Canfield Scientific

• 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.

• 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.

• Some participants who completed Period 1 did not enter Period 2, so the number starting Period 2 did not match the number completing Period 1.
• The optional actigraphy substudy was removed to reduce participant burden and simplify site logistics.
• Screening height measurement was added for adolescents to enable glomerular-filtration-rate calculation for eligibility assessment.
• An adolescent substudy was added to meet a regulatory commitment for long-term adolescent exposure.
• The blinded extension was extended from Week 136 to Week 260 to collect longer-term efficacy and safety data.
• COVID-19 procedures introduced direct-to-participant investigational-product shipment and defined limits for study-drug interruption to support continuity.
• Onsite tablet-based electronic patient-reported outcome collection was specified from Week 16.

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

• Following identification of significant noncompliance at one clinical site, all site data, including data from 10 adolescent participants, were excluded from the final analysis.
• Some participants who completed the double-blind period did not enter the blinded extension period.
• The optional actigraphy substudy was removed to reduce participant burden and streamline site workflows.

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