Hereditary Angioedema (HAE)Phase 3NCT07204938
A Long-Term Study of Navenibart in Participants With Hereditary Angioedema
A Phase 3 study testing navenibart in people with Hereditary Angioedema (HAE), run by Astria Therapeutics, Inc. at 40 sites in 18 countries.
Trial summary
This is a Phase 3 multicenter trial in 2 parts to evaluate the long-term safety and efficacy of navenibart in adult and adolescent participants with hereditary angioedema (HAE) who participated in STAR-0215-301 (NCT06842823; ALPHA-ORBIT). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hereditary Angioedema (HAE)
- What is being tested?
- navenibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 40 sitesin 18 countries
- Study dates
- 1 Oct 2025to Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Participants from STAR-0215-301 who met one of the following conditions:
- Completed STAR-0215-301 through the Day 181 visit
- Withdrew from STAR-0215-301 but met the following criteria:
- Received 2 doses of IP ii. completed ≥ 2 months of trial follow-up after the second dose of IP iii. Met other eligibility criteria as assessed by Investigator
Who cannot join
- Participation in an investigational clinical trial other than STAR-0215- 301 in the 30 days or any exposure to an investigational drug (other than navenibart in STAR-0215-301) within 5 half-lives before informed consent/assent
- 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 30 days before Screening.
- Known sensitivity to the ingredients in the formulation of IP
Trial locations and contacts
40 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
40 sites in 18 countries
United States10 sites
Site 5
Centennial, Colorado, 80112
Site 6
Cincinnati, Ohio, 45236
Site 19
Colorado Springs, Colorado, 80907
Site 9
Hershey, Pennsylvania, 17033
Site 3
Little Rock, Arkansas, 72205
Site 7
San Diego, California, 92122
Site 4
Santa Monica, California, 90404
Site 2
Scottsdale, Arizona, 85251
Site 1
Walnut Creek, California, 94598
Site 21
Wheaton, Maryland, 20902
United Kingdom6 sites
Site 12
Bristol, BS10 5N
Site 8
Cambridge, CB2 0QQ
Site 28
Frimley, GU16 7UJ
Site 15
Hampstead, NW3 2QG
Site 13
London, E1 2ES
Site 14
Plymouth, PL6 8HD
Israel4 sites
Site 29
Ashkelon, 783604
Site 30
Haifa, 3104802
Site 31
Petah Tikva, 49100
Site 24
Petah Tikva, 4920235
Japan3 sites
Site 27
Fukuoka, 830-0011
Site 40
Kawagoe, Saitama, 350-0844
Site 33
Kawasaki, 216-8511
About this study
Official title: A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants With Hereditary Angioedema - ORBIT-EXPANSE
This is a Phase 3 multicenter trial in 2 parts to evaluate the long-term safety and efficacy of navenibart in adult and adolescent participants with hereditary angioedema (HAE) who participated in STAR-0215-301 (NCT06842823; ALPHA-ORBIT). Part 1 provides all participants with navenibart in a dose-controlled fashion; Part 2 introduces a personalized dosing option (PDO) for participants based on individual needs.
- Conditions
- Hereditary Angioedema (HAE)
- Being tested
- navenibart
- Keywords
- HAE, Angioedema, Long-Term, Safety
- Medical subject headings
- Angioedemas, Hereditary, Angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navenibartDrug
Also called STAR-0215
Navenibart will be administered as a subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Adult Dosing Regimen 1 | Experimental | Participants will receive 600 mg of navenibart every 3 months. Receives: Drug: navenibart |
| Adult Dosing Regimen 2 | Experimental | Participants will receive 300 mg of navenibart every 3 months. Receives: Drug: navenibart |
| Adult Dosing Regimen 3 | Experimental | Participants will receive 600 mg of navenibart every 6 months. Receives: Drug: navenibart |
| Adolescent Dosing Regimen 1 | Experimental | Participants will receive 300 mg of navenibart every 3 months. Receives: Drug: navenibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Day 1 through Month 48
Secondary outcomes (8)
Number of time-normalized investigator-confirmed HAE attacks
Measured: Day 1 through Month 48
Number of moderate or severe investigator-confirmed HAE attacks
Measured: Day 1 through Month 48
Number of investigator-confirmed HAE attacks that require on-demand treatment
Measured: Day 1 through Month 48
Percent reduction in monthly investigator-confirmed HAE attacks
Measured: Day 1 through Month 48
Time to first investigator-confirmed HAE attack after first dose
Measured: Day 1 through Month 48
The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction in investigator-confirmed HAE attack rate
Measured: Day 1 through Month 48
Number of participants with no investigator-confirmed HAE attacks
Measured: Day 1 through Month 48
Angioedema Quality of Life questionnaire total score
The Angioedema Quality of Life Questionnaire (AE-QoL) consists of 17 questions divided into four domains: functioning (4 questions), fatigue/mood (5), fears/shame (6), and food/nutrition (2). Each question is answered on a 5-point scale from "never" to "very often." Scores are calculated for each domain and then normalized to a scale from 0 to 100, where 0 represents the best possible quality of life and 100 the worst.
