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

Aristea Therapeutics

Status and phase: Withdrawn; Phase 2

Conditions: Familial Mediterranean Fever

Treatments: Drug: RIST4721

Study type: Interventional

Funder types: Industry

Identifiers

NCT05448391

RIST4721-212

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

RIST4721 400 mg

Experimental group

Description:

RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks

Treatment:

Drug: RIST4721