drugset / Trial / NCT05461170
SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.
RandomizedSequentialOpen-labelTreatment
Summary
This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy
Timeline
- Start
- 2022-09-17
- Primary completion
- 2031-11
- Completion
- 2032-05
Publications
- Noack J, Anglero-Rodriguez Y, Gall J, Zhou J, LeBlanc S, Liebow A, Bakardjiev A, Hebner CM, Purcell LA, Jadhav V, Corti D, Lempp FA. Combination therapy with tobevibart and elebsiran potently reduces hepatitis B virus surface antigen levels in preclinical in vivo models. Antimicrob Agents Chemother. 2026 Mar 4;70(3):e0112725. doi: 10.1128/aac.01127-25. Epub 2026 Jan 26.
- Asselah T, Chattergoon MA, Jucov A, Streinu-Cercel A, Lampertico P, Wedemeyer H, Kennedy PT, Gane EJ, Bullard BL, Chow S, Santos D, Camus G, Lu Y, Pilowa C, Hwang C, Correll T, Agarwal K; SOLSTICE Trial Investigators. A Phase 2 Trial of Tobevibart plus Elebsiran in Hepatitis D. N Engl J Med. 2026 Jan 22;394(4):343-353. doi: 10.1056/NEJMoa2508827. Epub 2025 Nov 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tobevibart | Monoclonal antibody | — | Subcutaneous |
| Subject | VIR-2218 | Small interfering RNA (siRNA) | — | Subcutaneous |