Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06007677
Other study ID # STAR-0215-202
Secondary ID 2023-506540-16
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date September 26, 2023
Est. completion date August 2030

Study information

Verified date April 2024
Source Astria Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 56
Est. completion date August 2030
Est. primary completion date August 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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). 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
STAR-0215
STAR-0215 will be administered as a subcutaneous injection.

Locations

Country Name City State
Canada University of Alberta Edmonton Alberta
Canada Ottawa Allergy Research Corporation Ottawa Ontario
United States Alabama Allervie Clinical Research Birmingham Alabama
United States Institute for Asthma and Allergy, PC Chevy Chase Maryland
United States Optimed Research Columbus Ohio
United States AARA Research Center Dallas Texas
United States Little Rock Allergy & Asthma Clinical Research Center Little Rock Arkansas
United States Washington University School of Medicine Saint Louis Missouri
United States Raffi Tachdjian MD, Inc Santa Monica California
United States Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD Scottsdale Arizona
United States Allergy & Asthma Clinical Research Walnut Creek California

Sponsors (1)

Lead Sponsor Collaborator
Astria Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Experiencing Treatment-emergent Adverse Events Day 1 through up to 6 years and 4 months
Secondary Change From Baseline in Monthly HAE Attack Rate Day 1, up to 5 years
Secondary Severity of HAE Attacks Experienced by Participants All HAE attacks will be classified according to severity (mild, moderate, and severe). Day 1 through up to 5 years
Secondary Duration of HAE Attacks Duration will be reported as shorter than 12 hours, 12 to 24 hours, 24 to 48 hours, and longer than 48 hours. Day 1 through up to 5 years
Secondary Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy Day 1 through up to 5 years
Secondary Time to First HAE Attack After Each Dose Day 1 through up to 5 years
Secondary Number of HAE Attack-free Days Day 1 through up to 5 years
Secondary Number of Participants Experiencing Zero HAE Attacks Day 1 through up to 5 years
Secondary Serum Concentration of STAR-0215 Blood samples will be collected on dosing days to measure the serum concentration of STAR-0215. Every 3 months for first 2 years, Every 6 months for next 3 years
Secondary Plasma Levels of Cleaved High-molecular-weight Kininogen Blood samples will be collected on dosing days to measure the plasma levels of cleaved high-molecular-weight kininogen (a measure of plasma kallikrein activity). Every 3 months for first 2 years, Every 6 months for next 3 years
Secondary Number of Participants with Anti-drug Antibodies to STAR-0215 Blood samples will be collected on dosing days to assess the formation of STAR-0215 anti-drug antibodies in serum. Every 3 months for first 2 years, Every 6 months for next 3 years
See also
  Status Clinical Trial Phase
Completed NCT00997204 - EASSI - Evaluation of the Safety of Self-Administration With Icatibant Phase 3
Completed NCT00438815 - Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks Phase 3
Completed NCT00748202 - Berinert P Study of Subcutaneous Versus Intravenous Administration Phase 3
Completed NCT01426763 - A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase Phase 2
Terminated NCT04091113 - Hereditary Angioedema Kininogen Assay
Completed NCT00432510 - Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects Phase 1
Completed NCT03712228 - A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE) Phase 2
Active, not recruiting NCT05453968 - Berotralstat Treatment in Children With Hereditary Angioedema Phase 3
Recruiting NCT05511922 - PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial Phase 3
Recruiting NCT05505916 - An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE) Phase 3
Not yet recruiting NCT02159430 - Hereditary AngioEdema, Neurobiology and Psychopathology N/A
Completed NCT02303626 - 12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks Phase 2/Phase 3
Completed NCT01984788 - Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE Phase 2
Completed NCT04888650 - Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema
Completed NCT02448264 - First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers Phase 1
Completed NCT05118958 - Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations Phase 1
Completed NCT06414252 - Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients
Active, not recruiting NCT04739059 - Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks Phase 3
Completed NCT02819102 - An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates Phase 1
Completed NCT01679912 - A Call Center During HAE Attacks (SOS HAE) Phase 4