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NCT06007677
A Phase 2 Long-Term Open-Label Trial to Assess the Safety and Efficacy of Repeat Dosing of STAR-0215 in Adult Patients With Hereditary Angioedema (The ALPHA-SOLAR Trial)
Phase 2 trial testing STAR-0215 in Hereditary Angioedema in 56 participants. Participants enrolled and being followed up; not accepting new ones.
1 March 2031
Quick facts
| Lead sponsor | Astria Therapeutics, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 26 September 2023 |
| Primary completion | 1 March 2031 |
| Estimated completion | 1 March 2031 |
| Sites | 22 locations across United States, Bulgaria, Canada, Czechia, Germany, Poland, United Kingdom |
Drugs / interventions tested
- STAR-0215 — full drug profile →
Conditions studied
- Hereditary Angioedema — all drugs for Hereditary Angioedema →
Sponsor
Astria Therapeutics, Inc. — full company profile →
Who can join
18 and older, any sex, with Hereditary Angioedema. 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 Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through study completion, an average of 6 years
Sponsor's own description
The goal of this trial is to enable the collection of information about long-term safety and clinical activity of STAR-0215 in participants with hereditary angioedema (HAE). Participants will receive repeat doses of STAR-0215 for up to 5 years.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Patient Preferences for Long-Term Prophylactic Treatment in Hereditary Angioedema: A Discrete-Choice Experiment.
Villa KF, Mansfield C, Yarlas A, Ruggles JA, et al · · 2026 · cited 1× · PMID 41565919 · DOI 10.1007/s40271-025-00798-8
Verify or expand the search:
- PubMed search for NCT06007677
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of STAR-0215
Trials testing the same drug.
- NCT05695248 — A Study of STAR-0215 in Participants With Hereditary Angioedema · Phase 1, PHASE2 · completed
Other recruiting trials for Hereditary Angioedema
Currently open trials in the same condition.
- NCT06960213 — STOP-HAE: A Phase 3 Study of ADX-324 in HAE · Phase 3 · recruiting
- NCT06806657 — Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab · Phase 4 · recruiting
- NCT06573723 — Institutional Registry of Rare Diseases · recruiting
- NCT05691361 — Safety, Tolerability, PK, PD of ADX-324 in Healthy Volunteers and Hereditary Angioedema Patients · Phase 1, PHASE2 · active not recruiting
- NCT05505916 — An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angio · Phase 3 · 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 NCT06007677 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 21 July 2025
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/NCT06007677.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing