Overview
A Study to Evaluate RIST4721 in Familial Mediterranean Fever (FMF)
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2023-06-30
2023-06-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
An Open-label, Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of RIST4721 in Subjects with Familial Mediterranean FeverPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Aristea Therapeutics, Inc.
Criteria
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