Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hydroxychloroquine

    Drug

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

  • Placebo

    Drug

    Placebo during a 12 months double blind placebo-controlled period

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: HydroxychloroquineExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the steroid-sparing effect of hydroxychloroquine as an add-on therapy in patients with non severe extra-pulmonary sarcoidosis requiring a systemic treatment.

The primary endpoint is the percentage of patients in remission and off prednisone at month 9, without relapse until month 12. The primary endpoint will thus be assessed at M12. Remission is defined by either complete or partial response. Complete response is defined as the absence of clinical or paraclinical sign of disease activity. Partial response is defined as the persistence of clinical or paraclinical sign of disease activity, which do not require substantial treatment modification (high dose CS, immunosuppressant or anti-Tumor Necrosis Factor (TNF) drugs). Relapse is defined as the persistence, or recurrence of existing manifestations and/or the occurrence of new sarcoidosis manifestations requiring substantial treatment modification.

Time frame
at Year 1

Secondary outcomes

1

Organ-specific response assessed by the extra-pulmonary Physician Organ Severity Tool (ePOST)

score comprised between 0 and 6

Time frame
at Month 0, Month 1, Month 3, Month 6, Month 12, Month 18 and Month 24.
2

rate of complete, partial, stable or progression of the disease

Global clinical response will be assessed by the physician as complete, partial, stable, or progression

Time frame
at Month 0, Month 1, Month 3, Month 6, Month 12, Month 18 and Month 24.
3

Assess the total dose of local steroid treatments

Total dose in Gramme of local steroid treatments

Time frame
at Month 0, Month 1, Month 3, Month 6, Month 12, Month 18 and Month 24.
4

Assess the efficacy of HCQ in maintaining the relapse-free survival over a prolonged period

Relapse rate

Time frame
at Month 0, Month 1, Month 3, Month 6, Month 12, Month 18 and Month 24.

Other outcomes

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