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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 29, 2024
Sponsor:
Information provided by (Responsible Party):
Astria Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE January 6, 2023
First Posted Date  ICMJE January 23, 2023
Last Update Posted Date April 29, 2024
Actual Study Start Date  ICMJE February 21, 2023
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2024)		 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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2023)		 Number of Participants Experiencing Treatment-emergent Adverse Events [ Time Frame: Day 1 through Day 168 (Cohort 1) and Day 251 (Cohort2) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2023)
  • 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 [ 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).
  • 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.
  • 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 [ 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.
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2023)
  • Change From Baseline In Monthly HAE Attack Rate [ Time Frame: Baseline through Day 168 (Cohort 1) and Day 251 (Cohort 2) ]
  • Severity Of HAE Attacks Experienced By Participants [ Time Frame: Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251 ]
    All HAE attacks will be classified according to severity (mild, moderate, and severe).
  • Duration Of HAE Attacks [ Time Frame: Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251 ]
    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 Frame: Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251 ]
  • 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 ]
  • Serum Concentration Of STAR-0215 [ Time Frame: Cohort 1: Day 1 (pre-infusion, up to 4 hours post dose); Days 2, 7, 14, 28, 56, 84, 112, 140, and 168; Cohort 2: Days 1 and 84 (pre-infusion, up to 4 hours post dose); Days 2, 7, 14, 28, 56, 85, 90, 97, 111, 139, 167, 209, and 251 ]
    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 [ Time Frame: Cohort 1: Day 1 (pre-infusion, up to 4 hours post dose); Days 2, 7, 14, 28, 56, 84, 112, 140, and 168; Cohort 2: Days 1 and 84 (pre-infusion, up to 4 hours post dose); Days 2, 7, 14, 28, 56, 85, 90, 97, 111, 139, 167, 209, and 251 ]
    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 [ Time Frame: Cohort 1: Day 1 (pre-infusion); Days 14, 28, 56, 84, 112, 140, and 168; Cohort 2: Days 1 and 84 (pre-infusion); Days 14, 28, 56, 111, 167, and 251 ]
    Blood samples will be collected to assess the formation of STAR-0215 anti-drug antibodies in serum before and after study drug administration.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of STAR-0215 in Participants With Hereditary Angioedema
Official Title  ICMJE 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)
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. 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hereditary Angioedema
Intervention  ICMJE Drug: STAR-0215
STAR-0215 will be administered as a subcutaneous bolus injection.
Study Arms  ICMJE
  • Experimental: Cohort 1 - Single Dose
    Participants will receive 1 dose of STAR-0215.
    Intervention: Drug: STAR-0215
  • Experimental: Cohort 2 - Multiple Dose
    Participants will receive 2 doses of STAR-0215 administered 3 months apart.
    Intervention: Drug: STAR-0215
  • Experimental: Cohort 3 - Multiple Dose
    Participants will receive 2 doses of STAR-0215 administered 1 month apart.
    Intervention: Drug: STAR-0215
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2023)		 28
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2023)		 18
Estimated Study Completion Date  ICMJE September 2025
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christopher Morabito, MD 1-617-349-1971 cmorabito@astriatx.com
Listed Location Countries  ICMJE Bulgaria,   Canada,   Czechia,   Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05695248
Other Study ID Numbers  ICMJE STAR-0215-201
2022-502953-32 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Astria Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Astria Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Astria Therapeutics, Inc.
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP