Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion

NCT01551069 | Completed Phase 3

• 2 other identifiers: EFC12368U1111-1126-8072
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• A change in CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) activity score

  from baseline (at visit 2) to 16 weeks treatment (at visit 6)

Secondary Outcomes (10)

• A change in CLASI activity score

  from baseline (at visit 2) to 52 weeks treatment (at visit 15)

• BILAG (British Isles Lupus Assessment Group) index to be conducted in patients complicated with SLE

  7 timepoints during 52 weeks

• RAPID 3 (Routine assessment of patient index data 3) to be conducted in patients complicated with SLE : daily life activity, pain associated with the original disease, patient's severity related to the original disease

  7 timepoints during 52 weeks

• QOL related to skin manifestations (skindex-29)

  4 timepoints during 52 weeks

• Dose reduction of concomitant corticosteroid

  From 16 weeks to 55 weeks after the initiation of the treatment

Study Arms (2)

HCQ

ACTIVE COMPARATOR

HCQ 200\~400mg, once daily, oral administration

Drug: hydroxychloroquine (Z0188)

Placebo

OTHER

HCQ-placebo, once daily, oral administration

Drug: Placebo

Interventions

hydroxychloroquine (Z0188) DRUG

Pharmaceutical form:tablet Route of administration: oral

Also known as: Plaquenil®

HCQ

Placebo DRUG

Pharmaceutical form:tablet Route of administration: oral

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed as cutaneous lupus erythematosus (CLE)

You may not qualify if:

• Patients receiving corticosteroid more than 15mg/day of the equivalent dose of prednisolone.
• Patients whose CLASI activity scores were less than 4 point at the initiation of Screening (Visit 1) and Day1 (Visit 2) (evaluated by a dermatology specialist).
• Patients whose fluctuations of CLASI activity scores were ≥20% between Visit 1 and Visit 2 (evaluated by a dermatology specialist). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (22)

Investigational Site Number 392017

Bunkyō City, Japan

Location

Investigational Site Number 392022

Bunkyō City, Japan

Location

Investigational Site Number 392011

Chuo-Ku, Kumamoto-Shi, Japan

Location

Investigational Site Number 392003

Chūōku, Japan

Location

Investigational Site Number 392001

Fuchu-Shi, Japan

Location

Investigational Site Number 392008

Iruma-Gun, Japan

Location

Investigational Site Number 392009

Iruma-Gun, Japan

Location

Investigational Site Number 392005

Itabashi-Ku, Japan

Location

Investigational Site Number 392014

Kamogawa, Japan

Location

Investigational Site Number 392019

Kanazawa, Japan

Location

Investigational Site Number 392007

Kitakyushu, Japan

Location

Investigational Site Number 392020

Maebashi, Japan

Location

Investigational Site Number 392012

Nagasaki, Japan

Location

Investigational Site Number 392010

Nagoya, Japan

Location

Investigational Site Number 392013

Nakagami-Gun, Japan

Location

Investigational Site Number 392006

Sagamihara-Shi, Japan

Location

Investigational Site Number 392018

Sagamihara-Shi, Japan

Location

Investigational Site Number 392002

Shinjuku-Ku, Japan

Location

Investigational Site Number 392023

Tomigusuku-Shi, Japan

Location

Investigational Site Number 392021

Uruma, Japan

Location

Investigational Site Number 392004

Wakayama, Japan

Location

Investigational Site Number 392016

Yokohama, Japan

Location

Related Publications (2)

• Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

  PMID: 33687069 DERIVED

• Yokogawa N, Eto H, Tanikawa A, Ikeda T, Yamamoto K, Takahashi T, Mizukami H, Sato T, Yokota N, Furukawa F. Effects of Hydroxychloroquine in Patients With Cutaneous Lupus Erythematosus: A Multicenter, Double-Blind, Randomized, Parallel-Group Trial. Arthritis Rheumatol. 2017 Apr;69(4):791-799. doi: 10.1002/art.40018.

  PMID: 27992698 DERIVED

MeSH Terms

Interventions

Hydroxychloroquine

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 12, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

JP (22)