A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants with Hereditary Angioedema

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants with Hereditary Angioedema - ALPHA-ORBIT

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250452

Enrollment

Registered

2025-10-24

Start date

2025-10-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Angioedema

Interventions

Navenibart (STAR-0215) i) 600 mg SC every 3 months (Q3M), ii) 600 mg SC followed 3 months later by 300 mg SC Q3M or iii) 600 mg SC every 6 months (Q6M).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Documented diagnosis of HAE (Type 1 or 2). The following must be met: a. Documented clinical history consistent with HAE b. Lab findings consistent with HAE Type 1 or 2 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.

Exclusion criteria

Exclusion criteria: 1. 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. 2. 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): a. Lanadelumab within 90 days prior to Run-In b. Berotralstat within 21 days prior to Run-In c. Plasma-derived C1INH for LTP within 14 days prior to Run-In d. Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In e. All other prophylactic therapies, including investigational drugs, require consultation with the Medical Monitor

Design outcomes

Primary

Measure	Time frame
Number of time-normalized investigator-confirmed HAE attacks during the 6-month Treatment Period.	—

Countries

Australia, Austria, Brazil, Bulgaria, Canada, CzechRepublic, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Macedonia, Netherlands, New Zealand, Poland, Portugal, South Africa, South Korea, Spain, United Kingdom, United States

Contacts

Public ContactRie Dyson

Fortrea Japan K.K.

rie.dyson@fortrea.com+81-90-5202-7413

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026