A Study of STAR-0215 in Participants With Hereditary Angioedema

Hereditary Angioedema Clinical Trial

Official title:

A Phase 1b/2 Single and Multiple Dose Study to Assess the Safety, Tolerability, Clinical Activity, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of STAR-0215 in Participants With Hereditary Angioedema (The ALPHA-STAR Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05695248
• Other study ID #: STAR-0215-201
• Secondary ID: 2022-502953-32
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 21, 2023
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Astria Therapeutics, Inc.
• Contact: Christopher Morabito, MD
• Phone: 1-617-349-1971
• Email: cmorabito[@]astriatx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the drug STAR-0215 in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of STAR-0215, and two other groups will get 2 doses of STAR-0215. Researchers will study the effects of STAR-0215 in participants with HAE as this is the first time that the drug has been given to participants with HAE.

Description:

This is a Phase 1b/2 single and multiple dose trial evaluating the safety, tolerability, clinical activity, pharmacokinetics, pharmacodynamics, and immunogenicity of subcutaneous administration of STAR-0215 in participants with type I or type II HAE in 3 dose cohorts. The first cohort will receive 1 dose of STAR-0215; the second and third cohorts will receive 2 sequential doses. This is the first trial of STAR-0215 in participants with HAE and the first evaluation of a multiple-dose regimen. After the required follow up period, participants who are willing and eligible to consent can begin participation in the long-term open label extension study (STAR-0215-202, ALPHA-SOLAR).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Documented diagnosis of HAE (type I or II). The following must be met:

a. Documented clinical history consistent with HAE (for example, subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria).

2. Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.

Exclusion Criteria:

1. Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria.

2. Use of therapies prescribed for the prevention of HAE attacks prior to Screening:

1. lanadelumab within 90 days

2. berotralstat within 21 days

3. all other prophylactic therapies, within 7 days

3. 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.

4. Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema

Intervention

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

Locations

Country	Name	City	State
Bulgaria	Diagnostical Consultative Center Convex Ltd.	Sofia
Canada	University of Alberta	Edmonton	Alberta
Canada	Ottawa Allergy Research Corporation	Ottawa	Ontario
Czechia	Institute of Clinical Immunology/Allergology, Faculty Hospital	Hradec Králové
Germany	Charité Universitätsmedizin Berlin	Berlin
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	St. James's Hospital	Leeds
United States	Allergy & Asthma Clinic of Northwest Arkansas	Bentonville	Arkansas
United States	Allervie Clinical Research	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
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	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Little Rock Allergy & Asthma Clinical Research Center	Little Rock	Arkansas
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	UC San Diego US HAEA Angioedema Center	San Diego	California
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,  Bulgaria,  Canada,  Czechia,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Treatment-emergent Adverse Events		Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), and Day 475 (Cohort 3)
Secondary	Change From Baseline in Monthly HAE Attack Rate		Baseline through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
Secondary	Severity of HAE Attacks Experienced by Participants	All HAE attacks will be classified according to severity (mild, moderate, and severe).	Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251; Cohort 3: Day 1 through Day 195
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.	Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251; Cohort 3: Day 1 through Day 195
Secondary	Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy		Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251; Cohort 3: Day 1 through Day 195
Secondary	Time to First HAE Attack After First and Last Dosing		Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251; Cohort 3: Day 1 through Day 195
Secondary	Serum Concentration of STAR-0215	Blood samples will be collected to measure the serum concentration of STAR-0215 before and after study drug administration.	Cohort 1: Day 1 (pre-dose, 4 hours post dose) up to Day 168; Cohort 2: Days 1 and 84 (pre-dose, 4 hours post dose) up to Day 251; Cohort 3: Days 1 and 28 (pre-dose, 4 hours post dose) up to Day 195
Secondary	Plasma Levels of Cleaved High-molecular-weight Kininogen	Blood samples will be collected to measure the plasma levels of cleaved high-molecular-weight kininogen (a measure of plasma kallikrein activity).	Cohort 1: Day 1 (pre-dose, 4 hours post dose) up to Day 168; Cohort 2: Days 1 and 84 (pre-dose, 4 hours post dose) up to Day 251; Cohort 3: Days 1 and 28 (pre-dose, 4 hours post dose) up to Day 195
Secondary	Number of Participants with Anti-drug Antibodies To STAR-0215	Blood samples will be collected to assess the formation of STAR-0215 anti-drug antibodies in serum before and after study drug administration.	Cohort 1: Day 1 (pre-dose); Days 14, 28, 56, 84, 112, 140, and 168; Cohort 2: Days 1 and 84 (pre-dose); Days 14, 28, 56, 111, 167, and 251; Cohort 3: Days 1 and 28 (pre-dose); Days 14, 55, 111, and 195