Clinical trial NCT06007677: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hereditary Angioedema
Keywords: HAE
Angioedema
Long-term
Safety
Lead sponsor: Astria Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 for up to 5 years.


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).
* Open to participants who are STAR-0215 naïve and were not enrolled in STAR-0215-201 (NCT05695248), have a documented diagnosis of HAE (Type 1 or Type 2).

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.

Primary outcomes:
measure: Number of Participants Experiencing Treatment-emergent Adverse Events
timeFrame: Day 1 through study completion, an average of 6 years
Secondary outcomes:
measure: Change From Baseline in Monthly HAE Attack Rate
timeFrame: Day 1, up to 5 years
measure: Severity of HAE Attacks Experienced by Participants
timeFrame: Day 1 through up to 5 years
measure: Duration of HAE Attacks
timeFrame: Day 1 through up to 5 years
measure: Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy
timeFrame: Day 1 through up to 5 years
measure: Time to First HAE Attack After Each Dose
timeFrame: Day 1 through up to 5 years
measure: Number of HAE Attack-free Days
timeFrame: Day 1 through up to 5 years
measure: Number of Participants Experiencing Zero HAE Attacks
timeFrame: Day 1 through up to 5 years
measure: Serum Concentration of STAR-0215
timeFrame: Every 3 months for first 2 years, Every 6 months for next 3 years
measure: Plasma Levels of Cleaved High-molecular-weight Kininogen
timeFrame: Every 3 months for first 2 years, Every 6 months for next 3 years
measure: Number of Participants with Anti-drug Antibodies to STAR-0215
timeFrame: Every 3 months for first 2 years, Every 6 months for next 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Allervie Clinical Research
state: Alabama
city: Scottsdale
country: United States
facility: Medical Research of Arizona a Division of Allergy, Asthma &amp; Immunology Associates, LTD
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Allergy &amp; Asthma Clinical Research Center
state: Arkansas
city: San Diego
country: United States
facility: UC San Diego US HAEA Angioedema Center
state: California
city: Santa Monica
country: United States
facility: Raffi Tachdjian MD, Inc
state: California
city: Walnut Creek
country: United States
facility: Allergy &amp; Asthma Clinical Research
state: California
city: Chevy Chase
country: United States
facility: Institute for Asthma and Allergy, PC
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Columbus
country: United States
facility: Optimed Research
state: Ohio
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: AARA Research Center
state: Texas
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center Convex Ltd.
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corporation
state: Ontario
city: Hradec Králové
country: Czechia
facility: Institute of Clinical Immunology/Allergology, Faculty Hospital, Hradec Kralove
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Leeds
country: United Kingdom
facility: St. James's Hospital
Study officials:
References: