Clinical Trials Logo
  1. Home
  2. Familial Mediterranean Fever
  3. NCT05448391
  4. Details
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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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
  Status Clinical Trial Phase
Recruiting NCT00658060 - Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients N/A
Recruiting NCT05190991 - Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever Phase 2
Completed NCT00094900 - Interleukin-1 Trap to Treat Autoinflammatory Diseases Phase 2
Not yet recruiting NCT06033339 - Assessment of microRNAs Role in Familial Mediterranean Fever FMF Pathophysiology N/A
Completed NCT01705756 - Kineret (Anakinra), in Adult Patients With Colchicine-Resistant Familial Mediterranean Fever Phase 3
Recruiting NCT06338891 - Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks
Recruiting NCT05596643 - Investigation of Autonomic Dysfunction in Patients With Familial Mediterranean Fever
Enrolling by invitation NCT02175589 - Controlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene Mutation Phase 2
Completed NCT05177120 - Central Sensitization in Familial Mediterranean Fever (FMF)
Active, not recruiting NCT06257342 - Physical Abilities of Teenagers With Familial Mediterranean Fever
Recruiting NCT04478409 - Characterization of a Functional Test for Mediterranean Family Fever Screening - 2
Recruiting NCT06034795 - Evaluation of Bone Metabolism in Children and Adolescents With Familial Mediterranean Fever
Completed NCT04729218 - The Movement Imagery Ability in Patients With Familial Mediterranean Fever
Terminated NCT01059279 - Heat Intolerance in the Group of FMF Patients
Enrolling by invitation NCT04724993 - Effects of Online Aerobic Exercise Training and Physical Activity Counseling in Juvenile Familial Mediterranean Fever N/A
Completed NCT03747315 - A Diagnostic Test for Familial Mediterranean Fever
Completed NCT01075906 - Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients Phase 1
Completed NCT00582907 - Rilonacept for Treatment of Familial Mediterranean Fever (FMF) Phase 2
Withdrawn NCT00323440 - Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission N/A
Not yet recruiting NCT05488561 - Clinical and Molecular Evaluation of Childern With Familial Meditterranean Fever and Their Siblings N/A