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

NCT ID: NCT05448391

Last Updated: 2023-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Familial Mediterranean Fever

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RIST4721 400 mg

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

Group Type EXPERIMENTAL

RIST4721

Intervention Type DRUG

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

Interventions

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RIST4721

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristea Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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RIST4721-212

Identifier Type: -

Identifier Source: org_study_id

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