A Study to Evaluate RIST4721 in Familial Mediterranean Fever (FMF)

An Open-label, Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of RIST4721 in Subjects With Familial Mediterranean Fever

A 12-week Open-label, Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of RIST4721 in Subjects with Familial Mediterranean Fever followed by an additional Open-label Extension Phase.

Inclusion Criteria:

• Diagnosis of type 1 FMF disease but no active flare at the time of screening according to Tel Hashomer criteria or EUROFEVER/Paediatric Rheumatology International Trials Organization (PRINTO) criteria for FMF
• Documented to be heterozygous or homozygous for at least one of the known clearly pathogenic MEFV gene exon 10 mutations
• Males and females must be willing to use birth control as indicated

Exclusion Criteria:

• Breastfeeding or pregnant
• Known immunodeficiency or subject is immunocompromised
• Active/latent infection with HBV, HCV, HIV, SARS-CoV-2 or TB