Status:
COMPLETED
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
Lead Sponsor:
Sanofi
Conditions:
Cutaneous Lupus Erythematosus
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Primary Objective: * Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE) Secondary Objectives: * Assess the effect of SAR443122 on the physician's global assessment of disease a...
Detailed Description
Total study duration per participant was up 20 weeks including: * A screening period of up to 4 weeks * A treatment period of 12 weeks * A post treatment follow-up period of 4 weeks
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Participants with cutaneous lupus erythematosus either in the form of discoid/chronic cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus for at least 3 months before Screening.
- Participants with histologically confirmed and documented diagnosis within one year prior to Screening or during Screening period prior to randomization.
- Active cutaneous lupus erythematosus skin lesions and a Cutaneous Erythematosus.
- Disease Area and Severity Index activity (CLASI-A) ≥10 both at Screening and Baseline.
- Participant who was candidate for systemic treatment per Investigator's judgement.
- Exclusion criteria:
- Systemic lupus erythematosus according to the 2012 SLICC criteria with major organ involvement.
- Suspected or proven drug induced lupus erythematosus, including patients with positive antihistone autoantibody tests.
- Autoimmune disease(s) other than systemic lupus erythematosus.
- Active skin diseases that may interfere with the study or study assessments.
- Exclusion related to tuberculosis, non-tuberculous mycobacterial infections, HIV, HBV, HCV, Herpes zoster, COVID-19 and other recurrent or recent serious infections.
- Prolonged QTcF ≥ 450 ms (by Fridericia formula) or clinically significant findings on electrocardiogram (ECG).
- Cannot avoid excessive UV exposure 4 weeks prior to baseline and during the study. Routine sun exposure through work are permitted but requires the use of sun block to sun exposed areas for at least 4 weeks prior to baseline and during the study.
- Concomitant treatment with topical immunosuppressants beyond a stable regimen of low to medium potency topical corticosteroids and/or topical calcineurin inhibitors during the study and two weeks before baseline visit.
- Initiation and/or changes in dosage of chloroquine/hydroxychloroquine within 12 weeks prior to Screening visit (or during Screening period) and/or the dose exceeding 2.3 mg/kg/day for chloroquine or 400 mg/day for hydroxychloroquine.
- Systemic treatments for cutaneous or systemic lupus erythematosus or immunosuppressive therapy for autoimmune disease other than the study medication.
- Systemic corticosteroids treatment \<4 weeks before baseline visit.
- Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study.
- Laboratory abnormalities at the Screening visit.
- The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2023
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04781816
Start Date
April 1 2021
End Date
June 26 2023
Last Update
August 27 2025
Active Locations (50)
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1
GNP Research Site Number : 8400008
Cooper City, Florida, United States, 33024
2
DJL Clinical Research, PLLC Site Number : 8400003
Charlotte, North Carolina, United States, 28211
3
ClinOhio Research Services Site Number : 8400007
Columbus, Ohio, United States, 43213
4
Prolato Clinical Research Center Site Number : 8400010
Houston, Texas, United States, 77054