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Enrolling by invitation NCT07204938

A Long-Term Study of Navenibart in Participants With Hereditary Angioedema

Phase III Interventional Hereditary Angioedema (HAE)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: navenibart.
Who it may be relevant to
Registry conditions: Hereditary Angioedema (HAE). Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Brazil, Bulgaria, Canada, Czechia +13
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants With Hereditary Angioedema - ORBIT-EXPANSE

Overview

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.

Interventions

  • Drug navenibart
    Navenibart will be administered as a subcutaneous injection.

Primary outcome measures

  • Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Day 1 through Month 48]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

Inclusion criteria

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:

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 10 centers
  • Site 2 — Scottsdale
  • Site 3 — Little Rock
  • Site 7 — San Diego
  • Site 4 — Santa Monica
  • Site 1 — Walnut Creek
  • Site 5 — Centennial
  • Site 19 — Colorado Springs
  • Site 21 — Wheaton
  • … and 2 more centers
United Kingdom · 6 centers
  • Site 12 — Bristol
  • Site 8 — Cambridge
  • Site 28 — Frimley
  • Site 15 — Hampstead
  • Site 13 — London
  • Site 14 — Plymouth
Israel · 4 centers
  • Site 29 — Ashkelon
  • Site 30 — Haifa
  • Site 31 — Petah Tikva
  • Site 24 — Petah Tikva
Japan · 3 centers
  • Site 40 — Kawagoe
  • Site 27 — Fukuoka
  • Site 33 — Kawasaki
Italy · 2 centers
  • Site 37 — Milan
  • Site 38 — Monserrato
Poland · 2 centers
  • Site 35 — Krakow
  • Site 16 — Rzeszów
Spain · 2 centers
  • Site 34 — Madrid
  • Site 26 — Valencia
Brazil · 1 center
  • Site 22 — Santo André
Bulgaria · 1 center
  • Site 20 — Sofia
Canada · 1 center
  • Site 23 — Edmonton
Czechia · 1 center
  • Site 36 — Prague
France · 1 center
  • Site 39 — Paris
Germany · 1 center
  • Site 25 — Frankfurt
Hong Kong · 1 center
  • Site 10 — Hong Kong
Netherlands · 1 center
  • Site 17 — Amsterdam
North Macedonia · 1 center
  • Site 18 — Skopje
Puerto Rico · 1 center
  • Site 32 — San Juan
South Africa · 1 center
  • Site 11 — Cape Town

Identifiers

NCT: NCT07204938 · STAR-0215-302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