A Study of STAR-0215 in Participants With Hereditary Angioedema

January 13, 2023 updated by: Astria Therapeutics, Inc.

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)

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 the other group 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.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

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 2 dose cohorts. The first cohort will receive 1 dose of STAR-0215; the second cohort 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.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 4 HAE attacks within the 12 months prior to Screening, per participant report.
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 - Single Dose
Participants will receive 1 dose of 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.
STAR-0215 will be administered as a subcutaneous bolus injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Experiencing Treatment-emergent Adverse Events
Time Frame: Day 1 through Day 168 (Cohort 1) and Day 251 (Cohort2)
Day 1 through Day 168 (Cohort 1) and Day 251 (Cohort2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline In Monthly HAE Attack Rate
Time Frame: Baseline through Day 168 (Cohort 1) and Day 251 (Cohort 2)
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).
Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251
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.
Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251
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 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
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.
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
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).
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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