Hereditary Angioedema (HAE)Phase 3ALPHA-ORBITNCT06842823
A 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 86 sites in 24 countries.
Trial summary
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). 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?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 86 sitesin 24 countries
- Study dates
- 20 Mar 2025to Jun 2027
- 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
- Documented diagnosis of HAE (Type 1 or 2). The following must be met:
- Documented clinical history consistent with HAE
- Lab findings consistent with HAE Type 1 or 2
- Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.
Who cannot join
- Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type 3), idiopathic angioedema, or angioedema associated with urticaria.
- 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 washout prior to entering the Run-In Period).
- Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In
- Plasma-derived C1INH for LTP within 14 days prior to Run-In
- Berotralstat within 21 days prior to Run-In
- Lanadelumab within 70 days prior to Run-In
- Garadacimab within 90 days prior to Run-In
Trial locations and contacts
86 sites in 24 countries.
86 sites in 24 countries
United States19 sites
Site 9
Birmingham, Alabama, 35209
Site 67
Boston, Massachusetts, 02114
Site 8
Centennial, Colorado, 80112
Site 7
Cincinnati, Ohio, 45236
Site 11
Colorado Springs, Colorado, 80907
Site 86
Dallas, Texas, 75231
Site 13
Detroit, Michigan, 48202
Site 15
Hummelstown, Pennsylvania, 17036
Site 3
Little Rock, Arkansas, 72205
Site 26
San Diego, California, 92122
Site 14
San Diego, California, 92123,
Site 4
Santa Monica, California, 90404
Site 2
Scottsdale, Arizona, 85251
Site 10
St Louis, Missouri, 63141
Site 25
Tampa, Florida, 33613
Site 12
Toledo, Ohio, 43617
Site 1
Walnut Creek, California, 94598
Site 69
Weston, Florida, 33331
Site 6
Wheaton, Maryland, 20902
Japan10 sites
Site 30
Fukuoka, Kurume-shi, 830-0011
Site 57
Hiroshima, 730-8518
Site 50
Hiroshima, 734-8551
Site 61
Kawagoe, Saitama, 350-8550
Site 58
Kawasaki, 216-8511
Site 80
Nagasaki, 852-8501
Site 47
Saga, 849-8501
Site 31
Saitama, Soka-shi, 340-0041
Site 73
Tokyo, 173-0032
Site 56
Tsu, Mei, 514-8507
Italy7 sites
Site 42
Milan, 20138
Site 85
Milan, 20157
Site 51
Monserrato, 09042
Site 51
Monserrato, CA 09042
Site 66
Padova, 35128
Site 40
San Donato Milanese, 20097
Site 41
Torino, 10128
United Kingdom6 sites
Site 19
Bristol, BS10 5N
Site 16
Cambridge, CB2 0QQ
Site 22
Frimley, GU16 7UJ
Site 24
Hampstead, London, NW3 2QG
Site 17
London, E1 2ES
Site 18
Plymouth, Devon, PL6 8HD
France5 sites
Site 46
La Tronche, 38700
Site 54
Lille, 59037
Site 65
Marseille, 13005
Site 72
Nice, 06202
Site 52
Paris, 75012
Israel5 sites
Site 55
Ashkelon, 7830604
Site 49
Haifa, 3104802
Site 35
Petah Tikva, 49100
Site 34
Petah Tikva, 4920235
Site 53
Tel Aviv, 6423906
Spain5 sites
Site 32
Barcelona
Site 63
Madrid, 28007
Site 84
Santa Cruz de Tenerife, 38010
Site 48
Seville, 41013
Site 36
Valencia, 46026
Poland4 sites
Site 71
Krakow, 31-503
Site 78
Lodz, 92-213
Site 29
Rzeszów, 35-051
Site 79
Warsaw, 04-141
Australia3 sites
Site 68
Campbelltown, New South Wales, 2560
Site 76
Melbourne, Victoria
Site 74
Murdoch, WA 6150
Germany3 sites
Site 38
Berlin, 12203
Site 44
Frankfurt, D-60590
Site 70
Hanover, 30625
South Korea3 sites
Site 77
Seongnam-si
Site 62
Seoul, Jongno
Site 60
Yangcheon, Seoul
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants With Hereditary Angioedema (HAE)
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.
- Conditions
- Hereditary Angioedema (HAE)
- Being tested
- navenibart, Placebo
- Keywords
- HAE, Angioedema
- 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.
