Adults aged 18 to 80 years old with cutaneous lupus erythematosus (either in the form of discoid/chronic or subacute) for at least 3 months, may qualify to participate. Individuals need a histologically confirmed and documented diagnosis of cutaneous lupus erythematosus (within one year prior to screening OR confirmed during screening) to be eligible. Active skin lesions and moderate to severe disease, must also be present.
Participants will receive investigational oral medication (active study drug) or placebo. Study medication and study-related procedures will be provided. Reimbursement for study-related expenses may be provided.
Study participation will last about 20 weeks and involve about 6 visits to the study centre.
The following information is from ClinicalTrials.gov
Last Update Posted: November 27, 2022
NCT04781816
Sanofi
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 activity (PhysGA - disease activity) Assess the effect of SAR443122 on CLE induced itch and overall pain Assess the effect of SAR443122 on the proportion of disease activity responders compared to placebo Assess the effect of SAR443122 on the CLASI components score Assess the effect of SAR443122 on the Investigator's global assessment for CLE (IGA-CLE) Assess oral cavities for patients with oral lesions Assess the disease specific quality of life (QoL) Assess the safety and tolerability of SAR443122 in patients with CLE Assess the pharmacokinetics (PK) exposure of SAR443122 in patients with CLE
Condition or Disease:
Cutaneous Lupus Erythematosus
Intervention/Treatment:
Drug: SAR443122Phase:
Phase 2
Ages Eligible for Study:
18 Years and 80 Years (Adult)
Sexes Eligible for Study:
All
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 is 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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.
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