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Using hydroxychloroquine to reduce steroid use in patients with extrapulmonary sarcoidosis

Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis: Multicenter, Prospective, Placebo-controlled, Randomized Trial

PHASE4 · Hospices Civils de Lyon · NCT05841758

This study is testing if hydroxychloroquine can help people with extrapulmonary sarcoidosis manage their symptoms while using fewer steroids.

Quick facts

PhasePHASE4
Study typeInterventional
Enrollment140 (estimated)
Ages18 Years and up
SexAll
SponsorHospices Civils de Lyon (other)
Drugs / interventionsprednisone
Locations21 sites (Avignon and 20 other locations)
Trial IDNCT05841758 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of hydroxychloroquine as a steroid-sparing agent in patients with extrapulmonary sarcoidosis. The study aims to determine whether hydroxychloroquine can help manage symptoms and reduce the need for long-term corticosteroid treatment, which is associated with significant side effects. Participants will be randomly assigned to receive either hydroxychloroquine or a placebo, and their responses will be monitored over time. The trial focuses on patients with non-severe forms of sarcoidosis affecting various organs outside the lungs.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with pathologically proven non-severe extrapulmonary sarcoidosis requiring systemic treatment.

Not a fit: Patients with severe sarcoidosis requiring other immunosuppressants or anti-TNF therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the reliance on corticosteroids, minimizing their associated side effects for patients with extrapulmonary sarcoidosis.

How similar studies have performed: While the use of hydroxychloroquine in sarcoidosis is being explored, this specific approach as a steroid-sparing agent is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion 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)

Where this trial is running

Avignon and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Sarcoidosis, Pulmonary, Sarcoidosis, Hydroxychloroquine, steroid-sparing agent, Extra pulmonary sarcoidosis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.