Scout Clinical

• The planned number of investigative sites was increased from 40 to 55.
• Weekly waking saliva collection was removed because of practical feasibility challenges and to reduce participant burden.
• Scheduled telephone contacts were reduced to lessen participant burden, while targeted as-needed contacts were retained or added for dose escalation, glucocorticoid tapering, safety monitoring, and compliance follow-up.
• COVID-19 mitigation measures allowed remote study visits and screening by telemedicine or at the participant's home where locally approved.
• Screening information collected within 45 days before Day 1 could be used when necessary, and screening data from the parallel SPR001-204 study could be transferred for eligibility determination.
• Eligibility criteria were revised to remove the elevated ACTH requirement, expand the acceptable glucocorticoid replacement range to 15-60 mg/day hydrocortisone equivalent, and update diagnostic and A4 requirements.

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.