A Study of STAR-0215 in Participants With Hereditary Angioedema

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Hereditary Angioedema
• Intervention / Treatment: Drug: STAR-0215

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 2; Phase 1

Contacts and Locations

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

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1680
    • Recruiting
    • Diagnostical Consultative Center Convex Ltd.
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2R3
      • Recruiting
      • University of Alberta
  • Ontario
    • Ottawa, Ontario, Canada, K1H 1E4
      • Recruiting
      • Ottawa Allergy Research Corporation
• Czechia
  • Hradec Králové, Czechia, 500 05
    • Recruiting
    • Institute of Clinical Immunology/Allergology, Faculty Hospital
• Germany
  • Berlin, Germany, 12203
    • Recruiting
    • Charité Universitätsmedizin Berlin
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Addenbrooke's Hospital
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • St. James's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Recruiting
      • Allervie Clinical Research
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Recruiting
      • Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD.
  • Arkansas
    • Bentonville, Arkansas, United States, 72712
      • Recruiting
      • Allergy & Asthma Clinic of Northwest Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • Little Rock Allergy & Asthma Clinical Research Center
  • California
    • San Diego, California, United States, 92122
      • Recruiting
      • UC San Diego US HAEA Angioedema Center
    • Santa Monica, California, United States, 90404
      • Recruiting
      • Raffi Tachdjian MD, Inc
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Allergy & Asthma Clinical Research
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Recruiting
      • Institute for Asthma and Allergy, PC
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
  • Ohio
    • Columbus, Ohio, United States, 43235
      • Recruiting
      • Optimed Research
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Penn State Health Milton S. Hershey Medical Center
  • Texas
    • Dallas, Texas, United States, 75231
      • Recruiting
      • AARA Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 - Single Dose; Participants will receive 1 dose of STAR-0215.	Drug: STAR-0215; STAR-0215 will be administered as a subcutaneous bolus injection.
Experimental: Cohort 2 - Multiple Dose; Participants will receive 2 doses of STAR-0215 administered 3 months apart.	Drug: STAR-0215; STAR-0215 will be administered as a subcutaneous bolus injection.
Experimental: Cohort 3 - Multiple Dose; Participants will receive 2 doses of STAR-0215 administered 1 month apart.	Drug: STAR-0215; STAR-0215 will be administered as a subcutaneous bolus injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Monthly HAE Attack Rate		Baseline through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Astria Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: HAE; 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-0215-201; 2022-502953-32 (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