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

Primary Purpose

Hereditary Angioedema

Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
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, Long-term, Safety

Eligibility Criteria

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

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.

Sites / Locations

  • Allergy & Asthma Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose Regimen 1: STAR-0215

Dose Regimen 2: STAR-0215

Arm Description

Participants will receive STAR-0215 every 3 months.

Participants will receive STAR-0215 every 6 months.

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
Number of HAE Attack-free Days
Number of Participants Experiencing Zero HAE Attacks
Serum Concentration of STAR-0215
Blood samples will be collected on dosing days to measure the serum concentration of STAR-0215.
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).
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.

Full Information

First Posted
August 17, 2023
Last Updated
October 16, 2023
Sponsor
Astria Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06007677
Brief Title
A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 26, 2023 (Actual)
Primary Completion Date
October 2029 (Anticipated)
Study Completion Date
October 2029 (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 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. The trial will continue for up to 5 years.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Regimen 1: STAR-0215
Arm Type
Experimental
Arm Description
Participants will receive STAR-0215 every 3 months.
Arm Title
Dose Regimen 2: STAR-0215
Arm Type
Experimental
Arm Description
Participants will receive STAR-0215 every 6 months.
Intervention Type
Drug
Intervention Name(s)
STAR-0215
Intervention Description
STAR-0215 will be administered as a subcutaneous injection.
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Treatment-emergent Adverse Events
Time Frame
Day 1 through up to 5 years
Secondary Outcome Measure Information:
Title
Change From Baseline in Monthly HAE Attack Rate
Time Frame
Day 1, up to 5 years
Title
Severity of HAE Attacks Experienced by Participants
Description
All HAE attacks will be classified according to severity (mild, moderate, and severe).
Time Frame
Day 1 through up to 5 years
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
Day 1 through up to 5 years
Title
Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy
Time Frame
Day 1 through up to 5 years
Title
Time to First HAE Attack After First and Last Dosing
Time Frame
Day 1 through up to 5 years
Title
Number of HAE Attack-free Days
Time Frame
Day 1 through up to 5 years
Title
Number of Participants Experiencing Zero HAE Attacks
Time Frame
Day 1 through up to 5 years
Title
Serum Concentration of STAR-0215
Description
Blood samples will be collected on dosing days to measure the serum concentration of STAR-0215.
Time Frame
Every 3 months for first 2 years, Every 6 months for next 3 years
Title
Plasma Levels of Cleaved High-molecular-weight Kininogen
Description
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).
Time Frame
Every 3 months for first 2 years, Every 6 months for next 3 years
Title
Number of Participants with Anti-drug Antibodies to STAR-0215
Description
Blood samples will be collected on dosing days to assess the formation of STAR-0215 anti-drug antibodies in serum.
Time Frame
Every 3 months for first 2 years, Every 6 months for next 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Allergy & Asthma Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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