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NCT06842823: ALPHA-ORBIT
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants With Hereditary Angioedema (HAE)
Phase 3 trial testing navenibart in Hereditary Angioedema (HAE) in 145 participants. Enrolling by invitation.
1 March 2027
Quick facts
| Lead sponsor | Astria Therapeutics, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 145 |
| Start date | 20 March 2025 |
| Primary completion | 1 March 2027 |
| Estimated completion | 1 September 2027 |
| Sites | 86 locations across United States, Australia, Austria, Brazil, Bulgaria, Canada, Czechia, France |
Drugs / interventions tested
- navenibart — full drug profile →
- Placebo
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.
-
Number of time-normalized investigator-confirmed HAE attacks during the 6-month Treatment Period.
Time frame: Day 1 through Day 181
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06842823
- 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 NCT06842823 (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: 4 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/NCT06842823.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing