Hereditary AngioedemaPhase 2NCT06007677
A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
A Phase 2 study testing STAR-0215 in people with Hereditary Angioedema, run by Astria Therapeutics, Inc. at 22 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- STAR-0215
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 26 Sep 2023to Mar 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
United States12 sites
Allervie Clinical Research
Birmingham, Alabama, 35209
Massachusetts General Hospital
Boston, Massachusetts, 02114
Institute for Asthma and Allergy, PC
Chevy Chase, Maryland, 20815
Optimed Research
Columbus, Ohio, 43235
AARA Research Center
Dallas, Texas, 75231
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Acuro Research
Little Rock, Arkansas, 72205
UC San Diego US HAEA Angioedema Center
San Diego, California, 92122
Raffi Tachdjian MD, Inc
Santa Monica, California, 90404
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD
Scottsdale, Arizona, 85251
Washington University School of Medicine
St Louis, Missouri, 63110
Allergy & Asthma Clinical Research
Walnut Creek, California, 94598
Germany3 sites
Charité Universitätsmedizin Berlin
Berlin, 12203
Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt, 60596
Universitätsklinikum Ulm
Ulm, 89075
Canada2 sites
University of Alberta
Edmonton, Alberta, T6G 2R3
Ottawa Allergy Research Corporation
Ottawa, Ontario, K1H 1E4
United Kingdom2 sites
Addenbrooke's Hospital
Cambridge, CB2 0QQ
St. James's Hospital
Leeds, LS9 7TF
Czechia1 site
Institute of Clinical Immunology/Allergology, Faculty Hospital, Hradec Kralove
Hradec Králové, 550 05
About this study
Official 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)
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.
- Conditions
- Hereditary Angioedema
- Being tested
- STAR-0215
- Keywords
- HAE, Angioedema, Long-term, Safety
- Medical subject headings
- Angioedemas, Hereditary, Angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR-0215Drug
STAR-0215 will be administered as a subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Dose Regimen 1 (Arm A): STAR-0215 | Experimental | Participants will receive STAR-0215 every 3 months. Receives: Drug: STAR-0215 |
| Dose Regimen 2 (Arm B): STAR-0215 | Experimental | Participants will receive STAR-0215 every 6 months. Receives: Drug: STAR-0215 |
| Dose Regimen 1 (Arm C): STAR-0215 | Experimental | STAR-0215 will be administered as a subcutaneous injection. Receives: Drug: STAR-0215 |
| Dose Regimen 3 (Arm D): STAR-0215 | Experimental | STAR-0215 will be administered as a subcutaneous injection. Receives: Drug: STAR-0215 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Treatment-emergent Adverse Events
Measured: Day 1 through study completion, an average of 6 years
Secondary outcomes (10)
Change From Baseline in Monthly HAE Attack Rate
Measured: Day 1, up to 5 years
Severity of HAE Attacks Experienced by Participants
All HAE attacks will be classified according to severity (mild, moderate, and severe).
Measured: Day 1 through up to 5 years
Duration of HAE Attacks
Duration will be reported as shorter than 12 hours, 12 to 24 hours, 24 to 48 hours, and longer than 48 hours.
Measured: Day 1 through up to 5 years
Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy
Measured: Day 1 through up to 5 years
Time to First HAE Attack After Each Dose
Measured: Day 1 through up to 5 years
Number of HAE Attack-free Days
Measured: Day 1 through up to 5 years
Number of Participants Experiencing Zero HAE Attacks
Measured: Day 1 through up to 5 years
Serum Concentration of STAR-0215
Blood samples will be collected on dosing days to measure the serum concentration of STAR-0215.
Measured: Every 3 months for first 2 years, Every 6 months for next 3 years
Plasma Levels of Cleaved High-molecular-weight Kininogen
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).
Measured: Every 3 months for first 2 years, Every 6 months for next 3 years
Number of Participants with Anti-drug Antibodies to STAR-0215
Blood samples will be collected on dosing days to assess the formation of STAR-0215 anti-drug antibodies in serum.
Measured: Every 3 months for first 2 years, Every 6 months for next 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start26 Sep 2023
- Primary completionMar 2031 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary AngioedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astria Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007677
- Sponsor's protocol ID
- STAR-0215-202
- Other IDs
- 2023-506540-16, 2023
- Status last verified
- Jul 2025
- First submitted
- 17 Aug 2023
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06007677
- Acronym / sponsor ID
- STAR-0215-202
- Conditions
- Hereditary Angioedema
- Keywords
- HAE, Angioedema, Long-term, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Astria Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Regimen 1 (Arm A): STAR-0215 | Experimental | Drug: STAR-0215Participants will receive STAR-0215 every 3 months. |
| Dose Regimen 2 (Arm B): STAR-0215 | Experimental | Drug: STAR-0215Participants will receive STAR-0215 every 6 months. |
| Dose Regimen 1 (Arm C): STAR-0215 | Experimental | Drug: STAR-0215STAR-0215 will be administered as a subcutaneous injection. |
| Dose Regimen 3 (Arm D): STAR-0215 | Experimental | Drug: STAR-0215STAR-0215 will be administered as a subcutaneous injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following conditions:
- 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).
Key exclusion criteria (8 listed)
- 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:
- Note: Other inclusion and exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAR-0215STAR-0215 will be administered as a subcutaneous injection. | Drug | Dose Regimen 1 (Arm A): STAR-0215, Dose Regimen 1 (Arm C): STAR-0215, Dose Regimen 2 (Arm B): STAR-0215, Dose Regimen 3 (Arm D): STAR-0215 |
Primary outcome
Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through study completion, an average of 6 years
10 secondary outcomes
Change From Baseline in Monthly HAE Attack Rate
Time frame: Day 1, up to 5 years
Severity of HAE Attacks Experienced by Participants
Time frame: Day 1 through up to 5 years
Duration of HAE Attacks
Time frame: 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
Time to First HAE Attack After Each Dose
Time frame: Day 1 through up to 5 years
Number of HAE Attack-free Days
Time frame: Day 1 through up to 5 years
Number of Participants Experiencing Zero HAE Attacks
Time frame: 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
Plasma Levels of Cleaved High-molecular-weight Kininogen
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STAR-0215 in people with Hereditary Angioedema, run by Astria Therapeutics, Inc. at 22 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Germany, Canada, United Kingdom, Bulgaria and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Treatment-emergent Adverse Events (time frame: Day 1 through study completion, an average of 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.