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New treatment option for Sarcoidosis, Pulmonary
Official title Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis
ClinicalTrials.gov ID: NCT05841758
What this study is testing
What is Hydroxychloroquine?
Hydroxychloroquine is an investigational medicine, given as an once-daily, being studied as a potential treatment for sarcoidosis, pulmonary.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Sarcoidosis is a systemic granulomatous disease of unknown aetiology, mainly affecting the lungs and lymphatics. It affects people worldwide (incidence, 4.7-64/100000; prevalence, 1-36/100000/year).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- at least 18 years of age
- pathologically proven sarcoidosis as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)/World Association of...
- non severe ocular sarcoidosis requiring systemic treatment
- non severe skin sarcoidosis requiring systemic treatment
- non severe osseous sarcoidosis requiring systemic treatment
You likely can't join if
- 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
See the full eligibility 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
- 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 treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Avignon, France
- Bobigny, France
- Créteil, France
- Dijon, France
- Lille, France
- Limoges, France
- Lyon, France
- Montpellier, France
- Nantes, France
- Paris, France
- Pessac, France
- Rennes, France
- Saint-Etienne, France
- Toulouse, France
- Tours, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Avignon, France; Bobigny, France; Créteil, France; Dijon, France; Lille, France; Limoges, France and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.