SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.

June 23, 2026 updated by: Vir Biotechnology, Inc.

A Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of VIR-2218 and VIR-3434 in Participants With Chronic Hepatitis D Virus Infection (SOLSTICE)

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants may be enrolled into Cohort 1 (1a and 1b) or Cohort 2 (2a, 2b1 or 2b2, 2c), 3, 4, and 5. All participants still receiving VIR-2218 or VIR-3434 monotherapy at the time of implementation of Protocol Amendment 4 will switch to combination therapy at Week 132 (Cohort 2a, 2b1/2b2) or Week 112 (Cohort 3).

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1431
        • Investigative Site
      • Sofia, Bulgaria, 1407
        • Investigative Site
      • Stara Zagora, Bulgaria, 6003
        • Investigative Site
  • France
      • Clichy, France, 92110
        • Investigative Site
      • Pessac, France, 33600
        • Investigative Site
      • Rennes, France, 35000
        • Investigative Site
      • Toulouse, France, 31000
        • Investigative Site
  • Germany
      • Frankfurt, Germany, 60596
        • Investigative Site
      • Hanover, Germany, 30625
        • Investigative Site
      • Tübingen, Germany, 72076
        • Investigative Site
  • Italy
      • Milan, Italy, 20122
        • Investigative Site
      • Pisa, Italy, 56124
        • Investigative Site
  • Moldova
      • Chisinau, Moldova, MD-2025
        • Investigative Site
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Investigative Site
  • New Zealand
      • Auckland, New Zealand, 1010
        • Investigative Site
  • Romania
      • Bucharest, Romania, 021105
        • Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TT
        • Investigative Site
      • London, United Kingdom, SE5 9RS
        • Investigative Site
      • London, United Kingdom, E1 1RF
        • Investigative Site
      • Manchester, United Kingdom, M8 5RB
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female ages 18 to < 70 years at screening
  • Chronic HDV infection for >/= 6 months
  • On NRTI therapy for at least 12 weeks prior to day 1
  • ALT>ULN and < 5x ULN
  • Non-cirrhotic and CPT-A cirrhotic

Exclusion Criteria:

  • Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
  • History of significant liver disease from non-HBV or non-HDV etiology
  • History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
  • History of anaphylaxis
  • History of immune complex disease
  • History of autoimmune disorder
  • History or evidence of alcohol or drug abuse
  • Prior or concomitant therapy with an immunomodulatory agent, IFN-alpha, cytotoxic or chemotherapeutic agent, or chronic corticosteroids.
  • Anti-HBs >10 mIU/mL at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1b (VIR-3434)
Participants will receive multiple doses of VIR-3434 for up to 96 weeks total.
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Placebo Comparator: Cohort 4 (NRTI)
Participants will receive NRTI for 12 weeks, then assign to Cohort 2c or Cohort 3.
Drug: NRTI
NRTI given orally.
Experimental: Cohort 1a (VIR-2218)
Participants will receive multiple doses of VIR-2218 for up to 96 weeks total.
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Experimental: Cohort 5 (VIR-2218)
Participants will receive multiple doses of VIR-2218 for 12 weeks, then assign to Cohort 2c.
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Experimental: Cohort 2a (VIR-2218)
Participants will receive multiple doses of VIR-2218 for up to 132 weeks, then assign to Cohort 2c.
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Experimental: Cohort 2b1 (VIR-3434)
Participants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c.
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Experimental: Cohort 2b2 (VIR-3434)
Participants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c.
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Experimental: Cohort 3 (VIR-3434)
Participants will receive multiple doses of VIR-3434 for up to 112 weeks, then assign to Cohort 2c.
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Experimental: Cohort 2c (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for up to 336 weeks.
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with undetectable HDV RNA (< limit of detection [LOD]) or ≥ 2 log10 decrease in HDV RNA from baseline and alanine aminotransferase (ALT) normalization (ALT < upper limit of normal [ULN]) at Week 24
Time Frame: Up to 24 Weeks
Up to 24 Weeks
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame: Up to 360 Weeks
Up to 360 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline and ALT normalization at Week 12, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time Frame: Up to 336 Weeks
Up to 336 Weeks
Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time Frame: Up to 336 Weeks
Up to 336 Weeks
Proportion of participants with undetectable HDV RNA (less than LOD) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time Frame: Up to 336 Weeks
Up to 336 Weeks
Proportion of participants with HDV RNA < lower limit of quantitation (LLOQ) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time Frame: Up to 336 Weeks
Up to 336 Weeks
Change from baseline in HDV RNA at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time Frame: Up to 336 Weeks
Up to 336 Weeks
Proportion of participants with ALT normalization at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time Frame: Up to 336 Weeks
Up to 336 Weeks
Incidence of anti-drug antibodies (ADA) and titers of ADA to VIR-3434 at specified study visits up to Week 336 (for cohorts with VIR3434)
Time Frame: Up to 336 Weeks
Up to 336 Weeks
Change from baseline in liver fibrosis at Week 48, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time Frame: Up to 336 Weeks.
Liver Fibrosis will be measured by conventional Transient Elastography imaging technique reported in kPa.
Up to 336 Weeks.
Change from baseline in Model for End Stage Liver Disease (MELD) score at Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time Frame: Up to 336 Weeks
MELD score will be calculated using serum bilirubin, serum creatinine, and International Normalized Ratio.
Up to 336 Weeks
Change from baseline in Child-Pugh-Turcotte (CPT) score at Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time Frame: Up to 336 Weeks
Up to 336 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vir Biotechnology, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2022

Primary Completion (Estimated)

November 1, 2031

Study Completion (Estimated)

May 1, 2032

Study Registration Dates

First Submitted

July 1, 2022

First Submitted That Met QC Criteria

July 12, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIR-CHDV-V201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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