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Can a malaria drug help sarcoidosis patients ditch steroids?

NCT ID NCT05841758

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study tests if hydroxychloroquine, a drug used for malaria and autoimmune diseases, can help people with sarcoidosis reduce or stop taking steroids. Sarcoidosis causes inflammation, often in the lungs, but this trial focuses on cases affecting the skin, eyes, or bones. 140 adults will receive either hydroxychloroquine or a placebo for 12 months, and doctors will track whether they can safely lower their steroid dose without the disease flaring up.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hydroxychloroquine
What this could lead to
If successful, this could offer a safer, long-term treatment option for sarcoidosis patients, reducing their reliance on steroids and their side effects.
What could go wrong
This is a Phase 4 trial with a moderate size of 140 participants. Hydroxychloroquine is already used for other conditions, but its effectiveness for sarcoidosis is not yet proven, and it carries risks like retinal damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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)

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Conditions

The condition(s) this trial relates to.

pulmonary sarcoidosis sarcoidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sarcoidosis, pulmonary

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Tours - Médecine interne

    NOT_YET_RECRUITING

    Tours, France

  • Hôpital Cochin - Médecine interne

    NOT_YET_RECRUITING

    Paris, France

  • Hôpitaux Saint Joseph et Marie LANNELONGUE

    NOT_YET_RECRUITING

    Paris, France

  • Service de Médecine Interne Infectiologie Aïgue Polyvalente- Hôpital Henri Duffaud

    RECRUITING

    Avignon, 84 000, France

  • Service de Médecine Interne et Immunologie Clinique - CHU Dijon Bourgogne

    NOT_YET_RECRUITING

    Dijon, 21 079, France

  • Service de Médecine Interne et Immunologie Clinique - Hôpital Sud

    RECRUITING

    Rennes, 35 2000, France

  • Service de Médecine Interne et maladies infectieuses - Hôpital Haut Lévêque

    RECRUITING

    Pessac, 33 604, France

  • Service de Pneumologie - Hôpital Avicenne

    NOT_YET_RECRUITING

    Bobigny, 93000, France

  • Service de medecine interne - Hôpital Claude Huriez

    NOT_YET_RECRUITING

    Lille, 59 000, France

  • Service de medecine interne - Hôpital Duputryen

    NOT_YET_RECRUITING

    Limoges, 87 042, France

  • Service de medecine interne - Hôpital Henri Mondor

    NOT_YET_RECRUITING

    Créteil, 94000, France

  • Service de medecine interne - Hôpital Hôtel Dieu

    NOT_YET_RECRUITING

    Nantes, 44000, France

  • Service de medecine interne - Hôpital Nord

    NOT_YET_RECRUITING

    Saint-Etienne, 42 055, France

  • Service de medecine interne - Hôpital Saint Eloi

    NOT_YET_RECRUITING

    Montpellier, 34 295, France

  • Service de medecine interne 2- Hôpital de la Pitié-Salpétrière

    NOT_YET_RECRUITING

    Paris, 75013, France

  • Service de médecine interne - Centre Hospitalier Saint Joseph Saint Luc

    NOT_YET_RECRUITING

    Lyon, 69007, France

  • Service de médecine interne - Clinique Saint exupéry

    RECRUITING

    Toulouse, 31077, France

  • Service de médecine interne - Hôpital Edouard Herriot

    NOT_YET_RECRUITING

    Lyon, 69004, France

  • Service de médecine interne - Hôpital Lariboisière

    NOT_YET_RECRUITING

    Paris, 75010, France

  • Service de médecine interne - Hôpital Lyon Sud

    RECRUITING

    Lyon, 69004, France

  • Service de médecine interne - Hôpital de la Croix Rousse

    RECRUITING

    Lyon, 69004, France

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