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
Verified date | February 2023 |
Source | Aristea Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Aristea Therapeutics, Inc. |
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 |
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