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hydroxychloroquine

Phase 3

Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus | Small molecule | Immunology |Sanofi|Last Updated: May 13, 2014

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment103

FDA Designations

No designations recorded

Clinical trial landscape

hydroxychloroquine · 1 trial · 1 indication

Phase 3 1
NCT01551069Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin LesionCutaneous Lupus Erythematosus-Systemic Lupus Erythematosus
COMPLETED103 Analytics
PHASE3COMPLETED
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
Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus
NCT01551069103
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HCQACTIVE_COMPARATORHCQ 200\~400mg, once daily, oral administration
PlaceboOTHERHCQ-placebo, once daily, oral administration

Interventions

NameTypeDescription
hydroxychloroquine (Z0188)DRUGPharmaceutical form:tablet Route of administration: oral
PlaceboDRUGPharmaceutical form:tablet Route of administration: oral
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion criteria : * Patients diagnosed as cutaneous lupus erythematosus (CLE) Exclusion criteria: * 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...

Countries:Japan
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Frequently asked questions about hydroxychloroquine

What is hydroxychloroquine used for in Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus?

Hydroxychloroquine is an investigational small molecule being studied for the treatment of active lupus erythematosus specific skin lesions in patients with Cutaneous Lupus Erythematosus or Systemic Lupus Erythematosus. It is currently in Phase 3 clinical development and is not yet approved for this indication.

Who makes hydroxychloroquine?

Sanofi (ticker: SNY) is developing hydroxychloroquine for Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus. The drug is a small molecule in the immunology therapeutic area and is currently being evaluated in Phase 3 clinical trials.

What phase is hydroxychloroquine in?

Hydroxychloroquine is in Phase 3 clinical development for Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus. It is an investigational drug, meaning it has not been approved by regulatory authorities for this use and is still undergoing clinical evaluation.

What clinical trials is hydroxychloroquine in?

Hydroxychloroquine has one completed Phase 3 clinical trial, NCT01551069, which assessed its efficacy and safety in patients with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus with active lupus erythematosus specific skin lesions. The trial enrolled 103 participants in Japan and was randomized, double-blind, and active-controlled.

Is hydroxychloroquine FDA approved?

Hydroxychloroquine is an investigational drug for Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus and is not FDA approved for this indication. It is currently in Phase 3 clinical development, meaning it has not yet completed the regulatory approval process.