NCT01551069

A Randomized, Double Blind, Baseline Controlled Study Using Placebo as Reference for Assessing the Efficacy and Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus in the Presence of Active Lupus Erythematosus Specific Skin Lesion

Completed Phase 3 Last updated 12 May 2014

What this trial tests

Phase 3 trial testing hydroxychloroquine (Z0188) in Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus in 103 participants. Completed in 1 April 2014.

Timeline

1 March 2012

Primary endpoint
1 December 2013

1 April 2014

Quick facts

Lead sponsor	Sanofi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	103
Start date	1 March 2012
Primary completion	1 December 2013
Estimated completion	1 April 2014
Sites	22 locations across Japan

Drugs / interventions tested

• hydroxychloroquine (Z0188) — full drug profile →
• Placebo

Conditions studied

• Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus — all drugs for Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus →

Sponsor

Sanofi — full company profile →

Who can join

18 and older, any sex, with Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• A change in CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) activity score
  Time frame: from baseline (at visit 2) to 16 weeks treatment (at visit 6)

Sponsor's own description

Primary Objective:

\- To investigate the efficacy on skin manifestation of 16 weeks treatment of once daily regimen of hydroxychloroquine sulphate (HCQ) in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) with active skin manifestation (CLASI \[Cutaneous Lupus Erythematosus Disease Area and Severity Index\] activity score is ≥4) concomitant treatment with or without corticosteroid.

Secondary Objectives:

* To evaluate the efficacy on skin manifestation and the safety of 16 weeks treatment of once daily regiment of HCQ versus placebo as the reference group in patients with CLE and SLE with active skin manifestation (CLASI activity score is ≥4) concomitant treatment with or without corticosteroid.
* To investigate the safety of 16 weeks treatment of once daily regiment of HCQ in patients with CLE and SLE with active skin manifestation concomitant treatment with or without corticosteroid.
* To investigate the safety and efficacy of 52 weeks long-term treatment of once daily regimen of HCQ in patients with CLE and SLE - To investigate the influence of the dose reduction of corticosteroid on CLE and SLE patients treated with HCQ concomitant with corticosteroid
* To investigate efficacy of once daily regimen of HCQ on systemic symptoms, musculoskeletal symptoms and immunological parameters in SLE patients.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting lysosomes in human disease: from basic research to clinical applications.
   Cao M, Luo X, Wu K, He X. · · 2021 · cited 162× · PMID 34744168 · DOI 10.1038/s41392-021-00778-y
2. Hydroxychloroquine in systemic lupus erythematosus: overview of current knowledge.
   Dima A, Jurcut C, Chasset F, Felten R, et al · · 2022 · cited 130× · PMID 35186126 · DOI 10.1177/1759720x211073001
3. Modulation of the immunity and inflammation by autophagy.
   Gan T, Qu S, Zhang H, Zhou XJ. · · 2023 · cited 27× · PMID 37405276 · DOI 10.1002/mco2.311
4. Interventions for cutaneous disease in systemic lupus erythematosus.
   Hannon CW, McCourt C, Lima HC, Chen S, et al · · 2021 · cited 26× · PMID 33687069 · DOI 10.1002/14651858.cd007478.pub2
5. Therapeutic Approaches for Cutaneous Lupus Erythematosus: a Changing Landscape of Clinical Trials.
   Wei E, Lopes Almeida Gomes L, Jun S, Saksena S, et al · · 2026 · PMID 41890817 · DOI 10.2147/jir.s547944