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

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: Enrolling by invitation
• Conditions: Hereditary Angioedema
• Intervention / Treatment: Drug: STAR-0215

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Christopher Morabito, MD; Phone Number: 1-617-349-1971; Email: cmorabito@astriatx.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Alabama Allervie Clinical Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Allergy & Asthma Clinical Research Center
  • California
    • Walnut Creek, California, United States, 94598
      • Allergy & Asthma Clinical Research

Participation Criteria

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).

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Regimen 1: 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: STAR-0215; Participants will receive STAR-0215 every 6 months.	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	Day 1 through up to 6 years and 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Monthly HAE Attack Rate		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).	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.	Day 1 through up to 5 years
Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy		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	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	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	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		Day 1 through up to 5 years

Collaborators and Investigators

• Sponsor: Astria Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030

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): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Safety; HAE; Long-term; Angioedema
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Vascular; Hypersensitivity; Urticaria; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Angioedema; Angioedemas, Hereditary
• 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