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hydroxychloroquine

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment103
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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 LesionPHASE3 COMPLETED 103 — — Mar 1, 2012Apr 1, 2014May 13, 201422 Japan
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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 — 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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