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NCT05448391 Clinical Trial

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

Familial Mediterranean Fever Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05448391
Other study ID # RIST4721-212
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date September 13, 2022
Est. completion date December 30, 2024

Study information
Verified date February 2023
Source Aristea Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 30, 2024
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 74 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Aristea Therapeutics, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs Baseline to Week 12
Secondary 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 Baseline to Week 12
See also
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