A Phase 2 interventional study of STAR-0215 in Hereditary Angioedema, sponsored by Astria Therapeutics, Inc.. Active, not recruiting at 22 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by Astria Therapeutics, Inc. (part of BioCryst Pharmaceuticals) · Phase 2, Interventional, and Treatment
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.
171 studies on the registry are indexed under Angioedemas, Hereditary; 24 are open to participants now.
This study's planned enrollment of 56 is above the median of 48 across 116 interventional studies indexed under Angioedemas, Hereditary.
Browse Angioedemas, Hereditary studies →Astria Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
First submitted before Astria Therapeutics, Inc. became part of BioCryst Pharmaceuticals.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following conditions:
Exclusion Criteria:
Use of therapies prescribed for the prevention of HAE attacks prior to Screening:
Note: Other inclusion and exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive STAR-0215 every 3 months.
Drug: STAR-0215
Participants will receive STAR-0215 every 6 months.
Drug: STAR-0215
STAR-0215 will be administered as a subcutaneous injection.
Drug: STAR-0215
STAR-0215 will be administered as a subcutaneous injection.
Drug: STAR-0215
STAR-0215 will be administered as a subcutaneous injection.
Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through study completion, an average of 6 years
Change From Baseline in Monthly HAE Attack Rate
Time frame: Day 1, up to 5 years
Severity of HAE Attacks Experienced by Participants
All HAE attacks will be classified according to severity (mild, moderate, and severe).
Time frame: Day 1 through up to 5 years
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.
Time frame: Day 1 through up to 5 years
Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy
Time frame: Day 1 through up to 5 years
Time to First HAE Attack After Each Dose
Time frame: Day 1 through up to 5 years
Number of HAE Attack-free Days
Time frame: Day 1 through up to 5 years
Number of Participants Experiencing Zero HAE Attacks
Time frame: Day 1 through up to 5 years
Serum Concentration of STAR-0215
Blood samples will be collected on dosing days to measure the serum concentration of STAR-0215.
Time frame: Every 3 months for first 2 years, Every 6 months for next 3 years
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).
Time frame: Every 3 months for first 2 years, Every 6 months for next 3 years
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.
Time frame: Every 3 months for first 2 years, Every 6 months for next 3 years
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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