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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
STAR-0215 will be administered as a subcutaneous bolus injection.
Allervie Clinical Research
Birmingham, Alabama, United States
Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), and Day 475 (Cohort 3)
Change From Baseline in Monthly HAE Attack Rate
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
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Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD.
Scottsdale, Arizona, United States
Allergy & Asthma Clinic of Northwest Arkansas
Bentonville, Arkansas, United States
Acuro Research, Inc.
Little Rock, Arkansas, United States
UC San Diego US HAEA Angioedema Center
San Diego, California, United States
Raffi Tachdjian MD, Inc
Santa Monica, California, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, United States
Institute for Asthma and Allergy, PC
Chevy Chase, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
...and 10 more locations
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).
Time frame: 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.
Time frame: 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