A Phase 3 interventional study of navenibart and Placebo in Hereditary Angioedema (HAE), sponsored by Astria Therapeutics, Inc.. Active, not recruiting at 86 sites in 24 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Astria Therapeutics, Inc. (part of BioCryst Pharmaceuticals) · Phase 3, Interventional, and Treatment
This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2 hereditary angioedema (HAE). The goal of this clinical trial is to evaluate the efficacy and safety of navenibart compared to placebo in preventing HAE attacks in participants with HAE.
171 studies on the registry are indexed under Angioedemas, Hereditary; 24 are open to participants now.
This study's enrollment of 157 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.
Documented diagnosis of HAE (Type 1 or 2). The following must be met:
Exclusion Criteria:
Use of therapies prescribed for the prevention of HAE attacks may not be used during the trial or within the below time frames prior to the Run-In Period (adult participants may be on these medications at the time of the Screening Visit, but will need to prior to entering the Run-In Period).
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.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 600 mg of navenibart every 3 months.
Drug: navenibart
Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.
Drug: navenibart
Participants will receive 600 mg of navenibart every 6 months.
Drug: navenibart
Participants will receive placebo every 3 months.
Drug: Placebo
Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.
Drug: navenibart
Navenibart will be administered as a subcutaneous injection.
Also known as: STAR-0215
Placebo will be administered as a subcutaneous injection.
Number of time-normalized investigator-confirmed HAE attacks during the 6-month Treatment Period.
Time frame: Day 1 through Day 181
Number of moderate or severe investigator-confirmed HAE attacks during the 6-month Treatment Period.
Time frame: Day 1 through Day 181
Number of investigator-confirmed HAE attacks that require on-demand treatment during the 6-month Treatment Period.
Time frame: Day 1 through Day 181
Percent reduction in monthly investigator-confirmed HAE attacks in the 6-month Treatment Period versus the Run-In Period.
Time frame: Baseline through Day 181
Time to first investigator-confirmed HAE attack after first and second dose.
Time frame: Day 1 through Day 181
The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction from the Run-In Period in investigator-confirmed HAE attack rate (for adult participants: compared to placebo during the 6-month Treatment Period).
Time frame: Baseline through Day 181
Number of participants with no investigator-confirmed HAE attacks during the 6-month Treatment Period.
Time frame: Day 1 through Day 181
Change from baseline (Day 1) in the Angioedema Quality of Life questionnaire total score.
Time frame: Day 1 through Day 181
Incidence of treatment-emergent adverse events.
Time frame: Day 1 through Day 361
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Navenibart