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A Study of STAR-0215 in Participants With Hereditary Angioedema

Primary Purpose

Hereditary Angioedema

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
STAR-0215
Sponsored by
Astria Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hereditary Angioedema focused on measuring HAE, Angioedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). 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: 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. 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, within 7 days 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.

Sites / Locations

  • Allervie Clinical ResearchRecruiting
  • Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD.Recruiting
  • Allergy & Asthma Clinic of Northwest ArkansasRecruiting
  • Little Rock Allergy & Asthma Clinical Research CenterRecruiting
  • Raffi Tachdjian MD, IncRecruiting
  • Allergy & Asthma Clinical ResearchRecruiting
  • Institute for Asthma and Allergy, PCRecruiting
  • Massachusetts General HospitalRecruiting
  • Washington University School of MedicineRecruiting
  • Optimed ResearchRecruiting
  • Penn State Health Milton S. Hershey Medical CenterRecruiting
  • AARA Research CenterRecruiting
  • University of AlbertaRecruiting
  • Ottawa Allergy Research CorporationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1 - Single Dose

Cohort 2 - Multiple Dose

Cohort 3 - Multiple Dose

Arm Description

Participants will receive 1 dose of STAR-0215.

Participants will receive 2 doses of STAR-0215 administered 3 months apart.

Participants will receive 2 doses of STAR-0215 administered 1 month apart.

Outcomes

Primary Outcome Measures

Number of Participants Experiencing Treatment-emergent Adverse Events

Secondary Outcome Measures

Change From Baseline in Monthly HAE Attack Rate
Severity of HAE Attacks Experienced by Participants
All HAE attacks will be classified according to severity (mild, moderate, and severe).
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.
Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy
Time to First HAE Attack After First and Last Dosing
Serum Concentration of STAR-0215
Blood samples will be collected to measure the serum concentration of STAR-0215 before and after study drug administration.
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).
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.

Full Information

First Posted
January 6, 2023
Last Updated
July 27, 2023
Sponsor
Astria Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05695248
Brief Title
A Study of STAR-0215 in Participants With Hereditary Angioedema
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astria Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Angioedema
Keywords
HAE, Angioedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 - Single Dose
Arm Type
Experimental
Arm Description
Participants will receive 1 dose of STAR-0215.
Arm Title
Cohort 2 - Multiple Dose
Arm Type
Experimental
Arm Description
Participants will receive 2 doses of STAR-0215 administered 3 months apart.
Arm Title
Cohort 3 - Multiple Dose
Arm Type
Experimental
Arm Description
Participants will receive 2 doses of STAR-0215 administered 1 month apart.
Intervention Type
Drug
Intervention Name(s)
STAR-0215
Intervention Description
STAR-0215 will be administered as a subcutaneous bolus injection.
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Treatment-emergent Adverse Events
Time Frame
Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
Secondary Outcome Measure Information:
Title
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)
Title
Severity of HAE Attacks Experienced by Participants
Description
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
Title
Duration of HAE Attacks
Description
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
Title
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
Title
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
Title
Serum Concentration of STAR-0215
Description
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
Title
Plasma Levels of Cleaved High-molecular-weight Kininogen
Description
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
Title
Number of Participants with Anti-drug Antibodies To STAR-0215
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). 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: 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. 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, within 7 days 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Morabito, MD
Phone
1-617-349-1971
Email
cmorabito@astriatx.com
Facility Information:
Facility Name
Allervie Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD.
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Individual Site Status
Recruiting
Facility Name
Allergy & Asthma Clinic of Northwest Arkansas
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Individual Site Status
Recruiting
Facility Name
Little Rock Allergy & Asthma Clinical Research Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
Raffi Tachdjian MD, Inc
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Allergy & Asthma Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Name
Institute for Asthma and Allergy, PC
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Optimed Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Name
AARA Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Ottawa Allergy Research Corporation
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1E4
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of STAR-0215 in Participants With Hereditary Angioedema

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