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

Hereditary Angioedema Clinical Trial

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06007677
• Other study ID #: STAR-0215-202
• Secondary ID: 2023-506540-16
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: September 26, 2023
• Est. completion date: August 2030

Study information

• Verified date: April 2024
• Source: Astria Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 56
• Est. completion date: August 2030
• Est. primary completion date: August 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema

Intervention

Drug:
• STAR-0215
STAR-0215 will be administered as a subcutaneous injection.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Ottawa Allergy Research Corporation	Ottawa	Ontario
United States	Alabama Allervie Clinical Research	Birmingham	Alabama
United States	Institute for Asthma and Allergy, PC	Chevy Chase	Maryland
United States	Optimed Research	Columbus	Ohio
United States	AARA Research Center	Dallas	Texas
United States	Little Rock Allergy & Asthma Clinical Research Center	Little Rock	Arkansas
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Raffi Tachdjian MD, Inc	Santa Monica	California
United States	Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD	Scottsdale	Arizona
United States	Allergy & Asthma Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Astria Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Treatment-emergent Adverse Events		Day 1 through up to 6 years and 4 months
Secondary	Change From Baseline in Monthly HAE Attack Rate		Day 1, up to 5 years
Secondary	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
Secondary	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
Secondary	Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy		Day 1 through up to 5 years
Secondary	Time to First HAE Attack After Each Dose		Day 1 through up to 5 years
Secondary	Number of HAE Attack-free Days		Day 1 through up to 5 years
Secondary	Number of Participants Experiencing Zero HAE Attacks		Day 1 through up to 5 years
Secondary	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
Secondary	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
Secondary	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