Measured: Day 1 through Month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Oct 2025
- Primary completionJun 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Angioedema (HAE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In Part 1, adult participants who completed STAR-0215-301 and received navenibart will maintain their fixed dosing regimen from STAR-0215-301, whereas those who were randomized to placebo in STAR-0215-301 will receive navenibart 600 mg Q3M. In Part 2, adult participants may move among dosing regimens via the personalized dosing option (PDO) based on their individual needs. Adult participants who did not complete STAR-0215-301 may be eligible to enroll in Part 2 of STAR-0215-302 if they meet certain criteria. Adolescent participants will continue to receive their fixed dosing regimen from STAR-0215-301 until they turn 18 years of age.
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astria Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204938
- Sponsor's protocol ID
- STAR-0215-302
- Status last verified
- Jul 2026
- First submitted
- 30 Sep 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants With Hereditary Angioedema - ORBIT-EXPANSE
- ClinicalTrials.gov ID
- NCT07204938
- Acronym / sponsor ID
- STAR-0215-302
- Conditions
- Hereditary Angioedema (HAE)
- Keywords
- HAE, Angioedema, Long-Term, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Astria Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3 multicenter trial in 2 parts to evaluate the long-term safety and efficacy of navenibart in adult and adolescent participants with hereditary angioedema (HAE) who participated in STAR-0215-301 (NCT06842823; ALPHA-ORBIT). Part 1 provides all participants with navenibart in a dose-controlled fashion; Part 2 introduces a personalized dosing option (PDO) for participants based on individual needs.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- In Part 1, adult participants who completed STAR-0215-301 and received navenibart will maintain their fixed dosing regimen from STAR-0215-301, whereas those who were randomized to placebo in STAR-0215-301 will receive navenibart 600 mg Q3M. In Part 2, adult participants may move among dosing regimens via the personalized dosing option (PDO) based on their individual needs. Adult participants who did not complete STAR-0215-301 may be eligible to enroll in Part 2 of STAR-0215-302 if they meet certain criteria. Adolescent participants will continue to receive their fixed dosing regimen from STAR-0215-301 until they turn 18 years of age.
| Arm | Type | Receives |
|---|---|---|
| Adult Dosing Regimen 1 | Experimental | Drug: navenibartParticipants will receive 600 mg of navenibart every 3 months. |
| Adult Dosing Regimen 2 | Experimental | Drug: navenibartParticipants will receive 300 mg of navenibart every 3 months. |
| Adult Dosing Regimen 3 | Experimental | Drug: navenibartParticipants will receive 600 mg of navenibart every 6 months. |
| Adolescent Dosing Regimen 1 | Experimental | Drug: navenibartParticipants will receive 300 mg of navenibart every 3 months. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Completed STAR-0215-301 through the Day 181 visit
- Withdrew from STAR-0215-301 but met the following criteria:
- Received 2 doses of IP ii. completed ≥ 2 months of trial follow-up after the second dose of IP iii. Met other eligibility criteria as assessed by Investigator
Key exclusion criteria (3 listed)
- Participation in an investigational clinical trial other than STAR-0215- 301 in the 30 days or any exposure to an investigational drug (other than navenibart in STAR-0215-301) within 5 half-lives before informed consent/assent
- 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 30 days before Screening.
- Known sensitivity to the ingredients in the formulation of IP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| navenibartAlso: STAR-0215Navenibart will be administered as a subcutaneous injection. | Drug | Adolescent Dosing Regimen 1, Adult Dosing Regimen 1, Adult Dosing Regimen 2, Adult Dosing Regimen 3 |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Day 1 through Month 48
8 secondary outcomes
Number of time-normalized investigator-confirmed HAE attacks
Time frame: Day 1 through Month 48
Number of moderate or severe investigator-confirmed HAE attacks
Time frame: Day 1 through Month 48
Number of investigator-confirmed HAE attacks that require on-demand treatment
Time frame: Day 1 through Month 48
Percent reduction in monthly investigator-confirmed HAE attacks
Time frame: Day 1 through Month 48
Time to first investigator-confirmed HAE attack after first dose
Time frame: Day 1 through Month 48
The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction in investigator-confirmed HAE attack rate
Time frame: Day 1 through Month 48
Number of participants with no investigator-confirmed HAE attacks
Time frame: Day 1 through Month 48
Angioedema Quality of Life questionnaire total score
Time frame: Day 1 through Month 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing navenibart in people with Hereditary Angioedema (HAE), run by Astria Therapeutics, Inc. at 40 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, United Kingdom, Israel, Japan, Italy and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: Day 1 through Month 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.