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:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT05841758
Eligibility Criteria:
* Inclusion Criteria :
* at least 18 years of age
* pathologically proven sarcoidosis as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)/World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) criteria
* non severe ocular sarcoidosis requiring systemic treatment
* non severe skin sarcoidosis requiring systemic treatment
* non severe osseous sarcoidosis requiring systemic treatment
* non severe sarcoidosis with joint involvement requiring systemic treatment
* non severe sarcoidosis-related hypercalcemia requiring systemic treatment
* non severe peripheral nervous system sarcoidosis requiring systemic treatment
* non severe sarcoidosis-related non-severe Ear, Nose and Throat (ENT) involvement requiring systemic treatment
* symptomatic hypercalciuria \>200 mg/24h (24 h urine) OR
* \- \> 20 mg/mmol creatinine on urine sample
* \- \> 180 mg/g creatinine on urine sample
* signed informed consent
* affiliated to National French social security system
* Exclusion Criteria :
* severe sarcoidosis involvement requiring another immunosuppressant or anti-TNF antibody or methylprednisolone i.v. pulses
* previous (\<3 months before screening) or concurrent treatment with immunosuppressants
* previous treatment with corticoid (patient weaned for 3 months before inclusion)
* previous treatment with antimalarial drugs (HCQ/CQ) (patient must have been off plaquenil for at least 12 months)
* treatment with citalopram, escitalopram, hydroxyzin, domperidone and piperaquine
* known hypersensitivity or intolerance to HCQ/CQ or 4-aminoquinoline derivatives and prednisone
* heart rhythm disorders on EKG (QT prolongation) (except atrial fibrillations)
* severe ophthalmological impairment or ophthalmological impairment that does not allow ophthalmic monitoring; previous history of maculopathy or retinopathy
* end-stage lung, liver, cardiac, or renal disease
* sarcoidosis with central nervous system involvement
* cardiac sarcoidosis
* clinical evidence of active infection (including infection with herpes virus and varicella-zoster virus) or severe/unstabilized comorbidity (e.g. moderate to severe heart failure) or unstabilized psychosis
* chronic viral (HIV or HBV) infection
* untreated latent/active tuberculosis
* pregnancy or lactation (βHCG will be test by blood analysis at inclusion)
* concurrent vaccination with live vaccines during therapy
* inability to understand information about the protocol and to sign informed consent or not suitable candidate to comply with the requirements of this study
* patient participating in other interventional research
* persons under court protection
* Use of effective contraception for the duration of the study . (Contraception is considered effective when it consists of one of the following: use of a male condom during all sexual activity and/or efficient oral hormonal contraception (better considered combined contraception) and/or an intrauterine device (IUD) and/or hormone-releasing intrauterine system (IUS) and/or history of bilateral tubal ligation and/or history of vasectomy, provided the male partner is the trial participant's only sexual partner and/or sexual abstinence)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05841758
Study Brief:
Protocol Section:
NCT05841758