PlaceboDrug
Placebo will be administered as a subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Adult Navenibart Dosing Regimen 1 | Experimental | Participants will receive 600 mg of navenibart every 3 months. Receives: Drug: navenibart |
| Adult Navenibart Dosing Regimen 2 | Experimental | Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3. Receives: Drug: navenibart |
| Adult Navenibart Dosing Regimen 3 | Experimental | Participants will receive 600 mg of navenibart every 6 months. Receives: Drug: navenibart |
| Placebo (adult) | Placebo comparator | Participants will receive placebo every 3 months. Receives: Drug: Placebo |
| Adolescent Navenibart Dosing Regimen 1 | Experimental | Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3. Receives: Drug: navenibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of time-normalized investigator-confirmed HAE attacks during the 6-month Treatment Period.
Measured: Day 1 through Day 181
Secondary outcomes (7)
Number of moderate or severe investigator-confirmed HAE attacks during the 6-month Treatment Period.
Measured: Day 1 through Day 181
Number of investigator-confirmed HAE attacks that require on-demand treatment during the 6-month Treatment Period.
Measured: Day 1 through Day 181
Percent reduction in monthly investigator-confirmed HAE attacks in the 6-month Treatment Period versus the Run-In Period.
Measured: Baseline through Day 181
Time to first investigator-confirmed HAE attack after first and second dose.
Measured: 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).
Measured: Baseline through Day 181
Number of participants with no investigator-confirmed HAE attacks during the 6-month Treatment Period.
Measured: Day 1 through Day 181
Change from baseline (Day 1) in the Angioedema Quality of Life questionnaire total score.
Measured: Day 1 through Day 181
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start20 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adult participants will be randomly assigned to one of 4 arms. Adolescent participants will be assigned to a single experimental group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astria Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842823
- Sponsor's protocol ID
- STAR-0215-301
- Acronym
- ALPHA-ORBIT
- Status last verified
- Jun 2026
- First submitted
- 19 Feb 2025
- Last updated
- 30 Jun 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 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants With Hereditary Angioedema (HAE)
- ClinicalTrials.gov ID
- NCT06842823
- Acronym / sponsor ID
- ALPHA-ORBIT / STAR-0215-301
- Conditions
- Hereditary Angioedema (HAE)
- Keywords
- HAE, Angioedema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Astria Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Feb 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Adult participants will be randomly assigned to one of 4 arms. Adolescent participants will be assigned to a single experimental group.
| Arm | Type | Receives |
|---|---|---|
| Adult Navenibart Dosing Regimen 1 | Experimental | Drug: navenibartParticipants will receive 600 mg of navenibart every 3 months. |
| Adult Navenibart Dosing Regimen 2 | Experimental | Drug: navenibartParticipants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3. |
| Adult Navenibart Dosing Regimen 3 | Experimental | Drug: navenibartParticipants will receive 600 mg of navenibart every 6 months. |
| Placebo (adult) | Placebo comparator | Drug: PlaceboParticipants will receive placebo every 3 months. |
| Adolescent Navenibart Dosing Regimen 1 | Experimental | Drug: navenibartParticipants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3. |
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)
- Documented diagnosis of HAE (Type 1 or 2). The following must be met:
- Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.
Key exclusion criteria (7 listed)
- Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type 3), idiopathic angioedema, or angioedema associated with urticaria.
- 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 washout prior to entering the Run-In Period).
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 Navenibart Dosing Regimen 1, Adult Navenibart Dosing Regimen 1, Adult Navenibart Dosing Regimen 2, Adult Navenibart Dosing Regimen 3 |
| PlaceboPlacebo will be administered as a subcutaneous injection. | Drug | Placebo (adult) |
Primary outcome
Number of time-normalized investigator-confirmed HAE attacks during the 6-month Treatment Period.
Time frame: Day 1 through Day 181
7 secondary outcomes
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
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 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Hereditary Angioedema (HAE)
RecruitingPhase 3
Donidalorsen Treatment in Children With Hereditary Angioedema
Hereditary Angioedema (HAE)
RecruitingObservational study
A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
Hereditary Angioedema (HAE)
Active, not recruitingPhase 3
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
Hereditary Angioedema
RecruitingPhase 3
Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks
Acute Hereditary Angio Edema
Active, not recruitingPhase 1/2
NTLA-2002 in Adults With Hereditary Angioedema (HAE)
Hereditary Angioedema
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
86 sites in 24 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 86 sites in 24 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 7 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: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United States, Japan, Italy, United Kingdom, France and 19 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. Some participants in this study may receive a placebo. 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?
Number of time-normalized investigator-confirmed HAE attacks during the 6-month Treatment Period. (time frame: Day 1 through Day 181). 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 Jun 2026.