HydroxyChloroquine as steroid-sparing Agent in Extra-pulmonary SARcoidosis. A multicenter, prospective, placebo-controlled, randomized trial. CAESAR

Phase 1

Recruiting

• Conditions: Extra pulmonary sarcoidosis; MedDRA version: 20.1Level: PTClassification code: 10039486Term: Sarcoidosis Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2022-502155-65-00
• Lead Sponsor: Hospices Civils De Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-22
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

at least 18 years of age, non severe sarcoidosis-related non-severe ENT involvement requiring systemic treatment, •pathologically proven sarcoidosis as defined by the ATS/ERS/WASOG criteria (the non-severe / severe criteria are defined in Appendix 9 of the protocol), patient able to give free, informed and written consent, affiliated to National French social security system, nons evere 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

Exclusion Criteria

severe sarcoidosis involvement requiring another immunosuppressant or anti-TNF antibody or methylprednisolone i.v. pulses, patient participating in other interventional research, persons under court protection, previous (<3 months before screening) or concurrent treatment with immunosuppressants, previous treatment with antimalarial drugs (HCQ/CQ), treatment with citalopram, escitalopram, hydroxyzin, domperidone and piperaquine, known hypersensitivity or intoloerance to HCQ/CQ or 4-aminoquinoline derivatives and prednisone, history of drug induced maculopathy, heart rhythm disorders on EKG (QT prolongation), 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, •women must not be pregnant, breastfeeding, or considering pregnancy during the study or within 30 days of the last study drug administration. (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), 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 (ßHCG 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified