Signant Health

• The study used 46 sites across Canada (10), Czechia (3), Germany (2), Hungary (3), Poland (8), Spain (3), the United Kingdom (3), and the United States (14).
• A total of 293 participants signed consent and 229 were randomized, compared with approximately 225 participants planned for randomization.
• Enrollment was geographically balanced between North America/Western Europe (53.1%) and Eastern Europe (46.9%).

These findings describe the trial, not the service provider’s performance or responsibility.

• Approximately 50% of the first 22 Part 1 participants experienced on-treatment ALT elevations, and protocol management criteria were amended because some elevations were prolonged.
• New enrollment was temporarily halted in December 2022 after significant ALT elevations were observed more frequently in Part 2 participants with screening or baseline HBsAg >10,000 IU/mL.
• Enrollment was not reopened because the sponsor discontinued further investment in its hepatitis B and D discovery and development programs.
• Part 2 open-label treatment was reduced to Week 96 and follow-up to 24 weeks under protocol amendment 5.
• Sustained HBV response was not collected or analyzed because follow-up was shortened and participants continued NA treatment during follow-up.

These findings describe the trial, not the service provider’s performance or responsibility.

• Recruitment began on 1 March 2022, and 98 participants were randomized at 57 sites in 19 countries.
• A May 2022 amendment changed the primary endpoint from complete remission on minimal OCS to CRoff at week 36 and added CRmin and IGA-BP-off-OCS secondary endpoints.
• Infection-related eligibility criteria were tightened across amendments, including exclusion of active or chronic infections and later clinically significant active infection unresolved before baseline.
• A March 2023 amendment added exclusions for latent infection, severe renal impairment, specified safety or procedure-affecting conditions, concurrent interventional-study enrollment, inadequately treated HIV, and recent live or live-attenuated vaccination.
• Sponsor confirmation of participant eligibility was removed in the March 2023 amendment.
• The March 2023 amendment required at least 30 minutes of on-site safety monitoring after investigational-product administration, and this requirement was removed in February 2024.
• The Day 10 PK sampling requirement in Part A was clarified to require samples from at least 28 participants rather than all participants.
• All adverse events in the MedDRA Infections and Infestations system organ class were designated adverse events of special interest in the May 2022 amendment.

These findings describe the trial, not the service provider’s performance or responsibility.