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NCT07204938
A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants With Hereditary Angioedema - ORBIT-EXPANSE
Phase 3 trial testing navenibart in Hereditary Angioedema (HAE) in 145 participants. Enrolling by invitation.
1 June 2031
Quick facts
| Lead sponsor | Astria Therapeutics, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 145 |
| Start date | 1 October 2025 |
| Primary completion | 1 June 2031 |
| Estimated completion | 1 December 2031 |
| Sites | 28 locations across United States, Brazil, Bulgaria, Canada, Germany, Hong Kong, Israel, Japan |
Drugs / interventions tested
- navenibart — full drug profile →
Conditions studied
- Hereditary Angioedema (HAE) — all drugs for Hereditary Angioedema (HAE) →
Sponsor
Astria Therapeutics, Inc. — full company profile →
Who can join
12 and older, any sex, with Hereditary Angioedema (HAE). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Day 1 through Month 48
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07204938
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hereditary Angioedema (HAE)
Currently open trials in the same condition.
- NCT07251933 — A Study of Lanadelumab in Children With Hereditary Angioedema (HAE) in Multiple Countries · recruiting
- NCT07046806 — Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients · Phase 1, PHASE2 · recruiting
- NCT06806618 — HAE Burden and Crisis Management · recruiting
- NCT06846398 — A Phase 2 in Adult Subjects With Hereditary Angioedema · Phase 2 · active not recruiting
- NCT05469789 — A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE) · active not recruiting
Other Astria Therapeutics, Inc. trials
Trials by the same sponsor.
- NCT05695248 — A Study of STAR-0215 in Participants With Hereditary Angioedema · Phase 1, PHASE2 · completed
- NCT05477160 — A Study of STAR-0215 in Healthy Adult Participants · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07204938 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Astria Therapeutics, Inc.
- Last refreshed: 1 June 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07204938.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing