Astria STAR-0215-302 trial for Navenibart in Hereditary Angioedema
| ISRCTN | ISRCTN10574179 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10574179 |
| Clinical Trials Information System (CTIS) | 2025-521142-22 |
| Integrated Research Application System (IRAS) | 1012485 |
| Central Portfolio Management System (CPMS) | 70310 |
| Protocol serial number | STAR-0215-302 |
| Sponsor | Astria Therapeutics, Inc (USA) |
| Funder | Astria Therapuetics, Inc. |
- Submission date
- 19/09/2025
- Registration date
- 09/02/2026
- Last edited
- 10/03/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Haematological Disorders
Plain English summary of protocol
Background and study aims
Researchers are looking for new ways to manage hereditary angioedema (HAE). HAE is a rare disorder that causes repeated and unpredictable attacks of swelling in the face, arms and legs, abdomen, genitals, and airway. These attacks can be severe, painful, disabling, and life- threatening. Treatments for HAE include medicines that help lessen the severity of an attack as it is happening (on-demand treatment) and medicines that help prevent HAE attacks (preventive treatment). These medicines often need to be taken frequently, which can be a burden for patients.
The drug being studied in this trial is called navenibart. Navenibart is a monoclonal antibody ( an antibody is part of the body’s immune defense system) . It is being developed to prevent HAE attacks. It does this by blocking plasma kallikrein, an enzyme that produces a substance called bradykinin, which causes HAE attacks. Early results suggest that navenibart can potentially help patients by preventing HAE attacks. Astria Therapeutics Inc., the company that makes navenibart, wants to find out more about its effects in people with HAE, both adults (18 years or older) and adolescents (12 to 17 years old).
The main aim of this trial is to evaluate the safety and tolerability of navenibart in patients with HAE during long-term (more than 6 months and up to five years) use.
Who can participate?
Participants from STAR-0215-301(ALPHA-ORBIT) who meet certain criteria can participate. About 145 participants with HAE will take part in the trial globally, including both adults (18 years or older) and adolescents (12 to 17 years old). There will be approximately 12 participants with HAE taking part in the UK.
What does the trial involve?
Participants will be in this trial for up to 5 years. All participants will receive navenibart.
For adult participants who completed the ALPHA-ORBIT trial, this trial is divided into two parts. In Part 1, which will last at least 6 months for each participant, adults who received navenibart in ALPHA-ORBIT will continue at the same dose. Adults who received placebo in ALPHA-ORBIT will receive 600 mg of navenibart every 3 months. In Part 2, adults can change their navenibart dose in collaboration with the study doctors.
All adolescent participants will continue to receive navenibart at the same dose as ALPHA-ORBIT.
Trial drug will be given subcutaneously (an injection given in the fatty tissue just under the skin using a small needle).
What are the possible benefits and risks of participating?
There may not be a direct medical benefit from receiving the study drug. A study participant’s HAE may get better, stay the same, or even get worse.
It is possible that the results may not help individuals but the information we get from this study will help us improve treatment for people with HAE in the future.
Where is the study run from?
Astria Therapeutics, Inc (USA)
When is the study starting and how long is it expected to run for?
February 2026 to June 2031
Who is funding the study?
Astria Therapeutics, Inc (USA)
Who is the main contact?
alphaorbit_general@astriatx.com
Contact information
Public, Scientific
22 Boston Wharf Road, 10th Floor
Boston
MA 02210
United States of America
| Phone | +1 617 349 1971 |
|---|---|
| alphaorbit_general@astriatx.com |
Principal investigator
Portsmouth Road
Frimley
GU16 7UJ
United Kingdom
| Phone | +44 1276 604 604 |
|---|---|
| patrick.yong@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional non randomized |
| Secondary study design | Non randomised study |
| Scientific title | A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants with Hereditary Angioedema – ORBIT-EXPANSE |
| Study objectives | Primary objective: To assess the long-term safety and tolerability of navenibart in participants with hereditary angioedema (HAE) Secondary objectives: 1. To assess the long-term clinical efficacy of navenibart as a preventive treatment for HAE in participants with HAE 2. To assess the quality of life associated with the use of navenibart in participants with HAE |
| Ethics approval(s) |
Approved 09/12/2025, London - Chelsea Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; no telephone number provided; chelsea.rec@hra.nhs.uk), ref: 25/LO/0762 |
| Health condition(s) or problem(s) studied | Hereditary angioedema |
| Intervention | Adult participants will receive one of three dosing regimens: Regimen 1: Participants will receive 600 mg of navenibart (STAR-0215) via subcutaneous injection every 3 months. Regimen 2: Participants will receive 300 mg of navenibart (STAR-0215) via subcutaneous injection every 3 months. Regimen 3: Participants will receive 600 mg of navenibart (STAR-0215) via subcutaneous injection every 6 months. Adolescent participants will receive 300 mg of navenibart (STAR-0215) via subcutaneous injection every 3 months. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Navenibart 150mg/ml |
| Primary outcome measure(s) |
Incidence of treatment-emergent adverse events measured using patient records at first dosing visit through final follow-up visit |
| Key secondary outcome measure(s) |
First dosing visit through final follow-up visit measured using patient records: |
| Completion date | 30/06/2031 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 12 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 145 |
| Key inclusion criteria | 1. Participants from STAR-0215-301 who met one of the following conditions: a. Completed STAR-0215-301 through the Day 181 visit b. Withdrew from STAR-0215-301 and met all of the following criteria: i. 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 | 1. 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 2. Any exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy [HRT]) within 30 days before informed consent/assent. 3. Known sensitivity to the ingredients in the formulation of IP |
| Date of first enrolment | 12/02/2026 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- United Kingdom
- Australia
- Austria
- Brazil
- Bulgaria
- Canada
- Czech Republic
- France
- Germany
- Hong Kong
- Hungary
- Israel
- Italy
- Japan
- Korea, South
- Netherlands
- New Zealand
- North Macedonia
- Poland
- Portugal
- South Africa
- Spain
- United States of America
Study participating centres
Frimley
Camberley
GU16 7UJ
England
80 Newark Street
London
E1 2ES
England
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
England
Pond Street
London
NW3 2QG
England
Derriford Road
Derriford
Plymouth
PL6 8DH
England
Cambridge
CB2 0AU
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
10/03/2026: Internal review.
11/12/2025: ISRCTN received notification of combined HRA/MHRA approval for this trial on 11/12/2025.
19/09/2025: Trial's existence confirmed by NHS HRA.
