An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants with Active Sjogren’s Disease, Idiopathic Inflammatory Myopathy, or Pemphigus (NCT07229144)

This is an early-stage (Phase 1b) study to test the safety and tolerability of a study drug called OM336 in people with pemphigus that has not responded well to standard treatments. OM336 is administered subcutaneously in ascending dose cohorts. Eligible participants will receive four injections of the study drug over a month. After this period, all participants will continue on the study and be monitored for up to 48 weeks. What is involved? A screening period of up to 28 days to check eligibility, A 4-week treatment period where participants will receive the study drug, A follow-up period (with regular visits for health checks, blood tests and study assessments) of up to 48 weeks after the last dose of study drug.

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Johannes S Kern

Key inclusion data

Adults ≥18 years of age; Diagnosed with active pemphigus that have not responded to standard treatments; Meet other study-specific health and safety criteria. Please note, other eligibility criteria may apply.