A Study to Evaluate RIST4721 in Familial Mediterranean Fe... | NCT05448391

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

NCT05448391

Sponsor

Aristea Therapeutics, Inc.

Status

Withdrawn

Last Update Posted

Feb 13, 2023Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Familial Mediterranean Fever

Interventions

RIST4721

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to safety findings in other ongoing Phase 2 trials.

Expanded Access Info

Start Date

Sep 13, 2022Actual

Primary Completion Date

Nov 30, 2023Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Jul 1, 2022

First Submission Date that Met QC Criteria

Jul 6, 2022

First Posted Date

Jul 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2023

Last Update Posted Date

Feb 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RIST4721 400 mg	Experimental	RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks	Drug: RIST4721

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RIST4721	Drug	RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets	RIST4721 400 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs		Baseline to Week 12

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010505	Familial Mediterranean Fever

Ancestor Terms

ID	Term
D056660	Hereditary Autoinflammatory Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided