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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1126-8072 | Other Identifier | UTN |
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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:
Total 59 weeks (screening;4 weeks, treatment;52 weeks, Follow-up; 3 weeks)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCQ | Active Comparator | HCQ 200~400mg, once daily, oral administration |
|
| Placebo | Other | HCQ-placebo, once daily, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydroxychloroquine (Z0188) | Drug | Pharmaceutical form:tablet Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria :
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 392017 | Bunkyō City | Japan | ||||
| Investigational Site Number 392022 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33687069 | Derived | 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. | |
| 27992698 | 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. |
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| Placebo | Drug | Pharmaceutical form:tablet Route of administration: oral |
|
| 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 |
| Global assessment by investigator (skin and other) | 3 timepoints during 52 weeks |
| Global assessment by patient (skin) | 3 timepoints during 52 weeks |
| Immunological parameters | up to maximum of 13 timepoints during 52 weeks |
| Number of patients with serious adverse events / adverse events | up to a maximum of 59 weeks |
| Ophthalmologic examination (visual acuity examination, slit-lamp examination, funduscopic examination, visual field examination and color vision examination) | 14 timepoints during 52 weeks |
| Bunkyō City |
| Japan |
| Investigational Site Number 392011 | Chuo-Ku, Kumamoto-Shi | Japan |
| Investigational Site Number 392003 | Chūōku | Japan |
| Investigational Site Number 392001 | Fuchu-Shi | Japan |
| Investigational Site Number 392008 | Iruma-Gun | Japan |
| Investigational Site Number 392009 | Iruma-Gun | Japan |
| Investigational Site Number 392005 | Itabashi-Ku | Japan |
| Investigational Site Number 392014 | Kamogawa | Japan |
| Investigational Site Number 392019 | Kanazawa | Japan |
| Investigational Site Number 392007 | Kitakyushu | Japan |
| Investigational Site Number 392020 | Maebashi | Japan |
| Investigational Site Number 392012 | Nagasaki | Japan |
| Investigational Site Number 392010 | Nagoya | Japan |
| Investigational Site Number 392013 | Nakagami-Gun | Japan |
| Investigational Site Number 392006 | Sagamihara-Shi | Japan |
| Investigational Site Number 392018 | Sagamihara-Shi | Japan |
| Investigational Site Number 392002 | Shinjuku-Ku | Japan |
| Investigational Site Number 392023 | Tomigusuku-Shi | Japan |
| Investigational Site Number 392021 | Uruma | Japan |
| Investigational Site Number 392004 | Wakayama | Japan |
| Investigational Site Number 392016 | Yokohama | Japan |
| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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