NAVENIBART for Hereditary angioedema | Hereditary angioedema type 1 | Hereditary angioedema type 2

Inclusion criteria

• {"criterion_text":"- At least 18 years of age at the time of Screening."}
• {"criterion_text":"- STAR-0215-201 status was 1 of the following: a. Completed all visits through 6 months after their last dose in STAR-0215-201 b. Eligible for participation in STAR-0215-201 (met all inclusion criteria [with the exception of the criterion for the minimum number of HAE attacks during the Run-In Period] and met none of the exclusion criteria) 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. c. Eligible for participation in 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 d. Discontinued participation in STAR-0215-201 (for personal or social reasons) 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. Participants who discontinued for safety reasons are not eligible."}
• {"criterion_text":"- For participants who are STAR-0215-naïve and were not enrolled in STAR-0215-201: Documented diagnosis of HAE (Type 1 or Type 2). All of the following must be met: a. Documented clinical history consistent with HAE (e.g. subcutaneous [SC] or mucosal, nonpruritic swelling episodes without accompanying urticaria). b. Age at reported onset of first angioedema symptoms 30 years of age or younger, or a family history consistent with HAE Type 1 or Type 2. c. C1-esterase inhibitor protein (C1-INH) antigen or functional level less than 40% of the normal level. Participants with antigen or functional C1-INH level 40% to 50% of the normal level may be eligible if they also have a C4 level below the normal range and a family history consistent with HAE Type 1 or Type 2. Testing for C1-INH and C4 will be performed at Screening. Historical test results for C1-INH may be used to confirm eligibility if the screening C1-INH antigen test or functional level or C4 level laboratory values are inconclusive, after discussion with the Medical Monitor. If the C1-INH functional level by enzyme immunoassay (EIA) does not qualify a participant with known or clinically suspected Type 2 HAE for study eligibility, a chromogenic assay may be obtained after discussion with the Sponsor's Medical Monitor. Functional level via chromogenic assay is inclusionary if the C1-INH functional level is < 74%. In this situation, the chromogenic assay should be ordered by the site per their usual process for ordering the test."}
• {"criterion_text":"- For participants who are STAR-0215-naïve and were not enrolled in STAR-0215-201: At least 2 HAE attacks during the Run-In Period, as confirmed by an investigator based on protocol-specified definition of an HAE attack."}

Exclusion criteria

• {"criterion_text":"- 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 3), idiopathic angioedema, or angioedema associated with urticaria"}
• {"criterion_text":"- Any exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening. (Note: These medications are prohibited in STAR-0215-201)"}
• {"criterion_text":"- Any exposure to androgens (e.g. stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening. Note: These medications are prohibited in STAR-0215-201"}
• {"criterion_text":"- Use of therapies prescribed for the prevention of HAE attacks (with the exception of STAR-0215 for participants who received STAR-0215 in STAR-0215-201) prior to Screening: a. lanadelumab within 90 days b. berotralstat within 21 days c. all other prophylactic therapies, discuss with the Medical Monitor Note: These medications are prohibited in STAR-0215-201."}

Primary endpoints

• {"endpoint_text":"- Incidence of adverse events (AEs)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in monthly HAE attack rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence of monthly HAE attack severity (mild, moderate, and severe)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Duration of monthly HAE attack (shorter than 12 hours, 12 to 24 hours, 24 to 48 hours, and longer than 48 hours)","definition_or_measurement_approach":""}
• {"endpoint_text":"- The number of monthly HAE attacks requiring on-demand therapy","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to first HAE attack after each dose","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of HAE attack-free days","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of HAE attack-free participants (i.e., participants having 0 HAE attacks during the specified treatment period)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Concentration of STAR-0215 and the derived PK parameters","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in plasma kallikrein activity","definition_or_measurement_approach":""}
• {"endpoint_text":"- Formation of anti-drug (STAR-0215) antibodies","definition_or_measurement_approach":""}

Methods

• Recruitment arrangements (document titles present: K1_Recruitment arrangements and K1_STAR-0215-202_Recruitment arrangements) - details provided in recruitment documents (titles listed in CTIS documents list).
• Astria Subject App / Participant App (document titles: K2_Other subject information material_AlphaSOLAR_Participant App; Astria Subject App QRG) - digital app referenced in recruitment materials (document titles).
• Greater Gift Certificate (document title: K2_Other subject information material_Greater Gift Certificate) - incentive material referenced in recruitment documents (document title).
• Subject ID card (document title: K2_STAR-0215-202_Other subject information material_Subject ID card) - participant ID material referenced in recruitment documents (document title).
• Use of Greenphire ICF (document title: L2_STAR-0215-202_Other subject information material_Greenphire for site 321) - referenced in subject information documents (document title).
• Participant guidelines and AE-QoL materials (document titles: Participant Guidelines HAE Attack Collection; K2_Other subject information material_AE-QoL) - participant guidance materials referenced in recruitment package.

Germany

Earliest CTIS Part Ii Submission Date

03-10-2024

Latest Decision Or Authorization Date

04-06-2025

Processing Time Days

244

Number Of Sites

3

Number Of Participants

10

Poland

Earliest CTIS Part Ii Submission Date

19-08-2024

Latest Decision Or Authorization Date

08-06-2025

Processing Time Days

293

Number Of Sites

1

Number Of Participants

10

Bulgaria

Earliest CTIS Part Ii Submission Date

14-10-2024

Latest Decision Or Authorization Date

06-06-2025

Processing Time Days

235

Number Of Sites

1

Number Of Participants

3

Czechia

Earliest CTIS Part Ii Submission Date

14-10-2024

Latest Decision Or Authorization Date

03-06-2025

Processing Time Days

232

Number Of Sites

1

Number Of Participants

3

Primary sponsor

Full Name

Astria Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Endpoint Clinical Inc.

Responsibilities

IVRS - Treatment Randomisation

Name

Fortrea Inc.

Responsibilities

Monitoring, Regulatory (eg preparation of applications to CA and Ethics Committee, IVRS - Treatment Randomization, SUSAR Reporting, Project Management)

Third parties

• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"Clinical chemistry, Clinical Hematology, Serology/Endocrinology, Analytical Chemistry, Pharmacogenetics, Biomarkers, Transcriptomics","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Code 7 (role specified in CTIS as code 7)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Clinical chemistry, Clinical Hematology, Serology/Endocrinology, Analytical Chemistry, Pharmacogenetics, Biomarkers, Transcriptomics","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"IVRS - Treatment Randomisation","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Monitoring, Regulatory (eg preparation of applications to CA and Ethics Committee, IVRS - Treatment Randomization, SUSAR Reporting, Project Management)","organisation_type":"Pharmaceutical company"}