
STAR-0215 will be administered as a subcutaneous injection.
Experimental: Dose Regimen 3 (Arm D): STAR-0215
STAR-0215 will be administered as a subcutaneous injection.
Drug: STAR-0215
STAR-0215 will be administered as a subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Experiencing Treatment-emergent Adverse Events
Time Frame: Day 1 through study completion, an average of 6 years
Day 1 through study completion, an average of 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Monthly HAE Attack Rate
Time Frame: Day 1, up to 5 years
Day 1, up to 5 years
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).
Day 1 through up to 5 years
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.
Day 1 through up to 5 years
Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy
Time Frame: Day 1 through up to 5 years
Day 1 through up to 5 years
Number of HAE Attack-free Days
Time Frame: Day 1 through up to 5 years
Day 1 through up to 5 years
Number of Participants Experiencing Zero HAE Attacks
Time Frame: Day 1 through up to 5 years
Day 1 through up to 5 years
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.
Every 3 months for first 2 years, Every 6 months for next 3 years
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).
Every 3 months for first 2 years, Every 6 months for next 3 years
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.
Every 3 months for first 2 years, Every 6 months for next 3 years
Time to First HAE Attack After Each Dose
Time Frame: Day 1 through up to 5 years
Day 1 through up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astria Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2023

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 21, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAR-0215-202
  • 2023-506540-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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