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AzTrials

Cutaneous Lupus Erythematosus-Systemic Lupus ErythematosusPhase 3NCT01551069

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

A Phase 3 study testing hydroxychloroquine (Z0188) in people with Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus, run by Sanofi at 22 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
hydroxychloroquine (Z0188)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
103 participants
Where
22 sitesJapan
Study dates
Mar 2012to Apr 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed as cutaneous lupus erythematosus (CLE)

Who cannot join

  • 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Japan22 sites

  • Investigational Site Number 392017

    Bunkyō City

  • Investigational Site Number 392022

    Bunkyō City

  • Investigational Site Number 392011

    Chuo-Ku, Kumamoto-Shi

  • Investigational Site Number 392003

    Chūōku

  • Investigational Site Number 392001

    Fuchu-Shi

  • Investigational Site Number 392008

    Iruma-Gun

  • Investigational Site Number 392009

    Iruma-Gun

  • Investigational Site Number 392014

    Kamogawa

  • Investigational Site Number 392019

    Kanazawa

  • Investigational Site Number 392007

    Kitakyushu

  • Investigational Site Number 392020

    Maebashi

  • Investigational Site Number 392012

    Nagasaki

  • Investigational Site Number 392010

    Nagoya

  • Investigational Site Number 392013

    Nakagami-Gun

  • Investigational Site Number 392006

    Sagamihara-Shi

  • Investigational Site Number 392018

    Sagamihara-Shi

  • Investigational Site Number 392002

    Shinjuku-Ku

  • Investigational Site Number 392005

    tabashi City

  • Investigational Site Number 392023

    Tomigusuku-Shi

  • Investigational Site Number 392021

    Uruma

  • Investigational Site Number 392004

    Wakayama

  • Investigational Site Number 392016

    Yokohama

Other trials in Japan

About this study

Official title: 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

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.
Read more

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.
Read the detailed description

Total 59 weeks (screening;4 weeks, treatment;52 weeks, Follow-up; 3 weeks)

Being tested
hydroxychloroquine (Z0188), Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hydroxychloroquine (Z0188)Drug

    Also called Plaquenil®

    Pharmaceutical form:tablet

    Route of administration: oral

  • PlaceboDrug

    Pharmaceutical form:tablet

    Route of administration: oral

Study groups in NCT01551069
Study groupRoleWhat they receive
HCQActive comparatorHCQ 200~400mg, once daily, oral administration
Receives: Drug: hydroxychloroquine (Z0188)
PlaceboOtherHCQ-placebo, once daily, oral administration
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (10)

  1. A change in CLASI activity score

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

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

    Measured: 7 timepoints during 52 weeks

  3. 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

    Measured: 7 timepoints during 52 weeks

  4. QOL related to skin manifestations (skindex-29)

    Measured: 4 timepoints during 52 weeks

  5. Dose reduction of concomitant corticosteroid

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

  6. Global assessment by investigator (skin and other)

    Measured: 3 timepoints during 52 weeks

  7. Global assessment by patient (skin)

    Measured: 3 timepoints during 52 weeks

  8. Immunological parameters

    Measured: up to maximum of 13 timepoints during 52 weeks

  9. Number of patients with serious adverse events / adverse events

    Measured: up to a maximum of 59 weeks

  10. Ophthalmologic examination (visual acuity examination, slit-lamp examination, funduscopic examination, visual field examination and color vision examination)

    Measured: 14 timepoints during 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionDec 2013
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01551069
Sponsor's protocol ID
EFC12368
Other IDs
U1111-1126-8072
Status last verified
May 2014
First submitted
8 Mar 2012
Last updated
13 May 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33687069

  • 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.

    PubMed 27992698

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing hydroxychloroquine (Z0188) in people with Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus, run by Sanofi at 22 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01551069, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.

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