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A Study of STAR-0215 in Participants With Hereditary Angioedema

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ClinicalTrials.gov Identifier: NCT05695248
Recruitment Status : Recruiting
First Posted : January 23, 2023
Last Update Posted : April 8, 2024
Sponsor:
Information provided by (Responsible Party):
Astria Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hereditary Angioedema Drug: STAR-0215 Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 21, 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. Severity of HAE Attacks Experienced by Participants [ Time Frame: Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251; Cohort 3: Day 1 through Day 195 ]
    All HAE attacks will be classified according to severity (mild, moderate, and severe).

  3. Duration of HAE Attacks [ Time Frame: Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251; Cohort 3: Day 1 through Day 195 ]
    Duration will be reported as shorter than 12 hours, 12 to 24 hours, 24 to 48 hours, and longer than 48 hours.

  4. 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 ]
  5. 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 ]
  6. Serum Concentration of STAR-0215 [ 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 ]
    Blood samples will be collected to measure the serum concentration of STAR-0215 before and after study drug administration.

  7. Plasma Levels of Cleaved High-molecular-weight Kininogen [ 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 ]
    Blood samples will be collected to measure the plasma levels of cleaved high-molecular-weight kininogen (a measure of plasma kallikrein activity).

  8. Number of Participants with Anti-drug Antibodies To STAR-0215 [ 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 ]
    Blood samples will be collected to assess the formation of STAR-0215 anti-drug antibodies in serum before and after study drug administration.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05695248


Contacts
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Contact: Christopher Morabito, MD 1-617-349-1971 cmorabito@astriatx.com

Locations
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Sponsors and Collaborators
Astria Therapeutics, Inc.
More Information
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Responsible Party: Astria Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05695248    
Other Study ID Numbers: STAR-0215-201
2022-502953-32 ( EudraCT Number )
First Posted: January 23, 2023    Key Record Dates
Last Update Posted: April 8, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astria Therapeutics, Inc.:
HAE
Angioedema
Additional relevant MeSH terms:
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Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hereditary Complement Deficiency Diseases
Primary Immunodeficiency Diseases
Genetic Diseases, Inborn
Immunologic Deficiency Syndromes