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)

Astria Therapeutics, Inc.22 sites in 7 countries56 target enrollmentSeptember 26, 2023

ConditionsHereditary Angioedema

InterventionsSTAR-0215

DrugsSTAR-0215

Overview

Phase: Phase 2
Intervention: STAR-0215
Conditions: Hereditary Angioedema
Sponsor: Astria Therapeutics, Inc.
Enrollment: 56
Locations: 22
Primary Endpoint: Number of Participants Experiencing Treatment-emergent Adverse Events
Status: Active, not recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 26, 2023

End Date

March 1, 2031

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Astria Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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).

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.

Arms & Interventions

Dose Regimen 1 (Arm A): STAR-0215

Participants will receive STAR-0215 every 3 months.

Intervention: STAR-0215

Dose Regimen 2 (Arm B): STAR-0215

Participants will receive STAR-0215 every 6 months.

Intervention: STAR-0215

Dose Regimen 1 (Arm C): STAR-0215

STAR-0215 will be administered as a subcutaneous injection.

Intervention: STAR-0215

Dose Regimen 3 (Arm D): STAR-0215

STAR-0215 will be administered as a subcutaneous injection.

Intervention: STAR-0215

Outcomes

Primary Outcomes

Number of Participants Experiencing Treatment-emergent Adverse Events

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

Secondary Outcomes

Change From Baseline in Monthly HAE Attack Rate(Day 1, up to 5 years)
Severity of HAE Attacks Experienced by Participants(Day 1 through up to 5 years)
Duration of HAE Attacks(Day 1 through up to 5 years)
Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy(Day 1 through up to 5 years)
Time to First HAE Attack After Each Dose(Day 1 through up to 5 years)
Number of HAE Attack-free Days(Day 1 through up to 5 years)
Number of Participants Experiencing Zero HAE Attacks(Day 1 through up to 5 years)
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(Every 3 months for first 2 years, Every 6 months for next 3 years)
Number of Participants with Anti-drug Antibodies to STAR-0215(Every 3 months for first 2 years, Every 6 months for next 3 years)