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RECRUITING
NCT05841758
PHASE4

Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

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). Although it is most often a benign acute or subacute condition, sarcoidosis may progress to a disabling chronic disease in 25% of the cases, with severe complications in about 5%, such as lung fibrosis, cardiac or neurosarcoidosis, defacing lupus pernio or blindness due to uveitis. When indicated, corticosteroids (CS) are the mainstay of treatment. Due to the kinetics of granuloma resolution, the usual and quite 'dogmatic' duration of treatment is said to be one year, following four classical steps. The long-term use of CS is hindered by cumulative toxicity and efforts have to be made to taper them, as quickly as possible, to the lowest effective dose. A recent report mentioned 39% of the CS-treated patients requiring a steroid-sparing agent. Chloroquine (CQ) and hydroxychloroquine (HCQ) are anti-malarial drugs that have been used since the 1960's as steroidsparing agents on the basis of a landmark study by Siltzbach reporting their efficacy in 43 patients with skin and intrathoracic sarcoidosis. Subsequently, two small randomized controlled trials have shown significant and prolonged improvement on pulmonary symptoms. Only small case series/reports have shown CQ/HCQ efficacy on extra-pulmonary sarcoidosis with response rates ranging from 67 to 100%. Nevertheless, CQ/HCQ are daily used for skin, bone, and joint sarcoidosis, as well as hypercalcemia. Nowadays, HCQ is preferred over CQ because of a lower incidence of gastrointestinal and ocular adverse reactions, which can be minimized by close attention to the dosage and regular retinal examination. Its profile of safety is well-known since it has long been employed to treat systemic lupus erythematous or rheumatoid arthritis. Its action is thought to rely on its ability to accumulate in lysosomes of phagocytic cells, to affect antigen presentation and reduce pro-inflammatory cytokines. The investigator hypothesize that HCQ may be an efficacious add-on therapy for extra-pulmonary sarcoidosis leading to a significant steroid-sparing effect.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2024-07-30

Completion Date

2029-07-01

Last Updated

2025-09-15

Healthy Volunteers

No

Interventions

DRUG

Hydroxychloroquine

Hydroxychloroquine (200-400 mg /day during a 12 months double blind placebo-controlled period)

DRUG

Placebo

Placebo during a 12 months double blind placebo-controlled period

Locations (21)

Service de Médecine Interne Infectiologie Aïgue Polyvalente- Hôpital Henri Duffaud

Avignon, France

Service de Pneumologie - Hôpital Avicenne

Bobigny, France

Service de medecine interne - Hôpital Henri Mondor

Créteil, France

Service de Médecine Interne et Immunologie Clinique - CHU Dijon Bourgogne

Dijon, France

Service de medecine interne - Hôpital Claude Huriez

Lille, France

Service de medecine interne - Hôpital Duputryen

Limoges, France

Service de médecine interne - Hôpital de la Croix Rousse

Lyon, France

Service de médecine interne - Hôpital Edouard Herriot

Lyon, France

Service de médecine interne - Hôpital Lyon Sud

Lyon, France

Service de médecine interne - Centre Hospitalier Saint Joseph Saint Luc

Lyon, France

Service de medecine interne - Hôpital Saint Eloi

Montpellier, France

Service de medecine interne - Hôpital Hôtel Dieu

Nantes, France

Service de médecine interne - Hôpital Lariboisière

Paris, France

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

Paris, France

Hôpital Cochin - Médecine interne

Paris, France

Hôpitaux Saint Joseph et Marie LANNELONGUE

Paris, France

Service de Médecine Interne et maladies infectieuses - Hôpital Haut Lévêque

Pessac, France

Service de Médecine Interne et Immunologie Clinique - Hôpital Sud

Rennes, France

Service de medecine interne - Hôpital Nord

Saint-Etienne, France

Service de médecine interne - Clinique Saint exupéry

Toulouse, France

CHU Tours - Médecine interne

Tours, France