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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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