Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT06666335
Eligibility Criteria:
Inclusion Criteria:
1. Informed consent form signed by the patient or a legal guardian representative.
2. Male or female patients, 2 years of age or older with a body weight ≥ 10 kg.
3. Diagnosis of FMF confirmed by a positive genetic testing i.e., mutations in both alleles of the MEFV gene (i.e. homozygous or compound heterozygous).
4. Patient must have an estimated mean of at least 2 acute FMF attacks per month within 2 months prior to enrollment to the study.
5. Patient must be resistant to colchicine treatment.
6. Female patients of childbearing potential and male patients with female partners of childbearing potential must use an effective method of contraception during the study (abstinence being a possible option) as well as a negative pregnancy test prior to enrollment for females of childbearing potential and participating in the study.
7. Negative tuberculosis screening confirmed at screening visit by the Mantoux Tuberculin skin test (TST) using purified protein derivative (PPD), or by Interferon-Gamma-Release Assays (IGRAs) e.g., QuantiFERON® TB Gold Plus (QFT-Plus) or T-Spot® (TB Test) within 8 weeks prior to enrollment. Negative results must be complemented by the medical history, physical examination, and Chest X-Ray. Patients presenting positive TST or IGRA with or without active or clinical suspicion of latent tuberculosis are not eligible to enter the study. Previously vaccinated for Tuberculosis patients: IGRA positive patients are not eligible to enter the study; TST positive patients with an induration of 15 mm and more are also not eligible to enter the study, TST positive patients (with an induration up to 15 mm) are also not eligible to enter the study, unless an IGRA test is subsequently performed and provides a negative result.
Exclusion Criteria:
1. Previous enrollment to this study.
2. Participation in another clinical interventional study 30 days prior to enrollment.
3. Treatment with an investigational drug within 5 half-lives prior to enrollment.
4. Previous or current treatment with anakinra, or any other IL-1 inhibitor.
6\. Live vaccines within 4 weeks prior to enrollment.
7\. Known presence or suspicion of active, chronic or recurrent bacterial, fungal or viral infections, including but not limited to tuberculosis, HIV infection, Covid-19 infection, hepatitis B or C infection at baseline.
8\. Clinical evidence of liver disease or liver injury as indicated by presence of abnormal liver tests
9\. Presence of severe chronic kidney disease
10\. Diagnosis of amyloidosis at baseline.
Other protocol defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT06666335
Study Brief:
Protocol Section:
NCT06666335