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

Aristea Therapeutics, Inc.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Familial Mediterranean Fever

Interventions

RIST4721DRUG

RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs

Time frame: Baseline to Week 12

Secondary Outcomes

Proportion of responders who achieve resolution of their index flare after initiating study treatment and do not experience a new flare from the time of resolution of the index flare until Week 12

Time frame: Baseline to Week 12

Data from ClinicalTrials.gov

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